79C3C34C52B45572883A05D425EB0F82
Medical Devices Regulation 2017/745
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.000064:
p.000064: 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported
p.000064: data are reliable and robust, and that the conduct of the clinical investigation is in compliance with
p.000064: the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a
p.000064: clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis
p.000064: of an assessment that takes into consideration all character istics of the clinical investigation including the
p.000064: following:
p.000064:
p.000064: (a) the objective and methodology of the clinical investigation; and
p.000064:
p.000064: (b) the degree of deviation of the intervention from normal clinical practice.
p.000064:
p.000064: 5.5.2017 EN
p.000064: Official Journal of the European Union
p.000065: L 117/65
p.000065:
p.000065: 3. All clinical investigation information shall be recorded, processed, handled, and stored
p.000065: by the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
p.000065: interpreted and verified while the confiden tiality of records and the personal data of the subjects
p.000065: remain protected in accordance with the applicable law on personal data protection.
p.000065:
p.000065: 4. Appropriate technical and organisational measures shall be implemented to protect information and
p.000065: personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction
p.000065: or accidental loss, in particular where the processing involves transmission over a network.
p.000065:
p.000065: 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that
p.000065: clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved
p.000065: investigation plan.
p.000065:
p.000065: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate
p.000065: identification and, where necessary, an immediate recall of the devices used in the investigation.
p.000065:
p.000065:
p.000065: Article 73
p.000065:
p.000065: Electronic system on clinical investigations
p.000065:
p.000065: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000065: electronic system:
p.000065:
p.000065: (a) to create the single identification numbers for clinical investigations referred to in Article 70(1);
p.000065:
p.000065: (b) to be used as an entry point for the submission of all applications or notifications for clinical
p.000065: investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data
p.000065: in this context;
p.000065:
p.000065: (c) for the exchange of information relating to clinical investigations in accordance with this
p.000065: Regulation between the Member States and between them and the Commission including the exchange of
p.000065: information referred to in Articles 70 and 76;
p.000065:
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Political / criminal
Searching for indicator criminal:
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p.000009: the results of clinical investi gations conducted outside the Union in accordance with international guidelines to be
p.000009: accepted within the Union. In addition, the rules should be in line with the most recent
p.000009: version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research
p.000009: Involving Human Subjects.
p.000009:
p.000009:
p.000009: (65) It should be left to the Member State where a clinical investigation is to be conducted
p.000009: to determine the appropriate authority to be involved in the assessment of the application to conduct
p.000009: a clinical investigation and to organise the involvement of ethics committees within the timelines for the
p.000009: authorisation of that clinical investi gation as set out in this Regulation. Such decisions are a matter
p.000009: of internal organisation for each Member State. In that context, Member States should ensure the
p.000009: involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the
p.000009: necessary expertise is available.
p.000009:
p.000009:
p.000009: (66) Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
p.000009: or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in
p.000009: such cases, including issues of causality and the level of damages and sanctions, should remain governed by
p.000009: national law.
p.000009:
p.000009:
p.000009: (67) An electronic system should be set up at Union level to ensure that every clinical
p.000009: investigation is recorded and reported in a publicly accessible database. To protect the right to the
p.000009: protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the
p.000009: European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation
p.000009: should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal
p.000009: products, the electronic system on clinical investigations should be in teroperable with the EU database to be set up
p.000009: for clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009: (68) Where a clinical investigation is to be conducted in more than one Member State, the sponsor
p.000009: should have the possibility of submitting a single application in order to reduce administrative burden.
p.000009: In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health
p.000009: and safety-related aspects of the investigational device and of the scientific design of that
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p.000086:
p.000086: Article 109
p.000086:
p.000086: Confidentiality
p.000086:
p.000086: 1. Unless otherwise provided for in this Regulation and without prejudice to existing
p.000086: national provisions and practices in the Member States on confidentiality, all parties involved in the
p.000086: application of this Regulation shall respect the confidentiality of information and data obtained in carrying out
p.000086: their tasks in order to protect the following:
p.000086:
p.000086: (a) personal data, in accordance with Article 110;
p.000086:
p.000086: (b) commercially confidential information and trade secrets of a natural or legal person, including
p.000086: intellectual property rights; unless disclosure is in the public interest;
p.000086:
p.000086: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000086: audits.
p.000086:
p.000086: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent
p.000086: authorities and between competent authorities and the Commission shall not be disclosed without the prior
p.000086: agreement of the originating authority.
p.000086:
p.000086: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000086: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000086: obligations of the persons concerned to provide information under criminal law.
p.000086:
p.000086: 5.5.2017 EN
p.000086: Official Journal of the European Union
p.000087: L 117/87
p.000087:
p.000087: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000087: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000087:
p.000087: Article 110
p.000087:
p.000087: Data protection
p.000087:
p.000087: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the
p.000087: Member States pursuant to this Regulation.
p.000087:
p.000087: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000087: Commission pursuant to this Regulation.
p.000087:
p.000087: Article 111
p.000087:
p.000087: Levying of fees
p.000087:
p.000087: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the
p.000087: activities set out in this Regulation, provided that the level of the fees is set in a transparent
p.000087: manner and on the basis of cost-recovery principles.
p.000087:
p.000087: 2. Member States shall inform the Commission and the other Member States at least three months
p.000087: before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly
p.000087: available on request.
p.000087:
p.000087: Article 112
p.000087:
p.000087: Funding of activities related to designation and monitoring of notified bodies
p.000087:
p.000087: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
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Political / political affiliation
Searching for indicator party:
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p.000018: (33) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000018: country on the Union market;
p.000018:
p.000018: (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer
p.000018: or the importer, that makes a device available on the market, up until the point of putting into service;
p.000018:
p.000018: (35) ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or
p.000018: the person referred to in Article 22(1) and 22(3);
p.000018:
p.000018: (36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of
p.000018: patients or the promotion of public health;
p.000018:
p.000018: (37) ‘user’ means any healthcare professional or lay person who uses a device;
p.000018:
p.000018: (38) ‘lay person’ means an individual who does not have formal education in a relevant field of
p.000018: healthcare or medical discipline;
p.000018:
p.000018: (39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse
p.000018: including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the
p.000018: technical and functional safety of the used device;
p.000018:
p.000018: (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation
p.000018: relating to a device have been fulfilled;
p.000018:
p.000018: (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000018: including calibration, testing, certification and inspection;
p.000018:
p.000018: (42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000018:
p.000018: (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000018: conformity with the applicable requirements set out in this Regulation and other applicable Union
p.000018: harmonisation legislation providing for its affixing;
p.000018:
p.000018: (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect,
p.000018: analyse and assess the clinical data pertaining to a device in order to verify the safety and
p.000018: performance, including clinical benefits, of the device when used as intended by the manufacturer;
p.000018:
p.000018: (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects,
p.000018: undertaken to assess the safety or performance of a device;
p.000018:
p.000018: (46) ‘investigational device’ means a device that is assessed in a clinical investigation;
p.000018:
p.000018: (47) ‘clinical investigation plan’ means a document that describes the rationale, objectives,
p.000018: design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
p.000018:
p.000018: (48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and
p.000018: is sourced from the following:
p.000018:
p.000018: — clinical investigation(s) of the device concerned,
p.000018:
...
p.000114: Official Journal of the European Union
p.000114: 5.5.2017
p.000114:
p.000114: ANNEX V
p.000114:
p.000114: CE MARKING OF CONFORMITY
p.000114:
p.000114: 1. The CE marking shall consist of the initials ‘CE’ taking the following form:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
p.000114:
p.000114: 3. The various components of the CE marking shall have substantially the same vertical dimension, which
p.000114: may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
p.000114:
p.000114: 5.5.2017 EN
p.000114: Official Journal of the European Union
p.000115: L 117/115
p.000115:
p.000115: ANNEX VI
p.000115:
p.000115: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000115: WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN
p.000115: ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
p.000115:
p.000115: PART A
p.000115:
p.000115: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000115: WITH ARTICLES 29(4) AND 31
p.000115:
p.000115: Manufacturers or, when applicable, authorised representatives, and, when applicable, importers
p.000115: shall submit the information referred to in Section 1 and shall ensure that the information on their
p.000115: devices referred to in Section 2 is complete, correct and updated by the relevant party.
p.000115:
p.000115: 1. Information relating to the economic operator
p.000115:
p.000115: 1.1. type of economic operator(manufacturer, authorised representative, or importer),
p.000115: 1.2. name, address and contact details of the economic operator,
p.000115:
p.000115: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000115: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000115:
p.000115: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000115: referred to in Article 15.
p.000115:
p.000115: 2. Information relating to the device
p.000115:
p.000115: 2.1. Basic UDI-DI,
p.000115:
p.000115: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000115: identification number of that notified body and the link to the information that appears on the
p.000115: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000115: 2.3. Member State in which the device is to or has been placed on the market in the Union,
p.000115: 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made
p.000115: available,
p.000115: 2.5. risk class of the device,
p.000115: 2.6. reprocessed single-use device (y/n),
p.000115:
p.000115: 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of
...
p.000123: responsibilities and authority of its top-level management and of other personnel who may have an influence
p.000123: upon the performance by the notified body and upon the results of its conformity assessment activities.
p.000123:
p.000123: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000123: and responsi bility for each of the following:
p.000123:
p.000123: — the provision of adequate resources for conformity assessment activities;
p.000123:
p.000123: — the development of procedures and policies for the operation of the notified body;
p.000123:
p.000123: — the supervision of implementation of the procedures, policies and quality management systems of the notified body;
p.000123:
p.000123: — the supervision of the notified body's finances;
p.000123:
p.000123: — the activities and decisions taken by the notified body, including contractual agreements;
p.000123:
p.000123: — the delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000123: defined activities;
p.000123:
p.000123: — the interaction with the authority responsible for notified bodies and the obligations regarding
p.000123: communi cations with other competent authorities, the Commission and other notified bodies.
p.000123:
p.000123: 1.2. Independence and impartiality
p.000123:
p.000123: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in
p.000123: relation to which it performs conformity assessment activities. The notified body shall also be independent
p.000123: of any other economic operator having an interest in the device as well as of any competitors of the
p.000123: manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for
p.000123: competing manufacturers.
p.000123:
p.000124: L 117/124 EN
p.000124: Official Journal of the European Union
p.000124: 5.5.2017
p.000124:
p.000124: 1.2.2. The notified body shall be organised and operated so as to safeguard the
p.000124: independence, objectivity and impartiality of its activities. The notified body shall document and
p.000124: implement a structure and procedures for safeguarding impartiality and for promoting and applying
p.000124: the principles of impartiality throughout its organisation, personnel and assessment activities. Such
p.000124: procedures shall provide for the identification, investi gation and resolution of any case in which a
p.000124: conflict of interest may arise, including involvement in consultancy services in the field of devices prior
p.000124: to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented.
p.000124:
p.000124: 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the
p.000124: conformity assessment tasks shall not:
p.000124:
p.000124: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess,
...
p.000146: into account the state of the art.
p.000146:
p.000146: 2.2. Implementation of the quality management system shall ensure compliance with this
p.000146: Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality
p.000146: management system shall be documented in a systematic and orderly manner in the form of a quality
p.000146: manual and written policies and procedures such as quality programmes, quality plans and quality records.
p.000146:
p.000146: 5.5.2017 EN
p.000146: Official Journal of the European Union
p.000147: L 117/147
p.000147:
p.000147: Moreover, the documentation to be submitted for the assessment of the quality management system shall include an
p.000147: adequate description of, in particular:
p.000147: (a) the manufacturer's quality objectives;
p.000147: (b) the organisation of the business and in particular:
p.000147:
p.000147: — the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the
p.000147: responsibilities of the managerial staff and their organisational authority,
p.000147:
p.000147: — the methods of monitoring whether the operation of the quality management system is efficient and in
p.000147: particular the ability of that system to achieve the desired design and device quality, including control
p.000147: of devices which fail to conform,
p.000147:
p.000147: — where the design, manufacture and/or final verification and testing of the devices, or parts of any
p.000147: of those processes, is carried out by another party, the methods of monitoring the efficient operation of the
p.000147: quality management system and in particular the type and extent of control applied to the other party,
p.000147: and
p.000147:
p.000147: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000147: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000147: representative to accept the mandate;
p.000147:
p.000147: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
p.000147: devices and the corresponding documentation as well as the data and records arising from those
p.000147: procedures and techniques. Those procedures and techniques shall specifically cover:
p.000147:
p.000147: — the strategy for regulatory compliance, including processes for identification of
p.000147: relevant legal requirements, qualification, classification, handling of equivalence, choice of and
p.000147: compliance with conformity assessment procedures,
p.000147:
p.000147: — identification of applicable general safety and performance requirements and solutions to fulfil those
p.000147: requirements, taking applicable CS and, where opted for, harmonised standards or other adequate
p.000147: solutions into account,
p.000147: — risk management as referred to in Section 3 of Annex I,
p.000147: — the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up,
p.000147:
p.000147: — solutions for fulfilling the applicable specific requirements regarding design and construction,
p.000147: including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
p.000147:
p.000147: — solutions for fulfilling the applicable specific requirements regarding the information to be supplied
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Political / stateless persons
Searching for indicator nation:
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p.000133:
p.000133: — document its rationale for the selection of those parameters;
p.000133:
p.000133: — carry out the appropriate examinations and tests in order to verify that the solutions
p.000133: adopted by the manufacturer meet the general safety and performance requirements set out in Annex I.
p.000133: Such examinations and tests shall include all tests necessary to verify that the manufacturer has in
p.000133: fact applied the relevant standards it has opted to use;
p.000133:
p.000133: — agree with the applicant as to where the necessary tests will be performed if they are not to be
p.000133: carried out directly by the notified body; and
p.000133:
p.000133: — assume full responsibility for test results. Test reports submitted by the manufacturer shall only be
p.000133: taken into account if they have been issued by conformity assessment bodies which are competent and
p.000133: independent of the manufacturer.
p.000133: Verification by examination and testing of every product The notified body shall:
p.000133:
p.000133: (a) have documented procedures, sufficient expertise and facilities for the verification by examination and
p.000133: testing of every product in accordance with Part B of Annex XI;
p.000133:
p.000134: L 117/134 EN
p.000134: Official Journal of the European Union
p.000134: 5.5.2017
p.000134:
p.000134: (b) establish a test plan identifying all relevant and critical parameters which need to be tested by
p.000134: the notified body or under its responsibility in order to:
p.000134: — verify, for class IIb devices, the conformity of the device with the type described in the EU
p.000134: type-exami nation certificate and with the requirements of this Regulation which apply to those devices,
p.000134: — confirm, for class IIa devices, the conformity with the technical documentation referred to in Annexes
p.000134: II and III and with the requirements of this Regulation which apply to those devices;
p.000134: (c) document its rationale for the selection of the parameters referred to in point (b);
p.000134: (d) have documented procedures to carry out the appropriate assessments and tests in order to verify
p.000134: the conformity of the device with the requirements of this Regulation by examining and testing every product
p.000134: as specified in Section 15 of Annex XI;
p.000134: (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and
p.000134: where necessary tests that are not to be carried out by the notified body itself are to be performed; and
p.000134: (f) assume full responsibility for test results in accordance with documented procedures; test reports
p.000134: submitted by the manufacturer shall only be taken into account if they have been issued by conformity
p.000134: assessment bodies which are competent and independent of the manufacturer.
p.000134:
p.000134: 4.5.4. Pre-clinical evaluation assessment
p.000134:
p.000134: The notified body shall have documented procedures in place for the review of the manufacturer's
p.000134: procedures and documentation relating to the evaluation of pre-clinical aspects. The notified body shall examine,
p.000134: validate and verify that the manufacturer's procedures and documentation adequately address:
p.000134: (a) the planning, conduct, assessment, reporting and, where appropriate, updating of the pre-clinical
p.000134: evaluation, in particular of
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Political / vulnerable
Searching for indicator vulnerable:
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p.000058: other interests and the clinical data generated are scientifically valid, reliable and robust.
p.000058:
p.000058: Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an
p.000058: ethics committee in accordance with national law. Member States shall ensure that the procedures for
p.000058: review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the
p.000058: application for auth orisation of a clinical investigation. At least one lay person shall participate in the ethical
p.000058: review.
p.000058:
p.000058: 4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the
p.000058: following conditions are met:
p.000058:
p.000058: (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical
p.000058: investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000058:
p.000058: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion
p.000058: in relation to the clinical investigation, which is valid for that entire Member State under its national law;
p.000058:
p.000058: (c) the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the
p.000058: Union;
p.000058:
p.000058: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
p.000058:
p.000058: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000058: inconveniences and compliance with this condition is constantly monitored;
p.000058:
p.000058: (f) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative has given informed consent in accordance with Article 63;
p.000058:
p.000058: (g) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative, has been provided with the contact details of an entity where further information can be
p.000058: received in case of need;
p.000058:
p.000058: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of
p.000058: the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000058:
p.000058: (i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any
p.000058: other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of
p.000058: distress are specifically defined in the clinical investigation plan and constantly monitored;
p.000058:
p.000058: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor
...
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
p.000097: the unintentional ingress of substances into the device taking into account the device and the nature of
p.000097: the environment in which it is intended to be used.
p.000097:
p.000097: 10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked
p.000097: to the size and the properties of particles which are or can be released into the patient's or user's
p.000097: body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
p.000097:
p.000097: 11. Infection and microbial contamination
p.000097:
p.000097: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as
p.000097: far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
p.000097:
p.000097: (a) reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as
p.000097: needle stick injuries,
p.000097:
p.000097: (b) allow easy and safe handling,
p.000097:
p.000097: (c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
p.000097:
p.000097: (d) prevent microbial contamination of the device or its content such as specimens or fluids.
p.000097:
...
p.000170: Member State concerned.
p.000170:
p.000170: 3.2. Identification and description of the device, including its intended purpose, its manufacturer,
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
...
Searching for indicator vulnerability:
(return to top)
p.000008: requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal
p.000008: treatment of notified bodies.
p.000008:
p.000008: (56) For class III implantable devices and class IIb active devices intended to administer and/or
p.000008: remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert
p.000008: panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed
p.000008: about devices that have been granted a certificate following a conformity assessment procedure involving
p.000008: an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to
p.000008: a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and
p.000008: developing CS on categories of devices that have undergone that consultation process.
p.000008:
p.000008: (57) For class III devices and for certain class IIb devices, a manufacturer should be able to
p.000008: consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation,
p.000008: on its clinical development strategy and on proposals for clinical investigations.
p.000008:
p.000008: (58) It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the
p.000008: division of devices into four product classes in line with international practice. The classification
p.000008: rules, which are based on the vulnerability of the human body, should take into account the potential
p.000008: risks associated with the technical design and manufacture of the devices. To maintain the same level of safety as
p.000008: provided by Directive 90/385/EEC, active implantable devices should be in the highest risk class.
p.000008:
p.000008: (59) Rules under the old regime applied to invasive devices do not sufficiently take
p.000008: account of the level of invasiveness and potential toxicity of certain devices which are introduced
p.000008: into the human body. In order to obtain a suitable risk-based classification of devices that are
p.000008: composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human
p.000008: body, it is necessary to introduce specific classi fication rules for such devices. The classification rules
p.000008: should take into account the place where the device performs its action in or on the human body, where
p.000008: it is introduced or applied, and whether a systemic absorption of the substances of which the device
p.000008: is composed, or of the products of metabolism in the human body of those substances occurs.
p.000008:
p.000008: (60) The conformity assessment procedure for class I devices should be carried out, as a general
p.000008: rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such
p.000008: devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should
p.000008: be compulsory.
p.000008:
p.000008: (61) The conformity assessment procedures for devices should be further strengthened and streamlined
p.000008: whilst the requirements for notified bodies as regards the performance of their assessments should be
p.000008: clearly specified to ensure a level playing field.
p.000008:
p.000008: (62) It is appropriate that certificates of free sale contain information that makes it possible to
p.000008: use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market,
p.000008: withdrawn from the market or recalled, and on any certificate on its conformity.
p.000008:
p.000008: (63) To ensure a high level of safety and performance, demonstration of compliance with the general
p.000008: safety and performance requirements laid down in this Regulation should be based on clinical data that,
p.000008: for class III devices and implantable devices should, as a general rule, be sourced from clinical
p.000008: investigations that have been carried out under the responsibility of a sponsor. It should be possible both for
p.000008: the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical
p.000008: investigation.
p.000008:
p.000008: 5.5.2017 EN
p.000008: Official Journal of the European Union
p.000009: L 117/9
p.000009:
p.000009: (64) The rules on clinical investigations should be in line with well-established international
...
Health / Cognitive Impairment
Searching for indicator impairment:
(return to top)
p.000019: (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000019: participate in a particular clinical investigation, after having been informed of all aspects of the
p.000019: clinical investigation that are relevant to the subject's decision to participate or, in the case of
p.000019: minors and of incapacitated subjects, an authoris ation or agreement from their legally designated representative
p.000019: to include them in the clinical investigation;
p.000019:
p.000019: (56) ‘ethics committee’ means an independent body established in a Member State in accordance with the
p.000019: law of that Member State and empowered to give opinions for the purposes of this Regulation, taking
p.000019: into account the views of laypersons, in particular patients or patients' organisations;
p.000019:
p.000019: (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward
p.000019: clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the
p.000019: context of a clinical investigation, whether or not related to the investigational device;
p.000019:
p.000019: (58) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000019:
p.000019: (a) death,
p.000019:
p.000019: (b) serious deterioration in the health of the subject, that resulted in any of the following:
p.000019:
p.000019: (i) life-threatening illness or injury,
p.000019:
p.000019: (ii) permanent impairment of a body structure or a body function,
p.000019:
p.000019: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000019:
p.000019: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent
p.000019: impairment to a body structure or a body function,
p.000019:
p.000019: (v) chronic disease,
p.000019:
p.000019: (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000019:
p.000019: (59) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000019: performance of an investigational device, including malfunction, use errors or inadequacy in
p.000019: information supplied by the manufacturer;
p.000019:
p.000019: (60) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000019: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000019: and review experience gained from devices they place on the market, make available on the market or put into service
p.000019: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000019:
p.000019: (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities
p.000019: to check and ensure that devices comply with the requirements set out in the relevant Union
p.000019: harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
p.000019:
p.000019: (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made
p.000019: available to the end user;
p.000019:
p.000020: L 117/20 EN
p.000020: Official Journal of the European Union
p.000020: 5.5.2017
p.000020:
p.000020: (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000020: made available on the market;
...
p.000100: the dangers arising from exposure to ionising radiation.
p.000100:
p.000100: (b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to
p.000100: ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of
p.000100: the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
p.000100:
p.000100: (c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such
p.000100: a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose
p.000100: whilst minimising radiation exposure of the patient and user.
p.000100:
p.000100: (d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed
p.000100: and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the
p.000100: beam type, energy and, where appropriate, the quality of radiation.
p.000100:
p.000100: 17. Electronic programmable systems — devices that incorporate electronic programmable systems and
p.000100: software that are devices in themselves
p.000100:
p.000100: 17.1. Devices that incorporate electronic programmable systems, including software, or software that
p.000100: are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000100: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate
p.000100: or reduce as far as possible consequent risks or impairment of performance.
p.000100:
p.000100: 17.2. For devices that incorporate software or for software that are devices in themselves, the
p.000100: software shall be developed and manufactured in accordance with the state of the art taking into account
p.000100: the principles of development life cycle, risk management, including information security, verification and
p.000100: validation.
p.000100:
p.000100: 5.5.2017 EN
p.000100: Official Journal of the European Union
p.000101: L 117/101
p.000101:
p.000101: 17.3. Software referred to in this Section that is intended to be used in combination with mobile
p.000101: computing platforms shall be designed and manufactured taking into account the specific features of the
p.000101: mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their
p.000101: use (varying environment as regards level of light or noise).
p.000101:
p.000101: 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics
p.000101: and IT security measures, including protection against unauthorised access, necessary to run the software as
p.000101: intended.
p.000101:
p.000101: 18. Active devices and devices connected to them
p.000101:
p.000101: 18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be
p.000101: adopted to eliminate or reduce as far as possible consequent risks.
p.000101:
...
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.000052: manufacturer may apply to a notified body of its choice, provided that the chosen notified body is
p.000052: designated for conformity assessment activities related to the types of devices concerned. The manufacturer
p.000052: may not lodge an application in parallel with another notified body for the same conformity assessment
p.000052: procedure.
p.000052:
p.000052: 2. The notified body concerned shall, by means of the electronic system referred to in Article 57,
p.000052: inform the other notified bodies of any manufacturer that withdraws its application prior to the
p.000052: notified body's decision regarding the conformity assessment.
p.000052:
p.000052: 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they
p.000052: have withdrawn an application with another notified body prior to the decision of that notified body and provide
p.000052: information about any previous application for the same conformity assessment that has been refused by another
p.000052: notified body.
p.000052:
p.000052: 4. The notified body may require any information or data from the manufacturer, which is necessary
p.000052: in order to properly conduct the chosen conformity assessment procedure.
p.000052:
p.000052: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment
p.000052: activities with the highest degree of professional integrity and the requisite technical and scientific
p.000052: competence in the specific field and shall be free from all pressures and inducements, particularly
p.000052: financial, which might influence their judgement or the results of their conformity assessment activities,
p.000052: especially as regards persons or groups with an interest in the results of those activities.
p.000052:
p.000052:
p.000052: Article 54
p.000052:
p.000052: Clinical evaluation consultation procedure for certain class III and class IIb devices
p.000052:
p.000052: 1. In addition to the procedures applicable pursuant to Article 52, a notified body shall also
p.000052: follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX
p.000052: or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the
p.000052: following devices:
p.000052:
p.000052: (a) class III implantable devices, and
p.000052:
p.000052: (b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to
p.000052: in Section 6.4 of Annex VIII (Rule 12).
p.000052:
p.000052: 2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
p.000052:
p.000052: (a) in the case of renewal of a certificate issued under this Regulation;
p.000052:
p.000052: 5.5.2017 EN
p.000052: Official Journal of the European Union
p.000053: L 117/53
p.000053:
p.000053: (b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same
p.000053: intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body
p.000053: that the modifications do not adversely affect the benefit-risk ratio of the device; or
p.000053:
...
p.000058:
p.000058: (f) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative has given informed consent in accordance with Article 63;
p.000058:
p.000058: (g) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative, has been provided with the contact details of an entity where further information can be
p.000058: received in case of need;
p.000058:
p.000058: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of
p.000058: the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000058:
p.000058: (i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any
p.000058: other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of
p.000058: distress are specifically defined in the clinical investigation plan and constantly monitored;
p.000058:
p.000058: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor
p.000058: or, where appropriate, a qualified dental practitioner or any other person entitled by national law to
p.000058: provide the relevant patient care under clinical investigation conditions;
p.000058:
p.000058: (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where
p.000058: applicable, on his or her legally designated representatives, to participate in the clinical investigation;
p.000058:
p.000058: 5.5.2017 EN
p.000058: Official Journal of the European Union
p.000059: L 117/59
p.000059:
p.000059: (l) the investigational device(s) in question conform(s) to the applicable general safety and
p.000059: performance requirements set out in Annex I apart from the aspects covered by the clinical investigation
p.000059: and that, with regard to those aspects, every precaution has been taken to protect the health and
p.000059: safety of the subjects. This includes, where appropriate, technical and biological safety testing and
p.000059: pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention,
p.000059: taking into consideration the state of the art;
p.000059:
p.000059: (m) the requirements of Annex XV are fulfilled.
p.000059:
p.000059: 5. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000059: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000059: clinical investi gation at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC,
p.000059: the withdrawal of the informed consent shall not affect the activities already carried out and the use of
...
p.000102:
p.000102: 21.1. Devices for supplying the patient with energy or substances shall be designed and constructed
p.000102: in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of
p.000102: the patient and of the user.
p.000102:
p.000102: 21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in
p.000102: the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable
p.000102: means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances
p.000102: from an energy and/or substance source.
p.000102:
p.000102: 21.3. The function of the controls and indicators shall be clearly specified on the devices. Where
p.000102: a device bears instructions required for its operation or indicates operating or adjustment parameters by
p.000102: means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
p.000102:
p.000102: 22. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
p.000102:
p.000102: 22.1. Devices for use by lay persons shall be designed and manufactured in such a way
p.000102: that they perform appropriately for their intended purpose taking into account the skills and the
p.000102: means available to lay persons and the influence resulting from variation that can be reasonably
p.000102: anticipated in the lay person's technique and environment. The information and instructions provided by
p.000102: the manufacturer shall be easy for the lay person to understand and apply.
p.000102:
p.000102: 5.5.2017 EN
p.000102: Official Journal of the European Union
p.000103: L 117/103
p.000103:
p.000103: 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:
p.000103:
p.000103: — ensure that the device can be used safely and accurately by the intended user at all stages of the
p.000103: procedure, if necessary after appropriate training and/or information,
p.000103:
p.000103: — reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle
p.000103: stick injuries, and
p.000103:
p.000103: — reduce as far as possible the risk of error by the intended user in the handling of the device
p.000103: and, if applicable, in the interpretation of the results.
p.000103:
p.000103: 22.3. Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
p.000103:
p.000103: — can verify that, at the time of use, the device will perform as intended by the manufacturer, and
p.000103:
p.000103: — if applicable, is warned if the device has failed to provide a valid result.
p.000103:
p.000103: CHAPTER III
p.000103:
p.000103: REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
p.000103:
p.000103:
p.000103: 23. Label and instructions for use
p.000103:
...
p.000123: or natural persons exercising control over the notified body.
p.000123:
p.000123: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of
p.000123: that organisation as well as its organisational structure and governance, and the relationship with the
p.000123: notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable
p.000123: to both the notified body and the organisation to which it belongs.
p.000123:
p.000123: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a
p.000123: third country or is owned by another legal entity, the activities and responsibilities of those entities,
p.000123: as well as their legal and operational relationships with the notified body, shall be clearly defined
p.000123: and documented. Personnel of those entities performing conformity assessment activities under this
p.000123: Regulation shall be subject to the applicable requirements of this Regulation.
p.000123:
p.000123: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000123: body shall be such that they ensure that there is confidence in the performance by the notified body
p.000123: and in the results of the conformity assessment activities it conducts.
p.000123:
p.000123: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
p.000123: responsibilities and authority of its top-level management and of other personnel who may have an influence
p.000123: upon the performance by the notified body and upon the results of its conformity assessment activities.
p.000123:
p.000123: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000123: and responsi bility for each of the following:
p.000123:
p.000123: — the provision of adequate resources for conformity assessment activities;
p.000123:
p.000123: — the development of procedures and policies for the operation of the notified body;
p.000123:
p.000123: — the supervision of implementation of the procedures, policies and quality management systems of the notified body;
p.000123:
p.000123: — the supervision of the notified body's finances;
p.000123:
p.000123: — the activities and decisions taken by the notified body, including contractual agreements;
p.000123:
p.000123: — the delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000123: defined activities;
p.000123:
p.000123: — the interaction with the authority responsible for notified bodies and the obligations regarding
p.000123: communi cations with other competent authorities, the Commission and other notified bodies.
p.000123:
p.000123: 1.2. Independence and impartiality
p.000123:
p.000123: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in
p.000123: relation to which it performs conformity assessment activities. The notified body shall also be independent
p.000123: of any other economic operator having an interest in the device as well as of any competitors of the
...
p.000143:
p.000143: — are intended to undergo chemical change in the body in which case they are classified as class III, except if the
p.000143: devices are placed in the teeth;
p.000143:
p.000143: — are intended to administer medicinal products, in which case they are classified as class III;
p.000143: — are active implantable devices or their accessories, in which cases they are classified as class III;
p.000143: — are breast implants or surgical meshes, in which cases they are classified as class III;
p.000143:
p.000143: — are total or partial joint replacements, in which case they are classified as class III, with the
p.000143: exception of ancillary components such as screws, wedges, plates and instruments; or
p.000143:
p.000143: — are spinal disc replacement implants or are implantable devices that come into contact with the
p.000143: spinal column, in which case they are classified as class III with the exception of components such as
p.000143: screws, wedges, plates and instruments.
p.000143:
p.000143: 6. ACTIVE DEVICES
p.000143:
p.000143: 6.1. Rule 9
p.000143:
p.000143: All active therapeutic devices intended to administer or exchange energy are classified as class IIa
p.000143: unless their characteristics are such that they may administer energy to or exchange energy
p.000143: with the human body in a potentially hazardous way, taking account of the nature, the density and
p.000143: site of application of the energy, in which case they are classified as class IIb.
p.000143:
p.000143: All active devices intended to control or monitor the performance of active therapeutic class IIb
p.000143: devices, or intended directly to influence the performance of such devices are classified as class IIb.
p.000143:
p.000143: All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or
p.000143: monitor such devices, or which directly influence their performance, are classified as class IIb.
p.000143:
p.000143: All active devices that are intended for controlling, monitoring or directly influencing the performance
p.000143: of active implantable devices are classified as class III.
p.000143:
p.000143:
p.000143: 6.2. Rule 10
p.000143:
p.000143: Active devices intended for diagnosis and monitoring are classified as class IIa:
p.000143:
p.000143: — if they are intended to supply energy which will be absorbed by the human body, except for devices
p.000143: intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
p.000143:
p.000143: — if they are intended to image in vivo distribution of radiopharmaceuticals; or
p.000143:
p.000143: — if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless
p.000143: they are specifically intended for monitoring of vital physiological parameters and the nature of
p.000143: variations of those parameters is such that it could result in immediate danger to the patient, for
p.000143: instance variations in cardiac performance, respiration, activity of the central nervous system, or they
p.000143: are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they
p.000143: are classified as class IIb.
p.000143:
p.000143: Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology,
p.000143: including interventional radiology devices and devices which control or monitor such devices, or which
p.000143: directly influence their performance, are classified as class IIb.
p.000143:
p.000144: L 117/144 EN
p.000144: Official Journal of the European Union
p.000144: 5.5.2017
p.000144:
p.000144: 6.3. Rule 11
p.000144:
p.000144: Software intended to provide information which is used to take decisions with diagnosis or therapeutic
p.000144: purposes is classified as class IIa, except if such decisions have an impact that may cause:
p.000144: — death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
p.000144: — a serious deterioration of a person's state of health or a surgical intervention, in which case it
p.000144: is classified as class IIb.
p.000144:
p.000144: Software intended to monitor physiological processes is classified as class IIa, except if it
p.000144: is intended for monitoring of vital physiological parameters, where the nature of variations of those
p.000144: parameters is such that it could result in immediate danger to the patient, in which case it is classified as
p.000144: class IIb.
p.000144:
p.000144: All other software is classified as class I.
p.000144:
p.000144: 6.4. Rule 12
p.000144:
p.000144: All active devices intended to administer and/or remove medicinal products, body liquids or other
p.000144: substances to or from the body are classified as class IIa, unless this is done in a manner that is
p.000144: potentially hazardous, taking account of the nature of the substances involved, of the part of the body
p.000144: concerned and of the mode of application in which case they are classified as class IIb.
p.000144:
p.000144: 6.5. Rule 13
p.000144:
p.000144: All other active devices are classified as class I.
p.000144:
...
Searching for indicator substance:
(return to top)
p.000002:
p.000002:
p.000002: (8) It should be the responsibility of the Member States to decide on a case-by-case basis
p.000002: whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification
p.000002: decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should
p.000002: be allowed to, on its own initiative or at the duly substantiated request of a Member State,
p.000002: having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether
p.000002: or not a specific product, category or group of products falls within the scope of this Regulation.
p.000002: When deliberating on the regulatory status of products in borderline cases involving medicinal products,
p.000002: human tissues and cells, biocidal products or food products, the Commission should ensure an
p.000002: appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency
p.000002: and the European Food Safety Authority, as relevant.
p.000002:
p.000002:
p.000002: (9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the
p.000002: possibility of taking a Union-wide decision regarding the regulatory status of a product should
p.000002: also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
p.000002:
p.000002:
p.000002: (10) Products which combine a medicinal product or substance and a medical device are regulated
p.000002: either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3)
p.000002: The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market
p.000002: assessment, and of exchange of information in the context of vigilance activities involving such combination
p.000002: products. For medicinal products that integrate a medical device part, compliance with the general safety
p.000002: and performance requirements laid down in this Regulation for the device part should be adequately
p.000002: assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should
p.000002: therefore be amended.
p.000002:
p.000002: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
p.000002: general principles and requirements of food law, establishing the European Food Safety Authority and laying
p.000002: down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
p.000002: (2) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic
p.000002: products (OJ L 342,
p.000002: 22.12.2009, p. 59).
p.000002: (3) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000002: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000002:
p.000002: 5.5.2017 EN
p.000002: Official Journal of the European Union
p.000003: L 117/3
p.000003:
...
p.000014: this Article;
p.000014: (e) cosmetic products covered by Regulation (EC) No 1223/2009;
p.000014: (f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or
p.000014: consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells
p.000014: of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
p.000014: (g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive
p.000014: 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices
p.000014: manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered
p.000014: non-viable;
p.000014: (h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological
p.000014: material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to
p.000014: achieve or support the intended purpose of the product;
p.000014: (i) food covered by Regulation (EC) No 178/2002.
p.000014: 7. Any device which, when placed on the market or put into service, incorporates as an integral
p.000014: part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU)
p.000014: 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply
p.000014: to the in vitro diagnostic medical device part of the device.
p.000014:
p.000014: 8. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000014: part, a substance which, if used separately, would be considered to be a medicinal product as defined
p.000014: in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood
p.000014: or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action
p.000014: ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.
p.000014:
p.000014: However, if the action of that substance is principal and not ancillary to that of the device, the integral
p.000014: product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament
p.000014: and of the Council (1), as applicable. In that case, the relevant general safety and performance
p.000014: requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the
p.000014: device part are concerned.
p.000014:
p.000014: 9. Any device which is intended to administer a medicinal product as defined in point
p.000014: 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the
p.000014: provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
p.000014:
p.000014: However, if the device intended to administer a medicinal product and the medicinal product are placed
p.000014: on the market in such a way that they form a single integral product which is intended exclusively for
p.000014: use in the given combination and which is not reusable, that single integral product
p.000014: shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In
p.000014: that case, the relevant general safety and performance requirements set out in Annex I to this
p.000014: Regulation shall apply as far as the safety and performance of the device part of the single integral
p.000014: product are concerned.
p.000014:
...
p.000016: the purpose of being used for a specific medical purpose;
p.000016:
p.000016: (11) ‘system’ means a combination of products, either packaged together or not, which are intended to
p.000016: be inter- connected or combined to achieve a specific medical purpose;
p.000016:
p.000016: (12) ‘intended purpose’ means the use for which a device is intended according to the data
p.000016: supplied by the manufacturer on the label, in the instructions for use or in promotional or sales
p.000016: materials or statements and as specified by the manufacturer in the clinical evaluation;
p.000016:
p.000016: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or
p.000016: on the packaging of each unit or on the packaging of multiple devices;
p.000016:
p.000016: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000016: intended purpose and proper use and of any precautions to be taken;
p.000016:
p.000016: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is
p.000016: created through in ternationally accepted device identification and coding standards and that allows
p.000016: unambiguous identification of specific devices on the market;
p.000016:
p.000016: 5.5.2017 EN
p.000016: Official Journal of the European Union
p.000017: L 117/17
p.000017:
p.000017: (16) ‘non-viable’ means having no potential for metabolism or multiplication;
p.000017:
p.000017: (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a
p.000017: manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells
p.000017: or tissues;
p.000017:
p.000017: (18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an
p.000017: unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in
p.000017: the number size distribution, one or more external dimensions is in the size range 1-100 nm;
p.000017:
p.000017: Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1
p.000017: nm shall also be deemed to be nanomaterials;
p.000017:
p.000017: (19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece
p.000017: of matter with defined physical boundaries;
p.000017:
p.000017: (20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly
p.000017: bound particles or aggregates where the resulting external surface area is similar to the sum of the
p.000017: surface areas of the individual components;
p.000017:
p.000017: (21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle
p.000017: comprising of strongly bound or fused particles;
p.000017:
p.000017: (22) ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
p.000017:
p.000017: (23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
p.000017:
...
p.000075: population affected. The competent authority shall also evaluate the adequacy of the field safety
p.000075: corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other
p.000075: corrective action, in particular taking into account the principle of inherent safety contained in Annex
p.000075: I.
p.000075:
p.000075: Upon request by the national competent authority, manufacturers shall provide all documents necessary for
p.000075: the risk assessment.
p.000075:
p.000075: 4. The competent authority shall monitor the manufacturer's investigation of a serious incident.
p.000075: Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent
p.000075: investigation.
p.000075:
p.000075: 5. The manufacturer shall provide a final report to the competent authority setting out its
p.000075: findings from the investi gation by means of the electronic system referred to in Article 92. The
p.000075: report shall set out conclusions and where relevant indicate corrective actions to be taken.
p.000075:
p.000075: 6. In the case of devices referred to in the first subparagraph of Article 1(8) and where the
p.000075: serious incident or field safety corrective action may be related to a substance which, if used
p.000075: separately, would be considered to be a medicinal product, the evaluating competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national
p.000075: competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article
p.000075: 52(9), of that serious incident or field safety corrective action.
p.000075:
p.000075: In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and
p.000075: where the serious incident or field safety corrective action may be related to the derivatives of
p.000075: tissues or cells of human origin utilised for the manufacture of the device, and in the case of
p.000075: devices falling under this Regulation pursuant to Article 1(10), the competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent
p.000075: authority for human tissues and cells that was consulted by the notified body in accordance with Article
p.000075: 52(10).
p.000075:
p.000075: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the
p.000075: evaluating competent authority shall, through the electronic system referred to in Article 92, inform,
p.000075: without delay, the other competent authorities of the corrective action taken or envisaged by the
p.000075: manufacturer or required of it to minimise the risk of recurrence of the serious incident, including
p.000075: information on the underlying events and the outcome of its assessment.
p.000075:
p.000075: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
...
p.000096: — are invasive and come into direct contact with the human body,
p.000096: — (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
p.000096: — transport or store such medicines, body fluids or substances, including gases, to be (re)administered
p.000096: to the body,
p.000096:
p.000096: shall only contain the following substances in a concentration that is above 0,1 % weight by weight
p.000096: (w/w) where justified pursuant to Section 10.4.2:
p.000096:
p.000096: (a) substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or
p.000096: 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
p.000096: and of the Council (1), or
p.000096:
p.000096: (b) substances having endocrine-disrupting properties for which there is scientific evidence of probable
p.000096: serious effects to human health and which are identified either in accordance with the procedure set out
p.000096: in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or,
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
...
p.000097: in accordance with appropriate procedures, to ensure that they are sterile when placed on the
p.000097: market and that, unless the packaging which is intended to maintain their sterile condition is
p.000097: damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer,
p.000097: until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is
p.000097: clearly evident to the final user.
p.000097:
p.000097: 11.5. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means
p.000097: of appropriate, validated methods.
p.000097:
p.000097: 11.6. Devices intended to be sterilised shall be manufactured and packaged in appropriate and
p.000097: controlled conditions and facilities.
p.000097:
p.000097: 11.7. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product
p.000097: and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging
p.000097: system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
p.000097:
p.000098: L 117/98 EN
p.000098: Official Journal of the European Union
p.000098: 5.5.2017
p.000098:
p.000098: 11.8. The labelling of the device shall distinguish between identical or similar devices placed on
p.000098: the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are
p.000098: sterile.
p.000098:
p.000098: 12. Devices incorporating a substance considered to be a medicinal product and devices that are
p.000098: composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
p.000098:
p.000098: 12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality,
p.000098: safety and usefulness of the substance which, if used separately, would be considered to be a medicinal
p.000098: product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by
p.000098: analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable
p.000098: conformity assessment procedure under this Regulation.
p.000098:
p.000098: 12.2. Devices that are composed of substances or of combinations of substances that are intended to
p.000098: be introduced into the human body, and that are absorbed by or locally dispersed in the human body
p.000098: shall comply, where applicable and in a manner limited to the aspects not covered by this
p.000098: Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the
p.000098: evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with
p.000098: other devices, medicinal products or other substances and potential for adverse reactions, as required by
p.000098: the applicable conformity assessment procedure under this Regulation.
p.000098:
p.000098: 13. Devices incorporating materials of biological origin
p.000098:
p.000098: 13.1. For devices manufactured utilising derivatives of tissues or cells of human origin which are
p.000098: non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article
p.000098: 1(6), the following shall apply:
p.000098:
p.000098: (a) donation, procurement and testing of the tissues and cells shall be done in
p.000098: accordance with Directive 2004/23/EC;
p.000098:
...
p.000102: possible risks.
p.000102:
p.000102: 20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of
p.000102: risk shall be made impossible by the design and construction of such parts or, failing this, by
p.000102: information given on the parts themselves and/or their housings.
p.000102:
p.000102: The same information shall be given on moving parts and/or their housings where the direction of
p.000102: movement needs to be known in order to avoid a risk.
p.000102:
p.000102: 20.6. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach
p.000102: given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions
p.000102: of use.
p.000102:
p.000102: 21. Protection against the risks posed to the patient or user by devices supplying energy or substances
p.000102:
p.000102: 21.1. Devices for supplying the patient with energy or substances shall be designed and constructed
p.000102: in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of
p.000102: the patient and of the user.
p.000102:
p.000102: 21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in
p.000102: the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable
p.000102: means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances
p.000102: from an energy and/or substance source.
p.000102:
p.000102: 21.3. The function of the controls and indicators shall be clearly specified on the devices. Where
p.000102: a device bears instructions required for its operation or indicates operating or adjustment parameters by
p.000102: means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
p.000102:
p.000102: 22. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
p.000102:
p.000102: 22.1. Devices for use by lay persons shall be designed and manufactured in such a way
p.000102: that they perform appropriately for their intended purpose taking into account the skills and the
p.000102: means available to lay persons and the influence resulting from variation that can be reasonably
p.000102: anticipated in the lay person's technique and environment. The information and instructions provided by
p.000102: the manufacturer shall be easy for the lay person to understand and apply.
p.000102:
p.000102: 5.5.2017 EN
p.000102: Official Journal of the European Union
p.000103: L 117/103
p.000103:
p.000103: 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:
p.000103:
p.000103: — ensure that the device can be used safely and accurately by the intended user at all stages of the
p.000103: procedure, if necessary after appropriate training and/or information,
p.000103:
...
p.000103:
p.000103: (g) Residual risks which are required to be communicated to the user and/or other person shall be included
p.000103: as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000103:
p.000103: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000103: internationally recognised symbols. Any symbol or identification colour used shall conform to the
p.000103: harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours
p.000103: shall be described in the documentation supplied with the device.
p.000103:
p.000104: L 117/104 EN
p.000104: Official Journal of the European Union
p.000104: 5.5.2017
p.000104:
p.000104: 23.2. Information on the label
p.000104:
p.000104: The label shall bear all of the following particulars:
p.000104: (a) the name or trade name of the device;
p.000104: (b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it
p.000104: is not obvious for the user, the intended purpose of the device;
p.000104: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000104: its registered place of business;
p.000104: (d) if the manufacturer has its registered place of business outside the Union, the name of the
p.000104: authorised rep resentative and address of the registered place of business of the authorised representative;
p.000104: (e) where applicable, an indication that the device contains or incorporates:
p.000104: — a medicinal substance, including a human blood or plasma derivative, or
p.000104: — tissues or cells, or their derivatives, of human origin, or
p.000104: — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
p.000104: (f) where applicable, information labelled in accordance with Section 10.4.5.;
p.000104: (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL
p.000104: NUMBER or an equivalent symbol, as appropriate;
p.000104: (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
p.000104: (i) an unambiguous indication of t the time limit for using or implanting the device safely,
p.000104: expressed at least in terms of year and month, where this is relevant;
p.000104: (j) where there is no indication of the date until when it may be used safely, the date of
p.000104: manufacture. This date of manufacture may be included as part of the lot number or serial number,
p.000104: provided the date is clearly identifiable;
p.000104: (k) an indication of any special storage and/or handling condition that applies;
p.000104: (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
p.000104: (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the
p.000104: device, and to any other person. This information may be kept to a minimum in which case more detailed information
p.000104: shall appear in the instructions for use, taking into account the intended users;
p.000104: (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication
...
p.000106: contra- indications, measures to be taken and limitations of use regarding the device. That information
p.000106: shall, where relevant, allow the user to brief the patient about any warnings, precautions,
p.000106: contra-indications, measures to be taken and limitations of use regarding the device. The information
p.000106: shall cover, where appropriate:
p.000106:
p.000106: — warnings, precautions and/or measures to be taken in the event of malfunction of the device or
p.000106: changes in its performance that may affect safety,
p.000106:
p.000106: — warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable
p.000106: external influences or environmental conditions, such as magnetic fields, external electrical and electro magnetic
p.000106: effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity,
p.000106: or temperature,
p.000106:
p.000106: — warnings, precautions and/or measures to be taken as regards the risks of interference posed by the
p.000106: reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or
p.000106: therapeutic treatment or other procedures such as electromagnetic interference emitted by the device
p.000106: affecting other equipment,
p.000106:
p.000106: — if the device is intended to administer medicinal products, tissues or cells of human or animal
p.000106: origin, or their derivatives, or biological substances, any limitations or incompatibility in the
p.000106: choice of substances to be delivered,
p.000106:
p.000106: — warnings, precautions and/or limitations related to the medicinal substance or biological material that
p.000106: is incorporated into the device as an integral part of the device; and
p.000106:
p.000106: — precautions related to materials incorporated into the device that contain or consist of CMR substances or
p.000106: endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the
p.000106: patient or user;
p.000106:
p.000106: 5.5.2017 EN
p.000106: Official Journal of the European Union
p.000107: L 117/107
p.000107:
p.000107: (t) in the case of devices that are composed of substances or of combinations of substances that are intended to
p.000107: be introduced into the human body and that are absorbed by or locally dispersed in the human body,
p.000107: warnings and precautions, where appropriate, related to the general profile of interaction of the device and its
p.000107: products of metabolism with other devices, medicinal products and other substances as well as contra-
p.000107: indications, undesirable side-effects and risks relating to overdose;
p.000107:
p.000107: (u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and
p.000107: substances to which patients can be exposed;
p.000107:
p.000107: (v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories
p.000107: and the consumables used with it, if any. This information shall cover, where appropriate:
p.000107:
p.000107: — infection or microbial hazards such as explants, needles or surgical equipment contaminated with
p.000107: potentially infectious substances of human origin, and
p.000107:
p.000107: — physical hazards such as from sharps.
p.000107:
...
p.000110: evidence of the validation of the software, as used in the finished device. This information shall
p.000110: typically include the summary results of all verification, validation and testing performed both in-house
p.000110: and in a simulated or actual user environment prior to final release. It shall also address all of the
p.000110: different hardware config urations and, where applicable, operating systems identified in the
p.000110: information supplied by the manufacturer);
p.000110:
p.000110: — stability, including shelf life; and
p.000110:
p.000110: — performance and safety.
p.000110:
p.000110: Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and
p.000110: of the Council (1) shall be demonstrated.
p.000110:
p.000110: Where no new testing has been undertaken, the documentation shall incorporate a rationale for that
p.000110: decision. An example of such a rationale would be that biocompatibility testing on identical materials
p.000110: was conducted when those materials were incorporated in a previous version of the device that has been
p.000110: legally placed on the market or put into service;
p.000110:
p.000110: (c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in
p.000110: Article 61(12) and Part A of Annex XIV;
p.000110:
p.000110: (d) the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not
p.000110: applicable.
p.000110:
p.000110: 6.2. Additional information required in specific cases
p.000110:
p.000110: (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be
p.000110: a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product
p.000110: derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a
p.000110: statement indicating this fact. In this case, the documentation shall identify the source of that
p.000110: substance and contain the data of the tests conducted to assess its safety, quality and usefulness,
p.000110: taking account of the intended purpose of the device.
p.000110:
p.000110: (b) Where a device is manufactured utilising tissues or cells of human or animal origin, or their
p.000110: derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a
p.000110: device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have
p.000110: an action ancillary to that of the device and is covered by this Regulation in accordance with the
p.000110: first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation
p.000110: shall identify all materials of human or animal origin used and provide detailed information concerning
p.000110: the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
p.000110:
p.000110: (c) In the case of devices that are composed of substances or combinations of substances that are
p.000110: intended to be introduced into the human body and that are absorbed by or locally dispersed in the
p.000110: human body, detailed information, including test design, complete test or study protocols, methods
p.000110: of data analysis, and data summaries and test conclusions, regarding studies in relation to:
p.000110:
p.000110: — absorption, distribution, metabolism and excretion;
p.000110:
p.000110: — possible interactions of those substances, or of their products of metabolism in the human body, with other
p.000110: devices, medicinal products or other substances, considering the target population, and its
p.000110: associated medical conditions;
p.000110:
p.000110: — local tolerance; and
...
p.000115:
p.000115: 1. Information relating to the economic operator
p.000115:
p.000115: 1.1. type of economic operator(manufacturer, authorised representative, or importer),
p.000115: 1.2. name, address and contact details of the economic operator,
p.000115:
p.000115: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000115: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000115:
p.000115: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000115: referred to in Article 15.
p.000115:
p.000115: 2. Information relating to the device
p.000115:
p.000115: 2.1. Basic UDI-DI,
p.000115:
p.000115: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000115: identification number of that notified body and the link to the information that appears on the
p.000115: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000115: 2.3. Member State in which the device is to or has been placed on the market in the Union,
p.000115: 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made
p.000115: available,
p.000115: 2.5. risk class of the device,
p.000115: 2.6. reprocessed single-use device (y/n),
p.000115:
p.000115: 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of
p.000115: that substance,
p.000115:
p.000115: 2.8. presence of a substance which, if used separately, may be considered to be a medicinal
p.000115: product derived from human blood or human plasma and name of this substance,
p.000115: 2.9. presence of tissues or cells of human origin, or their derivatives (y/n),
p.000115:
p.000115: 2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in
p.000115: Regulation (EU) No 722/2012 (y/n),
p.000115:
p.000115: 2.11. where applicable, the single identification number of the clinical investigation or investigations
p.000115: conducted in relation to the device or a link to the clinical investigation registration in the electronic system on
p.000115: clinical investi gations,
p.000115:
p.000115: 2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose
p.000115: of the device is other than a medical purpose,
p.000115:
p.000115: 2.13. in the case of devices designed and manufactured by another legal or natural person
p.000115: as referred in Article 10(15), the name, address and contact details of that legal or natural person,
p.000115:
p.000116: L 117/116 EN
p.000116: Official Journal of the European Union
p.000116: 5.5.2017
p.000116:
p.000116: 2.14. in the case of class III or implantable devices, the summary of safety and clinical performance,
p.000116:
p.000116: 2.15. status of the device (on the market, no longer placed on the market, recalled, field safety
p.000116: corrective action initiated).
p.000116:
p.000116: PART B
p.000116:
p.000116: CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH
p.000116: ARTICLES 28 AND 29
p.000116:
p.000116:
p.000116: The manufacturer shall provide to the UDI database the UDI-DI and all of the following information
...
p.000136:
p.000136: — clearly document responsibilities and mechanisms for communication of decisions, in particular, where
p.000136: the final signatory of a certificate differs from the decision maker or decision makers or does not
p.000136: fulfil the requirements laid down in Section 3.2.7,
p.000136:
p.000136: — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex
p.000136: XII for a period of validity not exceeding five years and shall indicate whether there are specific
p.000136: conditions or limitations associated with the certification,
p.000136:
p.000136: — issue a certificate or certificates for the applicant alone and shall not issue certificates covering
p.000136: multiple entities, and
p.000136:
p.000136: — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that
p.000136: they are entered into the electronic system referred to in Article 57.
p.000136:
p.000136: 5.5.2017 EN
p.000136: Official Journal of the European Union
p.000137: L 117/137
p.000137:
p.000137: 4.9. Changes and modifications
p.000137:
p.000137: The notified body shall have documented procedures and contractual arrangements with manufacturers in
p.000137: place relating to the manufacturers' information obligations and the assessment of changes to:
p.000137:
p.000137: — the approved quality management system or systems or to the product-range covered,
p.000137:
p.000137: — the approved design of a device,
p.000137:
p.000137: — the intended use of or claims made for the device,
p.000137:
p.000137: — the approved type of a device, and
p.000137:
p.000137: — any substance incorporated in or utilised for the manufacturing of a device and being subject to the
p.000137: specific procedures in accordance with Section 4.5.6.
p.000137:
p.000137: The procedures and contractual arrangements referred to in the first paragraph shall include measures for
p.000137: checking the significance of the changes referred to in the first paragraph.
p.000137:
p.000137: In accordance with its documented procedures, the notified body in question shall:
p.000137:
p.000137: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and
p.000137: relevant information relating to such changes,
p.000137:
p.000137: — assess the changes proposed and verify whether, after these changes, the quality management system, or
p.000137: the design of a device or type of a device, still meets the requirements of this Regulation, and
p.000137:
p.000137: — notify the manufacturer of its decision and provide a report or as applicable a supplementary report,
p.000137: which shall contain the justified conclusions of its assessment.
p.000137: 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures:
p.000137:
p.000137: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures
p.000137: shall include arrangements for unannounced on-site audits of manufacturers and, where applicable,
p.000137: subcontractors and suppliers carrying out product tests and the monitoring of compliance with any
p.000137: conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at
p.000137: defined intervals,
p.000137:
...
p.000141: the same type.
p.000141: 3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease
p.000141: or condition in question by itself or when it provides decisive information for the diagnosis.
p.000141:
p.000141: CHAPTER III
p.000141:
p.000141: CLASSIFICATION RULES
p.000141:
p.000141: 4. NON-INVASIVE DEVICES
p.000141:
p.000141: 4.1. Rule 1
p.000141:
p.000141: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
p.000141:
p.000141: 4.2. Rule 2
p.000141:
p.000141: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues,
p.000141: liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified
p.000141: as class IIa:
p.000141: — if they may be connected to a class IIa, class IIb or class III active device; or
p.000141: — if they are intended for use for channelling or storing blood or other body liquids or for storing organs,
p.000141: parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
p.000141: In all other cases, such devices are classified as class I.
p.000141:
p.000141: 4.3. Rule 3
p.000141:
p.000141: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells,
p.000141: blood, other body liquids or other liquids intended for implantation or administration into the body are classified as
p.000141: class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of
p.000141: gas, heat, in which case they are classified as class IIa.
p.000141:
p.000141: All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct
p.000141: contact with human cells, tissues or organs taken from the human body or used in vitro with human
p.000141: embryos before their implantation or administration into the body are classified as class III.
p.000141:
p.000141: 4.4. Rule 4
p.000141:
p.000141: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
p.000141: — class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
p.000141: — class IIb if they are intended to be used principally for injuries to skin which have breached the
p.000141: dermis or mucous membrane and can only heal by secondary intent;
p.000141:
p.000142: L 117/142 EN
p.000142: Official Journal of the European Union
p.000142: 5.5.2017
p.000142:
p.000142: — class IIa if they are principally intended to manage the micro-environment of injured skin
p.000142: or mucous membrane; and
p.000142: — class IIa in all other cases.
p.000142: This rule applies also to the invasive devices that come into contact with injured mucous membrane.
p.000142:
p.000142: 5. INVASIVE DEVICES
p.000142:
p.000142: 5.1. Rule 5
p.000142:
p.000142: All invasive devices with respect to body orifices, other than surgically invasive devices, which are
p.000142: not intended for connection to an active device or which are intended for connection to a class I active device are
p.000142: classified as:
p.000142: — class I if they are intended for transient use;
...
p.000144: 5.5.2017
p.000144:
p.000144: 6.3. Rule 11
p.000144:
p.000144: Software intended to provide information which is used to take decisions with diagnosis or therapeutic
p.000144: purposes is classified as class IIa, except if such decisions have an impact that may cause:
p.000144: — death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
p.000144: — a serious deterioration of a person's state of health or a surgical intervention, in which case it
p.000144: is classified as class IIb.
p.000144:
p.000144: Software intended to monitor physiological processes is classified as class IIa, except if it
p.000144: is intended for monitoring of vital physiological parameters, where the nature of variations of those
p.000144: parameters is such that it could result in immediate danger to the patient, in which case it is classified as
p.000144: class IIb.
p.000144:
p.000144: All other software is classified as class I.
p.000144:
p.000144: 6.4. Rule 12
p.000144:
p.000144: All active devices intended to administer and/or remove medicinal products, body liquids or other
p.000144: substances to or from the body are classified as class IIa, unless this is done in a manner that is
p.000144: potentially hazardous, taking account of the nature of the substances involved, of the part of the body
p.000144: concerned and of the mode of application in which case they are classified as class IIb.
p.000144:
p.000144: 6.5. Rule 13
p.000144:
p.000144: All other active devices are classified as class I.
p.000144:
p.000144: 7. SPECIAL RULES
p.000144:
p.000144: 7.1. Rule 14
p.000144:
p.000144: All devices incorporating, as an integral part, a substance which, if used separately, can be considered
p.000144: to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a
p.000144: medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of
p.000144: that Directive, and that has an action ancillary to that of the devices, are classified as class III.
p.000144:
p.000144: 7.2. Rule 15
p.000144:
p.000144: All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified
p.000144: as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class
p.000144: III.
p.000144:
p.000144: 7.3. Rule 16
p.000144:
p.000144: All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate,
p.000144: hydrating contact lenses are classified as class IIb.
p.000144:
p.000144: All devices intended specifically to be used for disinfecting or sterilising medical devices are
p.000144: classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended
p.000144: specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are
p.000144: classified as class IIb.
p.000144:
p.000144: This rule does not apply to devices that are intended to clean devices other than contact lenses by
p.000144: means of physical action only.
p.000144:
p.000144: 7.4. Rule 17
p.000144:
p.000144: Devices specifically intended for recording of diagnostic images generated by X-ray radiation are
p.000144: classified as class IIa.
p.000144:
p.000144: 5.5.2017 EN
...
p.000151: the expert panel. Where the expert panel finds that the level of clinical evidence is not sufficient or
p.000151: otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that
p.000151: evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the
p.000151: notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to
p.000151: certain groups of patients or certain medical indications and/or to impose a limit on the duration of
p.000151: validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or
p.000151: the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as
p.000151: appropriate. The notified body shall provide a full justification where it has not followed the advice of
p.000151: the expert panel in its conformity assessment report and the Commission shall without prejudice to
p.000151: Article 109 make both the scientific opinion of the expert panel and the written justification provided by the
p.000151: notified body publicly available via Eudamed.
p.000151:
p.000151: (h) The Commission, after consultation with the Member States and relevant scientific experts shall
p.000151: provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
p.000151:
p.000151:
p.000151: 5.2. Procedure in the case of devices incorporating a medicinal substance
p.000151:
p.000151:
p.000151: (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.000151: considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive
p.000151: 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action
p.000151: ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by
p.000151: analogy with the methods specified in Annex I to Directive 2001/83/EC.
p.000151:
p.000152: L 117/152 EN
p.000152: Official Journal of the European Union
p.000152: 5.5.2017
p.000152:
p.000152: (b) Before issuing an EU technical documentation assessment certificate, the notified body shall, having
p.000152: verified the usefulness of the substance as part of the device and taking account of the intended
p.000152: purpose of the device, seek a scientific opinion from one of the competent authorities designated by the
p.000152: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred
p.000152: to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under
p.000152: this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the
p.000152: substance into the device. Where the device incorporates a human blood or plasma derivative or a substance
p.000152: that, if used separately, may be considered to be a medicinal product falling exclusively within the
p.000152: scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
p.000152:
p.000152: (c) When issuing its opinion, the medicinal products authority consulted shall take into account the manufactur ing
p.000152: process and the data relating to the usefulness of incorporation of the substance into the device as
p.000152: determined by the notified body.
p.000152:
p.000152: (d) The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of
p.000152: receipt of all the necessary documentation.
p.000152:
p.000152: (e) The scientific opinion of the medicinal products authority consulted, and any possible
p.000152: update of that opinion, shall be included in the documentation of the notified body concerning the
p.000152: device. The notified body shall give due consideration to the views expressed in the scientific opinion
p.000152: when making its decision. The notified body shall not deliver the certificate if the scientific opinion is
p.000152: unfavourable and shall convey its final decision to the medicinal products authority consulted.
p.000152:
p.000152: (f) Before any change is made with respect to an ancillary substance incorporated in a device, in
p.000152: particular related to its manufacturing process, the manufacturer shall inform the notified body of the
p.000152: changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order
p.000152: to confirm that the quality and safety of the ancillary substance remain unchanged. The
p.000152: medicinal products authority consulted shall take into account the data relating to the usefulness of
p.000152: incorporation of the substance into the device as determined by the notified body, in order to ensure
p.000152: that the changes have no negative impact on the risk or benefit previously established concerning the
p.000152: incorporation of the substance into the device. The medicinal products authority consulted shall provide
p.000152: its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The
p.000152: notified body shall not deliver the supplement to the EU technical documentation assessment certificate
p.000152: if the scientific opinion provided by the medicinal products authority consulted is
p.000152: unfavourable. The notified body shall convey its final decision to the medicinal products authority
p.000152: consulted.
p.000152:
p.000152: (g) Where the medicinal products authority consulted obtains information on the ancillary substance,
p.000152: which could have an impact on the risk or benefit previously established concerning the incorporation of
p.000152: the substance into the device, it shall advise the notified body as to whether this information has an
p.000152: impact on the risk or benefit previously established concerning the incorporation of the substance into
p.000152: the device. The notified body shall take that advice into account in reconsidering its assessment of the conformity
p.000152: assessment procedure.
p.000152:
p.000152:
p.000152: 5.3. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of
p.000152: human or animal origin, or their derivatives, that are non-viable or rendered non-viable
p.000152:
p.000152:
p.000152:
p.000152: 5.3.1. Tissues or cells of human origin or their derivatives
p.000152:
p.000152:
p.000152: (a) For devices manufactured utilising derivatives of tissues or cells of human origin that are covered
p.000152: by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as
p.000152: an integral part, tissues or cells of human origin, or their derivatives, covered by Directive
p.000152: 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to
p.000152: issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the
p.000152: competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human
p.000152: tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing
p.000152: of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of
p.000152: the preliminary conformity assessment which provides, among other things, information about the
...
p.000153: human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion
p.000153: from one of the competent authorities designated by the Member States in accordance with Directive
p.000153: 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal
p.000153: products authority consulted’ depending on which has been consulted under this point, on the compliance
p.000153: of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
p.000153:
p.000153: (c) The opinion of the medicinal products authority consulted shall be drawn up within 150 days of
p.000153: receipt of all the necessary documentation.
p.000153:
p.000153: (d) The scientific opinion of the medicinal products authority consulted, and any possible update, shall
p.000153: be included in the documentation of the notified body concerning the device. The notified body shall
p.000153: give due consideration to the views expressed in the scientific opinion when making its decision and
p.000153: shall convey its final decision to the medicinal products authority consulted.
p.000153:
p.000153: 6. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000153: substance which, if used separately, would be considered to be a medicinal product derived from human
p.000153: blood or human plasma as referred to in Article 1(8)
p.000153:
p.000153: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000153: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000153: human blood
p.000153:
p.000154: L 117/154 EN
p.000154: Official Journal of the European Union
p.000154: 5.5.2017
p.000154:
p.000154: or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform
p.000154: the notified body of the release of the batch of devices and send it the official certificate
p.000154: concerning the release of the batch of human blood or plasma derivative used in the device, issued by
p.000154: a Member State laboratory or a laboratory designated for that purpose by a Member State in
p.000154: accordance with Article 114(2) of Directive 2001/83/EC.
p.000154:
p.000154: CHAPTER III
p.000154:
p.000154: ADMINISTRATIVE PROVISIONS
p.000154:
p.000154: 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000154: its authorised representative shall, for a period ending no sooner than 10 years, and in the case of
p.000154: implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at
p.000154: the disposal of the competent authorities:
p.000154:
p.000154: — the EU declaration of conformity,
p.000154:
p.000154: — the documentation referred to in the fifth indent of Section 2.1 and in particular the data and records arising
p.000154: from the procedures referred to in point (c) of the second paragraph of Section 2.2,
p.000154:
p.000154: — information on the changes referred to in Section 2.4,
p.000154:
p.000154: — the documentation referred to in Section 4.2, and
p.000154:
...
p.000157: quality plans and quality records.
p.000157:
p.000157: That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d)
p.000157: and (e) of Section 2.2 of Annex IX.
p.000157:
p.000157: 6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply.
p.000157:
p.000157: If the quality management system is such that it ensures that the devices conform to the type described in the EU
p.000157: type-examination certificate and that it conforms to the relevant provisions of this Regulation, the
p.000157: notified body shall issue an EU quality assurance certificate. The notified body shall notify the
p.000157: manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the
p.000157: notified body's audit and a reasoned assessment.
p.000157:
p.000158: L 117/158 EN
p.000158: Official Journal of the European Union
p.000158: 5.5.2017
p.000158:
p.000158: 6.4. Section 2.4 of Annex IX shall apply.
p.000158:
p.000158:
p.000158: 7. Surveillance
p.000158:
p.000158: Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of
p.000158: Annex IX shall apply.
p.000158:
p.000158: In the case of class III devices, surveillance shall also include a check that the quantities of
p.000158: produced or purchased raw material or crucial components approved for the type and correspond to the
p.000158: quantities of finished devices.
p.000158:
p.000158: 8. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000158: substance which, if used separately, would be considered to be a medicinal product derived from human blood or human
p.000158: plasma referred to in Article 1(8).
p.000158:
p.000158: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000158: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000158: human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the
p.000158: notified body of the release of the batch of devices and send it the official certificate concerning the
p.000158: release of the batch of human blood or plasma derivative used in the device, issued by a Member State
p.000158: laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of
p.000158: Directive 2001/83/EC.
p.000158:
p.000158:
p.000158: 9. Administrative provisions
p.000158:
p.000158: The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its
p.000158: authorised representative shall, for a period ending no sooner than 10 years, and in the case of
p.000158: implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at
p.000158: the disposal of the competent authorities:
p.000158:
p.000158: — the EU declaration of conformity,
p.000158:
p.000158: — the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
p.000158:
p.000158: — the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU
p.000158: type- examination certificate referred to in Annex X,
p.000158:
p.000158: — information on the changes referred to in Section 2.4 of Annex IX, and
p.000158:
p.000158: — the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX. Section 8
p.000158: of Annex IX shall apply.
p.000158:
p.000158: 10. Application to class IIa devices
p.000158:
...
p.000159: manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.
p.000159:
p.000159: 14. The notified body shall carry out the appropriate examinations and tests in order to verify the conformity
p.000159: of the device with the requirements of the Regulation by examining and testing every product
p.000159: as specified in Section 15.
p.000159:
p.000159: The examinations and tests referred to in the first paragraph of this Section shall not apply to
p.000159: aspects of the manufacturing process designed to secure sterility.
p.000159:
p.000159:
p.000159: 15. Verification by examination and testing of every product
p.000159:
p.000159: 15.1. Every device shall be examined individually and the appropriate physical or laboratory tests as
p.000159: defined in the relevant standard or standards referred to in Article 8, or equivalent tests and assessments, shall be
p.000159: carried out in order to verify, where appropriate, the conformity of the devices with the type described
p.000159: in the EU type- examination certificate and with the requirements of this Regulation which apply to them.
p.000159:
p.000160: L 117/160 EN
p.000160: Official Journal of the European Union
p.000160: 5.5.2017
p.000160:
p.000160: 15.2. The notified body shall affix, or have affixed, its identification number to each approved
p.000160: device and shall draw up an EU product verification certificate relating to the tests and assessments carried out.
p.000160:
p.000160: 16. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000160: substance which, if used separately, would be considered to be a medicinal product derived from human blood or human
p.000160: plasma referred to in Article 1(8).
p.000160:
p.000160: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000160: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000160: human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the
p.000160: notified body of the release of the batch of devices and send it the official certificate concerning the
p.000160: release of the batch of human blood or plasma derivative used in the device, issued by a Member State
p.000160: laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of
p.000160: Directive 2001/83/EC.
p.000160:
p.000160: 17. Administrative provisions
p.000160:
p.000160: The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years,
p.000160: and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the
p.000160: market, keep at the disposal of the competent authorities:
p.000160:
p.000160: — the EU declaration of conformity,
p.000160:
p.000160: — the documentation referred to in Section 12,
p.000160:
p.000160: — the certificate referred to in Section 15.2, and
p.000160:
p.000160: — the EU type-examination certificate referred to in Annex X. Section 8 of Annex IX shall apply.
p.000160: 18. Application to class IIa devices
p.000160:
p.000160: 18.1. By way of derogation from Section 11, by virtue of the EU declaration of conformity the
p.000160: manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are
p.000160: manufactured in conformity with the technical documentation referred to in Annexes II and III and meet
p.000160: the requirements of this Regulation which apply to them.
p.000160:
...
p.000162:
p.000162: 15. legally binding signature of the notified body in accordance with the applicable national law.
p.000162:
p.000162: 5.5.2017 EN
p.000162: Official Journal of the European Union
p.000163: L 117/163
p.000163:
p.000163: ANNEX XIII
p.000163:
p.000163: PROCEDURE FOR CUSTOM-MADE DEVICES
p.000163:
p.000163: 1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement
p.000163: containing all of the following information:
p.000163:
p.000163: — the name and address of the manufacturer, and of all manufacturing sites,
p.000163:
p.000163: — if applicable, the name and address of the authorised representative,
p.000163:
p.000163: — data allowing identification of the device in question,
p.000163:
p.000163: — a statement that the device is intended for exclusive use by a particular patient or user,
p.000163: identified by name, an acronym or a numerical code,
p.000163:
p.000163: — the name of the person who made out the prescription and who is authorised by national law by virtue
p.000163: of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
p.000163:
p.000163: — the specific characteristics of the product as indicated by the prescription,
p.000163:
p.000163: — a statement that the device in question conforms to the general safety and performance requirements
p.000163: set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been
p.000163: fully met, together with the grounds,
p.000163:
p.000163: — where applicable, an indication that the device contains or incorporates a medicinal substance, including a human
p.000163: blood or plasma derivative, or tissues or cells of human origin, or of animal origin as
p.000163: referred to in Regulation (EU) No 722/2012.
p.000163:
p.000163: 2. The manufacturer shall undertake to keep available for the competent national authorities
p.000163: documentation that indicates its manufacturing site or sites and allows an understanding to be formed of
p.000163: the design, manufacture and performance of the device, including the expected performance, so as to allow
p.000163: assessment of conformity with the requirements of this Regulation.
p.000163:
p.000163: 3. The manufacturer shall take all the measures necessary to ensure that the manufacturing process
p.000163: produces devices which are manufactured in accordance with the documentation referred to in Section 2.
p.000163:
p.000163: 4. The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years
p.000163: after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15
p.000163: years.
p.000163:
p.000163: Section 8 of Annex IX shall apply.
p.000163:
p.000163: 5. The manufacturer shall review and document experience gained in the post-production phase, including
p.000163: from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective
p.000163: action, In that context, it shall report in accordance with Article 87(1) to the competent authorities
p.000163: any serious incidents or field safety corrective actions or both as soon as it learns of them.
p.000163:
p.000164: L 117/164 EN
p.000164: Official Journal of the European Union
p.000164: 5.5.2017
...
p.000168:
p.000168: 1.4. status of the clinical investigation application (i.e. first submission, resubmission, significant
p.000168: amendment);
p.000168:
p.000168: 1.5. details and/or reference to the clinical evaluation plan;
p.000168:
p.000168: 1.6. If the application is a resubmission with regard to a device for which an application has been already
p.000168: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000168: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000168: changes from the previous application together with a rationale for those changes, in particular, whether
p.000168: any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000168:
p.000168: 1.7. if the application is submitted in parallel with an application for a clinical
p.000168: trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the
p.000168: clinical trial;
p.000168:
p.000168: 1.8. identification of the Member States and third countries in which the clinical investigation is
p.000168: to be conducted as part of a multicentre or multinational study at the time of application;
p.000168:
p.000168: 1.9. a brief description of the investigational device, its classification and other information necessary for
p.000168: the identifi cation of the device and device type;
p.000168:
p.000168: 1.10. information as to whether the device incorporates a medicinal substance, including a human
p.000168: blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal
p.000168: origin, or their derivatives;
p.000168:
p.000168: 1.11. summary of the clinical investigation plan including the objective or objectives of the clinical
p.000168: investigation, the number and gender of subjects, criteria for subject selection, whether there are
p.000168: subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies,
p.000168: planned dates of commencement and of completion of the clinical investigation;
p.000168:
p.000168: 1.12. if applicable, information regarding a comparator device, its classification and other
p.000168: information necessary for the identification of the comparator device;
p.000168:
p.000168: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are
p.000168: capable of conducting the clinical investigation in accordance with the clinical investigation plan;
p.000168:
p.000168: 1.14. details of the anticipated start date and duration of the investigation;
p.000168:
p.000168: 1.15. details to identify the notified body, if already involved at the stage of application for a clinical
p.000168: investigation;
p.000168:
p.000168: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics
p.000168: committee that is assessing or has assessed the application; and
p.000168:
p.000168: 1.17. the statement referred to in Section 4.1.
p.000168:
p.000168:
...
p.000169: placed on the market. In addition, information relating to any relevant training required.
p.000169:
p.000169: 2.3. Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in
p.000169: particular regarding in- design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or
p.000169: electrical tests, reliability tests, sterili sation validation, software verification and validation,
p.000169: performance tests, evaluation of biocompatibility and biological safety, as applicable.
p.000169:
p.000169: 2.4. Existing clinical data, in particular:
p.000169:
p.000169: — from relevant scientific literature available relating to the safety, performance, clinical benefits to
p.000169: patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices;
p.000169:
p.000169: — other relevant clinical data available relating to the safety, performance, clinical benefits to
p.000169: patients, design characteristics and intended purpose of equivalent or similar devices of the same
p.000169: manufacturer, including length of time on the market and a review of performance, clinical benefit and
p.000169: safety-related issues and any corrective actions taken.
p.000169:
p.000169: 2.5. Summary of the benefit-risk analysis and the risk management, including information regarding
p.000169: known or foreseeable risks, any undesirable effects, contraindications and warnings.
p.000169:
p.000169: 2.6. In the case of devices that incorporate a medicinal substance, including a human blood or
p.000169: plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin,
p.000169: or their derivatives, detailed information on the medicinal substance or on the tissues, cells
p.000169: or their derivatives, and on the compliance with the relevant general safety and performance
p.000169: requirements and the specific risk management in relation to the substance or tissues, cells or their
p.000169: derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the
p.000169: clinical benefit and/or safety of the device.
p.000169:
p.000169: 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements
p.000169: set out in Annex I, including the standards and CS applied, in full or in part, as well as a
p.000169: description of the solutions for fulfilling the relevant general safety and performance requirements, in so
p.000169: far as those standards and CS have not or have only been partly fulfilled or are lacking.
p.000169:
p.000169: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000169: the clinical investi gation and in particular information on any deviation from normal clinical practice.
p.000169:
p.000169:
p.000169: 3. Clinical Investigation Plan
p.000169:
p.000169: The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology,
p.000169: monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall
p.000169: contain in particular the information as laid down in this Annex. If part of this information is
p.000169: submitted in a separate document, it shall be referenced in the CIP.
p.000169:
p.000169:
p.000169: 3.1. General
p.000169:
p.000169: 3.1.1. Single identification number of the clinical investigation, as referred to in Article 70(1).
p.000169:
p.000169: 3.1.2. Identification of the sponsor — name, address and contact details of the sponsor and, where
...
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p.000072:
p.000072:
p.000072: Article 85
p.000072:
p.000072: Post-market surveillance report
p.000072:
p.000072: Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and
p.000072: conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000072: surveillance plan referred to in Article 84 together with a rationale and description of any preventive
p.000072: and corrective actions taken. The report shall be updated when necessary and made available to the competent
p.000072: authority upon request.
p.000072:
p.000072:
p.000072: Article 86
p.000072:
p.000072: Periodic safety update report
p.000072:
p.000072: 1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety
p.000072: update report (‘PSUR’) for each device and where relevant for each category or group of devices
p.000072: summarising the results and conclusions of the analyses of the post-market surveillance data gathered as
p.000072: a result of the post-market surveillance plan referred to in Article 84 together with a rationale and
p.000072: description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned,
p.000072: that PSUR shall set out:
p.000072:
p.000072: (a) the conclusions of the benefit-risk determination;
p.000072:
p.000072: (b) the main findings of the PMCF; and
p.000072:
p.000072: (c) the volume of sales of the device and an estimate evaluation of the size and other
p.000072: characteristics of the population using the device and, where practicable, the usage frequency of the device.
p.000072:
p.000072: Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR
p.000072: shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II
p.000072: and III.
p.000072:
p.000072: Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
p.000072: That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in
p.000072: Annexes II and III.
p.000072:
p.000072: For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.
p.000072:
p.000072: 2. For class III devices or implantable devices, manufacturers shall submit PSURs by means of the
p.000072: electronic system referred to in Article 92 to the notified body involved in the conformity assessment in
p.000072: accordance with Article 52. The notified body shall review the report and add its evaluation to that
p.000072: electronic system with details of any action taken. Such PSURs and the evaluation by the notified body
p.000072: shall be made available to competent authorities through that electronic system.
p.000072:
p.000072: 3. For devices other than those referred to in paragraph 2, manufacturers shall make PSURs
p.000072: available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
p.000072:
p.000072: 5.5.2017 EN
p.000072: Official Journal of the European Union
p.000073: L 117/73
p.000073:
p.000073: SECTION 2
p.000073:
p.000073: Vigilance
p.000073:
p.000073: Article 87
p.000073:
...
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p.000094: devices shall conform to safety principles, taking account of the generally acknowledged state of the
p.000094: art. To reduce risks, Manufac turers shall manage risks so that the residual risk associated with each hazard as
p.000094: well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions,
p.000094: manufacturers shall, in the following order of priority:
p.000094:
p.000094: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000094:
p.000094: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000094: risks that cannot be eliminated; and
p.000094:
p.000094: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to
p.000094: users.
p.000094:
p.000094: Manufacturers shall inform users of any residual risks.
p.000094:
p.000094: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000094:
p.000094: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000094: environment in which the device is intended to be used (design for patient safety), and
p.000094:
p.000094: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000094: where applicable, and the medical and physical conditions of intended users (design for lay, professional,
p.000094: disabled or other users).
p.000094:
p.000094: 5.5.2017 EN
p.000094: Official Journal of the European Union
p.000095: L 117/95
p.000095:
p.000095: 6. The characteristics and performance of a device shall not be adversely affected to such a
p.000095: degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised
p.000095: during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the
p.000095: stresses which can occur during normal conditions of use and has been properly maintained in accordance
p.000095: with the manufacturer's instructions.
p.000095:
p.000095: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000095: performance during their intended use are not adversely affected during transport and storage,
p.000095: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000095: information provided by the manufacturer.
p.000095:
p.000095: 8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and
p.000095: be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the
p.000095: achieved performance of the device during normal conditions of use.
p.000095:
p.000095: 9. For the devices referred to in Annex XVI, the general safety requirements set out in
p.000095: Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for
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p.000015: specific type of device in relation to aspects not covered by this Regulation.
p.000015:
p.000015: 15. This Regulation shall not affect national law concerning the organisation, delivery or financing
p.000015: of health services and medical care, such as the requirement that certain devices may only be supplied
p.000015: on a medical prescription, the requirement that only certain health professionals or healthcare institutions
p.000015: may dispense or use certain devices or that their use be accompanied by specific professional counselling.
p.000015:
p.000015: 16. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the
p.000015: media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular
p.000015: under Article 11 of the Charter of Fundamental Rights of the European Union.
p.000015:
p.000015:
p.000015: Article 2
p.000015:
p.000015: Definitions
p.000015:
p.000015: For the purposes of this Regulation, the following definitions apply:
p.000015: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or
p.000015: other article intended by the manufacturer to be used, alone or in combination, for human beings for
p.000015: one or more of the following specific medical purposes:
p.000015: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
p.000015: — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
p.000015: — investigation, replacement or modification of the anatomy or of a physiological or pathological process
p.000015: or state,
p.000015: — providing information by means of in vitro examination of specimens derived from the human body,
p.000015: including organ, blood and tissue donations,
p.000015: and which does not achieve its principal intended action by pharmacological, immunological or metabolic
p.000015: means, in or on the human body, but which may be assisted in its function by such means.
p.000015: The following products shall also be deemed to be medical devices:
p.000015: — devices for the control or support of conception;
p.000015: — products specifically intended for the cleaning, disinfection or sterilisation of devices as
p.000015: referred to in Article 1(4) and of those referred to in the first paragraph of this point.
p.000015:
p.000015: (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending
p.000015: Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
p.000015:
p.000016: L 117/16 EN
p.000016: Official Journal of the European Union
p.000016: 5.5.2017
p.000016:
p.000016: (2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device,
p.000016: is intended by its manufacturer to be used together with one or several particular medical device(s) to
p.000016: specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to
p.000016: specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended
p.000016: purpose(s);
p.000016:
...
p.000140:
p.000140: 1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
p.000140:
p.000140: 1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
p.000140:
p.000140: 1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
p.000140:
p.000140: 2. INVASIVE AND ACTIVE DEVICES
p.000140:
p.000140: 2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the
p.000140: eyeball, or any permanent artificial opening, such as a stoma.
p.000140:
p.000140: 2.2. ‘Surgically invasive device’ means:
p.000140: (a) an invasive device which penetrates inside the body through the surface of the body, including
p.000140: through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
p.000140: (b) a device which produces penetration other than through a body orifice.
p.000140: 2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting,
p.000140: drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection
p.000140: to an active device and which is intended by the manufacturer to be reused after appropriate
p.000140: procedures such as cleaning, disinfection and sterilisation have been carried out.
p.000140:
p.000140: 2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with
p.000140: other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or
p.000140: alleviation of an illness, injury or disability.
p.000140:
p.000140: 2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used,
p.000140: whether alone or in combination with other devices, to supply information for detecting, diagnosing,
p.000140: monitoring or treating physio logical conditions, states of health, illnesses or congenital deformities.
p.000140:
p.000140: 2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus
p.000140: aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria
p.000140: carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae
p.000140: pulmonales, vena cava superior and vena cava inferior.
p.000140:
p.000140: 2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.
p.000140:
p.000140: 2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a
p.000140: pathological change or change following disease or a wound.
p.000140:
p.000140: CHAPTER II
p.000140:
p.000140: IMPLEMENTING RULES
p.000140:
p.000140: 3.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.000140:
p.000140: 3.2. If the device in question is intended to be used in combination with another device, the
p.000140: classification rules shall apply separately to each of the devices. Accessories for a medical device and
p.000140: for a product listed in Annex XVI shall be classified in their own right separately from the device with which
p.000140: they are used.
p.000140:
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000019: clinical investigation site;
p.000019:
p.000019: (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000019: participate in a particular clinical investigation, after having been informed of all aspects of the
p.000019: clinical investigation that are relevant to the subject's decision to participate or, in the case of
p.000019: minors and of incapacitated subjects, an authoris ation or agreement from their legally designated representative
p.000019: to include them in the clinical investigation;
p.000019:
p.000019: (56) ‘ethics committee’ means an independent body established in a Member State in accordance with the
p.000019: law of that Member State and empowered to give opinions for the purposes of this Regulation, taking
p.000019: into account the views of laypersons, in particular patients or patients' organisations;
p.000019:
p.000019: (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward
p.000019: clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the
p.000019: context of a clinical investigation, whether or not related to the investigational device;
p.000019:
p.000019: (58) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000019:
p.000019: (a) death,
p.000019:
p.000019: (b) serious deterioration in the health of the subject, that resulted in any of the following:
p.000019:
p.000019: (i) life-threatening illness or injury,
p.000019:
p.000019: (ii) permanent impairment of a body structure or a body function,
p.000019:
p.000019: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000019:
p.000019: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent
p.000019: impairment to a body structure or a body function,
p.000019:
p.000019: (v) chronic disease,
p.000019:
p.000019: (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000019:
p.000019: (59) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000019: performance of an investigational device, including malfunction, use errors or inadequacy in
p.000019: information supplied by the manufacturer;
p.000019:
p.000019: (60) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000019: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000019: and review experience gained from devices they place on the market, make available on the market or put into service
p.000019: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000019:
p.000019: (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities
p.000019: to check and ensure that devices comply with the requirements set out in the relevant Union
p.000019: harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
p.000019:
p.000019: (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made
p.000019: available to the end user;
p.000019:
p.000020: L 117/20 EN
p.000020: Official Journal of the European Union
p.000020: 5.5.2017
p.000020:
p.000020: (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000020: made available on the market;
p.000020: (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device
p.000020: made available on the market, including use-error due to ergonomic features, as well as any inadequacy
p.000020: in the information supplied by the manufacturer and any undesirable side-effect;
p.000020: (65) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000020: lead to any of the following:
p.000020: (a) the death of a patient, user or other person,
p.000020: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000020: (c) a serious public health threat;
p.000020: (66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious
p.000020: deterioration in a person's state of health, or serious illness, that may require prompt remedial
p.000020: action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the
p.000020: given place and time;
p.000020: (67) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000020: non-conformity or other undesirable situation;
p.000020: (68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or
p.000020: medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the
p.000020: market;
p.000020: (69) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000020: relation to a field safety corrective action;
p.000020: (70) ‘harmonised standard’ means a European standard as defined in point
p.000020: (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
p.000020: (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000020: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000020:
p.000020: Article 3
p.000020:
p.000020: Amendment of certain definitions
p.000020:
p.000020: The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of
p.000020: nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article
p.000020: 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and
p.000020: international level.
p.000020:
p.000020:
p.000020: Article 4
...
p.000140:
p.000140: 1. DURATION OF USE
p.000140:
p.000140: 1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
p.000140:
p.000140: 1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
p.000140:
p.000140: 1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
p.000140:
p.000140: 2. INVASIVE AND ACTIVE DEVICES
p.000140:
p.000140: 2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the
p.000140: eyeball, or any permanent artificial opening, such as a stoma.
p.000140:
p.000140: 2.2. ‘Surgically invasive device’ means:
p.000140: (a) an invasive device which penetrates inside the body through the surface of the body, including
p.000140: through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
p.000140: (b) a device which produces penetration other than through a body orifice.
p.000140: 2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting,
p.000140: drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection
p.000140: to an active device and which is intended by the manufacturer to be reused after appropriate
p.000140: procedures such as cleaning, disinfection and sterilisation have been carried out.
p.000140:
p.000140: 2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with
p.000140: other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or
p.000140: alleviation of an illness, injury or disability.
p.000140:
p.000140: 2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used,
p.000140: whether alone or in combination with other devices, to supply information for detecting, diagnosing,
p.000140: monitoring or treating physio logical conditions, states of health, illnesses or congenital deformities.
p.000140:
p.000140: 2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus
p.000140: aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria
p.000140: carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae
p.000140: pulmonales, vena cava superior and vena cava inferior.
p.000140:
p.000140: 2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.
p.000140:
p.000140: 2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a
p.000140: pathological change or change following disease or a wound.
p.000140:
p.000140: CHAPTER II
p.000140:
p.000140: IMPLEMENTING RULES
p.000140:
p.000140: 3.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.000140:
p.000140: 3.2. If the device in question is intended to be used in combination with another device, the
p.000140: classification rules shall apply separately to each of the devices. Accessories for a medical device and
p.000140: for a product listed in Annex XVI shall be classified in their own right separately from the device with which
p.000140: they are used.
p.000140:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000009: investigations to the Member States in which those clinical investigations are being conducted. Member
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
p.000009: subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
p.000009:
p.000009:
p.000009: (70) The sponsor of a clinical investigation should submit a summary of results of the clinical
p.000009: investigation that is easily understandable for the intended user together with the clinical investigation
p.000009: report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to
p.000009: submit the summary of the results within the defined timelines for scientific reasons, the sponsor should
p.000009: justify this and specify when the results will be submitted.
p.000009:
p.000009:
p.000009: (71) This Regulation should cover clinical investigations intended to gather clinical evidence for
p.000009: the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and
p.000009: scientific assessments for other types of clinical investigations of medical devices.
p.000009:
p.000010: L 117/10 EN
p.000010: Official Journal of the European Union
p.000010: 5.5.2017
p.000010:
p.000010: (72) Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection
p.000010: measures. However, it should be left to Member States to determine the legally designated representatives
p.000010: of incapacitated subjects and minors.
p.000010:
p.000010: (73) The principles of replacement, reduction and refinement in the area of animal experimentation
p.000010: laid down in the Directive 2010/63/EU of the European Parliament and of the Council (1) should be
p.000010: observed. In particular, the unnecessary duplication of tests and studies should be avoided.
p.000010:
p.000010: (74) Manufacturers should play an active role during the post-market phase by systematically and
p.000010: actively gathering information from post-market experience with their devices in order to update their technical
p.000010: documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000010: activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000010: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000010: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000010: preventive and/or corrective actions, should be used to update any relevant part of technical
...
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
...
p.000096: in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or,
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
p.000097: the unintentional ingress of substances into the device taking into account the device and the nature of
p.000097: the environment in which it is intended to be used.
p.000097:
p.000097: 10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked
p.000097: to the size and the properties of particles which are or can be released into the patient's or user's
p.000097: body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
p.000097:
p.000097: 11. Infection and microbial contamination
p.000097:
p.000097: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as
p.000097: far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
p.000097:
p.000097: (a) reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as
p.000097: needle stick injuries,
p.000097:
p.000097: (b) allow easy and safe handling,
p.000097:
...
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
p.000009: subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
p.000009:
p.000009:
p.000009: (70) The sponsor of a clinical investigation should submit a summary of results of the clinical
p.000009: investigation that is easily understandable for the intended user together with the clinical investigation
p.000009: report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to
p.000009: submit the summary of the results within the defined timelines for scientific reasons, the sponsor should
p.000009: justify this and specify when the results will be submitted.
p.000009:
p.000009:
p.000009: (71) This Regulation should cover clinical investigations intended to gather clinical evidence for
p.000009: the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and
p.000009: scientific assessments for other types of clinical investigations of medical devices.
p.000009:
p.000010: L 117/10 EN
p.000010: Official Journal of the European Union
p.000010: 5.5.2017
p.000010:
p.000010: (72) Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection
p.000010: measures. However, it should be left to Member States to determine the legally designated representatives
p.000010: of incapacitated subjects and minors.
p.000010:
p.000010: (73) The principles of replacement, reduction and refinement in the area of animal experimentation
p.000010: laid down in the Directive 2010/63/EU of the European Parliament and of the Council (1) should be
p.000010: observed. In particular, the unnecessary duplication of tests and studies should be avoided.
p.000010:
p.000010: (74) Manufacturers should play an active role during the post-market phase by systematically and
p.000010: actively gathering information from post-market experience with their devices in order to update their technical
p.000010: documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000010: activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000010: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000010: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000010: preventive and/or corrective actions, should be used to update any relevant part of technical
p.000010: documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the
p.000010: purpose of transparency.
p.000010:
...
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
...
p.000096: in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or,
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
p.000097: the unintentional ingress of substances into the device taking into account the device and the nature of
p.000097: the environment in which it is intended to be used.
p.000097:
p.000097: 10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked
p.000097: to the size and the properties of particles which are or can be released into the patient's or user's
p.000097: body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
p.000097:
p.000097: 11. Infection and microbial contamination
p.000097:
p.000097: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as
p.000097: far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
p.000097:
p.000097: (a) reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as
p.000097: needle stick injuries,
p.000097:
p.000097: (b) allow easy and safe handling,
p.000097:
p.000097: (c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
p.000097:
...
Health / immuno-compromised
Searching for indicator immuno-compromised:
(return to top)
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
p.000170: 3.13. Description of the Informed consent process.
p.000170:
...
Health / injured
Searching for indicator injured:
(return to top)
p.000005: medical devices manufactured and used only within health institutions, including hospitals as well as
p.000005: institutions, such as laboratories and public health institutes that support the healthcare system and/or
p.000005: address patient needs, but which do not treat or care for patients directly, should not apply, since
p.000005: the aims of this Regulation would still be met in a proportionate manner. It should be noted that the
p.000005: concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests
p.000005: or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption
p.000005: applicable to health institutions does not apply to such establishments.
p.000005:
p.000005:
p.000005: (31) In view of the fact that natural or legal persons can claim compensation for damage caused by a
p.000005: defective device in accordance with applicable Union and national law, it is appropriate to
p.000005: require manufacturers to have measures in place to provide sufficient financial coverage in respect of
p.000005: their potential liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to
p.000005: the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay
p.000005: down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may
p.000005: have been injured by a defective device.
p.000005:
p.000005:
p.000005: (32) To ensure that devices manufactured in series production continue to be in conformity with the
p.000005: requirements of this Regulation and that experience from the use of the devices they manufacture is
p.000005: taken into account for the production process, all manufacturers should have a quality management system
p.000005: and a post-market surveillance system in place which should be proportionate to the risk class and the
p.000005: type of the device in question. In addition, in order to minimize risks or prevent incidents related to
p.000005: devices, manufacturers should establish a system for risk management and a system for reporting of incidents and
p.000005: field safety corrective actions.
p.000005:
p.000005:
p.000005: (33) The risk management system should be carefully aligned with and reflected in the clinical
p.000005: evaluation for the device, including the clinical risks to be addressed as part of clinical
p.000005: investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical
p.000005: evaluation processes should be inter-dependent and should be regularly updated.
p.000005:
p.000005:
p.000005: (34) It should be ensured that supervision and control of the manufacture of devices, and the post-market
p.000005: surveillance and vigilance activities concerning them, are carried out within the manufacturer's
...
p.000025: in which the manufacturer has its registered place of business may require that the manufacturer provide
p.000025: samples of the device free of charge or, where that is impracticable, grant access to the device.
p.000025: Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
p.000025: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000025: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000025: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000025: overriding public interest in disclosure, without prejudice to the protection of intellectual property
p.000025: rights.
p.000025:
p.000025: The competent authority need not comply with the obligation laid down in the third subparagraph where
p.000025: disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt
p.000025: with in the context of legal proceedings.
p.000025:
p.000025: 15. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000025: person the information on the identity of that person shall be part of the information to be
p.000025: submitted in accordance with Article 30(1).
p.000025:
p.000025: 16. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000025: accordance with applicable Union and national law.
p.000025:
p.000025: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000025: of the enterprise, have measures in place to provide sufficient financial coverage in respect
...
p.000140: drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection
p.000140: to an active device and which is intended by the manufacturer to be reused after appropriate
p.000140: procedures such as cleaning, disinfection and sterilisation have been carried out.
p.000140:
p.000140: 2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with
p.000140: other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or
p.000140: alleviation of an illness, injury or disability.
p.000140:
p.000140: 2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used,
p.000140: whether alone or in combination with other devices, to supply information for detecting, diagnosing,
p.000140: monitoring or treating physio logical conditions, states of health, illnesses or congenital deformities.
p.000140:
p.000140: 2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus
p.000140: aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria
p.000140: carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae
p.000140: pulmonales, vena cava superior and vena cava inferior.
p.000140:
p.000140: 2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.
p.000140:
p.000140: 2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a
p.000140: pathological change or change following disease or a wound.
p.000140:
p.000140: CHAPTER II
p.000140:
p.000140: IMPLEMENTING RULES
p.000140:
p.000140: 3.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.000140:
p.000140: 3.2. If the device in question is intended to be used in combination with another device, the
p.000140: classification rules shall apply separately to each of the devices. Accessories for a medical device and
p.000140: for a product listed in Annex XVI shall be classified in their own right separately from the device with which
p.000140: they are used.
p.000140:
p.000140: 3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the
p.000140: device.
p.000140:
p.000140: If the software is independent of any other device, it shall be classified in its own right.
p.000140:
p.000140: 5.5.2017 EN
p.000140: Official Journal of the European Union
p.000141: L 117/141
p.000141:
p.000141: 3.4. If the device is not intended to be used solely or principally in a specific part of the
p.000141: body, it shall be considered and classified on the basis of the most critical specified use.
p.000141:
p.000141: 3.5. If several rules, or if, within the same rule, several sub-rules, apply to the same device
p.000141: based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall
p.000141: apply.
p.000141:
p.000141: 3.6. In calculating the duration referred to in Section 1, continuous use shall mean:
...
p.000141: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
p.000141:
p.000141: 4.2. Rule 2
p.000141:
p.000141: All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues,
p.000141: liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified
p.000141: as class IIa:
p.000141: — if they may be connected to a class IIa, class IIb or class III active device; or
p.000141: — if they are intended for use for channelling or storing blood or other body liquids or for storing organs,
p.000141: parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
p.000141: In all other cases, such devices are classified as class I.
p.000141:
p.000141: 4.3. Rule 3
p.000141:
p.000141: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells,
p.000141: blood, other body liquids or other liquids intended for implantation or administration into the body are classified as
p.000141: class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of
p.000141: gas, heat, in which case they are classified as class IIa.
p.000141:
p.000141: All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct
p.000141: contact with human cells, tissues or organs taken from the human body or used in vitro with human
p.000141: embryos before their implantation or administration into the body are classified as class III.
p.000141:
p.000141: 4.4. Rule 4
p.000141:
p.000141: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
p.000141: — class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
p.000141: — class IIb if they are intended to be used principally for injuries to skin which have breached the
p.000141: dermis or mucous membrane and can only heal by secondary intent;
p.000141:
p.000142: L 117/142 EN
p.000142: Official Journal of the European Union
p.000142: 5.5.2017
p.000142:
p.000142: — class IIa if they are principally intended to manage the micro-environment of injured skin
p.000142: or mucous membrane; and
p.000142: — class IIa in all other cases.
p.000142: This rule applies also to the invasive devices that come into contact with injured mucous membrane.
p.000142:
p.000142: 5. INVASIVE DEVICES
p.000142:
p.000142: 5.1. Rule 5
p.000142:
p.000142: All invasive devices with respect to body orifices, other than surgically invasive devices, which are
p.000142: not intended for connection to an active device or which are intended for connection to a class I active device are
p.000142: classified as:
p.000142: — class I if they are intended for transient use;
p.000142: — class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx,
p.000142: in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and
p.000142: — class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the
p.000142: pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be
p.000142: absorbed by the mucous membrane, in which case they are classified as class IIa.
p.000142: All invasive devices with respect to body orifices, other than surgically invasive devices, intended for
p.000142: connection to a class IIa, class IIb or class III active device, are classified as class IIa.
p.000142:
p.000142: 5.2. Rule 6
p.000142:
p.000142: All surgically invasive devices intended for transient use are classified as class IIa unless they:
p.000142: — are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the
p.000142: central circulatory system through direct contact with those parts of the body, in which case they are
p.000142: classified as class III;
p.000142: — are reusable surgical instruments, in which case they are classified as class I;
...
Health / sexually transmitted disases
Searching for indicator sexually transmitted:
(return to top)
p.000144: is intended for monitoring of vital physiological parameters, where the nature of variations of those
p.000144: parameters is such that it could result in immediate danger to the patient, in which case it is classified as
p.000144: class IIb.
p.000144:
p.000144: All other software is classified as class I.
p.000144:
p.000144: 6.4. Rule 12
p.000144:
p.000144: All active devices intended to administer and/or remove medicinal products, body liquids or other
p.000144: substances to or from the body are classified as class IIa, unless this is done in a manner that is
p.000144: potentially hazardous, taking account of the nature of the substances involved, of the part of the body
p.000144: concerned and of the mode of application in which case they are classified as class IIb.
p.000144:
p.000144: 6.5. Rule 13
p.000144:
p.000144: All other active devices are classified as class I.
p.000144:
p.000144: 7. SPECIAL RULES
p.000144:
p.000144: 7.1. Rule 14
p.000144:
p.000144: All devices incorporating, as an integral part, a substance which, if used separately, can be considered
p.000144: to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a
p.000144: medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of
p.000144: that Directive, and that has an action ancillary to that of the devices, are classified as class III.
p.000144:
p.000144: 7.2. Rule 15
p.000144:
p.000144: All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified
p.000144: as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class
p.000144: III.
p.000144:
p.000144: 7.3. Rule 16
p.000144:
p.000144: All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate,
p.000144: hydrating contact lenses are classified as class IIb.
p.000144:
p.000144: All devices intended specifically to be used for disinfecting or sterilising medical devices are
p.000144: classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended
p.000144: specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are
p.000144: classified as class IIb.
p.000144:
p.000144: This rule does not apply to devices that are intended to clean devices other than contact lenses by
p.000144: means of physical action only.
p.000144:
p.000144: 7.4. Rule 17
p.000144:
p.000144: Devices specifically intended for recording of diagnostic images generated by X-ray radiation are
p.000144: classified as class IIa.
p.000144:
p.000144: 5.5.2017 EN
p.000144: Official Journal of the European Union
p.000145: L 117/145
p.000145:
p.000145: 7.5. Rule 18
p.000145:
p.000145: All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives,
p.000145: which are non- viable or rendered non-viable, are classified as class III, unless such devices are
p.000145: manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or
p.000145: rendered non-viable and are devices intended to come into contact with intact skin only.
p.000145:
...
Social / Access to Social Goods
Searching for indicator access:
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p.000006: putting into service of devices that comply with the requirements laid down in this Regulation. However, Member
p.000006: States should be allowed to decide whether to restrict the use of any specific type of device in relation
p.000006: to aspects that are not covered by this Regulation.
p.000006:
p.000006:
p.000006: (41) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000006: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000006: activities for devices, which is owing to improved incident reporting, targeted field safety corrective
p.000006: actions and better monitoring by competent authorities. It should also help to reduce medical errors and
p.000006: to fight against falsified devices. Use of the UDI system should also improve purchasing and waste
p.000006: disposal policies and stock-management by health institutions and other economic operators and, where
p.000006: possible, be compatible with other authentication systems already in place in those settings.
p.000006:
p.000006:
p.000006: (42) The UDI system should apply to all devices placed on the market except custom-made devices,
p.000006: and be based on internationally recognised principles including definitions that are compatible with those
p.000006: used by major trade partners. In order for the UDI system to become functional in time for the
p.000006: application of this Regulation, detailed rules should be laid down in this Regulation.
p.000006:
p.000006:
p.000006: (43) Transparency and adequate access to information, appropriately presented for the intended user,
p.000006: are essential in the public interest, to protect public health, to empower patients and healthcare professionals and
p.000006: to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to
p.000006: build confidence in the regulatory system.
p.000006:
p.000006:
p.000006: (44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European
p.000006: database on medical devices (Eudamed) that should integrate different electronic systems to collate and
p.000006: process information regarding devices on the market and the relevant economic operators, certain aspects
p.000006: of conformity assessment, notified
p.000006:
p.000006: (1) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
p.000006:
p.000006: 5.5.2017 EN
p.000006: Official Journal of the European Union
p.000007: L 117/7
p.000007:
p.000007: bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the
p.000007: database are to enhance overall transparency, including through better access to information for the public and
p.000007: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000007: States and to streamline and facilitate the flow of information between economic operators, notified
p.000007: bodies or sponsors and Member States as well as between Member States among themselves and with the
...
p.000010: the reporting of serious incidents occurring after a device has been placed on the market should be
p.000010: clearly distinguished to avoid double reporting.
p.000010:
p.000010: (80) Rules on market surveillance should be included in this Regulation to reinforce the rights and
p.000010: obligations of the national competent authorities, to ensure effective coordination of their market
p.000010: surveillance activities and to clarify the applicable procedures.
p.000010:
p.000010: (81) Any statistically significant increase in the number or severity of incidents that are not
p.000010: serious or in expected side-effects that could have a significant impact on the benefit-risk analysis and which
p.000010: could lead to unacceptable risks should be reported to the competent authorities in order to permit their
p.000010: assessment and the adoption of appropriate measures.
p.000010:
p.000010: (82) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated
p.000010: by the Member States based on their role and expertise in the field of medical devices including in
p.000010: vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by
p.000010: this Regulation and by Regulation (EU) 2017/746 of the European Parliament and of the
p.000010: Council (2), to provide advice to the Commission and to assist the Commission and the Member States
p.000010: in ensuring a harmonised implementation of this Regulation. The MDCG should be able to establish
p.000010: subgroups in order to have access to necessary in-depth
p.000010:
p.000010: (1) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the
p.000010: protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
p.000010: (2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
p.000010: medical devices and
p.000010: repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).
p.000010:
p.000010: 5.5.2017 EN
p.000010: Official Journal of the European Union
p.000011: L 117/11
p.000011:
p.000011: technical expertise in the field of medical devices including in vitro diagnostic medical devices. When
p.000011: establishing subgroups, appropriate consideration should be given to the possibility of involving existing
p.000011: groups at Union level in the field of medical devices.
p.000011:
p.000011:
p.000011: (83) Expert panels and expert laboratories should be designated by the Commission on the basis of
p.000011: their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific,
p.000011: technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in
p.000011: relation to the implementation of this Regulation. Moreover, expert panels should fulfil the
p.000011: tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of
...
p.000011: activities at national level, Member States should, in order to ensure transparency, inform the Commission
p.000011: and the other Member States before they decide on the level and structure of such fees. In order to
p.000011: further ensure transparency, the structure and level of the fees should be publicly available on request.
p.000011:
p.000011: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000011: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000011: data, the freedom of art and science, the freedom to conduct business and the right to property. This
p.000011: Regulation should be applied by the Member States in accordance with those rights and principles.
p.000011:
p.000011:
p.000011: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the
p.000011: Commission in order to amend certain non-essential provisions of this Regulation. It is of particular
p.000011: importance that the Commission carry out appropriate consultations during its preparatory work, including
p.000011: at expert level, and that those consultations be conducted in accordance with the principles laid down in the
p.000011: Interinstitutional Agreement of 13 April 2016 on Better Law-Making (1). In particular, to ensure equal
p.000011: participation in the preparation of delegated acts, the European Parliament and the Council receive all documents
p.000011: at the same time as Member States' experts, and their experts systematically have access to meetings of
p.000011: Commission expert groups dealing with preparation of delegated acts.
p.000011:
p.000011: (91) In order to ensure uniform conditions for the implementation of this Regulation,
p.000011: implementing powers should be conferred on the Commission. Those powers should be
p.000011: exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000011:
p.000011: (1) OJ L 123, 12.5.2016, p. 1.
p.000011: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000011: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise
p.000011: of implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000011:
p.000012: L 117/12 EN
p.000012: Official Journal of the European Union
p.000012: 5.5.2017
p.000012:
p.000012: (92) The advisory procedure should be used for implementing acts that set out the form and
p.000012: presentation of the data elements of manufacturers' summaries of safety and clinical performance, and that
p.000012: establish the model for certificates of free sale, given that such implementing acts are of a procedural
p.000012: nature and do not directly have an impact on health and safety at Union level.
p.000012:
p.000012:
p.000012: (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating
p.000012: to the extension to the territory of the Union of a national derogation from the applicable conformity
...
p.000021: (i) the name and address of the manufacturing health institution;
p.000021: (ii) the details necessary to identify the devices;
p.000021: (iii) a declaration that the devices meet the general safety and performance requirements set out in
p.000021: Annex I to this Regulation and, where applicable, information on which requirements are not fully met
p.000021: with a reasoned justifi cation therefor,
p.000021: (f) the health institution draws up documentation that makes it possible to have an understanding of the
p.000021: manufacturing facility, the manufacturing process, the design and performance data of the devices,
p.000021: including the intended purpose, and that is sufficiently detailed to enable the competent authority
p.000021: to ascertain that the general safety and performance requirements set out in Annex I to this Regulation
p.000021: are met;
p.000021: (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance
p.000021: with the documentation referred to in point (f), and
p.000021: (h) the health institution reviews experience gained from clinical use of the devices and takes all
p.000021: necessary corrective actions.
p.000021: Member States may require that such health institutions submit to the competent authority any
p.000021: further relevant information about such devices which have been manufactured and used on their territory.
p.000021: Member States shall retain the right to restrict the manufacture and the use of any specific type of
p.000021: such devices and shall be permitted access to inspect the activities of the health institutions.
p.000021:
p.000021: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000021:
p.000021: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000021: acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
p.000021: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000021:
p.000022: L 117/22 EN
p.000022: Official Journal of the European Union
p.000022: 5.5.2017
p.000022:
p.000022: Article 6
p.000022:
p.000022: Distance sales
p.000022:
p.000022: 1. A device offered by means of information society services, as defined in point (b)
p.000022: of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply
p.000022: with this Regulation.
p.000022:
p.000022: 2. Without prejudice to national law regarding the exercise of the medical profession, a device
p.000022: that is not placed on the market but used in the context of a commercial activity, whether in return
p.000022: for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by
p.000022: means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or
p.000022: by other means of communication, directly or through intermediaries, to a natural or legal person established in the
p.000022: Union shall comply with this Regulation.
p.000022:
...
p.000024: distributors of the device in question and, where applicable, the authorised representative and importers
p.000024: accordingly.
p.000024:
p.000024: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000024: of the Member States in which they made the device available and, where applicable, the notified body that
p.000024: issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any
p.000024: corrective action taken.
p.000024:
p.000024: 13. Manufacturers shall have a system for recording and reporting of incidents and field safety
p.000024: corrective actions as described in Articles 87 and 88.
p.000024:
p.000024: 5.5.2017 EN
p.000024: Official Journal of the European Union
p.000025: L 117/25
p.000025:
p.000025: 14. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000025: and documen tation necessary to demonstrate the conformity of the device, in an official
p.000025: Union language determined by the Member State concerned. The competent authority of the Member State
p.000025: in which the manufacturer has its registered place of business may require that the manufacturer provide
p.000025: samples of the device free of charge or, where that is impracticable, grant access to the device.
p.000025: Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
p.000025: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000025: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000025: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
...
p.000025:
p.000025: (a) verify that the EU declaration of conformity and technical documentation have been drawn
p.000025: up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the
p.000025: manufacturer;
p.000025:
p.000025: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if
p.000025: applicable, a copy of the relevant certificate, including any amendments and supplements, issued in
p.000025: accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
p.000025:
p.000025: (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied
p.000025: with the registration obligations laid down in Articles 27 and 29;
p.000025:
p.000026: L 117/26 EN
p.000026: Official Journal of the European Union
p.000026: 5.5.2017
p.000026:
p.000026: (d) in response to a request from a competent authority, provide that competent authority with all the
p.000026: information and documentation necessary to demonstrate the conformity of a device, in an official Union
p.000026: language determined by the Member State concerned;
p.000026: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000026: resentative has its registered place of business for samples, or access to a device and verify that
p.000026: the competent authority receives the samples or is given access to the device;
p.000026: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate
p.000026: or, if that is not possible, mitigate the risks posed by devices;
p.000026: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000026: patients and users about suspected incidents related to a device for which they have been designated;
p.000026: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000026: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's
p.000026: obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
p.000026:
p.000026: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000026: and has not complied with the obligations laid down in Article 10, the authorised representative shall
p.000026: be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000026:
p.000026: 6. An authorised representative who terminates its mandate on the ground referred to in point (h)
p.000026: of paragraph 3 shall immediately inform the competent authority of the Member State in which it is
p.000026: established and, where applicable, the notified body that was involved in the conformity assessment for
p.000026: the device of the termination of the mandate and the reasons therefor.
p.000026:
p.000026: 7. Any reference in this Regulation to the competent authority of the Member State in which the
...
p.000027: device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall
p.000027: also immediately inform the competent authorities of the Member States in which they made the device
p.000027: available and, if applicable, the notified body that issued a certificate in accordance with Article 56
p.000027: for the device in question, giving details, in particular, of the non-compliance and of any corrective
p.000027: action taken.
p.000027:
p.000027: 8. Importers who have received complaints or reports from healthcare professionals, patients
p.000027: or users about suspected incidents related to a device which they have placed on the market shall immediately
p.000027: forward this information to the manufacturer and its authorised representative.
p.000027:
p.000027: 9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of
p.000027: conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements,
p.000027: issued in accordance with Article 56.
p.000027:
p.000027: 10. Importers shall cooperate with competent authorities, at the latters' request, on any action
p.000027: taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have
p.000027: placed on the market. Importers, upon request by a competent authority of the Member State in which the
p.000027: importer has its registered place of business, shall provide samples of the device free of charge or, where
p.000027: that is impracticable, grant access to the device.
p.000027:
p.000027:
p.000027: Article 14
p.000027:
p.000027: General obligations of distributors
p.000027:
p.000027: 1. When making a device available on the market, distributors shall, in the context of their
p.000027: activities, act with due care in relation to the requirements applicable.
p.000027:
p.000027: 2. Before making a device available on the market, distributors shall verify that all of the
p.000027: following requirements are met:
p.000027: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000027: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
p.000027: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000027: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000027: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000027: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000027:
p.000028: L 117/28 EN
p.000028: Official Journal of the European Union
p.000028: 5.5.2017
p.000028:
p.000028: Where a distributor considers or has reason to believe that a device is not in conformity with the
p.000028: requirements of this Regulation, it shall not make the device available on the market until it has been
p.000028: brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's
p.000028: authorised representative, and the importer. Where the distributor considers or has reason to believe that
...
p.000028: non-compliance and of any corrective action taken.
p.000028:
p.000028: 5. Distributors that have received complaints or reports from healthcare professionals, patients
p.000028: or users about suspected incidents related to a device they have made available, shall immediately
p.000028: forward this information to the manufacturer and, where applicable, the manufacturer's authorised
p.000028: representative, and the importer. They shall keep a register of complaints, of non-conforming devices and
p.000028: of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and
p.000028: the importer informed of such monitoring and provide them with any information upon their request.
p.000028:
p.000028: 6. Distributors shall, upon request by a competent authority, provide it with all the information
p.000028: and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
p.000028:
p.000028: Distributors shall be considered to have fulfilled the obligation referred to in the first
p.000028: subparagraph when the manufacturer or, where applicable, the authorised representative for the
p.000028: device in question provides the required information. Distributors shall cooperate with competent
p.000028: authorities, at their request, on any action taken to eliminate the risks posed by devices which they
p.000028: have made available on the market. Distributors, upon request by a competent authority, shall provide free
p.000028: samples of the device or, where that is impracticable, grant access to the device.
p.000028:
p.000028:
p.000028: Article 15
p.000028:
p.000028: Person responsible for regulatory compliance
p.000028:
p.000028: 1. Manufacturers shall have available within their organisation at least one person
p.000028: responsible for regulatory compliance who possesses the requisite expertise in the field of medical
p.000028: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000028:
p.000028: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a
p.000028: university degree or of a course of study recognised as equivalent by the Member State concerned, in law,
p.000028: medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of
p.000028: professional experience in regulatory affairs or in quality management systems relating to medical devices;
p.000028:
p.000028: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000028: to medical devices.
p.000028:
p.000028: Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made
p.000028: devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of
p.000028: professional experience within a relevant field of manufacturing.
p.000028:
p.000028: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000028: not be required to have the person responsible for regulatory compliance within their organisation but
p.000028: shall have such person permanently and continuously at their disposal.
p.000028:
...
p.000031: submit it to the European Parliament and to the Council. On the basis of that report, the Commission
p.000031: shall, if appropriate, make proposals for amendments to this Regulation.
p.000031:
p.000031:
p.000031: Article 18
p.000031:
p.000031: Implant card and information to be supplied to the patient with an implanted device
p.000031:
p.000031: 1. The manufacturer of an implantable device shall provide together with the device the following:
p.000031:
p.000031: (a) information allowing the identification of the device, including the device name, serial number, lot number, the
p.000031: UDI, the device model, as well as the name, address and the website of the manufacturer;
p.000031:
p.000031: (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with
p.000031: regard to reciprocal interference with reasonably foreseeable external influences, medical
p.000031: examinations or environmental conditions;
p.000031:
p.000031: (c) any information about the expected lifetime of the device and any necessary follow-up;
p.000031:
p.000031: (d) any other information to ensure safe use of the device by the patient, including the information
p.000031: in point (u) of Section 23.4 of Annex I.
p.000031:
p.000032: L 117/32 EN
p.000032: Official Journal of the European Union
p.000032: 5.5.2017
p.000032:
p.000032: The information referred to in the first subparagraph shall be provided, for the purpose of making it
p.000032: available to the particular patient who has been implanted with the device, by any means that allow
p.000032: rapid access to that information and shall be stated in the language(s) determined by the concerned
p.000032: Member State. The information shall be written in a way that is readily understood by a lay person and
p.000032: shall be updated where appropriate. Updates of the information shall be made available to the patient via the
p.000032: website mentioned in point (a) of the first subparagraph.
p.000032:
p.000032: In addition, the manufacturer shall provide the information referred to in point (a) of the first
p.000032: subparagraph on an implant card delivered with the device.
p.000032:
p.000032: 2. Member States shall require health institutions to make the information referred to in paragraph
p.000032: 1 available, by any means that allow rapid access to that information, to any patients who have been
p.000032: implanted with the device, together with the implant card, which shall bear their identity.
p.000032:
p.000032: 3. The following implants shall be exempted from the obligations laid down in this Article:
p.000032: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips
p.000032: and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this
p.000032: list by adding other types of implants to it or by removing implants therefrom.
p.000032:
p.000032:
p.000032: Article 19
p.000032:
p.000032: EU declaration of conformity
p.000032:
p.000032: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation
p.000032: have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update
p.000032: the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the
p.000032: information set out in Annex IV and shall be translated into an official Union language or languages
p.000032: required by the Member State(s) in which the device is made available.
p.000032:
p.000032: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000032: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
...
p.000034: referred to in Article 10(8):
p.000034: (a) any economic operator to whom they have directly supplied a device;
p.000034: (b) any economic operator who has directly supplied them with a device;
p.000034: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000034:
p.000034: Article 26
p.000034:
p.000034: Medical devices nomenclature
p.000034:
p.000034: To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in
p.000034: Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is
p.000034: available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
p.000034: that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other
p.000034: stakeholders free of charge, where reasonably practicable.
p.000034:
p.000034: 5.5.2017 EN
p.000034: Official Journal of the European Union
p.000035: L 117/35
p.000035:
p.000035: Article 27
p.000035:
p.000035: Unique Device Identification system
p.000035:
p.000035: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000035: allow the identifi cation and facilitate the traceability of devices, other than custom-made and
p.000035: investigational devices, and shall consist of the following:
p.000035: (a) production of a UDI that comprises the following:
p.000035: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
p.000035: the information laid down in Part B of Annex VI;
p.000035: (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable
p.000035: the packaged devices, as specified in Part C of Annex VI;
p.000035: (b) placing of the UDI on the label of the device or on its packaging;
p.000035: (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in
p.000035: accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
p.000035: (d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in
p.000035: accordance with Article 28.
p.000035: 2. The Commission shall, by means of implementing acts, designate one or several entities to
p.000035: operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or
p.000035: those entities shall satisfy all of the following criteria:
p.000035: (a) the entity is an organisation with legal personality;
p.000035: (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution
p.000035: and use in accordance with the requirements of this Regulation;
p.000035: (c) its system for the assignment of UDIs conforms to the relevant international standards;
p.000035: (d) the entity gives access to its system for the assignment of UDIs to all interested users in
p.000035: accordance with a set of predetermined and transparent terms and conditions;
p.000035: (e) the entity undertakes to do the following:
p.000035: (i) operate its system for the assignment of UDIs for at least 10 years after its designation;
p.000035: (ii) make available to the Commission and to the Member States, upon request, information concerning
p.000035: its system for the assignment of UDIs;
p.000035: (iii) remain in compliance with the criteria for designation and the terms of designation.
p.000035: When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined
p.000035: in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity,
p.000035: with a view to minimising financial and administrative burdens for economic operators and health institutions.
p.000035:
p.000035: 3. Before placing a device, other than a custom-made device, on the market, the manufacturer shall
p.000035: assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance
p.000035: with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
p.000035:
p.000035: Before a device, other than a custom-made or investigational device, is placed on the market the
p.000035: manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in
p.000035: question are correctly submitted and transferred to the UDI database referred to in Article 28.
p.000035:
p.000035: 4. UDI carriers shall be placed on the label of the device and on all higher levels of
...
p.000036: all of the following:
p.000036: (a) confidentiality and data protection as referred to in Articles 109 and 110 respectively;
p.000036: (b) the risk-based approach;
p.000036: (c) the cost-effectiveness of the measures;
p.000036: (d) the convergence of UDI systems developed at international level;
p.000036: (e) the need to avoid duplications in the UDI system;
p.000036: (f) the needs of the healthcare systems of the Member States, and where possible, compatibility with
p.000036: other medical device identification systems that are used by stakeholders.
p.000036:
p.000036: Article 28
p.000036:
p.000036: UDI database
p.000036:
p.000036: 1. The Commission, after consulting the MDCG shall set up and manage a UDI database to validate,
p.000036: collate, process and make available to the public the information mentioned in Part B of Annex VI.
p.000036:
p.000036: 2. When designing the UDI database, the Commission shall take into account the general principles
p.000036: set out in Section 5 of Part C of Annex VI. The UDI database shall be designed in particular such
p.000036: that no UDI-PIs and no commercially confidential product information can be included therein.
p.000036:
p.000036: 3. The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be
p.000036: accessible to the public free of charge.
p.000036:
p.000036: 4. The technical design of the UDI database shall ensure maximum accessibility to information
p.000036: stored therein, including multi-user access and automatic uploads and downloads of that information. The
p.000036: Commission shall provide for technical and administrative support to manufacturers and other users of the UDI
p.000036: database.
p.000036:
p.000036: 5.5.2017 EN
p.000036: Official Journal of the European Union
p.000037: L 117/37
p.000037:
p.000037: Article 29
p.000037:
p.000037: Registration of devices
p.000037:
p.000037: 1. Before placing a device, other than a custom-made device, on the market, the manufacturer shall,
p.000037: in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in
p.000037: Part C of Annex VI to the device and shall provide it to the UDI database together with the other core
p.000037: data elements referred to in Part B of Annex VI related to that device.
p.000037:
p.000037: 2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3),
p.000037: that is not a custom- made device, the natural or legal person responsible shall assign to the system
p.000037: or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to
p.000037: the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system
p.000037: or procedure pack.
p.000037:
p.000037: 3. For devices that are the subject of a conformity assessment as referred to in Article 52(3)
p.000037: and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in
p.000037: paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
p.000037:
...
p.000039:
p.000039: (g) the electronic system on market surveillance referred to in Article 100.
p.000039:
p.000039: 3. When designing Eudamed the Commission shall give due consideration to compatibility with national
p.000039: databases and national web-interfaces to allow for import and export of data.
p.000039:
p.000039: 4. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators
p.000039: and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The
p.000039: Commission shall provide for technical and administrative support to users of Eudamed.
p.000039:
p.000039: 5. All the information collated and processed by Eudamed shall be accessible to the Member States
p.000039: and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and
p.000039: the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.
p.000039:
p.000039: The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format.
p.000039:
p.000039: 6. Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in
p.000039: paragraph 2 of this Article to collate and process information in accordance with this Regulation.
p.000039: Personal data shall be kept in a form which permits identification of data subjects for periods no longer than
p.000039: those referred to in Article 10(8).
p.000039:
p.000039: 7. The Commission and the Member States shall ensure that data subjects may effectively exercise
p.000039: their rights to information, of access, to rectification and to object in accordance with
p.000039: Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data
p.000039: subjects may effectively exercise the right of access to data relating to them, and the right to have
p.000039: inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission
p.000039: and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in
p.000039: accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as
p.000039: possible, but no later than 60 days after a request is made by a data subject.
p.000039:
p.000039: 8. The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary
p.000039: for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the
p.000039: examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission
p.000039: shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same
p.000039: information twice within the same module or in different modules of the system.
p.000039:
p.000039: 9. In relation to its responsibilities under this Article and the processing of personal data
p.000039: involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
p.000039:
p.000040: L 117/40 EN
p.000040: Official Journal of the European Union
p.000040: 5.5.2017
p.000040:
p.000040: Article 34
p.000040:
p.000040: Functionality of Eudamed
p.000040:
p.000040: 1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for
p.000040: Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May
...
p.000056: 81, and Annex XV; and
p.000056:
p.000056: (c) a consideration of currently available alternative treatment options for that purpose, if any.
p.000056:
p.000056: 4. In the case of implantable devices and class III devices, clinical investigations shall be performed, except
p.000056: if:
p.000056:
p.000056: — the device has been designed by modifications of a device already marketed by the same manufacturer,
p.000056:
p.000056: — the modified device has been demonstrated by the manufacturer to be equivalent to the marketed
p.000056: device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
p.000056:
p.000056: — the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with
p.000056: the relevant safety and performance requirements.
p.000056:
p.000056: In this case, the notified body shall check that the PMCF plan is appropriate and includes post market
p.000056: studies to demonstrate the safety and performance of the device.
p.000056:
p.000056: In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.
p.000056:
p.000056: 5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not
p.000056: manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation
p.000056: provided that the following conditions are fulfilled in addition to what is required in that paragraph:
p.000056:
p.000056: — the two manufacturers have a contract in place that explicitly allows the manufacturer of the second
p.000056: device full access to the technical documentation on an ongoing basis, and
p.000056:
p.000056: — the original clinical evaluation has been performed in compliance with the requirements of this Regulation, and the
p.000056: manufacturer of the second device provides clear evidence thereof to the notified body.
p.000056: 6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to
p.000056: implantable devices and class III devices:
p.000056:
p.000056: (a) which have been lawfully placed on the market or put into service in accordance with Directive
p.000056: 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
p.000056:
p.000056: — is based on sufficient clinical data, and
p.000056:
p.000056: — is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of
p.000056: device, where such a CS is available; or
p.000056:
p.000056: (b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates,
p.000056: wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in
p.000056: compliance with the relevant product-specific CS, where such a CS is available.
p.000056:
p.000056: 5.5.2017 EN
p.000056: Official Journal of the European Union
p.000057: L 117/57
p.000057:
p.000057: 7. Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the
p.000057: clinical evaluation report by the manufacturer and in the clinical evaluation assessment report by the notified body.
p.000057:
p.000057: 8. Where justified in view of well-established technologies, similar to those used in the exempted
...
p.000064: data are reliable and robust, and that the conduct of the clinical investigation is in compliance with
p.000064: the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a
p.000064: clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis
p.000064: of an assessment that takes into consideration all character istics of the clinical investigation including the
p.000064: following:
p.000064:
p.000064: (a) the objective and methodology of the clinical investigation; and
p.000064:
p.000064: (b) the degree of deviation of the intervention from normal clinical practice.
p.000064:
p.000064: 5.5.2017 EN
p.000064: Official Journal of the European Union
p.000065: L 117/65
p.000065:
p.000065: 3. All clinical investigation information shall be recorded, processed, handled, and stored
p.000065: by the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
p.000065: interpreted and verified while the confiden tiality of records and the personal data of the subjects
p.000065: remain protected in accordance with the applicable law on personal data protection.
p.000065:
p.000065: 4. Appropriate technical and organisational measures shall be implemented to protect information and
p.000065: personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction
p.000065: or accidental loss, in particular where the processing involves transmission over a network.
p.000065:
p.000065: 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that
p.000065: clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved
p.000065: investigation plan.
p.000065:
p.000065: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate
p.000065: identification and, where necessary, an immediate recall of the devices used in the investigation.
p.000065:
p.000065:
p.000065: Article 73
p.000065:
p.000065: Electronic system on clinical investigations
p.000065:
p.000065: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000065: electronic system:
p.000065:
p.000065: (a) to create the single identification numbers for clinical investigations referred to in Article 70(1);
p.000065:
p.000065: (b) to be used as an entry point for the submission of all applications or notifications for clinical
p.000065: investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data
p.000065: in this context;
p.000065:
p.000065: (c) for the exchange of information relating to clinical investigations in accordance with this
p.000065: Regulation between the Member States and between them and the Commission including the exchange of
p.000065: information referred to in Articles 70 and 76;
p.000065:
...
p.000076: authorities in this process.
p.000076: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000076: referred to in Article 114(3).
p.000076:
p.000076: 5.5.2017 EN
p.000076: Official Journal of the European Union
p.000077: L 117/77
p.000077:
p.000077: Article 92
p.000077:
p.000077: Electronic system on vigilance and on post-market surveillance
p.000077:
p.000077: 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to
p.000077: collate and process the following information:
p.000077:
p.000077: (a) the reports by manufacturers on serious incidents and field safety corrective actions referred to in
p.000077: Article 87(1) and Article 89(5);
p.000077:
p.000077: (b) the periodic summary reports by manufacturers referred to in Article 87(9);
p.000077:
p.000077: (c) the reports by manufacturers on trends referred to in Article 88;
p.000077:
p.000077: (d) the PSURs referred to in Article 86;
p.000077:
p.000077: (e) the field safety notices by manufacturers referred to in Article 89(8);
p.000077:
p.000077: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000077: them and the Commission in accordance with Article 89(7) and (9).
p.000077:
p.000077: That electronic system shall include relevant links to the UDI database.
p.000077:
p.000077: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000077: system to the competent authorities of the Member States and to the Commission. The notified bodies shall
p.000077: also have access to that information to the extent that it relates to devices for which they issued a certificate
p.000077: in accordance with Article 53.
p.000077:
p.000077: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels
p.000077: of access to the electronic system referred to in paragraph 1.
p.000077:
p.000077: 4. On the basis of arrangements between the Commission and competent authorities of third countries
p.000077: or internat ional organisations, the Commission may grant those competent authorities or international
p.000077: organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those
p.000077: arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent
p.000077: to those applicable in the Union.
p.000077:
p.000077: 5. The reports on serious incidents referred to in point (a) of Article 87(1) shall be
p.000077: automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of
p.000077: this Article, to the competent authority of the Member State in which the incident occurred.
p.000077:
p.000077: 6. The trend reports referred to in Article 88(1) shall be automatically transmitted upon receipt
p.000077: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000077: the Member State in which the incidents occurred.
p.000077:
p.000077: 7. The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall
p.000077: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000077: competent authorities of the following Member States:
p.000077:
p.000077: (a) the Member States in which the field safety corrective action is being or is to be undertaken;
p.000077:
p.000077: (b) the Member State in which the manufacturer has its registered place of business.
p.000077:
p.000077: 8. The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon
...
p.000077:
p.000078: L 117/78 EN
p.000078: Official Journal of the European Union
p.000078: 5.5.2017
p.000078:
p.000078: SECTION 3
p.000078:
p.000078: Market surveillance
p.000078:
p.000078: Article 93
p.000078:
p.000078: Market surveillance activities
p.000078:
p.000078: 1. The competent authorities shall perform appropriate checks on the conformity characteristics and
p.000078: performance of devices including, where appropriate, a review of documentation and physical or laboratory
p.000078: checks on the basis of adequate samples. The competent authorities shall, in particular, take account of
p.000078: established principles regarding risk assessment and risk management, vigilance data and complaints.
p.000078:
p.000078: 2. The competent authorities shall draw up annual surveillance activity plans and allocate a
p.000078: sufficient number of material and competent human resources in order to carry out those activities taking into
p.000078: account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local
p.000078: circumstances.
p.000078:
p.000078: 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
p.000078:
p.000078: (a) may require economic operators to, inter alia, make available the documentation and information
p.000078: necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary
p.000078: samples of devices or access to devices free of charge; and
p.000078:
p.000078: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of
p.000078: economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of
p.000078: professional users.
p.000078:
p.000078: 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities
p.000078: and make it accessible to other competent authorities by means of the electronic system referred to in Article 100.
p.000078:
p.000078: 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices
p.000078: that present an unacceptable risk or falsified devices where they deem it necessary to do so in the
p.000078: interests of the protection of public health.
p.000078:
p.000078: 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent
p.000078: authority shall draw up a report on the findings of the inspection that concern compliance with the
p.000078: legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions
p.000078: needed.
p.000078:
p.000078: 7. The competent authority which carried out the inspection shall communicate the content of the report referred
p.000078: to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before
...
p.000085:
p.000085: — clinical evaluation and PMCF,
p.000085:
p.000085: — performance studies,
p.000085:
p.000085: — performance evaluation and post-market performance follow-up,
p.000085:
p.000085: — physico-chemical characterisation, and
p.000085:
p.000085: — microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing
p.000085:
p.000085: for specific devices, or a category or group of devices, or for specific hazards related to a category
p.000085: or group of devices;
p.000085:
p.000085: (c) to develop and review clinical evaluation guidance and performance evaluation guidance for
p.000085: performance of conformity assessment in line with the state of the art with regard to clinical
p.000085: evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility,
p.000085: mechanical, electrical, electronic or non- clinical toxicological testing;
p.000085:
p.000085: (d) to contribute to the development of standards at international level, ensuring that such standards reflect
p.000085: the state of the art;
p.000085:
p.000085: (e) to provide opinions in response to consultations by manufacturers in accordance with Article 61(2),
p.000085: notified bodies and Member States in accordance with paragraphs 11 to 13 of this Article.
p.000085:
p.000085: (f) to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;
p.000085:
p.000085: (g) to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performance
p.000085: evaluation of certain in vitro diagnostic medical devices.
p.000085:
p.000085: 11. The Commission, shall facilitate the access of Member States and notified bodies and
p.000085: manufacturers to advice provided by expert panels and expert laboratories concerning, inter alia, the
p.000085: criteria for an appropriate data set for assessment of the conformity of a device, in particular with
p.000085: regard to the clinical data required for clinical evaluation, with regard to physico-chemical
p.000085: characterisation, and with regard to microbiological, biocompatibility, mechanical, electrical, electronic and
p.000085: non-clinical toxicological testing.
p.000085:
p.000085: 12. When adopting its scientific opinion in accordance with paragraph 9, the members of the expert panels shall
p.000085: use their best endeavours to reach consensus. If consensus cannot be reached, the expert panels shall decide by a
p.000085: majority of their members, and the scientific opinion shall mention the divergent positions and the
p.000085: grounds on which they are based.
p.000085:
p.000085: The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9
p.000085: and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109.
p.000085: The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation
p.000085: with the MDCG.
p.000085:
p.000085: 13. The Commission may require manufacturers and notified bodies to pay fees for the advice
p.000085: provided by expert panels and expert laboratories. The structure and the level of fees as well as the
...
p.000100: are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000100: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate
p.000100: or reduce as far as possible consequent risks or impairment of performance.
p.000100:
p.000100: 17.2. For devices that incorporate software or for software that are devices in themselves, the
p.000100: software shall be developed and manufactured in accordance with the state of the art taking into account
p.000100: the principles of development life cycle, risk management, including information security, verification and
p.000100: validation.
p.000100:
p.000100: 5.5.2017 EN
p.000100: Official Journal of the European Union
p.000101: L 117/101
p.000101:
p.000101: 17.3. Software referred to in this Section that is intended to be used in combination with mobile
p.000101: computing platforms shall be designed and manufactured taking into account the specific features of the
p.000101: mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their
p.000101: use (varying environment as regards level of light or noise).
p.000101:
p.000101: 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics
p.000101: and IT security measures, including protection against unauthorised access, necessary to run the software as
p.000101: intended.
p.000101:
p.000101: 18. Active devices and devices connected to them
p.000101:
p.000101: 18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be
p.000101: adopted to eliminate or reduce as far as possible consequent risks.
p.000101:
p.000101: 18.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means
p.000101: of determining the state of the power supply and an appropriate warning or indication for when the
p.000101: capacity of the power supply becomes critical. If necessary, such warning or indication shall be given
p.000101: prior to the power supply becoming critical.
p.000101:
p.000101: 18.3. Devices where the safety of the patient depends on an external power supply shall include an
p.000101: alarm system to signal any power failure.
p.000101:
p.000101: 18.4. Devices intended to monitor one or more clinical parameters of a patient shall be equipped
p.000101: with appropriate alarm systems to alert the user of situations which could lead to death or severe
p.000101: deterioration of the patient's state of health.
p.000101:
p.000101: 18.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible
p.000101: the risks of creating electromagnetic interference which could impair the operation of the device in
p.000101: question or other devices or equipment in the intended environment.
p.000101:
p.000101: 18.6. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to
p.000101: electro magnetic interference such that is adequate to enable them to operate as intended.
p.000101:
p.000101: 18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the
p.000101: risk of accidental electric shocks to the patient, user or any other person, both during normal use of the
p.000101: device and in the event of a single fault condition in the device, provided the device is installed and
p.000101: maintained as indicated by the manufacturer.
p.000101:
p.000101: 18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against
p.000101: unauthorised access that could hamper the device from functioning as intended.
p.000101:
p.000101: 19. Particular requirements for active implantable devices
p.000101:
p.000101: 19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or
p.000101: minimize as far as possible:
p.000101: (a) risks connected with the use of energy sources with particular reference, where electricity is
p.000101: used, to insulation, leakage currents and overheating of the devices,
p.000101: (b) risks connected with medical treatment, in particular those resulting from the use of defibrillators
p.000101: or high- frequency surgical equipment, and
p.000101: (c) risks which may arise where maintenance and calibration are impossible, including:
p.000101: — excessive increase of leakage currents,
p.000101: — ageing of the materials used,
p.000101: — excess heat generated by the device,
p.000101: — decreased accuracy of any measuring or control mechanism.
p.000101: 19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure
p.000101: — if applicable, the compatibility of the devices with the substances they are intended to administer, and
p.000101: — the reliability of the source of energy.
p.000101:
p.000102: L 117/102 EN
p.000102: Official Journal of the European Union
p.000102: 5.5.2017
p.000102:
p.000102: 19.3. Active implantable devices and, if appropriate, their component parts shall be
p.000102: identifiable to allow any necessary measure to be taken following the discovery of a potential risk
p.000102: in connection with the devices or their component parts.
p.000102:
...
p.000107: potentially infectious substances of human origin, and
p.000107:
p.000107: — physical hazards such as from sharps.
p.000107:
p.000107: If in accordance with the point (d) of Section 23.1 no instructions for use are required, this
p.000107: information shall be made available to the user upon request;
p.000107:
p.000107: (w) for devices intended for use by lay persons, the circumstances in which the user
p.000107: should consult a healthcare professional;
p.000107:
p.000107: (x) for the devices covered by this Regulation pursuant to Article 1(2), information regarding the
p.000107: absence of a clinical benefit and the risks related to use of the device;
p.000107:
p.000107: (y) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000107: identifier of the latest revision of the instructions for use;
p.000107:
p.000107: (z) a notice to the user and/or patient that any serious incident that has occurred in relation to
p.000107: the device should be reported to the manufacturer and the competent authority of the Member State in
p.000107: which the user and/or patient is established;
p.000107:
p.000107: (aa) information to be supplied to the patient with an implanted device in accordance with Article 18;
p.000107:
p.000107: (ab) for devices that incorporate electronic programmable systems, including software, or software that
p.000107: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000107: security measures, including protection against unauthorised access, necessary to run the software as
p.000107: intended.
p.000107:
p.000108: L 117/108 EN
p.000108: Official Journal of the European Union
p.000108: 5.5.2017
p.000108:
p.000108: ANNEX II
p.000108:
p.000108: TECHNICAL DOCUMENTATION
p.000108:
p.000108: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000108: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in
p.000108: particular the elements listed in this Annex.
p.000108:
p.000108: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000108:
p.000108: 1.1. Device description and specification
p.000108:
p.000108: (a) product or trade name and a general description of the device including its intended purpose and
p.000108: intended users;
p.000108: (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device
p.000108: in question, as soon as identification of this device becomes based on a UDI system, or otherwise a
p.000108: clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
p.000108: (c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored and
p.000108: other considerations such as patient selection criteria, indications, contra-indications, warnings;
p.000108: (d) principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
p.000108: (e) the rationale for the qualification of the product as a device;
...
p.000117: relevant certificates and EU declarations of conformity.
p.000117:
p.000117: Unit of Use DI
p.000117:
p.000117: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000117: UDI is not labelled on the individual device at the level of its unit of use, for example in the
p.000117: event of several units of the same device being packaged together.
p.000117:
p.000117: Configurable device
p.000117:
p.000117: A configurable device is a device that consists of several components which can be
p.000117: assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
p.000117:
p.000117: Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia
p.000117: systems, physiological Monitoring systems, radiology information systems (RIS).
p.000117:
p.000117: Configuration
p.000117:
p.000117: Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a
p.000117: device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to
p.000117: meet specific needs.
p.000117: Configurations include inter alia:
p.000117: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an
p.000117: intended function in computed tomography.
p.000117: — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia. UDI-DI
p.000117: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the
p.000117: ‘access key’ to information stored in a UDI database.
p.000117:
p.000117: Human Readable Interpretation (‘HRI’)
p.000117:
p.000117: HRI is a legible interpretation of the data characters encoded in the UDI carrier.
p.000117:
p.000117: Packaging levels
p.000117:
p.000117: Packaging levels means the various levels of device packaging that contain a defined quantity of devices,
p.000117: such as a carton or case.
p.000117:
p.000117: UDI-PI
p.000117:
p.000117: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
p.000117:
p.000117: The different types of UDI-PIs include serial number, lot number, software identification and
p.000117: manufacturing or expiry date or both types of date.
p.000117:
p.000118: L 117/118 EN
p.000118: Official Journal of the European Union
p.000118: 5.5.2017
p.000118:
p.000118: Radio Frequency Identification RFID
p.000118:
p.000118: RFID is a technology that uses communication through the use of radio waves to exchange data between a
p.000118: reader and an electronic tag attached to an object, for the purpose of identification.
p.000118:
p.000118: Shipping containers
p.000118:
p.000118: A shipping container is a container in relation to which traceability is controlled by a process specific to logistics
p.000118: systems.
p.000118:
p.000118: Unique Device Identifier (‘UDI’)
p.000118:
p.000118: The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted
p.000118: device identification and coding standard. It allows the unambiguous identification of a specific device
p.000118: on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
p.000118:
p.000118: The word ‘Unique’ does not imply serialisation of individual production units.
...
p.000119: misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the
p.000119: following UDI database data elements shall require a new UDI-DI:
p.000119: (a) name or trade name,
p.000119: (b) device version or model,
p.000119: (c) labelled as single use,
p.000119: (d) packaged sterile,
p.000119: (e) need for sterilization before use,
p.000119: (f) quantity of devices provided in a package,
p.000119: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.
p.000119: 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record
p.000119: of the original device manufacturer's UDI.
p.000119:
p.000119: 4. UDI carrier
p.000119:
p.000119: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on
p.000119: the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000119:
p.000119: 4.2. In the event of there being significant space constraints on the unit of use packaging, the
p.000119: UDI carrier may be placed on the next higher packaging level.
p.000119:
p.000119: 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be
p.000119: required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton
p.000119: containing several individually packaged devices. However, when the healthcare provider is not expected to
p.000119: have access, in cases such as in home healthcare settings, to the higher level of device packaging, the
p.000119: UDI shall be placed on the packaging of the individual device.
p.000119:
p.000119: 4.4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be
p.000119: required to appear on the point of sale packaging.
p.000119:
p.000119: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000119: readily identifiable.
p.000119:
p.000119: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000119: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000119:
p.000119: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000119: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000119: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000119: results in there being no space for the AIDC.
p.000119:
p.000119: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000119:
p.000119: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000119: standard provided by the issuing entities shall also be provided on the label.
p.000119:
p.000119: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
...
p.000125: have the same content.
p.000125:
p.000126: L 117/126 EN
p.000126: Official Journal of the European Union
p.000126: 5.5.2017
p.000126:
p.000126: 2.3. The top-level management of the notified body shall ensure that the quality
p.000126: management system is fully understood, implemented and maintained throughout the notified body
p.000126: organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this
p.000126: Regulation.
p.000126:
p.000126: 2.4. The notified body shall require all personnel to formally commit themselves by a signature or
p.000126: equivalent to comply with the procedures defined by the notified body. That commitment shall cover
p.000126: aspects relating to confidentiality and to independence from commercial and other interests, and any
p.000126: existing or prior association with clients. The personnel shall be required to complete written statements
p.000126: indicating their compliance with confidentiality, independence and impartiality principles.
p.000126:
p.000126: 3. RESOURCE REQUIREMENTS
p.000126:
p.000126: 3.1. General
p.000126:
p.000126: 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this
p.000126: Regulation with the highest degree of professional integrity and the requisite competence in the specific field,
p.000126: whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
p.000126:
p.000126: In particular, notified bodies shall have the necessary personnel and possess or have access to all
p.000126: equipment, facilities and competence needed to perform properly the technical, scientific and administrative
p.000126: tasks entailed in the conformity assessment activities in relation to which they have been designated.
p.000126:
p.000126: Such requirement presupposes at all times and for each conformity assessment procedure and each type of
p.000126: devices in relation to which they have been designated, that the notified body has permanent
p.000126: availability of sufficient administrative, technical and scientific personnel who possess experience and
p.000126: knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient
p.000126: numbers to ensure that the notified body in question can perform the conformity assessment tasks, including
p.000126: the assessment of the medical functionality, clinical evaluations and the performance and safety of
p.000126: devices, for which it has been designated, having regard to the requirements of this Regulation, in particular,
p.000126: those set out in Annex I.
p.000126:
p.000126: A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which
p.000126: it is designated. The notified body shall have sufficient internal competence to critically evaluate
p.000126: assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting
p.000126: are set out in Section 4.1.
p.000126:
p.000126: Personnel involved in the management of the operation of a notified body's conformity assessment
p.000126: activities for devices shall have appropriate knowledge to set up and operate a system for the selection
...
p.000130:
p.000130: 4.1. General
p.000130:
p.000130: The notified body shall have in place documented processes and sufficiently detailed procedures for the
p.000130: conduct of each conformity assessment activity for which it is designated, comprising the individual steps
p.000130: from pre- application activities up to decision making and surveillance and taking into account, when
p.000130: necessary, the respective specificities of the devices.
p.000130:
p.000130: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the
p.000130: internal activities of notified bodies and shall not be subcontracted.
p.000130: 4.2. Notified body quotations and pre-application activities The notified body shall:
p.000130:
p.000130: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000130: obtain certification from it. That description shall include which languages are acceptable for
p.000130: submission of documentation and for any related correspondence;
p.000130:
p.000130: (b) have documented procedures relating to, and documented details about, fees charged for specific
p.000130: conformity assessment activities and any other financial conditions relating to notified bodies' assessment
p.000130: activities for devices;
p.000130:
p.000130: (c) have documented procedures in relation to advertising of their conformity assessment
p.000130: services. Those procedures shall ensure that advertising or promotional activities in no way imply or
p.000130: are capable of leading to an inference that their conformity assessment will offer manufacturers earlier
p.000130: market access or be quicker, easier or less stringent than that of other notified bodies;
p.000130:
p.000130: (d) have documented procedures requiring the review of pre-application information, including the
p.000130: preliminary verification that the product is covered by this Regulation and its classification, prior to issuing any
p.000130: quotation to the manufacturer relating to a specific conformity assessment; and
p.000130:
p.000130: (e) ensure that all contracts relating to the conformity assessment activities covered by this
p.000130: Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation.
p.000130:
p.000130: 4.3. Application review and contract
p.000130:
p.000130: The notified body shall require a formal application signed by a manufacturer or an authorised
p.000130: representative containing all of the information and the manufacturer's declarations required by
p.000130: the relevant conformity assessment as referred to in Annexes IX to XI.
p.000130:
p.000130: The contract between a notified body and a manufacturer shall take the form of a written agreement
p.000130: signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions
p.000130: and contain obligations that enable the notified body to act as required under this Regulation, including
p.000130: an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the
p.000130: notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its
p.000130: information obligations.
p.000130:
p.000130: 5.5.2017 EN
p.000130: Official Journal of the European Union
...
p.000137: checking the significance of the changes referred to in the first paragraph.
p.000137:
p.000137: In accordance with its documented procedures, the notified body in question shall:
p.000137:
p.000137: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and
p.000137: relevant information relating to such changes,
p.000137:
p.000137: — assess the changes proposed and verify whether, after these changes, the quality management system, or
p.000137: the design of a device or type of a device, still meets the requirements of this Regulation, and
p.000137:
p.000137: — notify the manufacturer of its decision and provide a report or as applicable a supplementary report,
p.000137: which shall contain the justified conclusions of its assessment.
p.000137: 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures:
p.000137:
p.000137: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures
p.000137: shall include arrangements for unannounced on-site audits of manufacturers and, where applicable,
p.000137: subcontractors and suppliers carrying out product tests and the monitoring of compliance with any
p.000137: conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at
p.000137: defined intervals,
p.000137:
p.000137: — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of
p.000137: their designation. Such information shall be taken into account in the planning and conduct of surveillance
p.000137: activities, and
p.000137:
p.000137: — to review vigilance data to which they have access under Article 92(2) in order to estimate its
p.000137: impact, if any, on the validity of existing certificates. The results of the evaluation and
p.000137: any decisions taken shall be thoroughly documented.
p.000137:
p.000137: The notified body in question shall, upon receipt of information about vigilance cases from a
p.000137: manufacturer or competent authorities, decide which of the following options to apply:
p.000137:
p.000137: — not to take action on the basis that the vigilance case is clearly not related to the certification granted,
p.000137:
p.000137: — observe the manufacturer's and competent authority's activities and the results of the manufacturer's
p.000137: investi gation so as to determine whether the certification granted is at risk or whether adequate
p.000137: corrective action has been taken,
p.000137:
p.000137: — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits
p.000137: and product testing, where it is likely that the certification granted is at risk,
p.000137:
p.000137: — increase the frequency of surveillance audits,
p.000137:
p.000137: — review specific products or processes on the occasion of the next audit of the manufacturer, or
p.000137:
p.000137: — take any other relevant measure.
p.000137:
p.000138: L 117/138 EN
p.000138: Official Journal of the European Union
p.000138: 5.5.2017
p.000138:
p.000138: In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
p.000138:
...
p.000147: requirements, taking applicable CS and, where opted for, harmonised standards or other adequate
p.000147: solutions into account,
p.000147: — risk management as referred to in Section 3 of Annex I,
p.000147: — the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up,
p.000147:
p.000147: — solutions for fulfilling the applicable specific requirements regarding design and construction,
p.000147: including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
p.000147:
p.000147: — solutions for fulfilling the applicable specific requirements regarding the information to be supplied
p.000147: with the device, in particular the requirements of Chapter III of Annex I,
p.000147:
p.000147: — the device identification procedures drawn up and kept up to date from drawings, specifications or other
p.000147: relevant documents at every stage of manufacture, and
p.000147: — management of design or quality management system changes; and
p.000147:
p.000147: (d) the verification and quality assurance techniques at the manufacturing stage and in particular the
p.000147: processes and procedures which are to be used, particularly as regards sterilisation and the relevant documents; and
p.000147:
p.000147: (e) the appropriate tests and trials which are to be carried out before, during and after
p.000147: manufacture, the frequency with which they are to take place, and the test equipment to be used; it
p.000147: shall be possible to trace back adequately the calibration of that test equipment.
p.000147:
p.000147: In addition, the manufacturer shall grant the notified body access to the technical documentation
p.000147: referred to in Annexes II and III.
p.000147:
p.000147: 2.3. Audit
p.000147:
p.000147: The notified body shall audit the quality management system to determine whether it meets the
p.000147: requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related
p.000147: to a quality management system, the notified body shall assess conformity with those standards or CS.
p.000147: The notified body shall assume that a quality management system which satisfies the relevant
p.000147: harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly
p.000147: substantiates not doing so.
p.000147:
p.000148: L 117/148 EN
p.000148: Official Journal of the European Union
p.000148: 5.5.2017
p.000148:
p.000148: The audit team of the notified body shall include at least one member with past experience of assessments of the
p.000148: technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such
p.000148: experience is not immediately obvious or applicable, the notified body shall provide a documented
p.000148: rationale for the composition of that team. The assessment procedure shall include an audit on the
p.000148: manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to
p.000148: verify the manufac turing and other relevant processes.
p.000148:
p.000148: Moreover, in the case of class IIa and class IIb devices, the quality management system assessment
p.000148: shall be accompanied by the assessment of technical documentation for devices selected on a representative
...
p.000164: specifications and properties including physicochemical properties such as intensity of energy, tensile
p.000164: strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment
p.000164: methods, where relevant; has similar principles of operation and critical performance requirements;
p.000164:
p.000164: — Biological: the device uses the same materials or substances in contact with the same human tissues
p.000164: or body fluids for a similar kind and duration of contact and similar release characteristics of
p.000164: substances, including degradation products and leachables;
p.000164:
p.000164: 5.5.2017 EN
p.000164: Official Journal of the European Union
p.000165: L 117/165
p.000165:
p.000165: — Clinical: the device is used for the same clinical condition or purpose, including similar severity
p.000165: and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and
p.000165: physiology; has the same kind of user; has similar relevant critical performance in view of the expected
p.000165: clinical effect for a specific intended purpose.
p.000165:
p.000165: The characteristics listed in the first paragraph shall be similar to the extent that there would be
p.000165: no clinically significant difference in the safety and clinical performance of the device. Considerations
p.000165: of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that
p.000165: manufacturers have sufficient levels of access to the data relating to devices with which they are
p.000165: claiming equivalence in order to justify their claims of equivalence.
p.000165:
p.000165: 4. The results of the clinical evaluation and the clinical evidence on which it is based shall be
p.000165: documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
p.000165:
p.000165: The clinical evidence together with non-clinical data generated from non-clinical testing methods
p.000165: and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general
p.000165: safety and performance requirements and shall be part of the technical documentation for the device in question.
p.000165:
p.000165: Both favourable and unfavourable data considered in the clinical evaluation shall be included in the
p.000165: technical documentation.
p.000165:
p.000165:
p.000165: PART B
p.000165:
p.000165: POST-MARKET CLINICAL FOLLOW-UP
p.000165:
p.000165: 5. PMCF shall be understood to be a continuous process that updates the clinical evaluation referred
p.000165: to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market
p.000165: surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical
p.000165: data from the use in or on humans of a device which bears the CE marking and is placed on the
p.000165: market or put into service within its intended purpose as referred to in the relevant conformity
p.000165: assessment procedure, with the aim of confirming the safety and performance throughout the expected
...
p.000167: rationale for the design and chosen statistical methodology shall be presented as further described in Section
p.000167: 3.6 of Chapter II of this Annex.
p.000167:
p.000167: 2.2. The procedures used to perform the clinical investigation shall be appropriate to the device under
p.000167: investigation.
p.000167:
p.000167: 2.3. The research methodologies used to perform the clinical investigation shall be appropriate to
p.000167: the device under investigation.
p.000167:
p.000167: 2.4. Clinical investigations shall be performed in accordance with the clinical investigation plan
p.000167: by a sufficient number of intended users and in a clinical environment that is representative of the intended normal
p.000167: conditions of use of the device in the target patient population. Clinical investigations shall be in
p.000167: line with the clinical evaluation plan as referred to in Part A of Annex XIV.
p.000167:
p.000167: 2.5. All the appropriate technical and functional features of the device, in particular those
p.000167: involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the
p.000167: investigational design. A list of the technical and functional features of the device and the related
p.000167: expected clinical outcomes shall be provided.
p.000167:
p.000167: 2.6. The endpoints of the clinical investigation shall address the intended purpose, clinical benefits,
p.000167: performance and safety of the device. The endpoints shall be determined and assessed using scientifically
p.000167: valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant.
p.000167:
p.000167: 2.7. Investigators shall have access to the technical and clinical data regarding the device.
p.000167: Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the
p.000167: proper use of the investigational device, and as regards the clinical investigation plan and good
p.000167: clinical practice. This training shall be verified and where necessary arranged by the sponsor and documented
p.000167: appropriately.
p.000167:
p.000167: 2.8. The clinical investigation report, signed by the investigator, shall contain a critical
p.000167: evaluation of all the data collected during the clinical investigation, and shall include any negative findings.
p.000167:
p.000167: CHAPTER II
p.000167: DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
p.000167:
p.000167: For investigational devices covered by Article 62, the sponsor shall draw up and submit the application
p.000167: in accordance with Article 70 accompanied by the following documents:
p.000167:
p.000167: 1. Application form
p.000167:
p.000167: The application form shall be duly filled in, containing information regarding:
p.000167: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and
p.000167: contact details of its contact person or legal representative in accordance with Article 62(2) established in the
p.000167: Union;
p.000167:
p.000168: L 117/168 EN
p.000168: Official Journal of the European Union
p.000168: 5.5.2017
p.000168:
p.000168: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
...
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
p.000170: 3.13. Description of the Informed consent process.
p.000170:
p.000170: 3.14. Safety reporting, including definitions of adverse events and serious adverse events,
p.000170: device deficiencies, procedures and timelines for reporting.
p.000170:
p.000170: 5.5.2017 EN
p.000170: Official Journal of the European Union
p.000171: L 117/171
p.000171:
p.000171: 3.15. Criteria and procedures for follow-up of subjects following the end, temporary halt or early
p.000171: termination of an investigation, for follow-up of subjects who have withdrawn their consent and procedures
p.000171: for subjects lost to follow-up. Such procedures shall for implantable devices, cover as a minimum traceability.
p.000171:
p.000171: 3.16. A description of the arrangements for taking care of the subjects after their participation in
p.000171: the clinical investi gation has ended, where such additional care is necessary because of the subjects'
p.000171: participation in the clinical investigation and where it differs from that normally expected for the medical
p.000171: condition in question.
p.000171:
...
p.000171: from the aspects covered by the clinical investigation and that, with regard to those aspects, every
p.000171: precaution has been taken to protect the health and safety of the subject.
p.000171:
p.000171: 4.2. Where applicable according to national law, copy of the opinion or opinions of the ethics
p.000171: committee or committees concerned. Where according to national law the opinion or opinions of the ethics
p.000171: committee or committees is not required at the time of the submission of the application, a copy of the
p.000171: opinion or opinions shall be submitted as soon as available.
p.000171:
p.000171: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to
p.000171: Article 69 and the corresponding national law.
p.000171:
p.000171: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and
p.000171: the informed consent document.
p.000171:
p.000171: 4.5. Description of the arrangements to comply with the applicable rules on the protection and
p.000171: confidentiality of personal data, in particular:
p.000171:
p.000171: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000171: dissemination, alteration or loss of information and personal data processed;
p.000171:
p.000171: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000171: subjects; and
p.000171:
p.000171: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000171: possible adverse effects.
p.000171:
p.000171: 4.6. Full details of the available technical documentation, for example detailed risk
p.000171: analysis/management documen tation or specific test reports, shall, upon request, be submitted to the
p.000171: competent authority reviewing an application.
p.000171:
p.000171:
p.000171: CHAPTER III
p.000171:
p.000171: OTHER OBLIGATIONS OF THE SPONSOR
p.000171:
p.000171: 1. The sponsor shall undertake to keep available for the competent national authorities
p.000171: any documentation necessary to provide evidence for the documentation referred to in Chapter II of
p.000171: this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the
p.000171: investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000171:
p.000172: L 117/172 EN
p.000172: Official Journal of the European Union
p.000172: 5.5.2017
p.000172:
p.000172: 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or
p.000172: any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in
p.000172: a timely manner.
p.000172:
...
Searching for indicator access to information:
(return to top)
p.000006: used by major trade partners. In order for the UDI system to become functional in time for the
p.000006: application of this Regulation, detailed rules should be laid down in this Regulation.
p.000006:
p.000006:
p.000006: (43) Transparency and adequate access to information, appropriately presented for the intended user,
p.000006: are essential in the public interest, to protect public health, to empower patients and healthcare professionals and
p.000006: to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to
p.000006: build confidence in the regulatory system.
p.000006:
p.000006:
p.000006: (44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European
p.000006: database on medical devices (Eudamed) that should integrate different electronic systems to collate and
p.000006: process information regarding devices on the market and the relevant economic operators, certain aspects
p.000006: of conformity assessment, notified
p.000006:
p.000006: (1) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
p.000006:
p.000006: 5.5.2017 EN
p.000006: Official Journal of the European Union
p.000007: L 117/7
p.000007:
p.000007: bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the
p.000007: database are to enhance overall transparency, including through better access to information for the public and
p.000007: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000007: States and to streamline and facilitate the flow of information between economic operators, notified
p.000007: bodies or sponsors and Member States as well as between Member States among themselves and with the
p.000007: Commission. Within the internal market, this can be ensured effectively only at Union level and the
p.000007: Commission should therefore further develop and manage the European databank on medical
p.000007: devices set up by Commission Decision 2010/227/EU (1).
p.000007:
p.000007: (45) To facilitate the functioning of Eudamed, an internationally recognised medical device
p.000007: nomenclature should be available free of charge to manufacturers and other natural or legal persons
p.000007: required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available,
p.000007: where reasonably practicable, free of charge also to other stakeholders.
p.000007:
p.000007: (46) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and
p.000007: certificates should enable the public to be adequately informed about devices on the Union market. The electronic
p.000007: system on clinical investigations should serve as a tool for the cooperation between Member States and
p.000007: for enabling sponsors to submit, on a voluntary basis, a single application for several Member States
...
Social / Age
Searching for indicator age:
(return to top)
p.000060: the clinical investigation;
p.000060:
p.000060: (e) the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
p.000061: representative except for compensation for expenses and loss of earnings directly related to the participation in the
p.000061: clinical investigation;
p.000061: (e) the clinical investigation is intended to investigate treatments for a medical condition that only
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
...
p.000164: classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in
p.000164: respect of the device.
p.000164:
p.000164: 3. A clinical evaluation may be based on clinical data relating to a device for which equivalence
p.000164: to the device in question can be demonstrated. The following technical, biological and clinical
p.000164: characteristics shall be taken into consideration for the demonstration of equivalence:
p.000164:
p.000164: — Technical: the device is of similar design; is used under similar conditions of use; has similar
p.000164: specifications and properties including physicochemical properties such as intensity of energy, tensile
p.000164: strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment
p.000164: methods, where relevant; has similar principles of operation and critical performance requirements;
p.000164:
p.000164: — Biological: the device uses the same materials or substances in contact with the same human tissues
p.000164: or body fluids for a similar kind and duration of contact and similar release characteristics of
p.000164: substances, including degradation products and leachables;
p.000164:
p.000164: 5.5.2017 EN
p.000164: Official Journal of the European Union
p.000165: L 117/165
p.000165:
p.000165: — Clinical: the device is used for the same clinical condition or purpose, including similar severity
p.000165: and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and
p.000165: physiology; has the same kind of user; has similar relevant critical performance in view of the expected
p.000165: clinical effect for a specific intended purpose.
p.000165:
p.000165: The characteristics listed in the first paragraph shall be similar to the extent that there would be
p.000165: no clinically significant difference in the safety and clinical performance of the device. Considerations
p.000165: of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that
p.000165: manufacturers have sufficient levels of access to the data relating to devices with which they are
p.000165: claiming equivalence in order to justify their claims of equivalence.
p.000165:
p.000165: 4. The results of the clinical evaluation and the clinical evidence on which it is based shall be
p.000165: documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
p.000165:
p.000165: The clinical evidence together with non-clinical data generated from non-clinical testing methods
p.000165: and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general
p.000165: safety and performance requirements and shall be part of the technical documentation for the device in question.
p.000165:
p.000165: Both favourable and unfavourable data considered in the clinical evaluation shall be included in the
p.000165: technical documentation.
p.000165:
p.000165:
p.000165: PART B
p.000165:
p.000165: POST-MARKET CLINICAL FOLLOW-UP
p.000165:
p.000165: 5. PMCF shall be understood to be a continuous process that updates the clinical evaluation referred
...
p.000168: changes from the previous application together with a rationale for those changes, in particular, whether
p.000168: any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000168:
p.000168: 1.7. if the application is submitted in parallel with an application for a clinical
p.000168: trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the
p.000168: clinical trial;
p.000168:
p.000168: 1.8. identification of the Member States and third countries in which the clinical investigation is
p.000168: to be conducted as part of a multicentre or multinational study at the time of application;
p.000168:
p.000168: 1.9. a brief description of the investigational device, its classification and other information necessary for
p.000168: the identifi cation of the device and device type;
p.000168:
p.000168: 1.10. information as to whether the device incorporates a medicinal substance, including a human
p.000168: blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal
p.000168: origin, or their derivatives;
p.000168:
p.000168: 1.11. summary of the clinical investigation plan including the objective or objectives of the clinical
p.000168: investigation, the number and gender of subjects, criteria for subject selection, whether there are
p.000168: subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies,
p.000168: planned dates of commencement and of completion of the clinical investigation;
p.000168:
p.000168: 1.12. if applicable, information regarding a comparator device, its classification and other
p.000168: information necessary for the identification of the comparator device;
p.000168:
p.000168: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are
p.000168: capable of conducting the clinical investigation in accordance with the clinical investigation plan;
p.000168:
p.000168: 1.14. details of the anticipated start date and duration of the investigation;
p.000168:
p.000168: 1.15. details to identify the notified body, if already involved at the stage of application for a clinical
p.000168: investigation;
p.000168:
p.000168: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics
p.000168: committee that is assessing or has assessed the application; and
p.000168:
p.000168: 1.17. the statement referred to in Section 4.1.
p.000168:
p.000168:
p.000168: 2. Investigator's Brochure
p.000168:
p.000168:
p.000168: The investigator's brochure (IB) shall contain the clinical and non-clinical information on the
p.000168: investigational device that is relevant for the investigation and available at the time of application.
p.000168: Any updates to the IB or other relevant information that is newly available shall be brought to the
p.000168: attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular
p.000168: the following information:
p.000168:
...
Social / Child
Searching for indicator child:
(return to top)
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
p.000061: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious
...
Searching for indicator children:
(return to top)
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
p.000061: representative except for compensation for expenses and loss of earnings directly related to the participation in the
p.000061: clinical investigation;
p.000061: (e) the clinical investigation is intended to investigate treatments for a medical condition that only
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
...
p.000096: serious effects to human health and which are identified either in accordance with the procedure set out
p.000096: in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or,
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
p.000097: the unintentional ingress of substances into the device taking into account the device and the nature of
p.000097: the environment in which it is intended to be used.
p.000097:
p.000097: 10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked
p.000097: to the size and the properties of particles which are or can be released into the patient's or user's
p.000097: body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
p.000097:
p.000097: 11. Infection and microbial contamination
p.000097:
p.000097: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as
p.000097: far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
p.000097:
p.000097: (a) reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as
p.000097: needle stick injuries,
p.000097:
...
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
p.000170: 3.13. Description of the Informed consent process.
p.000170:
p.000170: 3.14. Safety reporting, including definitions of adverse events and serious adverse events,
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
p.000061: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious
p.000061: medical condition, the subject is unable to provide prior informed consent and to receive prior
p.000061: information on the clinical investi gation;
p.000061:
p.000062: L 117/62 EN
p.000062: Official Journal of the European Union
p.000062: 5.5.2017
p.000062:
p.000062: (b) there are scientific grounds to expect that participation of the subject in the clinical
p.000062: investigation will have the potential to produce a direct clinically relevant benefit for the subject
...
Searching for indicator restricted:
(return to top)
p.000047: of nine months after cessation of the notified body's activities on condition that another notified body
p.000047: has confirmed in writing that it will assume responsibilities for the devices covered by those
p.000047: certificates. The new notified body shall complete a full assessment of the devices affected by the end
p.000047: of that period before issuing new certificates for those devices. Where the notified body has ceased its
p.000047: activity, the authority responsible for notified bodies shall withdraw the designation.
p.000047:
p.000047: 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer
p.000047: meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has
p.000047: not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or
p.000047: partially withdraw the designation, depending on the seriousness of the failure to meet those requirements
p.000047: or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same
p.000047: period.
p.000047:
p.000047: The authority responsible for notified bodies shall immediately inform the Commission and the other Member
p.000047: States of any suspension, restriction or withdrawal of a designation.
p.000047:
p.000047: 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the
p.000047: notified body shall inform the manufacturers concerned at the latest within 10 days.
p.000047:
p.000047: 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for
p.000047: notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are
p.000047: kept and make them available to authorities in other Member States responsible for notified bodies and to
p.000047: authorities responsible for market surveillance at their request.
p.000047:
p.000047: 7. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for
p.000047: notified bodies shall:
p.000047:
p.000047: (a) assess the impact on the certificates issued by the notified body;
p.000047:
p.000047: (b) submit a report on its findings to the Commission and the other Member States within three months
p.000047: of having notified the changes to the designation;
p.000047:
p.000047: (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by
p.000047: the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
p.000047:
p.000047: (d) enter into the electronic system referred to in Article 57 information in relation to certificates
p.000047: of which it has required their suspension or withdrawal;
p.000047:
p.000047: (e) inform the competent authority for medical devices of the Member State in which the
p.000047: manufacturer has its registered place of business through the electronic system referred to in Article 57 of the
p.000047: certificates for which it has required suspension or withdrawal. That competent authority shall take the
p.000047: appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or
p.000047: others.
p.000047:
p.000047: 8. With the exception of certificates unduly issued, and where a designation has been suspended or
p.000047: restricted, the certificates shall remain valid in the following circumstances:
p.000047:
p.000047: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or
p.000047: restriction, that there is no safety issue in relation to certificates affected by the suspension or
p.000047: restriction, and the authority responsible for notified bodies has outlined a timeline and actions
p.000047: anticipated to remedy the suspension or restriction; or
p.000047:
p.000047: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000047: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000047: whether the notified body has the capability of continuing to monitor and remain responsible for existing
p.000047: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000047: responsible for notified bodies determines that the notified body does not have the capability to support
p.000047: existing certificates issued, the manufacturer shall provide, to the competent authority for medical
p.000047: devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000047: registered place of business, within three months of the suspension or restriction, a written confirmation
...
p.000080:
p.000080: 2. Where the economic operator does not bring the non-compliance to an end within the period
p.000080: referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate
p.000080: measures to restrict or prohibit the product being made available on the market or to ensure that it is
p.000080: recalled or withdrawn from the market. That Member State shall inform the Commission and the other
p.000080: Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
p.000080:
p.000080: 3. In order to ensure the uniform application of this Article, the Commission may, by means of
p.000080: implementing acts, specify appropriate measures to be taken by competent authorities to address given
p.000080: types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure
p.000080: referred to in Article 114(3).
p.000080:
p.000080:
p.000080: Article 98
p.000080:
p.000080: Preventive health protection measures
p.000080:
p.000080: 1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a
p.000080: device or a specific category or group of devices, considers that, in order to protect the health and
p.000080: safety of patients, users or other persons or other aspects of public health, the making available on the market or
p.000080: putting into service of a device or a specific category or group of devices should be prohibited, restricted
p.000080: or made subject to particular requirements or that such device or category or group of devices should
p.000080: be withdrawn from the market or recalled, it may take any necessary and justified measures.
p.000080:
p.000080: 5.5.2017 EN
p.000080: Official Journal of the European Union
p.000081: L 117/81
p.000081:
p.000081: 2. The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member
p.000081: States, giving the reasons for its decision, by means of the electronic system referred to in Article 100.
p.000081:
p.000081: 3. The Commission, in consultation with the MDCG and, where necessary, the economic operators
p.000081: concerned, shall assess the national measures taken. The Commission may decide, by means of implementing
p.000081: acts, whether the national measures are justified or not. In the absence of a Commission decision within
p.000081: six months of their notification, the national measures shall be considered to be justified. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000081:
p.000081: 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making
p.000081: available on the market or putting into service of a device, specific category or group of devices should be
p.000081: prohibited, restricted or made subject to particular requirements or that such device or category or group
p.000081: of devices should be withdrawn from the market or recalled in all Member States in order to protect
p.000081: the health and safety of patients, users or other persons or other aspects of public health, the
p.000081: Commission may adopt implementing acts to take the necessary and duly justified measures. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000081: 114(3).
p.000081:
p.000081:
p.000081: Article 99
p.000081:
p.000081: Good administrative practice
p.000081:
p.000081: 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 95 to 98
p.000081: shall state the exact grounds on which it is based. Where such a measure is addressed to a specific
p.000081: economic operator, the competent authority shall notify without delay the economic operator concerned of that
p.000081: measure, and shall at the same time inform that economic operator of the remedies available under the law
p.000081: or the administrative practice of the Member State concerned and of the time limits to which such remedies are
p.000081: subject. Where the measure is of general ap plicability, it shall be appropriately published.
p.000081:
p.000081: 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human
p.000081: health or safety, the economic operator concerned shall be given the opportunity to make submissions to
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000024:
p.000024: (d) resource management, including selection and control of suppliers and sub-contractors;
p.000024:
p.000024: (e) risk management as set out in in Section 3 of Annex I;
p.000024:
p.000024: (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
p.000024:
p.000024: (g) product realisation, including planning, design, development, production and service provision;
p.000024:
p.000024: (h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices
p.000024: and ensuring consistency and validity of information provided in accordance with Article 29;
p.000024:
p.000024: (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
p.000024:
p.000024: (j) handling communication with competent authorities, notified bodies, other economic operators,
p.000024: customers and/or other stakeholders;
p.000024:
p.000024: (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
p.000024:
p.000024: (l) management of corrective and preventive actions and verification of their effectiveness;
p.000024:
p.000024: (m) processes for monitoring and measurement of output, data analysis and product improvement.
p.000024:
p.000024: 10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in
p.000024: accordance with Article 83.
p.000024:
p.000024: 11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I
p.000024: in an official Union language(s) determined by the Member State in which the device is made available
p.000024: to the user or patient. The particulars on the label shall be indelible, easily legible and clearly
p.000024: comprehensible to the intended user or patient.
p.000024:
p.000024: 12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or
p.000024: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000024: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the
p.000024: distributors of the device in question and, where applicable, the authorised representative and importers
p.000024: accordingly.
p.000024:
p.000024: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000024: of the Member States in which they made the device available and, where applicable, the notified body that
p.000024: issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any
p.000024: corrective action taken.
p.000024:
p.000024: 13. Manufacturers shall have a system for recording and reporting of incidents and field safety
p.000024: corrective actions as described in Articles 87 and 88.
p.000024:
p.000024: 5.5.2017 EN
p.000024: Official Journal of the European Union
p.000025: L 117/25
p.000025:
p.000025: 14. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000025: and documen tation necessary to demonstrate the conformity of the device, in an official
p.000025: Union language determined by the Member State concerned. The competent authority of the Member State
p.000025: in which the manufacturer has its registered place of business may require that the manufacturer provide
p.000025: samples of the device free of charge or, where that is impracticable, grant access to the device.
p.000025: Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
...
p.000025: the competent authority, upon request.
p.000025:
p.000025: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000025: least the following tasks in relation to the devices that it covers:
p.000025:
p.000025: (a) verify that the EU declaration of conformity and technical documentation have been drawn
p.000025: up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the
p.000025: manufacturer;
p.000025:
p.000025: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if
p.000025: applicable, a copy of the relevant certificate, including any amendments and supplements, issued in
p.000025: accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
p.000025:
p.000025: (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied
p.000025: with the registration obligations laid down in Articles 27 and 29;
p.000025:
p.000026: L 117/26 EN
p.000026: Official Journal of the European Union
p.000026: 5.5.2017
p.000026:
p.000026: (d) in response to a request from a competent authority, provide that competent authority with all the
p.000026: information and documentation necessary to demonstrate the conformity of a device, in an official Union
p.000026: language determined by the Member State concerned;
p.000026: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000026: resentative has its registered place of business for samples, or access to a device and verify that
p.000026: the competent authority receives the samples or is given access to the device;
p.000026: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate
p.000026: or, if that is not possible, mitigate the risks posed by devices;
p.000026: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000026: patients and users about suspected incidents related to a device for which they have been designated;
p.000026: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000026: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's
p.000026: obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
p.000026:
p.000026: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000026: and has not complied with the obligations laid down in Article 10, the authorised representative shall
p.000026: be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000026:
p.000026: 6. An authorised representative who terminates its mandate on the ground referred to in point (h)
...
p.000031: shall, if appropriate, make proposals for amendments to this Regulation.
p.000031:
p.000031:
p.000031: Article 18
p.000031:
p.000031: Implant card and information to be supplied to the patient with an implanted device
p.000031:
p.000031: 1. The manufacturer of an implantable device shall provide together with the device the following:
p.000031:
p.000031: (a) information allowing the identification of the device, including the device name, serial number, lot number, the
p.000031: UDI, the device model, as well as the name, address and the website of the manufacturer;
p.000031:
p.000031: (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with
p.000031: regard to reciprocal interference with reasonably foreseeable external influences, medical
p.000031: examinations or environmental conditions;
p.000031:
p.000031: (c) any information about the expected lifetime of the device and any necessary follow-up;
p.000031:
p.000031: (d) any other information to ensure safe use of the device by the patient, including the information
p.000031: in point (u) of Section 23.4 of Annex I.
p.000031:
p.000032: L 117/32 EN
p.000032: Official Journal of the European Union
p.000032: 5.5.2017
p.000032:
p.000032: The information referred to in the first subparagraph shall be provided, for the purpose of making it
p.000032: available to the particular patient who has been implanted with the device, by any means that allow
p.000032: rapid access to that information and shall be stated in the language(s) determined by the concerned
p.000032: Member State. The information shall be written in a way that is readily understood by a lay person and
p.000032: shall be updated where appropriate. Updates of the information shall be made available to the patient via the
p.000032: website mentioned in point (a) of the first subparagraph.
p.000032:
p.000032: In addition, the manufacturer shall provide the information referred to in point (a) of the first
p.000032: subparagraph on an implant card delivered with the device.
p.000032:
p.000032: 2. Member States shall require health institutions to make the information referred to in paragraph
p.000032: 1 available, by any means that allow rapid access to that information, to any patients who have been
p.000032: implanted with the device, together with the implant card, which shall bear their identity.
p.000032:
p.000032: 3. The following implants shall be exempted from the obligations laid down in this Article:
p.000032: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips
p.000032: and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this
p.000032: list by adding other types of implants to it or by removing implants therefrom.
p.000032:
p.000032:
p.000032: Article 19
p.000032:
p.000032: EU declaration of conformity
p.000032:
p.000032: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation
p.000032: have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update
p.000032: the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the
p.000032: information set out in Annex IV and shall be translated into an official Union language or languages
p.000032: required by the Member State(s) in which the device is made available.
p.000032:
p.000032: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000032: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000032: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be
p.000032: drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the
p.000032: information required for identification of the Union legislation to which the declaration relates.
p.000032:
p.000032: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000032: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000032:
p.000032: 4. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the
p.000032: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000032:
p.000032:
p.000032: Article 20
p.000032:
p.000032: CE marking of conformity
p.000032:
p.000032: 1. Devices, other than custom-made or investigational devices, considered to be in conformity with the
p.000032: requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000032:
...
p.000043: the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue
p.000043: a recommendation with regard to the draft designation, which the authority responsible for notified bodies
p.000043: shall duly take into consideration for its decision on the designation of the notified body.
p.000043:
p.000043: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000043: arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the
p.000043: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000043: accordance with the examination procedure referred to in Article 114(3).
p.000043:
p.000043: Article 40
p.000043:
p.000043: Nomination of experts for joint assessment of applications for notification
p.000043:
p.000043: 1. The Member States and the Commission shall nominate experts qualified in the
p.000043: assessment of conformity assessment bodies in the field of medical devices to participate in the activities
p.000043: referred to in Articles 39 and 48.
p.000043:
p.000043: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this
p.000043: Article, together with information on their specific field of competence and expertise. That list shall
p.000043: be made available to Member States competent authorities through the electronic system referred to in Article 57.
p.000043:
p.000043: Article 41
p.000043:
p.000043: Language requirements
p.000043:
p.000043: All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages
p.000043: which shall be determined by the Member State concerned.
p.000043:
p.000043: Member States, in applying the first paragraph, shall consider accepting and using a commonly understood
p.000043: language in the medical field, for all or part of the documentation concerned.
p.000043:
p.000043: The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts
p.000043: thereof into an official Union language, such as is necessary for that documentation to be readily understood by the
p.000043: joint assessment team appointed in accordance with Article 39(3).
p.000043:
p.000043: Article 42
p.000043:
p.000043: Designation and notification procedure
p.000043:
p.000043: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to
p.000043: Article 39 was completed and which comply with Annex VII.
p.000043:
p.000043: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000043: have designated, using the electronic notification tool within the database of notified bodies developed
p.000043: and managed by the Commission (NANDO).
p.000043:
p.000043: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this
p.000043: Article, the scope of the designation indicating the conformity assessment activities as defined in this
p.000043: Regulation and the types of devices which the notified body is authorised to assess and, without
p.000043: prejudice to Article 44, any conditions associated with the designation.
p.000043:
p.000044: L 117/44 EN
p.000044: Official Journal of the European Union
p.000044: 5.5.2017
p.000044:
p.000044: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000044: for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and
p.000044: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of
...
p.000051: Annex XI.
p.000051:
p.000051: 9. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article,
p.000051: in the case of devices referred to in the first subparagraph of Article 1(8), the procedure specified
p.000051: in Section 5.2 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
p.000051:
p.000051: 10. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of
p.000051: devices that are covered by this Regulation in accordance with point (f) or (g) of Article 1(6) and with
p.000051: the first subparagraph of Article 1(10), the procedure specified in Section 5.3 of Annex IX or Section
p.000051: 6 of Annex X, as applicable, shall also apply.
p.000051:
p.000051: 11. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of
p.000051: devices that are composed of substances or of combinations of substances that are intended to be
p.000051: introduced into the human body via a body orifice or applied to the skin and that are absorbed by or
p.000051: locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X,
p.000051: as applicable, shall also apply.
p.000051:
p.000051: 12. The Member State in which the notified body is established may require that all or certain
p.000051: documents, including the technical documentation, audit, assessment and inspection reports, relating
p.000051: to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official
p.000051: Union language(s) determined by that Member State. In the absence of such requirement, those documents
p.000051: shall be available in any official Union language acceptable to the notified body.
p.000051:
p.000051: 13. Investigational devices shall be subject to the requirements set out in Articles 62 to 81.
p.000051:
p.000052: L 117/52 EN
p.000052: Official Journal of the European Union
p.000052: 5.5.2017
p.000052:
p.000052: 14. The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with
p.000052: a view to ensuring the harmonised application of the conformity assessment procedures by the notified
p.000052: bodies for any of the following aspects:
p.000052:
p.000052: (a) the frequency and the sampling basis of the assessment of the technical documentation on a
p.000052: representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX
p.000052: in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa
p.000052: devices;
p.000052:
p.000052: (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified
p.000052: bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
p.000052:
p.000052: (c) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample
p.000052: tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and
p.000052: 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
p.000052:
p.000052: The implementing acts referred to in the first subparagraph shall be adopted in accordance with the
p.000052: examination procedure referred to in Article 114(3).
p.000052:
p.000052:
...
p.000053: for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall
p.000053: take place through the electronic system referred to in Article 57 and shall include the summary of safety and
p.000053: clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions
p.000053: for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the
p.000053: expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the
p.000053: case of divergent views between the notified body and the expert panels, a full justifi cation shall
p.000053: also be included.
p.000053:
p.000053: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns
p.000053: apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate
p.000053: measures in accordance with Articles 95 and 97.
p.000053:
p.000053: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request
p.000053: scientific advice from the expert panels in relation to the safety and performance of any device.
p.000053:
p.000053:
p.000053: Article 56
p.000053:
p.000053: Certificates of conformity
p.000053:
p.000053: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000053: Union language determined by the Member State in which the notified body is established or otherwise in
p.000053: an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set
p.000053: out in Annex XII.
p.000053:
p.000053: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On
p.000053: application by the manufacturer, the validity of the certificate may be extended for further periods, each not
p.000053: exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment
p.000053: procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is
p.000053: valid.
p.000053:
p.000053: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups
p.000053: of patients or require manufacturers to undertake specific PMCF studies pursuant to Part B of Annex XIV.
p.000053:
p.000054: L 117/54 EN
p.000054: Official Journal of the European Union
p.000054: 5.5.2017
p.000054:
p.000054: 4. Where a notified body finds that the requirements of this Regulation are no longer met by the
p.000054: manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the
p.000054: certificate issued or impose any restrictions on it unless compliance with such requirements is ensured
p.000054: by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the
p.000054: notified body. The notified body shall give the reasons for its decision.
p.000054:
p.000054: 5. The notified body shall enter in the electronic system referred to in Article 57
...
p.000075: where the serious incident or field safety corrective action may be related to the derivatives of
p.000075: tissues or cells of human origin utilised for the manufacture of the device, and in the case of
p.000075: devices falling under this Regulation pursuant to Article 1(10), the competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent
p.000075: authority for human tissues and cells that was consulted by the notified body in accordance with Article
p.000075: 52(10).
p.000075:
p.000075: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the
p.000075: evaluating competent authority shall, through the electronic system referred to in Article 92, inform,
p.000075: without delay, the other competent authorities of the corrective action taken or envisaged by the
p.000075: manufacturer or required of it to minimise the risk of recurrence of the serious incident, including
p.000075: information on the underlying events and the outcome of its assessment.
p.000075:
p.000075: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000075: brought without delay to the attention of users of the device in question by means of a field safety notice. The
p.000075: field safety notice shall be edited in an official Union language or languages determined by the Member
p.000075: State in which the field safety corrective action is taken. Except in cases of urgency, the content of
p.000075: the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases
p.000075: referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly
p.000075: justified by the situation of the individual Member State, the content of the field safety notice shall be consistent
p.000075: in all Member States.
p.000075:
p.000075: The field safety notice shall allow the correct identification of the device or devices involved, in
p.000075: particular by including the relevant UDIs, and the correct identification, in particular, by
p.000075: including the SRN, if already issued, of the manufacturer that has undertaken the field safety
p.000075: corrective action. The field safety notice shall explain, in a clear manner, without understating the
p.000075: level of risk, the reasons for the field safety corrective action with reference to the device
p.000075: malfunction and associated risks for patients, users or other persons, and shall clearly indicate all
p.000075: the actions to be taken by users.
p.000075:
p.000075: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which
p.000075: that notice shall be accessible to the public.
p.000075:
p.000075: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
...
p.000169: submitted in a separate document, it shall be referenced in the CIP.
p.000169:
p.000169:
p.000169: 3.1. General
p.000169:
p.000169: 3.1.1. Single identification number of the clinical investigation, as referred to in Article 70(1).
p.000169:
p.000169: 3.1.2. Identification of the sponsor — name, address and contact details of the sponsor and, where
p.000169: applicable, the name, address and contact details of the sponsor's contact person or legal representative
p.000169: in accordance with Article 62(2) established in the Union.
p.000169:
p.000169: 3.1.3. Information on the principal investigator at each investigational site, the coordinating
p.000169: investigator for the investigation, the address details for each investigational site and the emergency
p.000169: contact details for the principal investigator at each site. The roles, responsibilities and qualifications
p.000169: of the various kinds of investigators shall be specified in the CIP.
p.000169:
p.000170: L 117/170 EN
p.000170: Official Journal of the European Union
p.000170: 5.5.2017
p.000170:
p.000170: 3.1.4. A brief description of how the clinical investigation is financed and a brief description of
p.000170: the agreement between the sponsor and the site.
p.000170:
p.000170: 3.1.5. Overall synopsis of the clinical investigation, in an official Union language determined by the
p.000170: Member State concerned.
p.000170:
p.000170: 3.2. Identification and description of the device, including its intended purpose, its manufacturer,
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
...
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p.000002: sales.
p.000002:
p.000002:
p.000002: (4) Key elements of the existing regulatory approach, such as the supervision of
p.000002: notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation,
p.000002: vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and
p.000002: traceability regarding medical devices should be introduced, to improve health and safety.
p.000002:
p.000002:
p.000002: (5) To the extent possible, guidance developed for medical devices at international level, in
p.000002: particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the
p.000002: International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the
p.000002: global convergence of regulations which contributes to a high level of safety protection worldwide, and
p.000002: to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and
p.000002: performance requirements, technical documen tation, classification rules, conformity assessment procedures and
p.000002: clinical investigations.
p.000002:
p.000002:
p.000002: (6) For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and
p.000002: other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments.
p.000002: In the interest of simplification, both directives, which have been amended several times, should be
p.000002: replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical
p.000002: devices.
p.000002:
p.000002:
p.000002: (7) The scope of application of this Regulation should be clearly delimited from other
p.000002: Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal
p.000002: products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of
p.000002: the Council (1) should be amended to exclude medical devices from its scope.
p.000002:
p.000002:
p.000002: (8) It should be the responsibility of the Member States to decide on a case-by-case basis
p.000002: whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification
p.000002: decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should
p.000002: be allowed to, on its own initiative or at the duly substantiated request of a Member State,
p.000002: having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether
p.000002: or not a specific product, category or group of products falls within the scope of this Regulation.
p.000002: When deliberating on the regulatory status of products in borderline cases involving medicinal products,
p.000002: human tissues and cells, biocidal products or food products, the Commission should ensure an
p.000002: appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency
p.000002: and the European Food Safety Authority, as relevant.
...
p.000005: administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p.
p.000005: 29).
p.000005:
p.000006: L 117/6 EN
p.000006: Official Journal of the European Union
p.000006: 5.5.2017
p.000006:
p.000006: (36) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to
p.000006: clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
p.000006:
p.000006:
p.000006: (37) Parallel trade in products already placed on the market is a lawful form of trade within the internal market
p.000006: on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of
p.000006: health and safety and from the need for protection of intellectual property rights provided for under
p.000006: Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different
p.000006: interpretations in the Member States. The conditions, in particular the requirements for relabelling
p.000006: and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the
p.000006: Court of Justice (1) in other relevant sectors and existing good practice in the field of medical devices.
p.000006:
p.000006:
p.000006: (38) The reprocessing and further use of single-use devices should only take place where permitted
p.000006: by national law and while complying with the requirements laid down in this Regulation. The reprocessor
p.000006: of a single-use device should be considered to be the manufacturer of the reprocessed device and should
p.000006: assume the obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should
p.000006: have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use
p.000006: devices within a health institution or by an external reprocessor acting on its behalf may differ from the
p.000006: obligations on a manufacturer described in this Regulation. In principle, such divergence should only
p.000006: be permitted where reprocessing and reuse of single-use devices within a health institution or by an
p.000006: external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS,
p.000006: with relevant harmonised standards and national provisions. The reprocessing of such devices
p.000006: should ensure an equivalent level of safety and performance to that of the corresponding
p.000006: initial single-use device.
p.000006:
p.000006:
p.000006: (39) Patients who are implanted with a device should be given clear and easily accessible essential
p.000006: information allowing the implanted device to be identified and other relevant information about the
p.000006: device, including any necessary health risk warnings or precautions to be taken, for example indications
p.000006: as to whether or not it is compatible with certain diagnostic devices or with scanners used for security
p.000006: controls.
p.000006:
p.000006:
p.000006: (40) Devices should, as a general rule, bear the CE marking to indicate their conformity with this
p.000006: Regulation so that they can move freely within the Union and be put into service in accordance with
p.000006: their intended purpose. Member States should not create obstacles to the placing on the market or
p.000006: putting into service of devices that comply with the requirements laid down in this Regulation. However, Member
p.000006: States should be allowed to decide whether to restrict the use of any specific type of device in relation
p.000006: to aspects that are not covered by this Regulation.
p.000006:
p.000006:
p.000006: (41) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000006: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000006: activities for devices, which is owing to improved incident reporting, targeted field safety corrective
p.000006: actions and better monitoring by competent authorities. It should also help to reduce medical errors and
...
p.000007: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000007: States and to streamline and facilitate the flow of information between economic operators, notified
p.000007: bodies or sponsors and Member States as well as between Member States among themselves and with the
p.000007: Commission. Within the internal market, this can be ensured effectively only at Union level and the
p.000007: Commission should therefore further develop and manage the European databank on medical
p.000007: devices set up by Commission Decision 2010/227/EU (1).
p.000007:
p.000007: (45) To facilitate the functioning of Eudamed, an internationally recognised medical device
p.000007: nomenclature should be available free of charge to manufacturers and other natural or legal persons
p.000007: required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available,
p.000007: where reasonably practicable, free of charge also to other stakeholders.
p.000007:
p.000007: (46) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and
p.000007: certificates should enable the public to be adequately informed about devices on the Union market. The electronic
p.000007: system on clinical investigations should serve as a tool for the cooperation between Member States and
p.000007: for enabling sponsors to submit, on a voluntary basis, a single application for several Member States
p.000007: and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance
p.000007: should enable manufac turers to report serious incidents and other reportable events and to support the
p.000007: coordination of the evaluation of such incidents and events by competent authorities. The electronic
p.000007: system regarding market surveillance should be a tool for the exchange of information between competent
p.000007: authorities.
p.000007:
p.000007: (47) In respect of data collated and processed through the electronic systems of Eudamed, Directive
p.000007: 95/46/EC of the European Parliament and of the Council (2) applies to the processing of
p.000007: personal data carried out in the Member States, under the supervision of the Member States'
p.000007: competent authorities, in particular the public independent authorities designated by the Member
p.000007: States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (3) applies to
p.000007: the processing of personal data carried out by the Commission within the framework of this Regulation,
p.000007: under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC)
p.000007: No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic
p.000007: systems.
p.000007:
p.000007: (48) For implantable devices and for class III devices, manufacturers should summarise the
p.000007: main safety and performance aspects of the device and the outcome of the clinical evaluation in a
...
p.000009: necessary expertise is available.
p.000009:
p.000009:
p.000009: (66) Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
p.000009: or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in
p.000009: such cases, including issues of causality and the level of damages and sanctions, should remain governed by
p.000009: national law.
p.000009:
p.000009:
p.000009: (67) An electronic system should be set up at Union level to ensure that every clinical
p.000009: investigation is recorded and reported in a publicly accessible database. To protect the right to the
p.000009: protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the
p.000009: European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation
p.000009: should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal
p.000009: products, the electronic system on clinical investigations should be in teroperable with the EU database to be set up
p.000009: for clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009: (68) Where a clinical investigation is to be conducted in more than one Member State, the sponsor
p.000009: should have the possibility of submitting a single application in order to reduce administrative burden.
p.000009: In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health
p.000009: and safety-related aspects of the investigational device and of the scientific design of that
p.000009: clinical investigation, the procedure for the assessment of such single application should be
p.000009: coordinated between the Member States under the direction of a coordinating Member State. Such coordinated
p.000009: assessment should not include the assessment of intrinsically national, local and ethical aspects of a
p.000009: clinical investigation, including informed consent. For an initial period of seven years from the date of
p.000009: application of this Regulation, Member States should be able to participate on a voluntary basis in the
p.000009: coordinated assessment. After that period, all Member States should be obliged to participate in the
p.000009: coordinated assessment. The Commission, based on the experience gained from the voluntary coordination
p.000009: between Member States, should draw up a report on the application of the relevant provisions regarding
p.000009: the coordinated assessment procedure. In the event that the findings of the report are negative, the
p.000009: Commission should submit a proposal to extend the period of participation on a voluntary
p.000009: basis in the coordinated assessment procedure.
p.000009:
p.000009:
p.000009: (69) Sponsors should report certain adverse events and device deficiencies that occur during clinical
p.000009: investigations to the Member States in which those clinical investigations are being conducted. Member
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
...
p.000014:
p.000014: 8. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000014: part, a substance which, if used separately, would be considered to be a medicinal product as defined
p.000014: in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood
p.000014: or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action
p.000014: ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.
p.000014:
p.000014: However, if the action of that substance is principal and not ancillary to that of the device, the integral
p.000014: product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament
p.000014: and of the Council (1), as applicable. In that case, the relevant general safety and performance
p.000014: requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the
p.000014: device part are concerned.
p.000014:
p.000014: 9. Any device which is intended to administer a medicinal product as defined in point
p.000014: 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the
p.000014: provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
p.000014:
p.000014: However, if the device intended to administer a medicinal product and the medicinal product are placed
p.000014: on the market in such a way that they form a single integral product which is intended exclusively for
p.000014: use in the given combination and which is not reusable, that single integral product
p.000014: shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In
p.000014: that case, the relevant general safety and performance requirements set out in Annex I to this
p.000014: Regulation shall apply as far as the safety and performance of the device part of the single integral
p.000014: product are concerned.
p.000014:
p.000014: (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.000014: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000014: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000014:
p.000014: 5.5.2017 EN
p.000014: Official Journal of the European Union
p.000015: L 117/15
p.000015:
p.000015: 10. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000015: part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to
p.000015: that of the device shall be assessed and authorised in accordance with this Regulation. In that case,
p.000015: the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
p.000015:
p.000015: However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the
p.000015: device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive
p.000015: 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to
p.000015: this Regulation shall apply as far as the safety and performance of the device part are concerned.
p.000015:
p.000015: 11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
p.000015:
p.000015: 12. Devices that are also machinery within the meaning of point (a) of the second paragraph of
...
p.000016: accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
p.000016:
p.000016: (4) ‘active device’ means any device, the operation of which depends on a source of energy other than
p.000016: that generated by the human body for that purpose, or by gravity, and which acts by changing the
p.000016: density of or converting that energy. Devices intended to transmit energy, substances or other elements between an
p.000016: active device and the patient, without any significant change, shall not be deemed to be active devices.
p.000016:
p.000016: Software shall also be deemed to be an active device;
p.000016:
p.000016: (5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
p.000016:
p.000016: — to be totally introduced into the human body, or
p.000016:
p.000016: — to replace an epithelial surface or the surface of the eye,
p.000016:
p.000016: by clinical intervention and which is intended to remain in place after the procedure.
p.000016:
p.000016: Any device intended to be partially introduced into the human body by clinical intervention and intended
p.000016: to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
p.000016:
p.000016: (6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either
p.000016: through a body orifice or through the surface of the body;
p.000016:
p.000016: (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or a
p.000016: commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
p.000016:
p.000016: (8) ‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
p.000016:
p.000016: (9) ‘falsified device’ means any device with a false presentation of its identity and/or of
p.000016: its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition
p.000016: does not include uninten tional non-compliance and is without prejudice to infringements of intellectual property
p.000016: rights;
p.000016:
p.000016: (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with
p.000016: the purpose of being used for a specific medical purpose;
p.000016:
p.000016: (11) ‘system’ means a combination of products, either packaged together or not, which are intended to
p.000016: be inter- connected or combined to achieve a specific medical purpose;
p.000016:
p.000016: (12) ‘intended purpose’ means the use for which a device is intended according to the data
p.000016: supplied by the manufacturer on the label, in the instructions for use or in promotional or sales
p.000016: materials or statements and as specified by the manufacturer in the clinical evaluation;
p.000016:
p.000016: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or
p.000016: on the packaging of each unit or on the packaging of multiple devices;
p.000016:
p.000016: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000016: intended purpose and proper use and of any precautions to be taken;
p.000016:
p.000016: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is
p.000016: created through in ternationally accepted device identification and coding standards and that allows
p.000016: unambiguous identification of specific devices on the market;
p.000016:
p.000016: 5.5.2017 EN
p.000016: Official Journal of the European Union
p.000017: L 117/17
p.000017:
p.000017: (16) ‘non-viable’ means having no potential for metabolism or multiplication;
p.000017:
p.000017: (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a
p.000017: manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells
p.000017: or tissues;
p.000017:
p.000017: (18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an
p.000017: unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in
p.000017: the number size distribution, one or more external dimensions is in the size range 1-100 nm;
p.000017:
p.000017: Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1
p.000017: nm shall also be deemed to be nanomaterials;
p.000017:
p.000017: (19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece
p.000017: of matter with defined physical boundaries;
p.000017:
p.000017: (20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly
p.000017: bound particles or aggregates where the resulting external surface area is similar to the sum of the
p.000017: surface areas of the individual components;
p.000017:
p.000017: (21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle
p.000017: comprising of strongly bound or fused particles;
p.000017:
p.000017: (22) ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
p.000017:
p.000017: (23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
p.000017:
p.000017: (24) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible
p.000017: relevance for the use of the device for the intended purpose, when used in accordance with the intended
p.000017: purpose given by the manufacturer;
p.000017:
p.000017: (25) ‘compatibility’ is the ability of a device, including software, when used together with one or more
p.000017: other devices in accordance with its intended purpose, to:
p.000017:
...
p.000030: ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer
p.000030: in relation to the device in question in order to respond to safety issues or to bring it into conformity
p.000030: with this Regulation.
p.000030:
p.000030: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000030: distributors or importers carrying out any of the activities mentioned in points (a) and (b)
p.000030: of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in
p.000030: which they plan to make the device available of the intention to make the relabelled or repackaged
p.000030: device available and, upon request, shall provide the manufacturer and the competent authority with a sample
p.000030: or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
p.000030: Within the same period of 28 days, the distributor or importer shall submit to the competent authority
p.000030: a certificate, issued by a notified body designated for the type of devices that are subject to
p.000030: activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system
p.000030: of the distributer or importer complies with the requirements laid down in paragraph 3.
p.000030:
p.000030:
p.000030: Article 17
p.000030:
p.000030: Single-use devices and their reprocessing
p.000030:
p.000030: 1. Reprocessing and further use of single-use devices may only take place where permitted by
p.000030: national law and only in accordance with this Article.
p.000030:
p.000030: 2. Any natural or legal person who reprocesses a single-use device to make it suitable for further
p.000030: use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the
p.000030: obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to
p.000030: the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The
p.000030: reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive
p.000030: 85/374/EEC.
p.000030:
p.000030: 3. By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a
p.000030: health institution, Member States may decide not to apply all of the rules relating to manufacturers'
p.000030: obligations laid down in this Regulation provided that they ensure that:
p.000030:
p.000030: (a) the safety and performance of the reprocessed device is equivalent to that of the
p.000030: original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied
p.000030: with;
p.000030:
p.000030: (b) the reprocessing is performed in accordance with CS detailing the requirements concerning:
p.000030:
p.000030: — risk management, including the analysis of the construction and material, related properties of the
p.000030: device (reverse engineering) and procedures to detect changes in the design of the original device as
p.000030: well as of its planned application after reprocessing,
p.000030:
p.000030: — the validation of procedures for the entire process, including cleaning steps,
p.000030:
p.000030: — the product release and performance testing,
p.000030:
p.000030: — the quality management system,
p.000030:
p.000030: — the reporting of incidents involving devices that have been reprocessed, and
p.000030:
p.000030: — the traceability of reprocessed devices.
p.000030:
p.000030: Member States shall encourage, and may require, health institutions to provide information to patients on
p.000030: the use of reprocessed devices within the health institution and, where appropriate, any other
p.000030: relevant information on the reprocessed devices that patients are treated with.
p.000030:
p.000030: 5.5.2017 EN
p.000030: Official Journal of the European Union
p.000031: L 117/31
p.000031:
p.000031: Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant
p.000031: to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
p.000031:
p.000031: 4. Member States may choose to apply the provisions referred to in paragraph 3 also as regards
p.000031: single-use devices that are reprocessed by an external reprocessor at the request of a health
p.000031: institution, provided that the reprocessed device in its entirety is returned to that health institution
p.000031: and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.
p.000031:
p.000031: 5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in
p.000031: point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific
p.000031: evidence and shall address the application of the general requirements on safety and performance laid
p.000031: down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be
p.000031: performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined
p.000031: in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and
p.000031: national provisions, shall be certified by a notified body.
p.000031:
p.000031: 6. Only single-use devices that have been placed on the market in accordance with this Regulation,
p.000031: or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed.
p.000031:
p.000031: 7. Only reprocessing of single-use devices that is considered safe according to the latest
p.000031: scientific evidence may be carried out.
p.000031:
p.000031: 8. The name and address of the legal or natural person referred to in paragraph 2 and the other relevant
p.000031: information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable,
p.000031: in the instructions for use of the reprocessed device.
p.000031:
p.000031: The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but
p.000031: shall be mentioned in the instructions for use of the reprocessed device.
p.000031:
p.000031: 9. A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions
p.000031: that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the
p.000031: following:
p.000031:
p.000031: (a) the reprocessing of single-use devices and the transfer of single-use devices to another Member
p.000031: State or to a third country with a view to their reprocessing;
p.000031:
p.000031: (b) the making available or further use of reprocessed single-use devices.
p.000031:
p.000031: Member States shall notify the Commission and the other Member States of those national provisions. The Commission
p.000031: shall make such information publicly available.
p.000031:
p.000031: 10. The Commission shall by 27 May 2024 draw up a report on the operation of this Article and
p.000031: submit it to the European Parliament and to the Council. On the basis of that report, the Commission
p.000031: shall, if appropriate, make proposals for amendments to this Regulation.
p.000031:
p.000031:
p.000031: Article 18
p.000031:
p.000031: Implant card and information to be supplied to the patient with an implanted device
p.000031:
p.000031: 1. The manufacturer of an implantable device shall provide together with the device the following:
p.000031:
p.000031: (a) information allowing the identification of the device, including the device name, serial number, lot number, the
p.000031: UDI, the device model, as well as the name, address and the website of the manufacturer;
p.000031:
p.000031: (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with
p.000031: regard to reciprocal interference with reasonably foreseeable external influences, medical
p.000031: examinations or environmental conditions;
p.000031:
p.000031: (c) any information about the expected lifetime of the device and any necessary follow-up;
p.000031:
p.000031: (d) any other information to ensure safe use of the device by the patient, including the information
p.000031: in point (u) of Section 23.4 of Annex I.
p.000031:
p.000032: L 117/32 EN
p.000032: Official Journal of the European Union
p.000032: 5.5.2017
p.000032:
...
p.000032: implanted with the device, together with the implant card, which shall bear their identity.
p.000032:
p.000032: 3. The following implants shall be exempted from the obligations laid down in this Article:
p.000032: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips
p.000032: and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this
p.000032: list by adding other types of implants to it or by removing implants therefrom.
p.000032:
p.000032:
p.000032: Article 19
p.000032:
p.000032: EU declaration of conformity
p.000032:
p.000032: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation
p.000032: have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update
p.000032: the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the
p.000032: information set out in Annex IV and shall be translated into an official Union language or languages
p.000032: required by the Member State(s) in which the device is made available.
p.000032:
p.000032: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000032: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000032: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be
p.000032: drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the
p.000032: information required for identification of the Union legislation to which the declaration relates.
p.000032:
p.000032: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000032: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000032:
p.000032: 4. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the
p.000032: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000032:
p.000032:
p.000032: Article 20
p.000032:
p.000032: CE marking of conformity
p.000032:
p.000032: 1. Devices, other than custom-made or investigational devices, considered to be in conformity with the
p.000032: requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000032:
p.000032: 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No
p.000032: 765/2008.
p.000032:
p.000032: 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile
p.000032: packaging. Where such affixing is not possible or not warranted on account of the nature of the device,
p.000032: the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use
p.000032: and on any sales packaging.
p.000032:
...
p.000037: or procedure pack.
p.000037:
p.000037: 3. For devices that are the subject of a conformity assessment as referred to in Article 52(3)
p.000037: and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in
p.000037: paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
p.000037:
p.000037: For the devices referred to in the first subparagraph, the notified body shall include a reference to
p.000037: the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of
p.000037: Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex
p.000037: VI is correct. After the issuing of the relevant certificate and before placing the device on the
p.000037: market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core
p.000037: data elements referred to in Part B of Annex VI related to that device.
p.000037:
p.000037: 4. Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if,
p.000037: already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI,
p.000037: with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
p.000037:
p.000037:
p.000037: Article 30
p.000037:
p.000037: Electronic system for registration of economic operators
p.000037:
p.000037: 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to
p.000037: create the single registration number referred to in Article 31(2) and to collate and process information
p.000037: that is necessary and propor tionate to identify the manufacturer and, where applicable, the authorised
p.000037: representative and the importer. The details regarding the information to be provided to that electronic system by
p.000037: the economic operators are laid down in Section 1 of Part A of Annex VI.
p.000037:
p.000037: 2. Member States may maintain or introduce national provisions on registration of distributors of devices which
p.000037: have been made available on their territory.
p.000037:
p.000037: 3. Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify
p.000037: that the manufacturer or authorised representative has provided to the electronic system the information
p.000037: referred to in paragraph 1.
p.000037:
p.000037: Where applicable, importers shall inform the relevant authorised representative or manufacturer if the
p.000037: information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the
p.000037: relevant entry/entries.
p.000037:
p.000037:
p.000037: Article 31
p.000037:
p.000037: Registration of manufacturers, authorised representatives and importers
p.000037:
p.000037: 1. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised
p.000037: representatives and importers shall, in order to register, submit to the electronic system referred to in
p.000037: Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have
p.000037: not already registered in accordance with this Article. In cases where the conformity assessment procedure
p.000037: requires the involvement of a notified body pursuant to Article 52, the information referred to in
p.000037: Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000037: notified body.
p.000037:
p.000037: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000037: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and
p.000037: issue it to the manufacturer, the authorised representative or the importer.
p.000037:
p.000038: L 117/38 EN
p.000038: Official Journal of the European Union
p.000038: 5.5.2017
p.000038:
p.000038: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for
p.000038: accessing Eudamed in order to fulfil its obligations under Article 29.
p.000038:
p.000038: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000038: Article, the economic operator shall update the data in the electronic system referred to in Article 30.
p.000038:
p.000038: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000038: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the
p.000038: event of a failure to do so within six months of those deadlines, any Member State may take appropriate
p.000038: corrective measures within its territory until that economic operator complies with that obligation.
p.000038:
p.000038: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority
p.000038: shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000038:
p.000038: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in
p.000038: Article 30 shall be accessible to the public.
p.000038:
...
p.000044: referred to in Article 57 the information relating to the notification of the notified body along with
p.000044: the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and
p.000044: 8 of this Article.
p.000044:
p.000044: 11. The designation shall become valid the day after the notification is published in
p.000044: NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified
p.000044: body.
p.000044:
p.000044: 12. The conformity assessment body concerned may perform the activities of a notified
p.000044: body only after the designation has become valid in accordance with paragraph 11.
p.000044:
p.000044: 13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000044: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000044: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000044: referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list
p.000044: based, inter alia, on information arising from the coordination activities described in Article 48.
p.000044:
p.000044:
p.000044: Article 43
p.000044:
p.000044: Identification number and list of notified bodies
p.000044:
p.000044: 1. The Commission shall assign an identification number to each notified body for which the
p.000044: notification becomes valid in accordance with Article 42(11). It shall assign a single identification
p.000044: number even when the body is notified under several Union acts. If they are successfully designated in
p.000044: accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain
p.000044: the identification number assigned to them pursuant to those Directives.
p.000044:
p.000044: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000044: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000044: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000044: It shall also make this list available on the electronic system referred to in Article 57. The Commission shall
p.000044: ensure that the list is kept up to date.
p.000044:
p.000044: 5.5.2017 EN
p.000044: Official Journal of the European Union
p.000045: L 117/45
p.000045:
p.000045: Article 44
p.000045:
p.000045: Monitoring and re-assessment of notified bodies
p.000045:
p.000045: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority
p.000045: responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out
p.000045: in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they
p.000045: have been designated.
p.000045:
p.000045: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on
...
p.000054: the information supplied by the manufacturer, including any promotional material;
p.000054: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000054: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000054: the incoming notified body;
p.000054: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000054: 2. The outgoing notified body shall withdraw the certificates it has issued for the device
p.000054: concerned on the date on which they become invalid.
p.000054:
p.000054: 5.5.2017 EN
p.000054: Official Journal of the European Union
p.000055: L 117/55
p.000055:
p.000055: Article 59
p.000055:
p.000055: Derogation from the conformity assessment procedures
p.000055:
p.000055: 1. By way of derogation from Article 52, any competent authority may authorise, on a duly
p.000055: justified request, the placing on the market or putting into service within the territory of the Member State
p.000055: concerned, of a specific device for which the procedures referred to in that Article have not been carried
p.000055: out but use of which is in the interest of public health or patient safety or health.
p.000055:
p.000055: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000055: authorise the placing on the market or putting into service of a device in accordance with paragraph 1
p.000055: where such authorisation is granted for use other than for a single patient.
p.000055:
p.000055: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional
p.000055: cases relating to public health or patient safety or health, may, by means of implementing acts, extend
p.000055: for a limited period of time the validity of an authorisation granted by a Member State in accordance with
p.000055: paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may
p.000055: be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the
p.000055: examination procedure referred to in Article 114(3).
p.000055:
p.000055: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000055: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
p.000055: Article 114(4).
p.000055:
p.000055:
p.000055: Article 60
p.000055:
p.000055: Certificate of free sale
p.000055:
p.000055: 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the
p.000055: Member State in which the manufacturer or the authorised representative has its registered place of
p.000055: business shall issue a certificate of free sale declaring that the manufacturer or the authorised
p.000055: representative, as applicable, has its registered place of business on its territory and that the device in
p.000055: question bearing the CE marking in accordance with this Regulation may be marketed in the Union. The certificate
...
p.000059:
p.000059: (a) enable the subject or his or her legally designated representative to understand:
p.000059:
p.000059: (i) the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
p.000059:
p.000059: (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her
p.000059: right to refuse to participate in and the right to withdraw from the clinical investigation at any time
p.000059: without any resulting detriment and without having to provide any justification;
p.000059:
p.000059: (iii) the conditions under which the clinical investigations is to be conducted, including the expected duration of
p.000059: the subject's participation in the clinical investigation; and
p.000059:
p.000059: (iv) the possible treatment alternatives, including the follow-up measures if the participation of the
p.000059: subject in the clinical investigation is discontinued;
p.000059:
p.000059: (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her
p.000059: legally designated representative;
p.000059:
p.000059: (c) be provided in a prior interview with a member of the investigating team who is appropriately
p.000059: qualified under national law;
p.000059:
p.000060: L 117/60 EN
p.000060: Official Journal of the European Union
p.000060: 5.5.2017
p.000060:
p.000060: (d) include information about the applicable damage compensation system referred to in Article 69; and
p.000060: (e) include the Union-wide unique single identification number of the clinical investigation referred to
p.000060: in Article 70(1) and information about the availability of the clinical investigation results in
p.000060: accordance with paragraph 6 of this Article.
p.000060: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to
p.000060: the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000060: representative.
p.000060:
p.000060: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
p.000060: information needs of specific patient populations and of individual subjects, as well as to the methods used to give
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
...
p.000062: consent, he or she shall be informed of the right to object to the use of data obtained from the clinical
p.000062: investigation.
p.000062:
p.000062:
p.000062: Article 69
p.000062:
p.000062: Damage compensation
p.000062:
p.000062: 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from
p.000062: par ticipation in a clinical investigation conducted on their territory are in place in the form of
p.000062: insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is
p.000062: appropriate to the nature and the extent of the risk.
p.000062:
p.000062: 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in
p.000062: the form appropriate for the Member State in which the clinical investigation is conducted.
p.000062:
p.000062:
p.000062: Article 70
p.000062:
p.000062: Application for clinical investigations
p.000062:
p.000062: 1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in
p.000062: which the clinical investigation is to be conducted (referred to for the purposes of this Article as
p.000062: ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.
p.000062:
p.000062: The application shall be submitted by means of the electronic system referred to in Article 73, which
p.000062: shall generate a Union-wide unique single identification number for the clinical investigation, which shall
p.000062: be used for all relevant communication in relation to that clinical investigation. Within 10 days of it receiving
p.000062: the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation
p.000062: falls within the scope of this Regulation and as to whether the application dossier is complete in accordance
p.000062: with Chapter II of Annex XV.
p.000062:
p.000062: 5.5.2017 EN
p.000062: Official Journal of the European Union
p.000063: L 117/63
p.000063:
p.000063: 2. Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex
p.000063: XV, the sponsor shall update the relevant data in the electronic system referred to in Article 73 and make that change
p.000063: to the documentation clearly identifiable. The Member State concerned shall be notified of the update by
p.000063: means of that electronic system.
p.000063:
p.000063: 3. Where the Member State concerned finds that the clinical investigation applied for does not fall
p.000063: within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor
p.000063: thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the
p.000063: application by means of the electronic system referred to in Article 73. The Member State concerned may extend
p.000063: this period by a maximum of 20 days where appropriate.
p.000063:
p.000063: Where the sponsor has not provided comments nor completed the application within the time limit referred
...
p.000065: by the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
p.000065: interpreted and verified while the confiden tiality of records and the personal data of the subjects
p.000065: remain protected in accordance with the applicable law on personal data protection.
p.000065:
p.000065: 4. Appropriate technical and organisational measures shall be implemented to protect information and
p.000065: personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction
p.000065: or accidental loss, in particular where the processing involves transmission over a network.
p.000065:
p.000065: 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that
p.000065: clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved
p.000065: investigation plan.
p.000065:
p.000065: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate
p.000065: identification and, where necessary, an immediate recall of the devices used in the investigation.
p.000065:
p.000065:
p.000065: Article 73
p.000065:
p.000065: Electronic system on clinical investigations
p.000065:
p.000065: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000065: electronic system:
p.000065:
p.000065: (a) to create the single identification numbers for clinical investigations referred to in Article 70(1);
p.000065:
p.000065: (b) to be used as an entry point for the submission of all applications or notifications for clinical
p.000065: investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data
p.000065: in this context;
p.000065:
p.000065: (c) for the exchange of information relating to clinical investigations in accordance with this
p.000065: Regulation between the Member States and between them and the Commission including the exchange of
p.000065: information referred to in Articles 70 and 76;
p.000065:
p.000065: (d) for information to be provided by the sponsor in accordance with Article 77, including the clinical
p.000065: investigation report and its summary as required in paragraph 5 of that Article;
p.000065:
p.000065: (e) for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.
p.000065:
p.000065: 2. When setting up the electronic system referred in paragraph 1 of this Article, the Commission
p.000065: shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for
p.000065: human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European
p.000065: Parliament and of the Council (1) as concerns combined clinical investigations of devices with a clinical trial
p.000065: under that Regulation.
p.000065:
p.000065: 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member
p.000065: States and the Commission. The information referred to in the other points of that paragraph shall be
...
p.000067: clinical investi gation report.
p.000067:
p.000067: In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases
p.000067: where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and
p.000067: adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
p.000067:
p.000067: 7. The summary and the clinical investigation report referred to in paragraph 5 of this Article
p.000067: shall become publicly accessible through the electronic system referred to in Article 73, at the
p.000067: latest when the device is registered in accordance with Article 29 and before it is placed on the
p.000067: market. In cases of early termination or temporary halt, the summary and the report shall become publicly
p.000067: accessible immediately after submission.
p.000067:
p.000067: If the device is not registered in accordance with Article 29 within one year of the summary and the report having
p.000067: been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become
p.000067: publicly accessible at that point in time.
p.000067:
p.000068: L 117/68 EN
p.000068: Official Journal of the European Union
p.000068: 5.5.2017
p.000068:
p.000068: Article 78
p.000068:
p.000068: Coordinated assessment procedure for clinical investigations
p.000068:
p.000068: 1. By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be
p.000068: conducted in more than one Member State may submit, for the purpose of Article 70, a single application
p.000068: that, upon receipt, is transmitted electronically to all Member States in which the clinical investigation is to be
p.000068: conducted.
p.000068:
p.000068: 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the
p.000068: Member States in which the clinical investigation is to be conducted acts as coordinating Member State.
p.000068: The Member States in which the clinical investigation is to be conducted shall, within six days of
p.000068: submission of the application, agree on one of them taking the role of the coordinating Member State. If they
p.000068: do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that
p.000068: role.
p.000068:
p.000068: 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member
p.000068: States concerned shall coordinate their assessment of the application, in particular of the documentation
p.000068: referred to in Chapter II of Annex XV.
p.000068:
p.000068: However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of
p.000068: Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1)
p.000068: to (5).
p.000068:
p.000068: 4. With regard to documentation other than that referred to in the second subparagraph of
p.000068: paragraph 3, the coordinating Member State shall:
p.000068: (a) within six days of receipt of the single application, notify the sponsor that it is the
p.000068: coordinating Member State (‘notification date’);
p.000068: (b) for the purpose of the validation of the application, take into account any considerations submitted
p.000068: within seven days of the notification date by any Member State concerned;
p.000068: (c) within 10 days of the notification date, assess whether the clinical investigation falls within the
p.000068: scope of this Regulation and whether the application is complete, and shall notify the sponsor
p.000068: accordingly. Article 70(1) and (3) to (5) shall apply to the coordinating Member State in relation to that
p.000068: assessment;
p.000068: (d) establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the
p.000068: validation date to the Member States concerned. By day 38 after the validation date, the other Member
p.000068: States concerned shall transmit their comments and proposals on the draft assessment report and the
p.000068: underlying application to the coordinating Member State which shall take due account of those comments
p.000068: and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of
p.000068: the validation date to the sponsor and the other Member States concerned.
p.000068: The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's
p.000068: application in accordance with Article 70(7).
p.000068:
p.000068: 5. As regards the assessment of the documentation referred to in the second subparagraph of
p.000068: paragraph 3, each Member State concerned may request, on a single occasion, additional information from
p.000068: the sponsor. The sponsor shall submit the requested additional information within the period set by the
p.000068: Member State concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last
p.000068: deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the
p.000068: additional information has been received.
p.000068:
p.000068: 6. For class IIb and class III devices, the coordinating Member State may also extend the periods
p.000068: referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
p.000068:
p.000068: 7. The Commission may, by means of implementing acts, further specify the procedures and
p.000068: timescales for coordinated assessments to be taken into account by Member States concerned when
p.000068: deciding on the sponsor's application. Such implementing acts may also set out the procedures and
p.000068: timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of
p.000068: this Article, in the case of reporting of adverse events pursuant to Article 80(4) and in the case of
p.000068: clinical investigations of combination products between medical devices and medicinal products, where the
p.000068: latter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No
p.000068: 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000068: 114(3).
p.000068:
p.000068: 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that
...
p.000069: subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed
p.000069: justification, through the electronic system referred to in Article 73, to the Commission, to all other Member
p.000069: States concerned and to the sponsor.
p.000069:
p.000069: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that
p.000069: the clinical investigation is not acceptable, that conclusion shall be deemed to be the conclusion of
p.000069: all Member States concerned.
p.000069:
p.000069: 10. A Member State concerned shall refuse to authorise a clinical investigation if it disagrees
p.000069: with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second
p.000069: subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections
p.000069: 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV are not complied with, or where an ethics committee has
p.000069: issued a negative opinion in relation to that clinical investigation, which is valid, in accordance with
p.000069: national law, for that entire Member State. That Member State shall provide for an appeal procedure in
p.000069: respect of such refusal.
p.000069:
p.000069: 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in
p.000069: Article 73 as to whether the clinical investigation is authorised, whether it is authorised subject to
p.000069: conditions, or whether authoris ation has been refused. Notification shall be done by way of one single
p.000069: decision within five days of the transmission, pursuant to point (d) of paragraph 4, by the coordinating Member
p.000069: State of the final assessment report. Where an author isation of a clinical investigation is subject to
p.000069: conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of
p.000069: that authorisation.
p.000069:
p.000069: 12. Any substantial modifications as referred to in Article 75 shall be notified to the Member
p.000069: States concerned by means of the electronic system referred to in Article 73. Any assessment
p.000069: as to whether there are grounds for disagreement as referred to in the second subparagraph of
p.000069: paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State,
p.000069: except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2,
p.000069: 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
p.000069:
p.000069: 13. The Commission shall provide administrative support to the coordinating Member State in the
p.000069: accomplishment of its tasks under this Chapter.
p.000069:
p.000069: 14. The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member
p.000069: States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 May 2027, all
p.000069: Member States shall be required to apply that procedure.
p.000069:
p.000069:
p.000069: Article 79
p.000069:
p.000069: Review of coordinated assessment procedure
p.000069:
p.000069: By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on
...
p.000070: 2. The sponsor shall report, without delay to all Member States in which the clinical investigation is being
p.000070: conducted, all of the following by means of the electronic system referred to in Article 73:
p.000070:
p.000070: (a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the
p.000070: investi gation procedure or where such causal relationship is reasonably possible;
p.000070:
p.000070: (b) any device deficiency that might have led to a serious adverse event if appropriate action had not
p.000070: been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000070: (c) any new findings in relation to any event referred to in points (a) and (b).
p.000070:
p.000070: The period for reporting shall take account of the severity of the event. Where necessary to ensure timely
p.000070: reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
p.000070:
p.000070: Upon request by any Member State in which the clinical investigation is being conducted, the sponsor
p.000070: shall provide all information referred to in paragraph 1.
p.000070:
p.000070: 3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any
p.000070: event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical
p.000070: investigation is performed under the same clinical investigation plan as the one applying to a clinical
p.000070: investigation covered by this Regulation by means of the electronic system referred to in Article 73.
p.000070:
p.000070: 4. In the case of a clinical investigation for which the sponsor has used the single
p.000070: application referred to in Article 78, the sponsor shall report any event as referred to in paragraph 2
p.000070: of this Article by means of the electronic system referred to in Article 73. Upon receipt, this report
p.000070: shall be transmitted electronically to all Member States in which the clinical investigation is being
p.000070: conducted.
p.000070:
p.000070: Under the direction of the coordinating Member State referred to in Article 78(2), the Member States
p.000070: shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify,
p.000070: suspend or terminate the clinical investigation or whether to revoke the authorisation for that clinical
p.000070: investigation.
p.000070:
p.000070: This paragraph shall not affect the rights of the other Member States to perform their own evaluation
p.000070: and to adopt measures in accordance with this Regulation in order to ensure the protection of public
p.000070: health and patient safety. The coordinating Member State and the Commission shall be kept informed of
p.000070: the outcome of any such evaluation and the adoption of any such measures.
p.000070:
p.000070: 5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in
p.000070: Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article.
p.000070:
p.000070: 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the
p.000070: serious adverse event and the preceding investigational procedure has been established.
p.000070:
p.000070:
p.000070: Article 81
p.000070:
p.000070: Implementing acts
p.000070:
...
p.000073: after the date on which the manufacturer becomes aware of the serious incident.
p.000073:
p.000073: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that
p.000073: is incomplete followed up by a complete report.
p.000073:
p.000073: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain
p.000073: about whether the incident is reportable, it shall nevertheless submit a report within the
p.000073: timeframe required in accordance with paragraphs 2 to 5.
p.000073:
p.000073: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000073: immediately, the manufacturer shall, without undue delay, report the field safety corrective
p.000073: action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being
p.000073: undertaken.
p.000073:
p.000073: 9. For similar serious incidents that occur with the same device or device type and for which the root cause
p.000073: has been identified or a field safety corrective action implemented or where the incidents are common and
p.000073: well documented, the manufacturer may provide periodic summary reports instead of individual serious
p.000073: incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in
p.000073: consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with
p.000073: the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single
p.000073: competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic
p.000073: summary reports following agreement with that competent authority.
p.000073:
p.000073: 10. The Member States shall take appropriate measures such as organising targeted information
p.000073: campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent
p.000073: authorities suspected serious incidents referred to in point (a) of paragraph 1.
p.000073:
p.000073: The competent authorities shall record centrally at national level reports they receive from healthcare
p.000073: professionals, users and patients.
p.000073:
p.000074: L 117/74 EN
p.000074: Official Journal of the European Union
p.000074: 5.5.2017
p.000074:
p.000074: 11. Where a competent authority of a Member State obtains such reports on suspected serious
p.000074: incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it
p.000074: shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the
p.000074: suspected serious incident without delay.
p.000074:
p.000074: Where the manufacturer of the device concerned considers that the incident is a serious incident, it
p.000074: shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the
...
p.000099:
p.000099: (a) the risk of injury, in connection with their physical features, including the
p.000099: volume/pressure ratio, dimensional and where appropriate ergonomic features;
p.000099:
p.000099: (b) risks connected with reasonably foreseeable external influences or environmental conditions,
p.000099: such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation
p.000099: associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in
p.000099: pressure and acceleration or radio signal interferences;
p.000099:
p.000099: (c) the risks associated with the use of the device when it comes into contact with materials,
p.000099: liquids, and substances, including gases, to which it is exposed during normal conditions of use;
p.000099:
p.000099: (d) the risks associated with the possible negative interaction between software and the IT environment
p.000099: within which it operates and interacts;
p.000099:
p.000099: (e) the risks of accidental ingress of substances into the device;
p.000099:
p.000099: (f) the risks of reciprocal interference with other devices normally used in the investigations or for
p.000099: the treatment given; and
p.000099:
p.000099: (g) risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials
p.000099: used or loss of accuracy of any measuring or control mechanism.
p.000099:
p.000099: 14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or
p.000099: explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended
p.000099: use of which includes exposure to or use in association with flammable or explosive substances or
p.000099: substances which could cause combustion.
p.000099:
p.000099: 14.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and
p.000099: maintenance can be done safely and effectively.
p.000099:
p.000099: 14.5. Devices that are intended to be operated together with other devices or products shall be
p.000099: designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
p.000099:
p.000099: 14.6 Any measurement, monitoring or display scale shall be designed and manufactured in line with
p.000099: ergonomic principles, taking account of the intended purpose, users and the environmental conditions in
p.000099: which the devices are intended to be used.
p.000099:
p.000099: 14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe
p.000099: disposal and the safe disposal of related waste substances by the user, patient or other person. To
p.000099: that end, manufacturers shall identify and test procedures and measures as a result of which their
p.000099: devices can be safely disposed after use. Such procedures shall be described in the instructions for use.
p.000099:
p.000099: 15. Devices with a diagnostic or measuring function
p.000099:
p.000099: 15.1. Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way
p.000099: as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate
...
p.000100: the requirements of the Directive 2013/59/Euratom laying down basic safety standards for protection against
p.000100: the dangers arising from exposure to ionising radiation.
p.000100:
p.000100: (b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to
p.000100: ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of
p.000100: the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
p.000100:
p.000100: (c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such
p.000100: a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose
p.000100: whilst minimising radiation exposure of the patient and user.
p.000100:
p.000100: (d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed
p.000100: and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the
p.000100: beam type, energy and, where appropriate, the quality of radiation.
p.000100:
p.000100: 17. Electronic programmable systems — devices that incorporate electronic programmable systems and
p.000100: software that are devices in themselves
p.000100:
p.000100: 17.1. Devices that incorporate electronic programmable systems, including software, or software that
p.000100: are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000100: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate
p.000100: or reduce as far as possible consequent risks or impairment of performance.
p.000100:
p.000100: 17.2. For devices that incorporate software or for software that are devices in themselves, the
p.000100: software shall be developed and manufactured in accordance with the state of the art taking into account
p.000100: the principles of development life cycle, risk management, including information security, verification and
p.000100: validation.
p.000100:
p.000100: 5.5.2017 EN
p.000100: Official Journal of the European Union
p.000101: L 117/101
p.000101:
p.000101: 17.3. Software referred to in this Section that is intended to be used in combination with mobile
p.000101: computing platforms shall be designed and manufactured taking into account the specific features of the
p.000101: mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their
p.000101: use (varying environment as regards level of light or noise).
p.000101:
p.000101: 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics
p.000101: and IT security measures, including protection against unauthorised access, necessary to run the software as
p.000101: intended.
p.000101:
p.000101: 18. Active devices and devices connected to them
p.000101:
p.000101: 18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be
p.000101: adopted to eliminate or reduce as far as possible consequent risks.
p.000101:
p.000101: 18.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means
p.000101: of determining the state of the power supply and an appropriate warning or indication for when the
p.000101: capacity of the power supply becomes critical. If necessary, such warning or indication shall be given
p.000101: prior to the power supply becoming critical.
p.000101:
p.000101: 18.3. Devices where the safety of the patient depends on an external power supply shall include an
p.000101: alarm system to signal any power failure.
p.000101:
p.000101: 18.4. Devices intended to monitor one or more clinical parameters of a patient shall be equipped
p.000101: with appropriate alarm systems to alert the user of situations which could lead to death or severe
p.000101: deterioration of the patient's state of health.
p.000101:
p.000101: 18.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible
p.000101: the risks of creating electromagnetic interference which could impair the operation of the device in
p.000101: question or other devices or equipment in the intended environment.
p.000101:
p.000101: 18.6. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to
p.000101: electro magnetic interference such that is adequate to enable them to operate as intended.
p.000101:
p.000101: 18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the
p.000101: risk of accidental electric shocks to the patient, user or any other person, both during normal use of the
p.000101: device and in the event of a single fault condition in the device, provided the device is installed and
p.000101: maintained as indicated by the manufacturer.
p.000101:
p.000101: 18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against
p.000101: unauthorised access that could hamper the device from functioning as intended.
p.000101:
p.000101: 19. Particular requirements for active implantable devices
p.000101:
p.000101: 19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or
p.000101: minimize as far as possible:
p.000101: (a) risks connected with the use of energy sources with particular reference, where electricity is
p.000101: used, to insulation, leakage currents and overheating of the devices,
p.000101: (b) risks connected with medical treatment, in particular those resulting from the use of defibrillators
p.000101: or high- frequency surgical equipment, and
p.000101: (c) risks which may arise where maintenance and calibration are impossible, including:
p.000101: — excessive increase of leakage currents,
p.000101: — ageing of the materials used,
p.000101: — excess heat generated by the device,
p.000101: — decreased accuracy of any measuring or control mechanism.
p.000101: 19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure
p.000101: — if applicable, the compatibility of the devices with the substances they are intended to administer, and
p.000101: — the reliability of the source of energy.
p.000101:
p.000102: L 117/102 EN
p.000102: Official Journal of the European Union
p.000102: 5.5.2017
p.000102:
...
p.000103: shall, if the manufacturer has a website, be made available and kept up to date on the website,
p.000103: taking into account the following:
p.000103:
p.000103: (a) The medium, format, content, legibility, and location of the label and instructions for
p.000103: use shall be appropriate to the particular device, its intended purpose and the technical
p.000103: knowledge, experience, education or training of the intended user(s). In particular, instructions for use
p.000103: shall be written in terms readily understood by the intended user and, where appropriate,
p.000103: supplemented with drawings and diagrams.
p.000103:
p.000103: (b) The information required on the label shall be provided on the device itself. If this is not
p.000103: practicable or appropriate, some or all of the information may appear on the packaging for each unit,
p.000103: and/or on the packaging of multiple devices.
p.000103:
p.000103: (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable
p.000103: information, such as radio-frequency identification (‘RFID’) or bar codes.
p.000103:
p.000103: (d) Instructions for use shall be provided together with devices. By way of exception, instructions for
p.000103: use shall not be required for class I and class IIa devices if such devices can be used safely
p.000103: without any such instructions and unless otherwise provided for elsewhere in this Section.
p.000103:
p.000103: (e) Where multiple devices are supplied to a single user and/or location, a single copy of the
p.000103: instructions for use may be provided if so agreed by the purchaser who in any case may request further
p.000103: copies to be provided free of charge.
p.000103:
p.000103: (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the
p.000103: extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent
p.000103: implementing rules adopted pursuant to this Regulation.
p.000103:
p.000103: (g) Residual risks which are required to be communicated to the user and/or other person shall be included
p.000103: as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000103:
p.000103: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000103: internationally recognised symbols. Any symbol or identification colour used shall conform to the
p.000103: harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours
p.000103: shall be described in the documentation supplied with the device.
p.000103:
p.000104: L 117/104 EN
p.000104: Official Journal of the European Union
p.000104: 5.5.2017
p.000104:
p.000104: 23.2. Information on the label
p.000104:
p.000104: The label shall bear all of the following particulars:
p.000104: (a) the name or trade name of the device;
p.000104: (b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it
p.000104: is not obvious for the user, the intended purpose of the device;
p.000104: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
...
p.000104: — a medicinal substance, including a human blood or plasma derivative, or
p.000104: — tissues or cells, or their derivatives, of human origin, or
p.000104: — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
p.000104: (f) where applicable, information labelled in accordance with Section 10.4.5.;
p.000104: (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL
p.000104: NUMBER or an equivalent symbol, as appropriate;
p.000104: (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
p.000104: (i) an unambiguous indication of t the time limit for using or implanting the device safely,
p.000104: expressed at least in terms of year and month, where this is relevant;
p.000104: (j) where there is no indication of the date until when it may be used safely, the date of
p.000104: manufacture. This date of manufacture may be included as part of the lot number or serial number,
p.000104: provided the date is clearly identifiable;
p.000104: (k) an indication of any special storage and/or handling condition that applies;
p.000104: (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
p.000104: (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the
p.000104: device, and to any other person. This information may be kept to a minimum in which case more detailed information
p.000104: shall appear in the instructions for use, taking into account the intended users;
p.000104: (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication
p.000104: of single use shall be consistent across the Union;
p.000104: (o) if the device is a single-use device that has been reprocessed, an indication of that fact, the
p.000104: number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
p.000104: (p) if the device is custom-made, the words ‘custom-made device’;
p.000104: (q) an indication that the device is a medical device. If the device is intended for clinical investigation only,
p.000104: the words ‘exclusively for clinical investigation’;
p.000104: (r) in the case of devices that are composed of substances or of combinations of substances that are
p.000104: intended to be introduced into the human body via a body orifice or applied to the skin and that are
p.000104: absorbed by or locally dispersed in the human body, the overall qualitative composition of the device
p.000104: and quantitative information on the main constituent or constituents responsible for achieving the
p.000104: principal intended action;
p.000104: (s) for active implantable devices, the serial number, and for other implantable devices, the serial
p.000104: number or the lot number.
p.000104: 23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
p.000104:
p.000104: The following particulars shall appear on the sterile packaging:
p.000104: (a) an indication permitting the sterile packaging to be recognised as such,
p.000104: (b) a declaration that the device is in a sterile condition,
p.000104:
p.000104: 5.5.2017 EN
p.000104: Official Journal of the European Union
p.000105: L 117/105
p.000105:
p.000105: (c) the method of sterilisation,
p.000105:
p.000105: (d) the name and address of the manufacturer,
p.000105:
p.000105: (e) a description of the device,
p.000105:
...
p.000105:
p.000105: — information on any necessary calibration to ensure that the device operates properly and safely during its
p.000105: intended lifetime, and
p.000105:
p.000105: — methods for eliminating the risks encountered by persons involved in installing, calibrating
p.000105: or servicing devices;
p.000105:
p.000105: (l) if the device is supplied sterile, instructions in the event of the sterile packaging being
p.000105: damaged or unintentionally opened before use;
p.000105:
p.000106: L 117/106 EN
p.000106: Official Journal of the European Union
p.000106: 5.5.2017
p.000106:
p.000106: (m) if the device is supplied non-sterile with the intention that it is sterilised before use, the
p.000106: appropriate instructions for sterilisation;
p.000106:
p.000106: (n) if the device is reusable, information on the appropriate processes for allowing reuse, including
p.000106: cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation
p.000106: appropriate to the Member State or Member States in which the device has been placed on the market.
p.000106: Information shall be provided to identify when the device should no longer be reused, e.g. signs of
p.000106: material degradation or the maximum number of allowable reuses;
p.000106:
p.000106: (o) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility
p.000106: of the manufacturer to comply with the general safety and performance requirements;
p.000106:
p.000106: (p) if the device bears an indication that it is for single use, information on known
p.000106: characteristics and technical factors known to the manufacturer that could pose a risk if the device
p.000106: were to be re-used. This information shall be based on a specific section of the manufacturer's risk
p.000106: management documentation, where such characteristics and technical factors shall be addressed in detail. If in
p.000106: accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be
p.000106: made available to the user upon request;
p.000106:
p.000106: (q) for devices intended for use together with other devices and/or general purpose equipment:
p.000106:
p.000106: — information to identify such devices or equipment, in order to obtain a safe combination, and/or
p.000106:
p.000106: — information on any known restrictions to combinations of devices and equipment;
p.000106:
p.000106: (r) if the device emits radiation for medical purposes:
p.000106:
p.000106: — detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted
p.000106: radiation,
p.000106:
p.000106: — the means of protecting the patient, user, or other person from unintended radiation during use of the device;
p.000106:
p.000106: (s) information that allows the user and/or patient to be informed of any warnings, precautions,
p.000106: contra- indications, measures to be taken and limitations of use regarding the device. That information
p.000106: shall, where relevant, allow the user to brief the patient about any warnings, precautions,
p.000106: contra-indications, measures to be taken and limitations of use regarding the device. The information
...
p.000108: software if appropriate), its formulation, its composition, its functionality and, where
p.000108: relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled
p.000108: pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key
p.000108: parts/components, including sufficient explanation to understand the drawings and diagrams;
p.000108: (k) a description of the raw materials incorporated into key functional elements and those making
p.000108: either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal
p.000108: circulation of body fluids;
p.000108: (l) technical specifications, such as features, dimensions and performance attributes, of the
p.000108: device and any variants/configurations and accessories that would typically appear in the product
p.000108: specification made available to the user, for example in brochures, catalogues and similar publications.
p.000108:
p.000108: 1.2. Reference to previous and similar generations of the device
p.000108:
p.000108: (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such
p.000108: devices exist;
p.000108: (b) an overview of identified similar devices available on the Union or international markets, where
p.000108: such devices exist.
p.000108:
p.000108: 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
p.000108:
p.000108: A complete set of:
p.000108: — the label or labels on the device and on its packaging, such as single unit packaging, sales
p.000108: packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member
p.000108: States where the device is envisaged to be sold; and
p.000108:
p.000108: 5.5.2017 EN
p.000108: Official Journal of the European Union
p.000109: L 117/109
p.000109:
p.000109: — the instructions for use in the languages accepted in the Member States where the device is
p.000109: envisaged to be sold.
p.000109:
p.000109: 3. DESIGN AND MANUFACTURING INFORMATION
p.000109:
p.000109: (a) information to allow the design stages applied to the device to be understood;
p.000109:
p.000109: (b) complete information and specifications, including the manufacturing processes and their validation,
p.000109: their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the
p.000109: technical documentation;
p.000109:
p.000109: (c) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities
p.000109: are performed.
p.000109:
p.000109: 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000109:
p.000109: The documentation shall contain information for the demonstration of conformity with the general safety
p.000109: and performance requirements set out in Annex I that are applicable to the device taking into account
p.000109: its intended purpose, and shall include a justification, validation and verification of the solutions
p.000109: adopted to meet those requirements. The demonstration of conformity shall include:
p.000109:
p.000109: (a) the general safety and performance requirements that apply to the device and an explanation as to
p.000109: why others do not apply;
p.000109:
...
p.000110: taking account of the intended purpose of the device.
p.000110:
p.000110: (b) Where a device is manufactured utilising tissues or cells of human or animal origin, or their
p.000110: derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a
p.000110: device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have
p.000110: an action ancillary to that of the device and is covered by this Regulation in accordance with the
p.000110: first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation
p.000110: shall identify all materials of human or animal origin used and provide detailed information concerning
p.000110: the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
p.000110:
p.000110: (c) In the case of devices that are composed of substances or combinations of substances that are
p.000110: intended to be introduced into the human body and that are absorbed by or locally dispersed in the
p.000110: human body, detailed information, including test design, complete test or study protocols, methods
p.000110: of data analysis, and data summaries and test conclusions, regarding studies in relation to:
p.000110:
p.000110: — absorption, distribution, metabolism and excretion;
p.000110:
p.000110: — possible interactions of those substances, or of their products of metabolism in the human body, with other
p.000110: devices, medicinal products or other substances, considering the target population, and its
p.000110: associated medical conditions;
p.000110:
p.000110: — local tolerance; and
p.000110:
p.000110: — toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and
p.000110: reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device.
p.000110:
p.000110: In the absence of such studies, a justification shall be provided.
p.000110:
p.000110: (d) In the case of devices containing CMR or endocrine-disrupting substances referred to in Section
p.000110: 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
p.000110:
p.000110: (1) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of
p.000110: laws, regulations and administrative provisions relating to the application of the principles of good
p.000110: laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50,
p.000110: 20.2.2004, p. 44).
p.000110:
p.000110: 5.5.2017 EN
p.000110: Official Journal of the European Union
p.000111: L 117/111
p.000111:
p.000111: (e) In the case of devices placed on the market in a sterile or defined microbiological condition, a
p.000111: description of the environmental conditions for the relevant manufacturing steps. In the case of devices
p.000111: placed on the market in a sterile condition, a description of the methods used, including the validation
p.000111: reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report
p.000111: shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
p.000111:
p.000111: (f) In the case of devices placed on the market with a measuring function, a description of the
...
p.000115: devices referred to in Section 2 is complete, correct and updated by the relevant party.
p.000115:
p.000115: 1. Information relating to the economic operator
p.000115:
p.000115: 1.1. type of economic operator(manufacturer, authorised representative, or importer),
p.000115: 1.2. name, address and contact details of the economic operator,
p.000115:
p.000115: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000115: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000115:
p.000115: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000115: referred to in Article 15.
p.000115:
p.000115: 2. Information relating to the device
p.000115:
p.000115: 2.1. Basic UDI-DI,
p.000115:
p.000115: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000115: identification number of that notified body and the link to the information that appears on the
p.000115: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000115: 2.3. Member State in which the device is to or has been placed on the market in the Union,
p.000115: 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made
p.000115: available,
p.000115: 2.5. risk class of the device,
p.000115: 2.6. reprocessed single-use device (y/n),
p.000115:
p.000115: 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of
p.000115: that substance,
p.000115:
p.000115: 2.8. presence of a substance which, if used separately, may be considered to be a medicinal
p.000115: product derived from human blood or human plasma and name of this substance,
p.000115: 2.9. presence of tissues or cells of human origin, or their derivatives (y/n),
p.000115:
p.000115: 2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in
p.000115: Regulation (EU) No 722/2012 (y/n),
p.000115:
p.000115: 2.11. where applicable, the single identification number of the clinical investigation or investigations
p.000115: conducted in relation to the device or a link to the clinical investigation registration in the electronic system on
p.000115: clinical investi gations,
p.000115:
p.000115: 2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose
p.000115: of the device is other than a medical purpose,
p.000115:
p.000115: 2.13. in the case of devices designed and manufactured by another legal or natural person
p.000115: as referred in Article 10(15), the name, address and contact details of that legal or natural person,
p.000115:
p.000116: L 117/116 EN
p.000116: Official Journal of the European Union
p.000116: 5.5.2017
p.000116:
p.000116: 2.14. in the case of class III or implantable devices, the summary of safety and clinical performance,
p.000116:
p.000116: 2.15. status of the device (on the market, no longer placed on the market, recalled, field safety
p.000116: corrective action initiated).
p.000116:
p.000116: PART B
p.000116:
p.000116: CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH
p.000116: ARTICLES 28 AND 29
p.000116:
p.000116:
p.000116: The manufacturer shall provide to the UDI database the UDI-DI and all of the following information
p.000116: relating to the manufacturer and the device:
p.000116:
p.000116: 1. quantity per package configuration,
p.000116:
p.000116: 2. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
p.000116:
p.000116: 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot
p.000116: number, serial number),
p.000116:
p.000116: 4. if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use,
p.000116: a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
p.000116:
p.000116: 5. name and address of the manufacturer (as indicated on the label),
p.000116:
p.000116: 6. the SRN issued in accordance with Article 31(2),
p.000116:
p.000116: 7. if applicable, name and address of the authorised representative (as indicated on the label),
p.000116:
p.000116: 8. the medical device nomenclature code as provided for in Article 26,
p.000116:
p.000116: 9. risk class of the device,
p.000116:
p.000116: 10. if applicable, name or trade name,
p.000116:
p.000116: 11. if applicable, device model, reference, or catalogue number,
p.000116:
p.000116: 12. if applicable, clinical size (including volume, length, gauge, diameter),
p.000116:
p.000116: 13. additional product description (optional),
p.000116:
p.000116: 14. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
p.000116:
p.000116: 15. if applicable, additional trade names of the device,
p.000116:
p.000116: 16. labelled as a single-use device (y/n),
p.000116:
p.000116: 17. if applicable, the maximum number of reuses,
p.000116:
p.000116: 18. device labelled sterile (y/n),
p.000116:
p.000116: 19. need for sterilisation before use (y/n),
p.000116:
p.000116: 20. containing latex (y/n),
p.000116:
p.000116: 21. where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
p.000116:
p.000116: 22. URL for additional information, such as electronic instructions for use (optional),
p.000116:
p.000116: 23. if applicable, critical warnings or contra-indications,
p.000116:
p.000116: 24. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action
p.000116: initiated).
p.000116:
p.000116: 5.5.2017 EN
p.000116: Official Journal of the European Union
p.000117: L 117/117
p.000117:
p.000117: PART C
p.000117:
p.000117: THE UDI SYSTEM
p.000117:
p.000117: 1. Definitions
p.000117:
p.000117: Automatic identification and data capture (‘AIDC’)
p.000117:
p.000117: AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart
p.000117: cards, biometrics and RFID.
p.000117:
p.000117: Basic UDI-DI
p.000117:
p.000117: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of
p.000117: the device unit of use. It is the main key for records in the UDI database and is referenced in
p.000117: relevant certificates and EU declarations of conformity.
p.000117:
p.000117: Unit of Use DI
p.000117:
p.000117: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000117: UDI is not labelled on the individual device at the level of its unit of use, for example in the
...
p.000118:
p.000118: 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.
p.000118:
p.000118: 3.4. The UDI-DI shall be unique at each level of device packaging.
p.000118:
p.000118: 3.5. If a lot number, serial number, software identification or expiry date appears on the label,
p.000118: it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need
p.000118: to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the
p.000118: UDI-PI.
p.000118:
p.000118: 3.6. Each component that is considered to be a device and is commercially available on its own
p.000118: shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own
p.000118: UDI.
p.000118:
p.000118: 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.
p.000118:
p.000118: 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.
p.000118:
p.000118: 5.5.2017 EN
p.000118: Official Journal of the European Union
p.000119: L 117/119
p.000119:
p.000119: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to
p.000119: misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the
p.000119: following UDI database data elements shall require a new UDI-DI:
p.000119: (a) name or trade name,
p.000119: (b) device version or model,
p.000119: (c) labelled as single use,
p.000119: (d) packaged sterile,
p.000119: (e) need for sterilization before use,
p.000119: (f) quantity of devices provided in a package,
p.000119: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.
p.000119: 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record
p.000119: of the original device manufacturer's UDI.
p.000119:
p.000119: 4. UDI carrier
p.000119:
p.000119: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on
p.000119: the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000119:
p.000119: 4.2. In the event of there being significant space constraints on the unit of use packaging, the
p.000119: UDI carrier may be placed on the next higher packaging level.
p.000119:
p.000119: 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be
p.000119: required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton
p.000119: containing several individually packaged devices. However, when the healthcare provider is not expected to
p.000119: have access, in cases such as in home healthcare settings, to the higher level of device packaging, the
p.000119: UDI shall be placed on the packaging of the individual device.
p.000119:
p.000119: 4.4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be
p.000119: required to appear on the point of sale packaging.
p.000119:
p.000119: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000119: readily identifiable.
p.000119:
p.000119: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000119: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000119:
p.000119: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000119: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000119: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000119: results in there being no space for the AIDC.
p.000119:
p.000119: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000119:
p.000119: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000119: standard provided by the issuing entities shall also be provided on the label.
p.000119:
p.000119: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000119: reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses
p.000119: shall be permanent and readable after each process performed to make the device ready for the subsequent
p.000119: use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in
p.000119: the following circumstances:
p.000119: (a) any type of direct marking would interfere with the safety or performance of the device;
p.000119: (b) the device cannot be directly marked because it is not technologically feasible.
p.000119: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000119:
p.000120: L 117/120 EN
p.000120: Official Journal of the European Union
p.000120: 5.5.2017
p.000120:
p.000120: 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the
p.000120: device's packaging, the placing of the UDI carrier on the packaging shall not be required.
p.000120:
p.000120: 4.13. In the case of single finished devices made up of multiple parts that must be assembled
p.000120: before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
p.000120:
p.000120: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal
p.000120: operation or storage.
p.000120:
p.000120: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for
p.000120: the device to operate or other data.
p.000120:
p.000120: 5. General principles of the UDI database
p.000120:
p.000120: 5.1. The UDI database shall support the use of all core UDI database data elements referred to in
p.000120: Part B of this Annex.
p.000120:
p.000120: 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying
p.000120: information and other device data elements in the UDI database.
p.000120:
p.000120: 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.
p.000120:
p.000120: 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices
p.000120: they have placed on the market, except for devices that are no longer available on the market.
p.000120:
p.000120: 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the
p.000120: device is in conformity with this Regulation.
p.000120:
p.000120: 5.6. The database shall allow for the linking of all the packaging levels of the device.
p.000120:
p.000120: 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.
p.000120:
...
p.000120:
p.000120: 6. Rules for specific device types
p.000120:
p.000120: 6.1. Implantable devices:
p.000120: 6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or
p.000120: marked using AIDC, with a UDI (UDI-DI + UDI-PI);
p.000120: 6.1.2. The UDI-PI shall have at least the following characteristics:
p.000120: (a) the serial number for active implantable devices,
p.000120: (b) the serial number or lot number for other implantable devices.
p.000120: 6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.
p.000120:
p.000120: 6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
p.000120:
p.000120: 6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure
p.000120: to make the device ready for the next use.
p.000120:
p.000120: 6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
p.000120:
p.000120: 5.5.2017 EN
p.000120: Official Journal of the European Union
p.000121: L 117/121
p.000121:
p.000121: 6.3. Systems and procedure packs as referred to in Article 22
p.000121:
p.000121: 6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system
p.000121: or procedure pack with a UDI including both UDI-DI and UDI-PI.
p.000121:
p.000121: 6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device
p.000121: itself. Exemptions:
p.000121: (a) individual single-use disposable devices, the uses of which are generally known to the persons by whom they are
p.000121: intended to be used, which are contained within a system or procedure pack, and which are not intended for individual
p.000121: use outside the context of the system or procedure pack, shall not be required to bear their own UDI
p.000121: carrier;
p.000121: (b) devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to
p.000121: bear a UDI carrier when included within a system or procedure pack.
p.000121: 6.3.3. Placement of the UDI carrier on systems or procedure packs
p.000121: (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
p.000121: (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the
p.000121: outside of the packaging of the system or procedure pack or inside transparent packaging.
p.000121:
p.000121: 6.4. Configurable devices:
p.000121:
p.000121: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable
p.000121: device UDI.
p.000121:
p.000121: 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per
p.000121: configuration within the group. A group of configurations is defined as the collection of possible
p.000121: configurations for a given device as described in the technical documentation.
p.000121:
p.000121: 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.
p.000121:
p.000121: 6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be
p.000121: exchanged during the lifetime of the system and shall be identified as the configurable device UDI.
p.000121:
...
p.000169: requirements and the specific risk management in relation to the substance or tissues, cells or their
p.000169: derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the
p.000169: clinical benefit and/or safety of the device.
p.000169:
p.000169: 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements
p.000169: set out in Annex I, including the standards and CS applied, in full or in part, as well as a
p.000169: description of the solutions for fulfilling the relevant general safety and performance requirements, in so
p.000169: far as those standards and CS have not or have only been partly fulfilled or are lacking.
p.000169:
p.000169: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000169: the clinical investi gation and in particular information on any deviation from normal clinical practice.
p.000169:
p.000169:
p.000169: 3. Clinical Investigation Plan
p.000169:
p.000169: The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology,
p.000169: monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall
p.000169: contain in particular the information as laid down in this Annex. If part of this information is
p.000169: submitted in a separate document, it shall be referenced in the CIP.
p.000169:
p.000169:
p.000169: 3.1. General
p.000169:
p.000169: 3.1.1. Single identification number of the clinical investigation, as referred to in Article 70(1).
p.000169:
p.000169: 3.1.2. Identification of the sponsor — name, address and contact details of the sponsor and, where
p.000169: applicable, the name, address and contact details of the sponsor's contact person or legal representative
p.000169: in accordance with Article 62(2) established in the Union.
p.000169:
p.000169: 3.1.3. Information on the principal investigator at each investigational site, the coordinating
p.000169: investigator for the investigation, the address details for each investigational site and the emergency
p.000169: contact details for the principal investigator at each site. The roles, responsibilities and qualifications
p.000169: of the various kinds of investigators shall be specified in the CIP.
p.000169:
p.000170: L 117/170 EN
p.000170: Official Journal of the European Union
p.000170: 5.5.2017
p.000170:
p.000170: 3.1.4. A brief description of how the clinical investigation is financed and a brief description of
p.000170: the agreement between the sponsor and the site.
p.000170:
p.000170: 3.1.5. Overall synopsis of the clinical investigation, in an official Union language determined by the
p.000170: Member State concerned.
p.000170:
p.000170: 3.2. Identification and description of the device, including its intended purpose, its manufacturer,
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
...
p.000172: a timely manner.
p.000172:
p.000172: 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years
p.000172: after the clinical investigation with the device in question has ended, or, in the event that the
p.000172: device is subsequently placed on the market, at least 10 years after the last device has been placed
p.000172: on the market. In the case of implantable devices, the period shall be at least 15 years.
p.000172:
p.000172: Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the
p.000172: period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative
p.000172: as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity
p.000172: prior to the end of this period.
p.000172:
p.000172: 4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the
p.000172: investi gation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
p.000172:
p.000172: 5. The Sponsor shall complete the follow-up of investigation subjects.
p.000172:
p.000172: 6. The Sponsor shall provide evidence that the investigation is being conducted in line with
p.000172: good clinical practice, for instance through internal or external inspection.
p.000172:
p.000172: 7. The Sponsor shall prepare a clinical investigation report which includes at least the following:
p.000172:
p.000172: — Cover/introductory page or pages indicating the title of the investigation, the investigational device,
p.000172: the single identification number, the CIP number and the details with signatures of the coordinating investigators and
p.000172: the principal investigators from each investigational site.
p.000172:
p.000172: — Details of the author and date of the report.
p.000172:
p.000172: — A summary of the investigation covering the title, purpose of the investigation, description of the
p.000172: investi gation, investigational design and methods used, the results of the investigation and conclusion
p.000172: of the investigation. The completion date of the investigation, and in particular details of
p.000172: early termination, temporary halts or suspensions of investigations.
p.000172:
p.000172: — Investigational device description, in particular clearly defined intended purpose.
p.000172:
p.000172: — A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring
p.000172: and quality measures, selection criteria, target patient populations, sample size, treatment schedules,
p.000172: follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation
p.000172: and analysis methods, as well as a justification.
p.000172:
p.000172: — Results of the clinical investigation covering, with rationale and justification, subject demographics,
p.000172: analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with
p.000172: the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical
p.000172: investigation, or lost to follow-up.
p.000172:
p.000172: — Summary of serious adverse events, adverse device effects, device deficiencies and any relevant
p.000172: corrective actions.
p.000172:
...
Social / Property Ownership
Searching for indicator home:
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p.000119: misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the
p.000119: following UDI database data elements shall require a new UDI-DI:
p.000119: (a) name or trade name,
p.000119: (b) device version or model,
p.000119: (c) labelled as single use,
p.000119: (d) packaged sterile,
p.000119: (e) need for sterilization before use,
p.000119: (f) quantity of devices provided in a package,
p.000119: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.
p.000119: 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record
p.000119: of the original device manufacturer's UDI.
p.000119:
p.000119: 4. UDI carrier
p.000119:
p.000119: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on
p.000119: the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000119:
p.000119: 4.2. In the event of there being significant space constraints on the unit of use packaging, the
p.000119: UDI carrier may be placed on the next higher packaging level.
p.000119:
p.000119: 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be
p.000119: required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton
p.000119: containing several individually packaged devices. However, when the healthcare provider is not expected to
p.000119: have access, in cases such as in home healthcare settings, to the higher level of device packaging, the
p.000119: UDI shall be placed on the packaging of the individual device.
p.000119:
p.000119: 4.4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be
p.000119: required to appear on the point of sale packaging.
p.000119:
p.000119: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000119: readily identifiable.
p.000119:
p.000119: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000119: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000119:
p.000119: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000119: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000119: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000119: results in there being no space for the AIDC.
p.000119:
p.000119: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000119:
p.000119: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000119: standard provided by the issuing entities shall also be provided on the label.
p.000119:
p.000119: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000119: reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses
p.000119: shall be permanent and readable after each process performed to make the device ready for the subsequent
p.000119: use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in
p.000119: the following circumstances:
p.000119: (a) any type of direct marking would interfere with the safety or performance of the device;
p.000119: (b) the device cannot be directly marked because it is not technologically feasible.
p.000119: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000119:
p.000120: L 117/120 EN
p.000120: Official Journal of the European Union
p.000120: 5.5.2017
p.000120:
p.000120: 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the
p.000120: device's packaging, the placing of the UDI carrier on the packaging shall not be required.
p.000120:
...
Searching for indicator property:
(return to top)
p.000005: provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally
p.000005: liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a
p.000005: written mandate. Considering the role of authorised representatives, the minimum requirements they
p.000005: should meet should be clearly defined, including the requirement of having available a person who
p.000005: fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person
p.000005: responsible for regulatory compliance.
p.000005:
p.000005: (1) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and
p.000005: administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p.
p.000005: 29).
p.000005:
p.000006: L 117/6 EN
p.000006: Official Journal of the European Union
p.000006: 5.5.2017
p.000006:
p.000006: (36) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to
p.000006: clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
p.000006:
p.000006:
p.000006: (37) Parallel trade in products already placed on the market is a lawful form of trade within the internal market
p.000006: on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of
p.000006: health and safety and from the need for protection of intellectual property rights provided for under
p.000006: Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different
p.000006: interpretations in the Member States. The conditions, in particular the requirements for relabelling
p.000006: and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the
p.000006: Court of Justice (1) in other relevant sectors and existing good practice in the field of medical devices.
p.000006:
p.000006:
p.000006: (38) The reprocessing and further use of single-use devices should only take place where permitted
p.000006: by national law and while complying with the requirements laid down in this Regulation. The reprocessor
p.000006: of a single-use device should be considered to be the manufacturer of the reprocessed device and should
p.000006: assume the obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should
p.000006: have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use
p.000006: devices within a health institution or by an external reprocessor acting on its behalf may differ from the
p.000006: obligations on a manufacturer described in this Regulation. In principle, such divergence should only
p.000006: be permitted where reprocessing and reuse of single-use devices within a health institution or by an
...
p.000011: regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related
p.000011: information regarding medical devices and to foster the further development of international regulatory
p.000011: guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety
p.000011: protection equivalent to that set by this Regulation.
p.000011:
p.000011:
p.000011: (87) Member States should take all necessary measures to ensure that the provisions of
p.000011: this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for
p.000011: their infringement.
p.000011:
p.000011:
p.000011: (88) Whilst this Regulation should not affect the right of Member States to levy fees for
p.000011: activities at national level, Member States should, in order to ensure transparency, inform the Commission
p.000011: and the other Member States before they decide on the level and structure of such fees. In order to
p.000011: further ensure transparency, the structure and level of the fees should be publicly available on request.
p.000011:
p.000011: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000011: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000011: data, the freedom of art and science, the freedom to conduct business and the right to property. This
p.000011: Regulation should be applied by the Member States in accordance with those rights and principles.
p.000011:
p.000011:
p.000011: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the
p.000011: Commission in order to amend certain non-essential provisions of this Regulation. It is of particular
p.000011: importance that the Commission carry out appropriate consultations during its preparatory work, including
p.000011: at expert level, and that those consultations be conducted in accordance with the principles laid down in the
p.000011: Interinstitutional Agreement of 13 April 2016 on Better Law-Making (1). In particular, to ensure equal
p.000011: participation in the preparation of delegated acts, the European Parliament and the Council receive all documents
p.000011: at the same time as Member States' experts, and their experts systematically have access to meetings of
p.000011: Commission expert groups dealing with preparation of delegated acts.
p.000011:
p.000011: (91) In order to ensure uniform conditions for the implementation of this Regulation,
p.000011: implementing powers should be conferred on the Commission. Those powers should be
p.000011: exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000011:
p.000011: (1) OJ L 123, 12.5.2016, p. 1.
p.000011: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000011: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise
p.000011: of implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000011:
...
p.000016:
p.000016: Software shall also be deemed to be an active device;
p.000016:
p.000016: (5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
p.000016:
p.000016: — to be totally introduced into the human body, or
p.000016:
p.000016: — to replace an epithelial surface or the surface of the eye,
p.000016:
p.000016: by clinical intervention and which is intended to remain in place after the procedure.
p.000016:
p.000016: Any device intended to be partially introduced into the human body by clinical intervention and intended
p.000016: to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
p.000016:
p.000016: (6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either
p.000016: through a body orifice or through the surface of the body;
p.000016:
p.000016: (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or a
p.000016: commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
p.000016:
p.000016: (8) ‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
p.000016:
p.000016: (9) ‘falsified device’ means any device with a false presentation of its identity and/or of
p.000016: its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition
p.000016: does not include uninten tional non-compliance and is without prejudice to infringements of intellectual property
p.000016: rights;
p.000016:
p.000016: (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with
p.000016: the purpose of being used for a specific medical purpose;
p.000016:
p.000016: (11) ‘system’ means a combination of products, either packaged together or not, which are intended to
p.000016: be inter- connected or combined to achieve a specific medical purpose;
p.000016:
p.000016: (12) ‘intended purpose’ means the use for which a device is intended according to the data
p.000016: supplied by the manufacturer on the label, in the instructions for use or in promotional or sales
p.000016: materials or statements and as specified by the manufacturer in the clinical evaluation;
p.000016:
p.000016: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or
p.000016: on the packaging of each unit or on the packaging of multiple devices;
p.000016:
p.000016: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000016: intended purpose and proper use and of any precautions to be taken;
p.000016:
p.000016: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is
p.000016: created through in ternationally accepted device identification and coding standards and that allows
p.000016: unambiguous identification of specific devices on the market;
p.000016:
p.000016: 5.5.2017 EN
p.000016: Official Journal of the European Union
p.000017: L 117/17
p.000017:
p.000017: (16) ‘non-viable’ means having no potential for metabolism or multiplication;
p.000017:
...
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
p.000025: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000025: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000025: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000025: overriding public interest in disclosure, without prejudice to the protection of intellectual property
p.000025: rights.
p.000025:
p.000025: The competent authority need not comply with the obligation laid down in the third subparagraph where
p.000025: disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt
p.000025: with in the context of legal proceedings.
p.000025:
p.000025: 15. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000025: person the information on the identity of that person shall be part of the information to be
p.000025: submitted in accordance with Article 30(1).
p.000025:
p.000025: 16. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000025: accordance with applicable Union and national law.
p.000025:
p.000025: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000025: of the enterprise, have measures in place to provide sufficient financial coverage in respect
p.000025: of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under
p.000025: national law.
p.000025:
p.000025:
p.000025: Article 11
p.000025:
p.000025: Authorised representative
p.000025:
p.000025: 1. Where the manufacturer of a device is not established in a Member State, the device may only
p.000025: be placed on the Union market if the manufacturer designates a sole authorised representative.
p.000025:
...
p.000026: established and, where applicable, the notified body that was involved in the conformity assessment for
p.000026: the device of the termination of the mandate and the reasons therefor.
p.000026:
p.000026: 7. Any reference in this Regulation to the competent authority of the Member State in which the
p.000026: manufacturer has its registered place of business shall be understood as a reference to the competent
p.000026: authority of the Member State in which the authorised representative, designated by a manufacturer referred
p.000026: to in paragraph 1, has its registered place of business.
p.000026:
p.000026: Article 12
p.000026:
p.000026: Change of authorised representative
p.000026:
p.000026: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000026: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000026: representative. That agreement shall address at least the following aspects:
p.000026: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000026: beginning of the mandate of the incoming authorised representative;
p.000026: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000026: supplied by the manufacturer, including any promotional material;
p.000026: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000026: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000026: forward to the manufacturer or incoming authorised representative any complaints or reports
p.000026: from healthcare professionals, patients or users about suspected incidents related to a device for which
p.000026: it had been designated as authorised rep resentative.
p.000026:
p.000026: Article 13
p.000026:
p.000026: General obligations of importers
p.000026:
p.000026: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000026:
p.000026: 2. In order to place a device on the market, importers shall verify that:
p.000026: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000026: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000026: designated by the manufacturer;
p.000026: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000026: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
p.000026:
p.000026: 5.5.2017 EN
p.000026: Official Journal of the European Union
p.000027: L 117/27
p.000027:
p.000027: Where an importer considers or has reason to believe that a device is not in conformity with the
p.000027: requirements of this Regulation, it shall not place the device on the market until it has been brought
p.000027: into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where
...
p.000054: (f) the notifications for conformity assessments and certificates referred to in Articles 54(3) and 55(1);
p.000054: (g) withdrawal or refusals of applications for the certificates as referred to in Article
p.000054: 53(2) and Section 4.3 of Annex VII;
p.000054: (h) the information regarding certificates referred to in Article 56(5);
p.000054: (i) the summary of safety and clinical performance referred to in Article 32.
p.000054: 2. The information collated and processed by the electronic system shall be accessible to the competent
p.000054: authorities of the Member States, to the Commission, where appropriate to the notified bodies and where
p.000054: provided elsewhere in this regulation or in Regulation (EU) 2017/746 to the public.
p.000054:
p.000054:
p.000054: Article 58
p.000054:
p.000054: Voluntary change of notified body
p.000054:
p.000054: 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with
p.000054: another notified body in respect of the conformity assessment of the same device, the detailed
p.000054: arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the
p.000054: incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the
p.000054: following aspects:
p.000054: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000054: (b) the date until which the identification number of the outgoing notified body may be indicated in
p.000054: the information supplied by the manufacturer, including any promotional material;
p.000054: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000054: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000054: the incoming notified body;
p.000054: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000054: 2. The outgoing notified body shall withdraw the certificates it has issued for the device
p.000054: concerned on the date on which they become invalid.
p.000054:
p.000054: 5.5.2017 EN
p.000054: Official Journal of the European Union
p.000055: L 117/55
p.000055:
p.000055: Article 59
p.000055:
p.000055: Derogation from the conformity assessment procedures
p.000055:
p.000055: 1. By way of derogation from Article 52, any competent authority may authorise, on a duly
p.000055: justified request, the placing on the market or putting into service within the territory of the Member State
p.000055: concerned, of a specific device for which the procedures referred to in that Article have not been carried
p.000055: out but use of which is in the interest of public health or patient safety or health.
p.000055:
p.000055: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000055: authorise the placing on the market or putting into service of a device in accordance with paragraph 1
p.000055: where such authorisation is granted for use other than for a single patient.
p.000055:
p.000055: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional
...
p.000086: participating in the sub-groups of the MDCG.
p.000086:
p.000086: 2. Experts and other third parties invited by the MDCG on a case-by-case basis shall declare any
p.000086: interests they may have in the issue in question.
p.000086:
p.000086:
p.000086: Article 108
p.000086:
p.000086: Device registers and databanks
p.000086:
p.000086: The Commission and the Member States shall take all appropriate measures to encourage the establishment
p.000086: of registers and databanks for specific types of devices setting common principles to collect comparable
p.000086: information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and
p.000086: performance of devices, or the traceability of implantable devices, or all of such characteristics.
p.000086:
p.000086:
p.000086: CHAPTER IX
p.000086:
p.000086: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
p.000086:
p.000086: Article 109
p.000086:
p.000086: Confidentiality
p.000086:
p.000086: 1. Unless otherwise provided for in this Regulation and without prejudice to existing
p.000086: national provisions and practices in the Member States on confidentiality, all parties involved in the
p.000086: application of this Regulation shall respect the confidentiality of information and data obtained in carrying out
p.000086: their tasks in order to protect the following:
p.000086:
p.000086: (a) personal data, in accordance with Article 110;
p.000086:
p.000086: (b) commercially confidential information and trade secrets of a natural or legal person, including
p.000086: intellectual property rights; unless disclosure is in the public interest;
p.000086:
p.000086: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000086: audits.
p.000086:
p.000086: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent
p.000086: authorities and between competent authorities and the Commission shall not be disclosed without the prior
p.000086: agreement of the originating authority.
p.000086:
p.000086: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000086: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000086: obligations of the persons concerned to provide information under criminal law.
p.000086:
p.000086: 5.5.2017 EN
p.000086: Official Journal of the European Union
p.000087: L 117/87
p.000087:
p.000087: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000087: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000087:
p.000087: Article 110
p.000087:
p.000087: Data protection
p.000087:
p.000087: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the
p.000087: Member States pursuant to this Regulation.
p.000087:
p.000087: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
p.000061: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious
p.000061: medical condition, the subject is unable to provide prior informed consent and to receive prior
p.000061: information on the clinical investi gation;
p.000061:
p.000062: L 117/62 EN
p.000062: Official Journal of the European Union
p.000062: 5.5.2017
p.000062:
p.000062: (b) there are scientific grounds to expect that participation of the subject in the clinical
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000019:
p.000019: (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities
p.000019: to check and ensure that devices comply with the requirements set out in the relevant Union
p.000019: harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
p.000019:
p.000019: (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made
p.000019: available to the end user;
p.000019:
p.000020: L 117/20 EN
p.000020: Official Journal of the European Union
p.000020: 5.5.2017
p.000020:
p.000020: (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000020: made available on the market;
p.000020: (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device
p.000020: made available on the market, including use-error due to ergonomic features, as well as any inadequacy
p.000020: in the information supplied by the manufacturer and any undesirable side-effect;
p.000020: (65) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000020: lead to any of the following:
p.000020: (a) the death of a patient, user or other person,
p.000020: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000020: (c) a serious public health threat;
p.000020: (66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious
p.000020: deterioration in a person's state of health, or serious illness, that may require prompt remedial
p.000020: action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the
p.000020: given place and time;
p.000020: (67) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000020: non-conformity or other undesirable situation;
p.000020: (68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or
p.000020: medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the
p.000020: market;
p.000020: (69) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000020: relation to a field safety corrective action;
p.000020: (70) ‘harmonised standard’ means a European standard as defined in point
p.000020: (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
p.000020: (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000020: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000020:
p.000020: Article 3
p.000020:
p.000020: Amendment of certain definitions
p.000020:
p.000020: The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of
...
p.000073:
p.000073: (a) any serious incident involving devices made available on the Union market, except expected
p.000073: side-effects which are clearly documented in the product information and quantified in the technical
p.000073: documentation and are subject to trend reporting pursuant to Article 88;
p.000073:
p.000073: (b) any field safety corrective action in respect of devices made available on the Union market, including any field
p.000073: safety corrective action undertaken in a third country in relation to a device which is also legally
p.000073: made available on the Union market, if the reason for the field safety corrective action is not limited
p.000073: to the device made available in the third country.
p.000073:
p.000073: The reports referred to in the first subparagraph shall be submitted through the electronic system
p.000073: referred to in Article 92.
p.000073:
p.000073: 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account
p.000073: of the severity of the serious incident.
p.000073:
p.000073: 3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1
p.000073: immediately after they have established the causal relationship between that incident and their device or
p.000073: that such causal relationship is reasonably possible and not later than 15 days after they become aware of the
p.000073: incident.
p.000073:
p.000073: 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred
p.000073: to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of
p.000073: that threat.
p.000073:
p.000073: 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's
p.000073: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000073: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000073: after the date on which the manufacturer becomes aware of the serious incident.
p.000073:
p.000073: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that
p.000073: is incomplete followed up by a complete report.
p.000073:
p.000073: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain
p.000073: about whether the incident is reportable, it shall nevertheless submit a report within the
p.000073: timeframe required in accordance with paragraphs 2 to 5.
p.000073:
p.000073: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000073: immediately, the manufacturer shall, without undue delay, report the field safety corrective
p.000073: action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being
p.000073: undertaken.
p.000073:
p.000073: 9. For similar serious incidents that occur with the same device or device type and for which the root cause
p.000073: has been identified or a field safety corrective action implemented or where the incidents are common and
p.000073: well documented, the manufacturer may provide periodic summary reports instead of individual serious
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000001: 5.5.2017 EN
p.000001: Official Journal of the European Union
p.000001: L 117/1
p.000001:
p.000001:
p.000001: I
p.000001:
p.000001: (Legislative acts)
p.000001:
p.000001:
p.000001:
p.000001: REGULATIONS
p.000001:
p.000001: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.000001: of 5 April 2017
p.000001: on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC)
p.000001: No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
p.000001:
p.000001: (Text with EEA relevance)
p.000001:
p.000001: THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
p.000001:
p.000001: Having regard to the Treaty on the Functioning of the European Union, and in particular
p.000001: Article 114 and Article 168(4)(c) thereof,
p.000001:
p.000001: Having regard to the proposal from the European Commission,
p.000001:
p.000001: After transmission of the draft legislative act to the national parliaments,
p.000001:
p.000001: Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the
p.000001: Regions,
p.000001: Acting in accordance with the ordinary legislative procedure (2), Whereas:
p.000001: (1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory
p.000001: framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental
p.000001: revision of those Directives is needed to establish a robust, transparent, predictable and sustainable
p.000001: regulatory framework for medical devices which ensures a high level of safety and health whilst supporting
p.000001: innovation.
p.000001:
p.000001: (2) This Regulation aims to ensure the smooth functioning of the internal market as regards
p.000001: medical devices, taking as a base a high level of protection of health for patients and users, and
p.000001: taking into account the small- and medium-sized enterprises that are active in this sector. At the same
p.000001: time, this Regulation sets high standards of quality and safety for medical devices in order to meet
p.000001: common safety concerns as regards such products. Both objectives are being pursued simultaneously and are
p.000001: inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on
p.000001: the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on
p.000001: the market and putting into service of medical devices and their accessories on the Union market thus
p.000001: allowing them to benefit from the principle of free movement of goods.
p.000001:
p.000001: (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
p.000001: (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of
p.000001: the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
p.000001: (3) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
p.000001: active implantable
p.000001: medical devices (OJ L 189, 20.7.1990, p. 17).
p.000001: (4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
p.000001:
p.000002: L 117/2 EN
p.000002: Official Journal of the European Union
p.000002: 5.5.2017
p.000002:
p.000002: As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
p.000002: ensuring, among other things, that data generated in clinical investigations are reliable and robust and
p.000002: that the safety of the subjects participating in a clinical investigation is protected.
p.000002:
p.000002:
p.000002: (3) This Regulation does not seek to harmonise rules relating to the further making available on
p.000002: the market of medical devices after they have already been put into service such as in the context of second-hand
p.000002: sales.
p.000002:
p.000002:
p.000002: (4) Key elements of the existing regulatory approach, such as the supervision of
p.000002: notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation,
p.000002: vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and
p.000002: traceability regarding medical devices should be introduced, to improve health and safety.
p.000002:
p.000002:
p.000002: (5) To the extent possible, guidance developed for medical devices at international level, in
p.000002: particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the
p.000002: International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the
p.000002: global convergence of regulations which contributes to a high level of safety protection worldwide, and
p.000002: to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and
p.000002: performance requirements, technical documen tation, classification rules, conformity assessment procedures and
p.000002: clinical investigations.
p.000002:
p.000002:
p.000002: (6) For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and
p.000002: other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments.
p.000002: In the interest of simplification, both directives, which have been amended several times, should be
p.000002: replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical
p.000002: devices.
p.000002:
p.000002:
p.000002: (7) The scope of application of this Regulation should be clearly delimited from other
p.000002: Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal
p.000002: products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of
p.000002: the Council (1) should be amended to exclude medical devices from its scope.
p.000002:
p.000002:
p.000002: (8) It should be the responsibility of the Member States to decide on a case-by-case basis
p.000002: whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification
p.000002: decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should
p.000002: be allowed to, on its own initiative or at the duly substantiated request of a Member State,
p.000002: having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether
p.000002: or not a specific product, category or group of products falls within the scope of this Regulation.
p.000002: When deliberating on the regulatory status of products in borderline cases involving medicinal products,
p.000002: human tissues and cells, biocidal products or food products, the Commission should ensure an
p.000002: appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency
p.000002: and the European Food Safety Authority, as relevant.
p.000002:
p.000002:
p.000002: (9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the
p.000002: possibility of taking a Union-wide decision regarding the regulatory status of a product should
p.000002: also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
p.000002:
p.000002:
p.000002: (10) Products which combine a medicinal product or substance and a medical device are regulated
p.000002: either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3)
p.000002: The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market
p.000002: assessment, and of exchange of information in the context of vigilance activities involving such combination
p.000002: products. For medicinal products that integrate a medical device part, compliance with the general safety
p.000002: and performance requirements laid down in this Regulation for the device part should be adequately
p.000002: assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should
p.000002: therefore be amended.
p.000002:
p.000002: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
p.000002: general principles and requirements of food law, establishing the European Food Safety Authority and laying
p.000002: down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
p.000002: (2) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic
p.000002: products (OJ L 342,
p.000002: 22.12.2009, p. 59).
p.000002: (3) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000002: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000002:
p.000002: 5.5.2017 EN
p.000002: Official Journal of the European Union
p.000003: L 117/3
p.000003:
p.000003: (11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the
p.000003: Council (1) and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplete in
p.000003: respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are
p.000003: non-viable or are rendered non-viable. Such products should come under the scope of this Regulation,
p.000003: provided they comply with the definition of a medical device or are covered by this Regulation.
p.000003:
p.000003:
p.000003: (12) Certain groups of products for which a manufacturer claims only an aesthetic or another
p.000003: non-medical purpose but which are similar to medical devices in terms of functioning and risks profile
p.000003: should be covered by this Regulation. In order for manufacturers to be able to demonstrate the
p.000003: conformity of such products, the Commission should adopt common specifications at least with regard
p.000003: to application of risk management and, where necessary, clinical evaluation regarding safety. Such
p.000003: common specifications should be developed specifically for a group of products without an intended medical
p.000003: purpose and should not be used for conformity assessment of the analogous devices with a medical purpose.
p.000003: Devices with both a medical and a non-medical intended purpose should fulfil both the requirements
p.000003: applicable to devices with, and to devices without, an intended medical purpose.
p.000003:
p.000003:
p.000003: (13) As is the case for products that contain viable tissues or cells of human or animal origin,
p.000003: that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it
p.000003: should be clarified that products that contain or consist of viable biological materials or viable
p.000003: organisms of another origin in order to achieve or support the intended purpose of those products are not covered
p.000003: by this Regulation either.
p.000003:
p.000003:
p.000003: (14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the
p.000003: Council (3) should continue to apply.
p.000003:
p.000003:
p.000003: (15) There is scientific uncertainty about the risks and benefits of nanomaterials used for devices.
p.000003: In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers,
p.000003: it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation
p.000003: 2011/696/EU (4), with the necessary flexibility to adapt that definition to scientific and technical
p.000003: progress and subsequent regulatory development at Union and international level. In the design and
p.000003: manufacture of devices, manufacturers should take special care when using nanoparticles for which there is
p.000003: a high or medium potential for internal exposure. Such devices should be subject to the most stringent
p.000003: conformity assessment procedures. In preparation of implementing acts regulating the practical and uniform
p.000003: application of the corresponding requirements laid down in this Regulation, the relevant scientific
p.000003: opinions of the relevant scientific committees should be taken into account.
p.000003:
p.000003:
p.000003: (16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council
p.000003: (5) are an integral part of the general safety and performance requirements laid down in this
p.000003: Regulation for devices. Consequently, this Regulation should be considered a lex specialis in relation to that
p.000003: Directive.
p.000003:
p.000003:
p.000003: (17) This Regulation should include requirements regarding the design and manufacture of devices
p.000003: emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom (6)
p.000003: which pursues other objectives.
p.000003:
p.000003:
p.000003: (18) This Regulation should include requirements for devices' design, safety and performance characteristics which
p.000003: are developed in such a way as to prevent occupational injuries, including protection from radiation.
p.000003:
p.000003: (1) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy
p.000003: medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
p.000003: (2) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of
p.000003: quality and safety for the
p.000003: donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L
p.000003: 102, 7.4.2004, p. 48).
p.000003: (3) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality
p.000003: and safety for the collection, testing, processing, storage and distribution of human blood and blood components (OJ L
p.000003: 33, 8.2.2003, p. 30).
p.000003: (4) Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011,
p.000003: p. 38).
p.000003: (5) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of
p.000003: the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
p.000003: (6) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the
p.000003: dangers arising
p.000003: from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,
p.000003: 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
p.000003:
p.000004: L 117/4 EN
p.000004: Official Journal of the European Union
p.000004: 5.5.2017
p.000004:
p.000004: (19) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to
p.000004: be used for one or more of the medical purposes set out in the definition of a medical device,
p.000004: qualifies as a medical device, while software for general purposes, even when used in a healthcare
p.000004: setting, or software intended for life-style and well-being purposes is not a medical device. The
p.000004: qualification of software, either as a device or an accessory, is independent of the software's location
p.000004: or the type of interconnection between the software and a device.
p.000004:
p.000004: (20) The definitions in this Regulation, regarding devices themselves, the making available of
p.000004: devices, economic operators, users and specific processes, the conformity assessment, clinical investigations
p.000004: and clinical evaluations, post-market surveillance, vigilance and market surveillance, standards and other
p.000004: technical specifications, should be aligned with well-established practice in the field at Union and
p.000004: international level in order to enhance legal certainty.
p.000004:
p.000004: (21) It should be made clear that it is essential that devices offered to persons in the Union by
p.000004: means of information society services within the meaning of Directive (EU) 2015/1535 of the
p.000004: European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide
p.000004: a diagnostic or therapeutic service to persons within the Union comply with the requirements of this
p.000004: Regulation, where the product in question is placed on the market or the service is provided in the Union.
p.000004:
p.000004: (22) To recognise the important role of standardisation in the field of medical devices, compliance
p.000004: with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the
p.000004: Council (2) should be a means for manufacturers to demonstrate conformity with the general safety and
p.000004: performance requirements and other legal requirements, such as those relating to quality and
p.000004: risk management, laid down in this Regulation.
p.000004:
p.000004: (23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to
p.000004: adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where
p.000004: no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay
p.000004: down common specifications which provide a means of complying with the general safety and performance
p.000004: requirements, and the requirements for clinical investigations and clinical evaluation and/or post-market
p.000004: clinical follow-up, laid down in this Regulation.
p.000004:
p.000004: (24) Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and
p.000004: taking account of European and international standards.
p.000004:
p.000004: (25) The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for
p.000004: the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and
p.000004: of the Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
p.000004:
p.000004: (26) The rules on Union market surveillance and control of products entering the Union market laid
p.000004: down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
p.000004: from choosing the competent authorities to carry out those tasks.
p.000004:
p.000004: (27) It is appropriate to set out clearly the general obligations of the different economic operators, including
p.000004: importers and distributors, building on the New Legislative Framework for the Marketing of Products,
p.000004: without prejudice to the specific obligations laid down in the various parts of this Regulation, to
p.000004: enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by
p.000004: the relevant operators.
p.000004:
p.000004: (1) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying
p.000004: down a procedure for the provision of information in the field of technical regulations and of rules on Information
p.000004: Society services (OJ L 241, 17.9.2015, p. 1).
p.000004: (2) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
p.000004: European standardisation,
p.000004: amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC,
p.000004: 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of
p.000004: the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and
p.000004: of the Council (OJ L 316, 14.11.2012, p. 12).
p.000004: (3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical
p.000004: devices (OJ L 331,
p.000004: 7.12.1998, p. 1).
p.000004: (4) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the
p.000004: requirements for accredita tion and market surveillance relating to the marketing of products and repealing Regulation
p.000004: (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
p.000004: (5) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
p.000004: marketing of
p.000004: products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
p.000004:
p.000004: 5.5.2017 EN
p.000004: Official Journal of the European Union
p.000005: L 117/5
p.000005:
p.000005: (28) For the purpose of this Regulation, the activities of distributors should be deemed to include
p.000005: acquisition, holding and supplying of devices.
p.000005:
p.000005:
p.000005: (29) Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting,
p.000005: that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC, should be
p.000005: incorporated into the enacting provisions of this Regulation to facilitate its application.
p.000005:
p.000005:
p.000005: (30) Health institutions should have the possibility of manufacturing, modifying and using devices
p.000005: in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be
p.000005: met at the appropriate level of performance by an equivalent device available on the market.
p.000005: In that context, it is appropriate to provide that certain rules of this Regulation, as regards
p.000005: medical devices manufactured and used only within health institutions, including hospitals as well as
p.000005: institutions, such as laboratories and public health institutes that support the healthcare system and/or
p.000005: address patient needs, but which do not treat or care for patients directly, should not apply, since
p.000005: the aims of this Regulation would still be met in a proportionate manner. It should be noted that the
p.000005: concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests
p.000005: or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption
p.000005: applicable to health institutions does not apply to such establishments.
p.000005:
p.000005:
p.000005: (31) In view of the fact that natural or legal persons can claim compensation for damage caused by a
p.000005: defective device in accordance with applicable Union and national law, it is appropriate to
p.000005: require manufacturers to have measures in place to provide sufficient financial coverage in respect of
p.000005: their potential liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to
p.000005: the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay
p.000005: down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may
p.000005: have been injured by a defective device.
p.000005:
p.000005:
p.000005: (32) To ensure that devices manufactured in series production continue to be in conformity with the
p.000005: requirements of this Regulation and that experience from the use of the devices they manufacture is
p.000005: taken into account for the production process, all manufacturers should have a quality management system
p.000005: and a post-market surveillance system in place which should be proportionate to the risk class and the
p.000005: type of the device in question. In addition, in order to minimize risks or prevent incidents related to
p.000005: devices, manufacturers should establish a system for risk management and a system for reporting of incidents and
p.000005: field safety corrective actions.
p.000005:
p.000005:
p.000005: (33) The risk management system should be carefully aligned with and reflected in the clinical
p.000005: evaluation for the device, including the clinical risks to be addressed as part of clinical
p.000005: investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical
p.000005: evaluation processes should be inter-dependent and should be regularly updated.
p.000005:
p.000005:
p.000005: (34) It should be ensured that supervision and control of the manufacture of devices, and the post-market
p.000005: surveillance and vigilance activities concerning them, are carried out within the manufacturer's
p.000005: organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
p.000005:
p.000005:
p.000005: (35) For manufacturers who are not established in the Union, the authorised representative plays a
p.000005: pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as
p.000005: their contact person established in the Union. Given that pivotal role, for the purposes of enforcement
p.000005: it is appropriate to make the authorised representative legally liable for defective devices in the event
p.000005: that a manufacturer established outside the Union has not complied with its general obligations. The
p.000005: liability of the authorised representative provided for in this Regulation is without prejudice to the
p.000005: provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally
p.000005: liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a
p.000005: written mandate. Considering the role of authorised representatives, the minimum requirements they
p.000005: should meet should be clearly defined, including the requirement of having available a person who
p.000005: fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person
p.000005: responsible for regulatory compliance.
p.000005:
p.000005: (1) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and
p.000005: administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p.
p.000005: 29).
p.000005:
p.000006: L 117/6 EN
p.000006: Official Journal of the European Union
p.000006: 5.5.2017
p.000006:
p.000006: (36) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to
p.000006: clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
p.000006:
p.000006:
p.000006: (37) Parallel trade in products already placed on the market is a lawful form of trade within the internal market
p.000006: on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of
p.000006: health and safety and from the need for protection of intellectual property rights provided for under
p.000006: Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different
p.000006: interpretations in the Member States. The conditions, in particular the requirements for relabelling
p.000006: and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the
p.000006: Court of Justice (1) in other relevant sectors and existing good practice in the field of medical devices.
p.000006:
p.000006:
p.000006: (38) The reprocessing and further use of single-use devices should only take place where permitted
p.000006: by national law and while complying with the requirements laid down in this Regulation. The reprocessor
p.000006: of a single-use device should be considered to be the manufacturer of the reprocessed device and should
...
p.000006: devices within a health institution or by an external reprocessor acting on its behalf may differ from the
p.000006: obligations on a manufacturer described in this Regulation. In principle, such divergence should only
p.000006: be permitted where reprocessing and reuse of single-use devices within a health institution or by an
p.000006: external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS,
p.000006: with relevant harmonised standards and national provisions. The reprocessing of such devices
p.000006: should ensure an equivalent level of safety and performance to that of the corresponding
p.000006: initial single-use device.
p.000006:
p.000006:
p.000006: (39) Patients who are implanted with a device should be given clear and easily accessible essential
p.000006: information allowing the implanted device to be identified and other relevant information about the
p.000006: device, including any necessary health risk warnings or precautions to be taken, for example indications
p.000006: as to whether or not it is compatible with certain diagnostic devices or with scanners used for security
p.000006: controls.
p.000006:
p.000006:
p.000006: (40) Devices should, as a general rule, bear the CE marking to indicate their conformity with this
p.000006: Regulation so that they can move freely within the Union and be put into service in accordance with
p.000006: their intended purpose. Member States should not create obstacles to the placing on the market or
p.000006: putting into service of devices that comply with the requirements laid down in this Regulation. However, Member
p.000006: States should be allowed to decide whether to restrict the use of any specific type of device in relation
p.000006: to aspects that are not covered by this Regulation.
p.000006:
p.000006:
p.000006: (41) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000006: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000006: activities for devices, which is owing to improved incident reporting, targeted field safety corrective
p.000006: actions and better monitoring by competent authorities. It should also help to reduce medical errors and
p.000006: to fight against falsified devices. Use of the UDI system should also improve purchasing and waste
p.000006: disposal policies and stock-management by health institutions and other economic operators and, where
p.000006: possible, be compatible with other authentication systems already in place in those settings.
p.000006:
p.000006:
p.000006: (42) The UDI system should apply to all devices placed on the market except custom-made devices,
p.000006: and be based on internationally recognised principles including definitions that are compatible with those
p.000006: used by major trade partners. In order for the UDI system to become functional in time for the
p.000006: application of this Regulation, detailed rules should be laid down in this Regulation.
p.000006:
p.000006:
p.000006: (43) Transparency and adequate access to information, appropriately presented for the intended user,
p.000006: are essential in the public interest, to protect public health, to empower patients and healthcare professionals and
p.000006: to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to
p.000006: build confidence in the regulatory system.
p.000006:
p.000006:
p.000006: (44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European
p.000006: database on medical devices (Eudamed) that should integrate different electronic systems to collate and
p.000006: process information regarding devices on the market and the relevant economic operators, certain aspects
p.000006: of conformity assessment, notified
p.000006:
p.000006: (1) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
p.000006:
p.000006: 5.5.2017 EN
p.000006: Official Journal of the European Union
p.000007: L 117/7
p.000007:
p.000007: bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the
p.000007: database are to enhance overall transparency, including through better access to information for the public and
p.000007: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000007: States and to streamline and facilitate the flow of information between economic operators, notified
p.000007: bodies or sponsors and Member States as well as between Member States among themselves and with the
p.000007: Commission. Within the internal market, this can be ensured effectively only at Union level and the
p.000007: Commission should therefore further develop and manage the European databank on medical
p.000007: devices set up by Commission Decision 2010/227/EU (1).
p.000007:
p.000007: (45) To facilitate the functioning of Eudamed, an internationally recognised medical device
p.000007: nomenclature should be available free of charge to manufacturers and other natural or legal persons
p.000007: required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available,
p.000007: where reasonably practicable, free of charge also to other stakeholders.
p.000007:
p.000007: (46) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and
p.000007: certificates should enable the public to be adequately informed about devices on the Union market. The electronic
p.000007: system on clinical investigations should serve as a tool for the cooperation between Member States and
p.000007: for enabling sponsors to submit, on a voluntary basis, a single application for several Member States
p.000007: and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance
p.000007: should enable manufac turers to report serious incidents and other reportable events and to support the
p.000007: coordination of the evaluation of such incidents and events by competent authorities. The electronic
p.000007: system regarding market surveillance should be a tool for the exchange of information between competent
p.000007: authorities.
p.000007:
p.000007: (47) In respect of data collated and processed through the electronic systems of Eudamed, Directive
p.000007: 95/46/EC of the European Parliament and of the Council (2) applies to the processing of
p.000007: personal data carried out in the Member States, under the supervision of the Member States'
p.000007: competent authorities, in particular the public independent authorities designated by the Member
p.000007: States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (3) applies to
p.000007: the processing of personal data carried out by the Commission within the framework of this Regulation,
p.000007: under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC)
p.000007: No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic
p.000007: systems.
p.000007:
p.000007: (48) For implantable devices and for class III devices, manufacturers should summarise the
p.000007: main safety and performance aspects of the device and the outcome of the clinical evaluation in a
p.000007: document that should be publicly available.
p.000007:
p.000007: (49) The summary of safety and clinical performance for a device should include in particular the
p.000007: place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation
p.000007: of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which
p.000007: that device and its alternatives can be considered.
p.000007:
p.000007: (50) The proper functioning of notified bodies is crucial for ensuring a high level of health and
p.000007: safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by
p.000007: the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at
p.000007: Union level.
p.000007:
p.000007: (51) Notified bodies' assessments of manufacturers' technical documentation, in particular documentation
p.000007: on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies.
p.000007: That evaluation should be part of the risk-based approach to the oversight and monitoring activities of
p.000007: notified bodies and should be based on sampling of the relevant documentation.
p.000007:
p.000007: (52) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with
p.000007: regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests
p.000007: on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
p.000007:
p.000007: (1) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102,
p.000007: 23.4.2010, p. 45).
p.000007: (2) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of
p.000007: individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995,
p.000007: p. 31).
p.000007: (3) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of
p.000007: individuals with
p.000007: regard to the processing of personal data by the Community institutions and bodies and on the free movement of such
p.000007: data (OJ L 8, 12.1.2001, p. 1).
p.000007:
p.000008: L 117/8 EN
p.000008: Official Journal of the European Union
p.000008: 5.5.2017
p.000008:
p.000008: (53) To increase transparency with regard to the oversight of notified bodies by national
p.000008: authorities, the authorities responsible for notified bodies should publish information on the national
p.000008: measures governing the assessment, designation and monitoring of notified bodies. In accordance with good
p.000008: administrative practice, this information should be kept up to date by those authorities in particular to
p.000008: reflect relevant, significant or substantive changes to the procedures in question.
p.000008:
p.000008: (54) The Member State in which a notified body is established should be responsible for enforcing the requirements
p.000008: of this Regulation with regard to that notified body.
p.000008:
p.000008: (55) In view, in particular, of the responsibility of Member States for the organisation and
p.000008: delivery of health services and medical care, they should be allowed to lay down additional requirements
p.000008: on notified bodies designated for the conformity assessment of devices and established on their territory
p.000008: as far as issues that are not regulated in this Regulation are concerned. Any such additional
p.000008: requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal
p.000008: treatment of notified bodies.
p.000008:
p.000008: (56) For class III implantable devices and class IIb active devices intended to administer and/or
p.000008: remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert
p.000008: panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed
p.000008: about devices that have been granted a certificate following a conformity assessment procedure involving
p.000008: an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to
p.000008: a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and
p.000008: developing CS on categories of devices that have undergone that consultation process.
p.000008:
p.000008: (57) For class III devices and for certain class IIb devices, a manufacturer should be able to
p.000008: consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation,
p.000008: on its clinical development strategy and on proposals for clinical investigations.
p.000008:
p.000008: (58) It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the
p.000008: division of devices into four product classes in line with international practice. The classification
p.000008: rules, which are based on the vulnerability of the human body, should take into account the potential
...
p.000008: rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such
p.000008: devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should
p.000008: be compulsory.
p.000008:
p.000008: (61) The conformity assessment procedures for devices should be further strengthened and streamlined
p.000008: whilst the requirements for notified bodies as regards the performance of their assessments should be
p.000008: clearly specified to ensure a level playing field.
p.000008:
p.000008: (62) It is appropriate that certificates of free sale contain information that makes it possible to
p.000008: use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market,
p.000008: withdrawn from the market or recalled, and on any certificate on its conformity.
p.000008:
p.000008: (63) To ensure a high level of safety and performance, demonstration of compliance with the general
p.000008: safety and performance requirements laid down in this Regulation should be based on clinical data that,
p.000008: for class III devices and implantable devices should, as a general rule, be sourced from clinical
p.000008: investigations that have been carried out under the responsibility of a sponsor. It should be possible both for
p.000008: the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical
p.000008: investigation.
p.000008:
p.000008: 5.5.2017 EN
p.000008: Official Journal of the European Union
p.000009: L 117/9
p.000009:
p.000009: (64) The rules on clinical investigations should be in line with well-established international
p.000009: guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical
p.000009: investigations of medical devices for human subjects, so as to make it easier for the results of clinical
p.000009: investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for
p.000009: the results of clinical investi gations conducted outside the Union in accordance with international guidelines to be
p.000009: accepted within the Union. In addition, the rules should be in line with the most recent
p.000009: version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research
p.000009: Involving Human Subjects.
p.000009:
p.000009:
p.000009: (65) It should be left to the Member State where a clinical investigation is to be conducted
p.000009: to determine the appropriate authority to be involved in the assessment of the application to conduct
p.000009: a clinical investigation and to organise the involvement of ethics committees within the timelines for the
p.000009: authorisation of that clinical investi gation as set out in this Regulation. Such decisions are a matter
p.000009: of internal organisation for each Member State. In that context, Member States should ensure the
p.000009: involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the
p.000009: necessary expertise is available.
p.000009:
p.000009:
p.000009: (66) Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
p.000009: or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in
p.000009: such cases, including issues of causality and the level of damages and sanctions, should remain governed by
p.000009: national law.
p.000009:
p.000009:
p.000009: (67) An electronic system should be set up at Union level to ensure that every clinical
p.000009: investigation is recorded and reported in a publicly accessible database. To protect the right to the
p.000009: protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the
p.000009: European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation
p.000009: should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal
p.000009: products, the electronic system on clinical investigations should be in teroperable with the EU database to be set up
p.000009: for clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009: (68) Where a clinical investigation is to be conducted in more than one Member State, the sponsor
p.000009: should have the possibility of submitting a single application in order to reduce administrative burden.
p.000009: In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health
p.000009: and safety-related aspects of the investigational device and of the scientific design of that
p.000009: clinical investigation, the procedure for the assessment of such single application should be
p.000009: coordinated between the Member States under the direction of a coordinating Member State. Such coordinated
p.000009: assessment should not include the assessment of intrinsically national, local and ethical aspects of a
p.000009: clinical investigation, including informed consent. For an initial period of seven years from the date of
p.000009: application of this Regulation, Member States should be able to participate on a voluntary basis in the
p.000009: coordinated assessment. After that period, all Member States should be obliged to participate in the
...
p.000009: basis in the coordinated assessment procedure.
p.000009:
p.000009:
p.000009: (69) Sponsors should report certain adverse events and device deficiencies that occur during clinical
p.000009: investigations to the Member States in which those clinical investigations are being conducted. Member
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
p.000009: subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
p.000009:
p.000009:
p.000009: (70) The sponsor of a clinical investigation should submit a summary of results of the clinical
p.000009: investigation that is easily understandable for the intended user together with the clinical investigation
p.000009: report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to
p.000009: submit the summary of the results within the defined timelines for scientific reasons, the sponsor should
p.000009: justify this and specify when the results will be submitted.
p.000009:
p.000009:
p.000009: (71) This Regulation should cover clinical investigations intended to gather clinical evidence for
p.000009: the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and
p.000009: scientific assessments for other types of clinical investigations of medical devices.
p.000009:
p.000010: L 117/10 EN
p.000010: Official Journal of the European Union
p.000010: 5.5.2017
p.000010:
p.000010: (72) Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection
p.000010: measures. However, it should be left to Member States to determine the legally designated representatives
p.000010: of incapacitated subjects and minors.
p.000010:
p.000010: (73) The principles of replacement, reduction and refinement in the area of animal experimentation
p.000010: laid down in the Directive 2010/63/EU of the European Parliament and of the Council (1) should be
p.000010: observed. In particular, the unnecessary duplication of tests and studies should be avoided.
p.000010:
p.000010: (74) Manufacturers should play an active role during the post-market phase by systematically and
p.000010: actively gathering information from post-market experience with their devices in order to update their technical
p.000010: documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000010: activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000010: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000010: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000010: preventive and/or corrective actions, should be used to update any relevant part of technical
p.000010: documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the
p.000010: purpose of transparency.
p.000010:
p.000010: (75) In order to better protect health and safety regarding devices on the market, the electronic
p.000010: system on vigilance for devices should be made more effective by creating a central portal at Union
p.000010: level for reporting serious incidents and field safety corrective actions.
p.000010:
p.000010: (76) Member States should take appropriate measures to raise awareness among healthcare professionals,
p.000010: users and patients about the importance of reporting incidents. Healthcare professionals, users and
p.000010: patients should be encouraged and enabled to report suspected serious incidents at national level using
p.000010: harmonised formats. The national competent authorities should inform manufacturers of any suspected serious
p.000010: incidents and, where a manufacturer confirms that such an incident has occurred, the authorities concerned
p.000010: should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
p.000010:
p.000010: (77) The evaluation of reported serious incidents and field safety corrective actions should be
p.000010: conducted at national level but coordination should be ensured where similar incidents have occurred or
p.000010: field safety corrective actions have to be carried out in more than one Member State, with the objective
p.000010: of sharing resources and ensuring consistency regarding the corrective action.
p.000010:
p.000010: (78) In the context of the investigation of incidents, the competent authorities should take into
p.000010: account, where appropriate, the information provided by and views of relevant stakeholders, including
p.000010: patient and healthcare professionals' organisations and manufacturers' associations.
p.000010:
p.000010: (79) The reporting of serious adverse events or device deficiencies during clinical investigations and
...
p.000010: could lead to unacceptable risks should be reported to the competent authorities in order to permit their
p.000010: assessment and the adoption of appropriate measures.
p.000010:
p.000010: (82) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated
p.000010: by the Member States based on their role and expertise in the field of medical devices including in
p.000010: vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by
p.000010: this Regulation and by Regulation (EU) 2017/746 of the European Parliament and of the
p.000010: Council (2), to provide advice to the Commission and to assist the Commission and the Member States
p.000010: in ensuring a harmonised implementation of this Regulation. The MDCG should be able to establish
p.000010: subgroups in order to have access to necessary in-depth
p.000010:
p.000010: (1) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the
p.000010: protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
p.000010: (2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
p.000010: medical devices and
p.000010: repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).
p.000010:
p.000010: 5.5.2017 EN
p.000010: Official Journal of the European Union
p.000011: L 117/11
p.000011:
p.000011: technical expertise in the field of medical devices including in vitro diagnostic medical devices. When
p.000011: establishing subgroups, appropriate consideration should be given to the possibility of involving existing
p.000011: groups at Union level in the field of medical devices.
p.000011:
p.000011:
p.000011: (83) Expert panels and expert laboratories should be designated by the Commission on the basis of
p.000011: their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific,
p.000011: technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in
p.000011: relation to the implementation of this Regulation. Moreover, expert panels should fulfil the
p.000011: tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of
p.000011: certain high-risk devices.
p.000011:
p.000011: (84) Closer coordination between national competent authorities through information exchange and
p.000011: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000011: consistently high level of health and safety protection within the internal market, in particular in the
p.000011: areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment
p.000011: should also apply across other authority activities described in this Regulation, such as the designation of
p.000011: notified bodies and should be encouraged in the area of market surveillance of devices. Joint working,
p.000011: coordination and communication of activities should also lead to more efficient use of resources and expertise at
p.000011: national level.
p.000011:
p.000011: (85) The Commission should provide scientific, technical and corresponding logistical support
p.000011: to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000011: implemented at Union level based on sound scientific evidence.
p.000011:
p.000011:
p.000011: (86) The Union and, where appropriate, the Member States should actively participate in international
p.000011: regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related
p.000011: information regarding medical devices and to foster the further development of international regulatory
p.000011: guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety
p.000011: protection equivalent to that set by this Regulation.
p.000011:
p.000011:
p.000011: (87) Member States should take all necessary measures to ensure that the provisions of
p.000011: this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for
p.000011: their infringement.
p.000011:
p.000011:
p.000011: (88) Whilst this Regulation should not affect the right of Member States to levy fees for
p.000011: activities at national level, Member States should, in order to ensure transparency, inform the Commission
p.000011: and the other Member States before they decide on the level and structure of such fees. In order to
p.000011: further ensure transparency, the structure and level of the fees should be publicly available on request.
p.000011:
p.000011: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000011: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000011: data, the freedom of art and science, the freedom to conduct business and the right to property. This
...
p.000011:
p.000011: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the
p.000011: Commission in order to amend certain non-essential provisions of this Regulation. It is of particular
p.000011: importance that the Commission carry out appropriate consultations during its preparatory work, including
p.000011: at expert level, and that those consultations be conducted in accordance with the principles laid down in the
p.000011: Interinstitutional Agreement of 13 April 2016 on Better Law-Making (1). In particular, to ensure equal
p.000011: participation in the preparation of delegated acts, the European Parliament and the Council receive all documents
p.000011: at the same time as Member States' experts, and their experts systematically have access to meetings of
p.000011: Commission expert groups dealing with preparation of delegated acts.
p.000011:
p.000011: (91) In order to ensure uniform conditions for the implementation of this Regulation,
p.000011: implementing powers should be conferred on the Commission. Those powers should be
p.000011: exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000011:
p.000011: (1) OJ L 123, 12.5.2016, p. 1.
p.000011: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000011: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise
p.000011: of implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000011:
p.000012: L 117/12 EN
p.000012: Official Journal of the European Union
p.000012: 5.5.2017
p.000012:
p.000012: (92) The advisory procedure should be used for implementing acts that set out the form and
p.000012: presentation of the data elements of manufacturers' summaries of safety and clinical performance, and that
p.000012: establish the model for certificates of free sale, given that such implementing acts are of a procedural
p.000012: nature and do not directly have an impact on health and safety at Union level.
p.000012:
p.000012:
p.000012: (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating
p.000012: to the extension to the territory of the Union of a national derogation from the applicable conformity
p.000012: assessment procedures, imperative grounds of urgency so require.
p.000012:
p.000012:
p.000012: (94) In order to enable it to designate issuing entities, expert panels and expert laboratories,
p.000012: implementing powers should be conferred on the Commission.
p.000012:
p.000012:
p.000012: (95) To allow economic operators, especially SMEs, notified bodies, Member States and the Commission
p.000012: to adapt to the changes introduced by this Regulation and to ensure its proper application, it is
p.000012: appropriate to provide for a sufficient transitional period for that adaptation and for the organisational
p.000012: arrangements that are to be made. However, certain parts of the Regulation that directly affect Member
p.000012: States and the Commission should be implemented as soon as possible. It is also particularly important
p.000012: that, by the date of application of this Regulation, a sufficient number of notified bodies be
p.000012: designated in accordance with the new requirements so as to avoid any shortage of medical devices on
p.000012: the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the
p.000012: requirements of this Regulation prior to the date of its application be without prejudice to the
p.000012: validity of the designation of those notified bodies under Directives 90/385/EEC and 93/42/EEC and to their
p.000012: capacity to continue issuing valid certificates under those two Directives until the date of application of this
p.000012: Regulation.
p.000012:
p.000012:
p.000012: (96) In order to ensure a smooth transition to the new rules for registration of devices and of
p.000012: certificates, the obligation to submit the relevant information to the electronic systems set up at Union
p.000012: level pursuant to this Regulation should, in the event that the corresponding IT systems are developed
p.000012: according to plan, only become fully effective from 18 months after the date of application of this
p.000012: Regulation. During this transitional period, certain provisions of Directives 90/385/EEC and 93/42/EEC
p.000012: should remain in force. However, in order to avoid multiple registrations, economic operators and notified
p.000012: bodies who register in the relevant electronic systems set up at Union level pursuant to this
p.000012: Regulation should be considered to be in compliance with the registration requirements adopted by the Member
p.000012: States pursuant to those provisions.
p.000012:
p.000012:
p.000012: (97) In order to provide for a smooth introduction of the UDI system, the moment of application of the
p.000012: obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of
p.000012: application of this Regulation depending upon the class of the device concerned.
p.000012:
p.000012:
p.000012: (98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules
p.000012: applies to the placing of medical devices on the market and the related aspects covered by this
p.000012: Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices
p.000012: they placed on the market and manufacturers' and Member States' obligations as regards vigilance
p.000012: activities for devices placed on the market pursuant to those Directives should however continue to
p.000012: apply. While it should be left to Member States to decide how to organise vigilance activities, it is
p.000012: desirable for them to have the possibility of reporting incidents related to devices placed on the market
p.000012: pursuant to the Directives using the same tools as those for reporting on devices placed on the market pursuant
p.000012: to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from
p.000012: the old regime to the new regime, to provide that Commission Regulation (EU)
p.000012: No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and continue to
p.000012: apply unless and until repealed by implementing acts adopted by the Commission pursuant to this
p.000012: Regulation.
p.000012:
p.000012: (1) Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L
p.000012: 72, 10.3.2012, p. 28).
p.000012: (2) Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the
p.000012: requirements laid down
p.000012: in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices
p.000012: manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
p.000012:
p.000012: 5.5.2017 EN
p.000012: Official Journal of the European Union
p.000013: L 117/13
p.000013:
p.000013: Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also
p.000013: remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely,
p.000013: no such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC
p.000013: (2) and Commission Implementing Regulation (EU) No 920/2013 (3).
p.000013:
p.000013: (99) The requirements of this Regulation should be applicable to all devices placed on the market
p.000013: or put into service from the date of application of this Regulation. However, in order to provide for a smooth
p.000013: transition it should be possible, for a limited period of time from that date, for devices to be placed on the market
p.000013: or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive
p.000013: 93/42/EEC.
p.000013:
p.000013: (100) The European Data Protection Supervisor has given an opinion (4) pursuant to Article
p.000013: 28(2) of Reg ulation (EC) No 45/2001.
p.000013:
p.000013: (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal
p.000013: market as regards medical devices and to ensure high standards of quality and safety for medical
p.000013: devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot
p.000013: be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be
p.000013: better achieved at Union level, the Union may adopt measures, in accordance with the principle of
p.000013: subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of
p.000013: proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve
p.000013: those objectives,
p.000013:
p.000013:
p.000013:
p.000013: HAVE ADOPTED THIS REGULATION:
p.000013:
p.000013:
p.000013: CHAPTER I
p.000013:
p.000013: SCOPE AND DEFINITIONS
p.000013:
p.000013: Article 1
p.000013:
p.000013: Subject matter and scope
p.000013:
p.000013: 1. This Regulation lays down rules concerning the placing on the market, making available on the
p.000013: market or putting into service of medical devices for human use and accessories for such devices in the Union. This
p.000013: Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the
p.000013: Union.
p.000013:
p.000013: 2. This Regulation shall also apply, as from the date of application of common specifications
p.000013: adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are
p.000013: listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised
p.000013: standards for analogous devices with a medical purpose, based on similar technology. The common
p.000013: specifications for each of the groups of products listed in Annex XVI shall address, at least,
p.000013: application of risk management as set out in Annex I for the group of products in question and, where
p.000013: necessary, clinical evaluation regarding safety.
p.000013:
p.000013: The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six
p.000013: months after the date of their entry into force or from 26 May 2020, whichever is the latest.
p.000013:
p.000013: Notwithstanding Article 122, Member States' measures regarding the qualification of the products
p.000013: covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the
p.000013: date of application, as referred to in the first subparagraph, of the relevant common specifications for that group
p.000013: of products.
p.000013:
p.000013: This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to
p.000013: in the first subparagraph.
p.000013:
p.000013: 3. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the
p.000013: requirements applicable to devices with an intended medical purpose and those applicable to devices
p.000013: without an intended medical purpose.
p.000013:
p.000013: (1) Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast
p.000013: implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43).
p.000013: (2) Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder
p.000013: joint replacements in the
p.000013: framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41).
p.000013: (3) Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of
p.000013: notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive
p.000013: 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8).
p.000013: (4) OJ C 358, 7.12.2013, p. 10.
p.000013:
p.000014: L 117/14 EN
p.000014: Official Journal of the European Union
p.000014: 5.5.2017
p.000014:
p.000014: 4. For the purposes of this Regulation, medical devices, accessories for medical devices, and
p.000014: products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred
p.000014: to as ‘devices’.
p.000014:
p.000014: 5. Where justified on account of the similarity between a device with an intended medical purpose
p.000014: placed on the market and a product without an intended medical purpose in respect of their characteristics and
p.000014: risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the
p.000014: list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other
p.000014: persons or other aspects of public health.
p.000014:
p.000014: 6. This Regulation does not apply to:
p.000014: (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
p.000014: (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether
p.000014: a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of
p.000014: the principal mode of action of the product;
p.000014: (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
p.000014: (d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on
p.000014: the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of
p.000014: this Article;
p.000014: (e) cosmetic products covered by Regulation (EC) No 1223/2009;
...
p.000014: device part are concerned.
p.000014:
p.000014: 9. Any device which is intended to administer a medicinal product as defined in point
p.000014: 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the
p.000014: provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
p.000014:
p.000014: However, if the device intended to administer a medicinal product and the medicinal product are placed
p.000014: on the market in such a way that they form a single integral product which is intended exclusively for
p.000014: use in the given combination and which is not reusable, that single integral product
p.000014: shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In
p.000014: that case, the relevant general safety and performance requirements set out in Annex I to this
p.000014: Regulation shall apply as far as the safety and performance of the device part of the single integral
p.000014: product are concerned.
p.000014:
p.000014: (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.000014: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000014: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000014:
p.000014: 5.5.2017 EN
p.000014: Official Journal of the European Union
p.000015: L 117/15
p.000015:
p.000015: 10. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000015: part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to
p.000015: that of the device shall be assessed and authorised in accordance with this Regulation. In that case,
p.000015: the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
p.000015:
p.000015: However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the
p.000015: device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive
p.000015: 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to
p.000015: this Regulation shall apply as far as the safety and performance of the device part are concerned.
p.000015:
p.000015: 11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
p.000015:
p.000015: 12. Devices that are also machinery within the meaning of point (a) of the second paragraph of
p.000015: Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a
p.000015: hazard relevant under that Directive exists, also meet the essential health and safety requirements set out
p.000015: in Annex I to that Directive to the extent to which those requirements are more specific than the
p.000015: general safety and performance requirements set out in Chapter II of Annex I to this Regulation.
p.000015:
p.000015: 13. This Regulation shall not affect the application of Directive 2013/59/Euratom.
p.000015:
p.000015: 14. This Regulation shall not affect the right of a Member State to restrict the use of any
p.000015: specific type of device in relation to aspects not covered by this Regulation.
p.000015:
p.000015: 15. This Regulation shall not affect national law concerning the organisation, delivery or financing
p.000015: of health services and medical care, such as the requirement that certain devices may only be supplied
p.000015: on a medical prescription, the requirement that only certain health professionals or healthcare institutions
p.000015: may dispense or use certain devices or that their use be accompanied by specific professional counselling.
p.000015:
p.000015: 16. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the
p.000015: media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular
p.000015: under Article 11 of the Charter of Fundamental Rights of the European Union.
p.000015:
p.000015:
p.000015: Article 2
p.000015:
p.000015: Definitions
p.000015:
p.000015: For the purposes of this Regulation, the following definitions apply:
p.000015: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or
p.000015: other article intended by the manufacturer to be used, alone or in combination, for human beings for
p.000015: one or more of the following specific medical purposes:
p.000015: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
p.000015: — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
p.000015: — investigation, replacement or modification of the anatomy or of a physiological or pathological process
p.000015: or state,
p.000015: — providing information by means of in vitro examination of specimens derived from the human body,
p.000015: including organ, blood and tissue donations,
p.000015: and which does not achieve its principal intended action by pharmacological, immunological or metabolic
p.000015: means, in or on the human body, but which may be assisted in its function by such means.
p.000015: The following products shall also be deemed to be medical devices:
p.000015: — devices for the control or support of conception;
p.000015: — products specifically intended for the cleaning, disinfection or sterilisation of devices as
p.000015: referred to in Article 1(4) and of those referred to in the first paragraph of this point.
p.000015:
p.000015: (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending
p.000015: Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
p.000015:
p.000016: L 117/16 EN
p.000016: Official Journal of the European Union
p.000016: 5.5.2017
p.000016:
p.000016: (2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device,
p.000016: is intended by its manufacturer to be used together with one or several particular medical device(s) to
p.000016: specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to
p.000016: specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended
p.000016: purpose(s);
p.000016:
p.000016: (3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of
p.000016: any person authorised by national law by virtue of that person's professional qualifications which gives, under that
p.000016: person's re sponsibility, specific design characteristics, and is intended for the sole use of a
p.000016: particular patient exclusively to meet their individual conditions and needs.
p.000016:
p.000016: However, mass-produced devices which need to be adapted to meet the specific requirements of any
p.000016: professional user and devices which are mass-produced by means of industrial manufacturing processes in
p.000016: accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
p.000016:
p.000016: (4) ‘active device’ means any device, the operation of which depends on a source of energy other than
p.000016: that generated by the human body for that purpose, or by gravity, and which acts by changing the
p.000016: density of or converting that energy. Devices intended to transmit energy, substances or other elements between an
p.000016: active device and the patient, without any significant change, shall not be deemed to be active devices.
p.000016:
...
p.000016: does not include uninten tional non-compliance and is without prejudice to infringements of intellectual property
p.000016: rights;
p.000016:
p.000016: (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with
p.000016: the purpose of being used for a specific medical purpose;
p.000016:
p.000016: (11) ‘system’ means a combination of products, either packaged together or not, which are intended to
p.000016: be inter- connected or combined to achieve a specific medical purpose;
p.000016:
p.000016: (12) ‘intended purpose’ means the use for which a device is intended according to the data
p.000016: supplied by the manufacturer on the label, in the instructions for use or in promotional or sales
p.000016: materials or statements and as specified by the manufacturer in the clinical evaluation;
p.000016:
p.000016: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or
p.000016: on the packaging of each unit or on the packaging of multiple devices;
p.000016:
p.000016: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000016: intended purpose and proper use and of any precautions to be taken;
p.000016:
p.000016: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is
p.000016: created through in ternationally accepted device identification and coding standards and that allows
p.000016: unambiguous identification of specific devices on the market;
p.000016:
p.000016: 5.5.2017 EN
p.000016: Official Journal of the European Union
p.000017: L 117/17
p.000017:
p.000017: (16) ‘non-viable’ means having no potential for metabolism or multiplication;
p.000017:
p.000017: (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a
p.000017: manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells
p.000017: or tissues;
p.000017:
p.000017: (18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an
p.000017: unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in
p.000017: the number size distribution, one or more external dimensions is in the size range 1-100 nm;
p.000017:
p.000017: Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1
p.000017: nm shall also be deemed to be nanomaterials;
p.000017:
p.000017: (19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece
p.000017: of matter with defined physical boundaries;
p.000017:
p.000017: (20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly
p.000017: bound particles or aggregates where the resulting external surface area is similar to the sum of the
p.000017: surface areas of the individual components;
p.000017:
p.000017: (21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle
p.000017: comprising of strongly bound or fused particles;
p.000017:
...
p.000017:
p.000017: (24) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible
p.000017: relevance for the use of the device for the intended purpose, when used in accordance with the intended
p.000017: purpose given by the manufacturer;
p.000017:
p.000017: (25) ‘compatibility’ is the ability of a device, including software, when used together with one or more
p.000017: other devices in accordance with its intended purpose, to:
p.000017:
p.000017: (a) perform without losing or compromising the ability to perform as intended, and/or
p.000017:
p.000017: (b) integrate and/or operate without the need for modification or adaption of any part of the combined
p.000017: devices, and/or
p.000017:
p.000017: (c) be used together without conflict/interference or adverse reaction.
p.000017:
p.000017: (26) ‘interoperability’ is the ability of two or more devices, including software, from the same
p.000017: manufacturer or from different manufacturers, to:
p.000017:
p.000017: (a) exchange information and use the information that has been exchanged for the correct execution of a specified
p.000017: function without changing the content of the data, and/or
p.000017:
p.000017: (b) communicate with each other, and/or
p.000017:
p.000017: (c) work together as intended.
p.000017:
p.000017: (27) ‘making available on the market’ means any supply of a device, other than an
p.000017: investigational device, for distribution, consumption or use on the Union market in the course of a commercial
p.000017: activity, whether in return for payment or free of charge;
p.000017:
p.000017: (28) ‘placing on the market’ means the first making available of a device, other than an
p.000017: investigational device, on the Union market;
p.000017:
p.000017: (29) ‘putting into service’ means the stage at which a device, other than an investigational device,
p.000017: has been made available to the final user as being ready for use on the Union market for the first time for its
p.000017: intended purpose;
p.000017:
p.000017: (30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or
p.000017: has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;
p.000017:
p.000017: (31) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete
p.000017: rebuilding of a device already placed on the market or put into service, or the making of a new device from used
p.000017: devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the
p.000017: refurbished device;
p.000017:
p.000018: L 117/18 EN
p.000018: Official Journal of the European Union
p.000018: 5.5.2017
p.000018:
p.000018: (32) ‘authorised representative’ means any natural or legal person established within the Union who has
p.000018: received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's
p.000018: behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
p.000018:
p.000018: (33) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000018: country on the Union market;
p.000018:
p.000018: (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer
p.000018: or the importer, that makes a device available on the market, up until the point of putting into service;
p.000018:
p.000018: (35) ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or
p.000018: the person referred to in Article 22(1) and 22(3);
p.000018:
p.000018: (36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of
p.000018: patients or the promotion of public health;
p.000018:
p.000018: (37) ‘user’ means any healthcare professional or lay person who uses a device;
p.000018:
p.000018: (38) ‘lay person’ means an individual who does not have formal education in a relevant field of
p.000018: healthcare or medical discipline;
p.000018:
p.000018: (39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse
p.000018: including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the
p.000018: technical and functional safety of the used device;
p.000018:
p.000018: (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation
p.000018: relating to a device have been fulfilled;
p.000018:
p.000018: (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000018: including calibration, testing, certification and inspection;
p.000018:
p.000018: (42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000018:
p.000018: (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000018: conformity with the applicable requirements set out in this Regulation and other applicable Union
p.000018: harmonisation legislation providing for its affixing;
p.000018:
p.000018: (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect,
p.000018: analyse and assess the clinical data pertaining to a device in order to verify the safety and
p.000018: performance, including clinical benefits, of the device when used as intended by the manufacturer;
p.000018:
p.000018: (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects,
p.000018: undertaken to assess the safety or performance of a device;
p.000018:
p.000018: (46) ‘investigational device’ means a device that is assessed in a clinical investigation;
p.000018:
p.000018: (47) ‘clinical investigation plan’ means a document that describes the rationale, objectives,
p.000018: design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
p.000018:
p.000018: (48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and
p.000018: is sourced from the following:
p.000018:
p.000018: — clinical investigation(s) of the device concerned,
p.000018:
p.000018: — clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence
p.000018: to the device in question can be demonstrated,
p.000018:
p.000018: — reports published in peer reviewed scientific literature on other clinical experience of either the
p.000018: device in question or a device for which equivalence to the device in question can be demonstrated,
p.000018:
p.000018: — clinically relevant information coming from post-market surveillance, in particular the post-market
p.000018: clinical follow-up;
p.000018:
p.000018: (49) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for
p.000018: the initiation, for the management and setting up of the financing of the clinical investigation;
p.000018:
p.000018: (50) ‘subject’ means an individual who participates in a clinical investigation;
p.000018:
p.000018: 5.5.2017 EN
p.000018: Official Journal of the European Union
p.000019: L 117/19
p.000019:
p.000019: (51) ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a
p.000019: sufficient amount and quality to allow a qualified assessment of whether the device is safe and
p.000019: achieves the intended clinical benefit(s), when used as intended by the manufacturer;
p.000019:
p.000019: (52) ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects
p.000019: which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve
p.000019: its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients,
p.000019: when used as intended by the manufacturer;
p.000019:
p.000019: (53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed
p.000019: in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s)
p.000019: related to diagnosis, or a positive impact on patient management or public health;
p.000019:
p.000019: (54) ‘investigator’ means an individual responsible for the conduct of a clinical investigation at a
p.000019: clinical investigation site;
p.000019:
p.000019: (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000019: participate in a particular clinical investigation, after having been informed of all aspects of the
p.000019: clinical investigation that are relevant to the subject's decision to participate or, in the case of
...
p.000019:
p.000019: (ii) permanent impairment of a body structure or a body function,
p.000019:
p.000019: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000019:
p.000019: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent
p.000019: impairment to a body structure or a body function,
p.000019:
p.000019: (v) chronic disease,
p.000019:
p.000019: (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000019:
p.000019: (59) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000019: performance of an investigational device, including malfunction, use errors or inadequacy in
p.000019: information supplied by the manufacturer;
p.000019:
p.000019: (60) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000019: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000019: and review experience gained from devices they place on the market, make available on the market or put into service
p.000019: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000019:
p.000019: (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities
p.000019: to check and ensure that devices comply with the requirements set out in the relevant Union
p.000019: harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
p.000019:
p.000019: (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made
p.000019: available to the end user;
p.000019:
p.000020: L 117/20 EN
p.000020: Official Journal of the European Union
p.000020: 5.5.2017
p.000020:
p.000020: (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000020: made available on the market;
p.000020: (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device
p.000020: made available on the market, including use-error due to ergonomic features, as well as any inadequacy
p.000020: in the information supplied by the manufacturer and any undesirable side-effect;
p.000020: (65) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000020: lead to any of the following:
p.000020: (a) the death of a patient, user or other person,
p.000020: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000020: (c) a serious public health threat;
p.000020: (66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious
p.000020: deterioration in a person's state of health, or serious illness, that may require prompt remedial
p.000020: action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the
p.000020: given place and time;
p.000020: (67) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000020: non-conformity or other undesirable situation;
p.000020: (68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or
p.000020: medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the
p.000020: market;
p.000020: (69) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000020: relation to a field safety corrective action;
p.000020: (70) ‘harmonised standard’ means a European standard as defined in point
p.000020: (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
p.000020: (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000020: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000020:
p.000020: Article 3
p.000020:
p.000020: Amendment of certain definitions
p.000020:
p.000020: The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of
p.000020: nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article
p.000020: 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and
p.000020: international level.
p.000020:
p.000020:
p.000020: Article 4
p.000020:
p.000020: Regulatory status of products
p.000020:
p.000020: 1. Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of
p.000020: a Member State, the Commission shall, after consulting the Medical Device Coordination Group established
p.000020: under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific
p.000020: product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory
p.000020: for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure
p.000020: referred to in Article 114(3) of this Regulation.
p.000020:
p.000020: 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of
p.000020: implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts
p.000020: shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000020:
p.000020: 3. The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro
p.000020: diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary,
p.000020: other products, in order to determine the appropriate regulatory status of a product, or category or group of
p.000020: products.
p.000020:
p.000020: 4. When deliberating on the possible regulatory status as a device of products involving medicinal
p.000020: products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate
p.000020: level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA)
p.000020: and the European Food Safety Authority (EFSA), as relevant.
p.000020:
p.000020: 5.5.2017 EN
p.000020: Official Journal of the European Union
p.000021: L 117/21
p.000021:
p.000021: CHAPTER II
p.000021:
p.000021: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS,
p.000021: REPROCESSING, CE MARKING, FREE MOVEMENT
p.000021:
p.000021: Article 5
p.000021:
p.000021: Placing on the market and putting into service
p.000021:
p.000021: 1. A device may be placed on the market or put into service only if it complies with this
p.000021: Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
p.000021:
p.000021: 2. A device shall meet the general safety and performance requirements set out in Annex I which
p.000021: apply to it, taking into account its intended purpose.
p.000021:
p.000021: 3. Demonstration of conformity with the general safety and performance requirements shall
p.000021: include a clinical evaluation in accordance with Article 61.
p.000021:
p.000021: 4. Devices that are manufactured and used within health institutions shall be considered as having
p.000021: been put into service.
p.000021:
p.000021: 5. With the exception of the relevant general safety and performance requirements set out
p.000021: in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used
p.000021: only within health institutions established in the Union, provided that all of the following conditions are met:
p.000021: (a) the devices are not transferred to another legal entity,
p.000021: (b) manufacture and use of the devices occur under appropriate quality management systems,
p.000021: (c) the health institution justifies in its documentation that the target patient group's specific needs
p.000021: cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the
p.000021: market,
p.000021: (d) the health institution provides information upon request on the use of such devices to its
p.000021: competent authority, which shall include a justification of their manufacturing, modification and use;
p.000021: (e) the health institution draws up a declaration which it shall make publicly available, including:
p.000021: (i) the name and address of the manufacturing health institution;
p.000021: (ii) the details necessary to identify the devices;
p.000021: (iii) a declaration that the devices meet the general safety and performance requirements set out in
p.000021: Annex I to this Regulation and, where applicable, information on which requirements are not fully met
p.000021: with a reasoned justifi cation therefor,
p.000021: (f) the health institution draws up documentation that makes it possible to have an understanding of the
p.000021: manufacturing facility, the manufacturing process, the design and performance data of the devices,
p.000021: including the intended purpose, and that is sufficiently detailed to enable the competent authority
p.000021: to ascertain that the general safety and performance requirements set out in Annex I to this Regulation
p.000021: are met;
p.000021: (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance
p.000021: with the documentation referred to in point (f), and
p.000021: (h) the health institution reviews experience gained from clinical use of the devices and takes all
p.000021: necessary corrective actions.
p.000021: Member States may require that such health institutions submit to the competent authority any
p.000021: further relevant information about such devices which have been manufactured and used on their territory.
p.000021: Member States shall retain the right to restrict the manufacture and the use of any specific type of
p.000021: such devices and shall be permitted access to inspect the activities of the health institutions.
p.000021:
p.000021: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000021:
p.000021: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000021: acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
p.000021: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000021:
p.000022: L 117/22 EN
p.000022: Official Journal of the European Union
p.000022: 5.5.2017
p.000022:
p.000022: Article 6
p.000022:
p.000022: Distance sales
p.000022:
p.000022: 1. A device offered by means of information society services, as defined in point (b)
p.000022: of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply
p.000022: with this Regulation.
p.000022:
p.000022: 2. Without prejudice to national law regarding the exercise of the medical profession, a device
p.000022: that is not placed on the market but used in the context of a commercial activity, whether in return
p.000022: for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by
p.000022: means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or
p.000022: by other means of communication, directly or through intermediaries, to a natural or legal person established in the
p.000022: Union shall comply with this Regulation.
p.000022:
p.000022: 3. Upon request by a competent authority, any natural or legal person offering a device
p.000022: in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy
p.000022: of the EU declaration of conformity of the device concerned.
p.000022:
p.000022: 4. A Member State may, on grounds of protection of public health, require a provider of information society
p.000022: services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
p.000022:
p.000022:
p.000022: Article 7
p.000022:
p.000022: Claims
p.000022:
p.000022: In the labelling, instructions for use, making available, putting into service and advertising of
p.000022: devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may
p.000022: mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
p.000022:
p.000022: (a) ascribing functions and properties to the device which the device does not have;
p.000022:
p.000022: (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not
p.000022: have;
p.000022:
p.000022: (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with
p.000022: its intended purpose;
p.000022:
p.000022: (d) suggesting uses for the device other than those stated to form part of the intended
p.000022: purpose for which the conformity assessment was carried out.
p.000022:
p.000022:
p.000022: Article 8
p.000022:
p.000022: Use of harmonised standards
p.000022:
p.000022: 1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of
p.000022: those standards, the references of which have been published in the Official Journal of the European
p.000022: Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards
p.000022: or parts thereof.
p.000022:
p.000022: The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance
p.000022: with this Regulation by economic operators or sponsors, including those relating to quality
p.000022: management systems, risk management, post-market surveillance systems, clinical investigations,
p.000022: clinical evaluation or post-market clinical follow-up (‘PMCF’).
p.000022:
p.000022: References in this Regulation to harmonised standards shall be understood as meaning harmonised standards
p.000022: the references of which have been published in the Official Journal of the European Union.
p.000022:
p.000022: 2. References in this Regulation to harmonised standards shall also include the monographs of the European
p.000022: Pharma copoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia,
p.000022: in particular on surgical sutures and on interaction between medicinal products and materials used in
p.000022: devices containing such medicinal products, provided that references to those monographs have been published in the
p.000022: Official Journal of the European Union.
p.000022:
p.000022: 5.5.2017 EN
p.000022: Official Journal of the European Union
p.000023: L 117/23
p.000023:
p.000023: Article 9
p.000023:
p.000023: Common specifications
p.000023:
p.000023: 1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no
p.000023: harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a
p.000023: need to address public health concerns, the Commission, after having consulted the MDCG, may, by means
p.000023: of implementing acts, adopt common specifications (CS) in respect of the general safety and performance
p.000023: requirements set out in Annex I, the technical documentation set out in Annexes II and III, the
p.000023: clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding
p.000023: clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination
p.000023: procedure referred to in Article 114(3).
p.000023:
p.000023: 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in
p.000023: conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
p.000023:
p.000023: 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify
p.000023: that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
p.000023:
p.000023: 4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the
p.000023: relevant CS for those products.
p.000023:
p.000023:
p.000023: Article 10
p.000023:
p.000023: General obligations of manufacturers
p.000023:
...
p.000023: 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent
p.000023: authorities documentation in accordance with Section 2 of Annex XIII.
p.000023:
p.000023: 6. Where compliance with the applicable requirements has been demonstrated following the applicable
p.000023: conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall
p.000023: draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of
p.000023: conformity in accordance with Article 20.
p.000023:
p.000023: 7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article
p.000023: 27 and with the registration obligations referred to in Articles 29 and 31.
p.000023:
p.000023: 8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if
p.000023: applicable, a copy of any relevant certificate, including any amendments and supplements, issued in
p.000023: accordance with Article 56, available for the competent authorities for a period of at least 10 years
p.000023: after the last device covered by the EU declaration of conformity has been placed on the market. In the
p.000023: case of implantable devices, the period shall be at least 15 years after the last device has been placed on
p.000023: the market.
p.000023:
p.000023: Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that
p.000023: technical documen tation in its entirety or a summary thereof.
p.000023:
p.000023: A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised
p.000023: representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the
p.000023: necessary documentation permanently available.
p.000023:
p.000024: L 117/24 EN
p.000024: Official Journal of the European Union
p.000024: 5.5.2017
p.000024:
p.000024: 9. Manufacturers shall ensure that procedures are in place to keep series production in
p.000024: conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in
p.000024: the harmonised standards or CS by reference to which the conformity of a device is declared shall be
p.000024: adequately taken into account in a timely manner. Manufacturers of devices, other than investigational
p.000024: devices, shall establish, document, implement, maintain, keep up to date and continually improve a
p.000024: quality management system that shall ensure compliance with this Regulation in the most effective
p.000024: manner and in a manner that is proportionate to the risk class and the type of device.
p.000024:
p.000024: The quality management system shall cover all parts and elements of a manufacturer's organisation dealing
p.000024: with the quality of processes, procedures and devices. It shall govern the structure, responsibilities,
p.000024: procedures, processes and management resources required to implement the principles and actions necessary
p.000024: to achieve compliance with the provisions of this Regulation.
p.000024:
p.000024: The quality management system shall address at least the following aspects:
p.000024:
p.000024: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and
p.000024: procedures for management of modifications to the devices covered by the system;
p.000024:
p.000024: (b) identification of applicable general safety and performance requirements and exploration of options to address
p.000024: those requirements;
p.000024:
p.000024: (c) responsibility of the management;
p.000024:
p.000024: (d) resource management, including selection and control of suppliers and sub-contractors;
p.000024:
p.000024: (e) risk management as set out in in Section 3 of Annex I;
p.000024:
p.000024: (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
p.000024:
p.000024: (g) product realisation, including planning, design, development, production and service provision;
p.000024:
p.000024: (h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices
p.000024: and ensuring consistency and validity of information provided in accordance with Article 29;
p.000024:
p.000024: (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
p.000024:
p.000024: (j) handling communication with competent authorities, notified bodies, other economic operators,
p.000024: customers and/or other stakeholders;
p.000024:
p.000024: (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
p.000024:
p.000024: (l) management of corrective and preventive actions and verification of their effectiveness;
p.000024:
p.000024: (m) processes for monitoring and measurement of output, data analysis and product improvement.
p.000024:
p.000024: 10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in
p.000024: accordance with Article 83.
p.000024:
p.000024: 11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I
p.000024: in an official Union language(s) determined by the Member State in which the device is made available
p.000024: to the user or patient. The particulars on the label shall be indelible, easily legible and clearly
p.000024: comprehensible to the intended user or patient.
p.000024:
p.000024: 12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or
p.000024: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000024: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the
p.000024: distributors of the device in question and, where applicable, the authorised representative and importers
p.000024: accordingly.
p.000024:
p.000024: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000024: of the Member States in which they made the device available and, where applicable, the notified body that
p.000024: issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any
p.000024: corrective action taken.
p.000024:
p.000024: 13. Manufacturers shall have a system for recording and reporting of incidents and field safety
p.000024: corrective actions as described in Articles 87 and 88.
p.000024:
p.000024: 5.5.2017 EN
p.000024: Official Journal of the European Union
p.000025: L 117/25
p.000025:
p.000025: 14. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000025: and documen tation necessary to demonstrate the conformity of the device, in an official
p.000025: Union language determined by the Member State concerned. The competent authority of the Member State
p.000025: in which the manufacturer has its registered place of business may require that the manufacturer provide
p.000025: samples of the device free of charge or, where that is impracticable, grant access to the device.
p.000025: Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
p.000025: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000025: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000025: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000025: overriding public interest in disclosure, without prejudice to the protection of intellectual property
p.000025: rights.
p.000025:
p.000025: The competent authority need not comply with the obligation laid down in the third subparagraph where
p.000025: disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt
p.000025: with in the context of legal proceedings.
p.000025:
p.000025: 15. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000025: person the information on the identity of that person shall be part of the information to be
p.000025: submitted in accordance with Article 30(1).
p.000025:
p.000025: 16. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000025: accordance with applicable Union and national law.
p.000025:
p.000025: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000025: of the enterprise, have measures in place to provide sufficient financial coverage in respect
p.000025: of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under
p.000025: national law.
p.000025:
p.000025:
p.000025: Article 11
p.000025:
p.000025: Authorised representative
p.000025:
p.000025: 1. Where the manufacturer of a device is not established in a Member State, the device may only
p.000025: be placed on the Union market if the manufacturer designates a sole authorised representative.
p.000025:
p.000025: 2. The designation shall constitute the authorised representative's mandate, it shall be valid only
p.000025: when accepted in writing by the authorised representative and shall be effective at least for all devices of the same
p.000025: generic device group.
p.000025:
p.000025: 3. The authorised representative shall perform the tasks specified in the mandate agreed
p.000025: between it and the manufacturer. The authorised representative shall provide a copy of the mandate to
p.000025: the competent authority, upon request.
p.000025:
p.000025: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000025: least the following tasks in relation to the devices that it covers:
p.000025:
p.000025: (a) verify that the EU declaration of conformity and technical documentation have been drawn
p.000025: up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the
p.000025: manufacturer;
p.000025:
p.000025: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if
p.000025: applicable, a copy of the relevant certificate, including any amendments and supplements, issued in
p.000025: accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
p.000025:
p.000025: (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied
p.000025: with the registration obligations laid down in Articles 27 and 29;
p.000025:
p.000026: L 117/26 EN
p.000026: Official Journal of the European Union
p.000026: 5.5.2017
p.000026:
p.000026: (d) in response to a request from a competent authority, provide that competent authority with all the
p.000026: information and documentation necessary to demonstrate the conformity of a device, in an official Union
p.000026: language determined by the Member State concerned;
p.000026: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000026: resentative has its registered place of business for samples, or access to a device and verify that
p.000026: the competent authority receives the samples or is given access to the device;
p.000026: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate
p.000026: or, if that is not possible, mitigate the risks posed by devices;
p.000026: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000026: patients and users about suspected incidents related to a device for which they have been designated;
p.000026: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000026: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's
p.000026: obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
p.000026:
p.000026: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000026: and has not complied with the obligations laid down in Article 10, the authorised representative shall
p.000026: be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000026:
...
p.000026: authority of the Member State in which the authorised representative, designated by a manufacturer referred
p.000026: to in paragraph 1, has its registered place of business.
p.000026:
p.000026: Article 12
p.000026:
p.000026: Change of authorised representative
p.000026:
p.000026: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000026: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000026: representative. That agreement shall address at least the following aspects:
p.000026: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000026: beginning of the mandate of the incoming authorised representative;
p.000026: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000026: supplied by the manufacturer, including any promotional material;
p.000026: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000026: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000026: forward to the manufacturer or incoming authorised representative any complaints or reports
p.000026: from healthcare professionals, patients or users about suspected incidents related to a device for which
p.000026: it had been designated as authorised rep resentative.
p.000026:
p.000026: Article 13
p.000026:
p.000026: General obligations of importers
p.000026:
p.000026: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000026:
p.000026: 2. In order to place a device on the market, importers shall verify that:
p.000026: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000026: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000026: designated by the manufacturer;
p.000026: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000026: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
p.000026:
p.000026: 5.5.2017 EN
p.000026: Official Journal of the European Union
p.000027: L 117/27
p.000027:
p.000027: Where an importer considers or has reason to believe that a device is not in conformity with the
p.000027: requirements of this Regulation, it shall not place the device on the market until it has been brought
p.000027: into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where
p.000027: the importer considers or has reason to believe that the device presents a serious risk or is a
p.000027: falsified device, it shall also inform the competent authority of the Member State in which the importer is
p.000027: established.
p.000027:
p.000027: 3. Importers shall indicate on the device or on its packaging or in a document accompanying the
p.000027: device their name, registered trade name or registered trade mark, their registered place of business and
p.000027: the address at which they can be contacted, so that their location can be established. They shall
p.000027: ensure that any additional label does not obscure any information on the label provided by the manufacturer.
p.000027:
p.000027: 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29.
p.000027: Importers shall add their details to the registration in accordance with Article 31.
p.000027:
p.000027: 5. Importers shall ensure that, while a device is under their responsibility, storage or transport
p.000027: conditions do not jeopardise its compliance with the general safety and performance requirements set out
p.000027: in Annex I and shall comply with the conditions set by the manufacturer, where available.
p.000027:
...
p.000027: taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have
p.000027: placed on the market. Importers, upon request by a competent authority of the Member State in which the
p.000027: importer has its registered place of business, shall provide samples of the device free of charge or, where
p.000027: that is impracticable, grant access to the device.
p.000027:
p.000027:
p.000027: Article 14
p.000027:
p.000027: General obligations of distributors
p.000027:
p.000027: 1. When making a device available on the market, distributors shall, in the context of their
p.000027: activities, act with due care in relation to the requirements applicable.
p.000027:
p.000027: 2. Before making a device available on the market, distributors shall verify that all of the
p.000027: following requirements are met:
p.000027: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000027: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
p.000027: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000027: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000027: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000027: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000027:
p.000028: L 117/28 EN
p.000028: Official Journal of the European Union
p.000028: 5.5.2017
p.000028:
p.000028: Where a distributor considers or has reason to believe that a device is not in conformity with the
p.000028: requirements of this Regulation, it shall not make the device available on the market until it has been
p.000028: brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's
p.000028: authorised representative, and the importer. Where the distributor considers or has reason to believe that
p.000028: the device presents a serious risk or is a falsified device, it shall also inform the competent authority
p.000028: of the Member State in which it is established.
p.000028:
p.000028: 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport
p.000028: conditions comply with the conditions set by the manufacturer.
p.000028:
p.000028: 4. Distributors that consider or have reason to believe that a device which they have made available on the
p.000028: market is not in conformity with this Regulation shall immediately inform the manufacturer and, where
p.000028: applicable, the manufac turer's authorised representative and the importer. Distributors shall co-operate
p.000028: with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and
p.000028: with competent authorities to ensure that the necessary corrective action to bring that device into conformity,
p.000028: to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe
...
p.000028: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000028:
p.000028: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a
p.000028: university degree or of a course of study recognised as equivalent by the Member State concerned, in law,
p.000028: medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of
p.000028: professional experience in regulatory affairs or in quality management systems relating to medical devices;
p.000028:
p.000028: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000028: to medical devices.
p.000028:
p.000028: Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made
p.000028: devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of
p.000028: professional experience within a relevant field of manufacturing.
p.000028:
p.000028: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000028: not be required to have the person responsible for regulatory compliance within their organisation but
p.000028: shall have such person permanently and continuously at their disposal.
p.000028:
p.000028: (1) Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized
p.000028: enterprises (OJ L 124, 20.5.2003, p. 36).
p.000028:
p.000028: 5.5.2017 EN
p.000028: Official Journal of the European Union
p.000029: L 117/29
p.000029:
p.000029: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000029: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
p.000029: system under which the devices are manufactured, before a device is released;
p.000029: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
p.000029: (c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
p.000029: (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
p.000029: (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is
p.000029: issued.
p.000029: 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2
p.000029: and 3, their respective areas of responsibility shall be stipulated in writing.
p.000029:
p.000029: 5. The person responsible for regulatory compliance shall suffer no disadvantage within the
p.000029: manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or
p.000029: not they are employees of the organisation.
p.000029:
p.000029: 6. Authorised representatives shall have permanently and continuously at their disposal at
p.000029: least one person responsible for regulatory compliance who possesses the requisite expertise regarding
p.000029: the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by
p.000029: either of the following qualifications:
p.000029: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a
p.000029: university degree or of a course of study recognised as equivalent by the Member State concerned, in law,
p.000029: medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of
p.000029: professional experience in regulatory affairs or in quality management systems relating to medical devices;
p.000029: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000029: to medical devices.
p.000029:
p.000029:
p.000029: Article 16
p.000029:
p.000029: Cases in which obligations of manufacturers apply to importers, distributors or other persons
p.000029:
p.000029: 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent
p.000029: on manufacturers if it does any of the following:
p.000029: (a) makes available on the market a device under its name, registered trade name or registered trade
p.000029: mark, except in cases where a distributor or importer enters into an agreement with a manufacturer
p.000029: whereby the manufacturer is identified as such on the label and is responsible for meeting the
p.000029: requirements placed on manufacturers in this Regulation;
p.000029: (b) changes the intended purpose of a device already placed on the market or put into service;
p.000029: (c) modifies a device already placed on the market or put into service in such a way that compliance with the
p.000029: applicable requirements may be affected.
p.000029: The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30)
p.000029: of Article 2, assembles or adapts for an individual patient a device already on the market without
p.000029: changing its intended purpose.
p.000029:
p.000029: 2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a
p.000029: device that could affect its compliance with the applicable requirements:
p.000029: (a) provision, including translation, of the information supplied by the manufacturer, in accordance with
p.000029: Section 23 of Annex I, relating to a device already placed on the market and of further information which is
p.000029: necessary in order to market the device in the relevant Member State;
p.000029: (b) changes to the outer packaging of a device already placed on the market, including a change of
p.000029: pack size, if the repackaging is necessary in order to market the device in the relevant Member State
p.000029: and if it is carried out in such conditions that the original condition of the device cannot be
p.000029: affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed
p.000029: that the original condition of the device is adversely affected if the packaging that is necessary for
p.000029: maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
p.000029:
p.000030: L 117/30 EN
p.000030: Official Journal of the European Union
p.000030: 5.5.2017
p.000030:
p.000030: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of
p.000030: paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a
p.000030: document accompanying the device, the activity carried out together with its name, registered trade name
p.000030: or registered trade mark, registered place of business and the address at which it can be contacted, so that its
p.000030: location can be established.
p.000030:
p.000030: Distributors and importers shall ensure that they have in place a quality management system that
p.000030: includes procedures which ensure that the translation of information is accurate and up-to-date, and that
p.000030: the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that
p.000030: preserve the original condition of the device and that the packaging of the repackaged device is not
p.000030: defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures
p.000030: ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer
p.000030: in relation to the device in question in order to respond to safety issues or to bring it into conformity
p.000030: with this Regulation.
p.000030:
p.000030: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000030: distributors or importers carrying out any of the activities mentioned in points (a) and (b)
p.000030: of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in
p.000030: which they plan to make the device available of the intention to make the relabelled or repackaged
p.000030: device available and, upon request, shall provide the manufacturer and the competent authority with a sample
p.000030: or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
p.000030: Within the same period of 28 days, the distributor or importer shall submit to the competent authority
p.000030: a certificate, issued by a notified body designated for the type of devices that are subject to
p.000030: activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system
p.000030: of the distributer or importer complies with the requirements laid down in paragraph 3.
p.000030:
p.000030:
p.000030: Article 17
p.000030:
p.000030: Single-use devices and their reprocessing
p.000030:
p.000030: 1. Reprocessing and further use of single-use devices may only take place where permitted by
p.000030: national law and only in accordance with this Article.
p.000030:
p.000030: 2. Any natural or legal person who reprocesses a single-use device to make it suitable for further
p.000030: use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the
p.000030: obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to
p.000030: the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The
p.000030: reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive
p.000030: 85/374/EEC.
p.000030:
p.000030: 3. By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a
p.000030: health institution, Member States may decide not to apply all of the rules relating to manufacturers'
p.000030: obligations laid down in this Regulation provided that they ensure that:
p.000030:
p.000030: (a) the safety and performance of the reprocessed device is equivalent to that of the
p.000030: original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied
p.000030: with;
p.000030:
p.000030: (b) the reprocessing is performed in accordance with CS detailing the requirements concerning:
p.000030:
p.000030: — risk management, including the analysis of the construction and material, related properties of the
p.000030: device (reverse engineering) and procedures to detect changes in the design of the original device as
p.000030: well as of its planned application after reprocessing,
p.000030:
p.000030: — the validation of procedures for the entire process, including cleaning steps,
p.000030:
p.000030: — the product release and performance testing,
p.000030:
p.000030: — the quality management system,
p.000030:
p.000030: — the reporting of incidents involving devices that have been reprocessed, and
p.000030:
p.000030: — the traceability of reprocessed devices.
p.000030:
p.000030: Member States shall encourage, and may require, health institutions to provide information to patients on
p.000030: the use of reprocessed devices within the health institution and, where appropriate, any other
p.000030: relevant information on the reprocessed devices that patients are treated with.
p.000030:
p.000030: 5.5.2017 EN
p.000030: Official Journal of the European Union
p.000031: L 117/31
p.000031:
p.000031: Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant
p.000031: to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
p.000031:
p.000031: 4. Member States may choose to apply the provisions referred to in paragraph 3 also as regards
p.000031: single-use devices that are reprocessed by an external reprocessor at the request of a health
p.000031: institution, provided that the reprocessed device in its entirety is returned to that health institution
p.000031: and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.
p.000031:
p.000031: 5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in
p.000031: point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific
p.000031: evidence and shall address the application of the general requirements on safety and performance laid
p.000031: down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be
p.000031: performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined
p.000031: in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and
p.000031: national provisions, shall be certified by a notified body.
p.000031:
p.000031: 6. Only single-use devices that have been placed on the market in accordance with this Regulation,
...
p.000031:
p.000031: Member States shall notify the Commission and the other Member States of those national provisions. The Commission
p.000031: shall make such information publicly available.
p.000031:
p.000031: 10. The Commission shall by 27 May 2024 draw up a report on the operation of this Article and
p.000031: submit it to the European Parliament and to the Council. On the basis of that report, the Commission
p.000031: shall, if appropriate, make proposals for amendments to this Regulation.
p.000031:
p.000031:
p.000031: Article 18
p.000031:
p.000031: Implant card and information to be supplied to the patient with an implanted device
p.000031:
p.000031: 1. The manufacturer of an implantable device shall provide together with the device the following:
p.000031:
p.000031: (a) information allowing the identification of the device, including the device name, serial number, lot number, the
p.000031: UDI, the device model, as well as the name, address and the website of the manufacturer;
p.000031:
p.000031: (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with
p.000031: regard to reciprocal interference with reasonably foreseeable external influences, medical
p.000031: examinations or environmental conditions;
p.000031:
p.000031: (c) any information about the expected lifetime of the device and any necessary follow-up;
p.000031:
p.000031: (d) any other information to ensure safe use of the device by the patient, including the information
p.000031: in point (u) of Section 23.4 of Annex I.
p.000031:
p.000032: L 117/32 EN
p.000032: Official Journal of the European Union
p.000032: 5.5.2017
p.000032:
p.000032: The information referred to in the first subparagraph shall be provided, for the purpose of making it
p.000032: available to the particular patient who has been implanted with the device, by any means that allow
p.000032: rapid access to that information and shall be stated in the language(s) determined by the concerned
p.000032: Member State. The information shall be written in a way that is readily understood by a lay person and
p.000032: shall be updated where appropriate. Updates of the information shall be made available to the patient via the
p.000032: website mentioned in point (a) of the first subparagraph.
p.000032:
p.000032: In addition, the manufacturer shall provide the information referred to in point (a) of the first
p.000032: subparagraph on an implant card delivered with the device.
p.000032:
p.000032: 2. Member States shall require health institutions to make the information referred to in paragraph
p.000032: 1 available, by any means that allow rapid access to that information, to any patients who have been
p.000032: implanted with the device, together with the implant card, which shall bear their identity.
p.000032:
p.000032: 3. The following implants shall be exempted from the obligations laid down in this Article:
p.000032: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips
p.000032: and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this
p.000032: list by adding other types of implants to it or by removing implants therefrom.
p.000032:
p.000032:
p.000032: Article 19
p.000032:
p.000032: EU declaration of conformity
p.000032:
p.000032: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation
p.000032: have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update
p.000032: the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the
p.000032: information set out in Annex IV and shall be translated into an official Union language or languages
p.000032: required by the Member State(s) in which the device is made available.
p.000032:
p.000032: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000032: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000032: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be
p.000032: drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the
p.000032: information required for identification of the Union legislation to which the declaration relates.
p.000032:
p.000032: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000032: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000032:
p.000032: 4. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the
p.000032: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000032:
p.000032:
p.000032: Article 20
p.000032:
p.000032: CE marking of conformity
p.000032:
p.000032: 1. Devices, other than custom-made or investigational devices, considered to be in conformity with the
p.000032: requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000032:
p.000032: 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No
p.000032: 765/2008.
p.000032:
p.000032: 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile
p.000032: packaging. Where such affixing is not possible or not warranted on account of the nature of the device,
p.000032: the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use
p.000032: and on any sales packaging.
p.000032:
p.000032: 4. The CE marking shall be affixed before the device is placed on the market. It may be followed
p.000032: by a pictogram or any other mark indicating a special risk or use.
p.000032:
p.000032: 5. Where applicable, the CE marking shall be followed by the identification number of the notified
p.000032: body responsible for the conformity assessment procedures set out in Article 52. The identification number
p.000032: shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE
p.000032: marking.
p.000032:
p.000032: 6. Where devices are subject to other Union legislation which also provides for the affixing of
p.000032: the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other
p.000032: legislation.
p.000032:
p.000032: 5.5.2017 EN
p.000032: Official Journal of the European Union
p.000033: L 117/33
p.000033:
p.000033: Article 21
p.000033:
p.000033: Devices for special purposes
p.000033:
p.000033: 1. Member States shall not create obstacles to:
p.000033: (a) investigational devices being supplied to an investigator for the purpose of a clinical
p.000033: investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the
p.000033: implementing acts adopted pursuant to Article 81 and in Annex XV;
p.000033: (b) custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.
p.000033: The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of
p.000033: the devices referred to in Article 74.
p.000033:
p.000033: 2. Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall
p.000033: be made available to the particular patient or user identified by name, an acronym or a numerical code.
p.000033:
p.000033: Member States may require that the manufacturer of a custom-made device submit to the competent
p.000033: authority a list of such devices which have been made available in their territory.
p.000033:
p.000033: 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create
p.000033: obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly
p.000033: indicates that such devices are intended for presentation or demonstration purposes only and cannot be made
p.000033: available until they have been brought into compliance with this Regulation.
p.000033:
p.000033:
p.000033: Article 22
p.000033:
p.000033: Systems and procedure packs
p.000033:
...
p.000033: put together;
p.000033: (c) the activity of combining devices and, if applicable, other products as a system or procedure pack
p.000033: was subject to appropriate methods of internal monitoring, verification and validation.
p.000033: 3. Any natural or legal person who sterilises systems or procedure packs referred to in paragraph
p.000033: 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures
p.000033: set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those
p.000033: procedures and the involvement of the notified body shall be limited to the aspects of the procedure
p.000033: relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person
p.000033: shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's
p.000033: instructions.
p.000033:
p.000033: 4. Where the system or procedure pack incorporates devices which do not bear the CE marking or where the
p.000033: chosen combination of devices is not compatible in view of their original intended purpose, or where the
p.000033: sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or
p.000033: procedure pack shall be treated as a device in its own right and shall be subject to the relevant
p.000033: conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations
p.000033: incumbent on manufacturers.
p.000033:
p.000034: L 117/34 EN
p.000034: Official Journal of the European Union
p.000034: 5.5.2017
p.000034:
p.000034: 5. The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves
p.000034: bear an additional CE marking but they shall bear the name, registered trade name or registered trade
p.000034: mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which
p.000034: that person can be contacted, so that the person's location can be established. Systems or procedure
p.000034: packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement
p.000034: referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities,
p.000034: after the system or procedure pack has been put together, for the period that is applicable under Article
p.000034: 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply.
p.000034:
p.000034:
p.000034: Article 23
p.000034:
p.000034: Parts and components
p.000034:
p.000034: 1. Any natural or legal person who makes available on the market an item specifically intended to
p.000034: replace an identical or similar integral part or component of a device that is defective or worn in
p.000034: order to maintain or restore the function of the device without changing its performance or safety
p.000034: characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety
p.000034: and performance of the device. Supporting evidence shall be kept available for the competent authorities of
p.000034: the Member States.
p.000034:
p.000034: 2. An item that is intended specifically to replace a part or component of a device and that
...
p.000034:
p.000034: CHAPTER III
p.000034:
p.000034: IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF
p.000034: SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
p.000034:
p.000034: Article 25
p.000034:
p.000034: Identification within the supply chain
p.000034:
p.000034: 1. Distributors and importers shall co-operate with manufacturers or authorised representatives
p.000034: to achieve an appropriate level of traceability of devices.
p.000034:
p.000034: 2. Economic operators shall be able to identify the following to the competent authority, for the period
p.000034: referred to in Article 10(8):
p.000034: (a) any economic operator to whom they have directly supplied a device;
p.000034: (b) any economic operator who has directly supplied them with a device;
p.000034: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000034:
p.000034: Article 26
p.000034:
p.000034: Medical devices nomenclature
p.000034:
p.000034: To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in
p.000034: Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is
p.000034: available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
p.000034: that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other
p.000034: stakeholders free of charge, where reasonably practicable.
p.000034:
p.000034: 5.5.2017 EN
p.000034: Official Journal of the European Union
p.000035: L 117/35
p.000035:
p.000035: Article 27
p.000035:
p.000035: Unique Device Identification system
p.000035:
p.000035: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000035: allow the identifi cation and facilitate the traceability of devices, other than custom-made and
p.000035: investigational devices, and shall consist of the following:
p.000035: (a) production of a UDI that comprises the following:
p.000035: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
p.000035: the information laid down in Part B of Annex VI;
p.000035: (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable
p.000035: the packaged devices, as specified in Part C of Annex VI;
p.000035: (b) placing of the UDI on the label of the device or on its packaging;
p.000035: (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in
p.000035: accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
p.000035: (d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in
p.000035: accordance with Article 28.
p.000035: 2. The Commission shall, by means of implementing acts, designate one or several entities to
p.000035: operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or
p.000035: those entities shall satisfy all of the following criteria:
p.000035: (a) the entity is an organisation with legal personality;
...
p.000035: with a view to minimising financial and administrative burdens for economic operators and health institutions.
p.000035:
p.000035: 3. Before placing a device, other than a custom-made device, on the market, the manufacturer shall
p.000035: assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance
p.000035: with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
p.000035:
p.000035: Before a device, other than a custom-made or investigational device, is placed on the market the
p.000035: manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in
p.000035: question are correctly submitted and transferred to the UDI database referred to in Article 28.
p.000035:
p.000035: 4. UDI carriers shall be placed on the label of the device and on all higher levels of
p.000035: packaging. Higher levels of packaging shall not be understood to include shipping containers.
p.000035:
p.000035: 5. The UDI shall be used for reporting serious incidents and field safety corrective actions in
p.000035: accordance with Article 87.
p.000035:
p.000035: 6. The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of
p.000035: conformity referred to in Article 19.
p.000035:
p.000035: 7. As part of the technical documentation referred to in Annex II, the manufacturer shall keep
p.000035: up-to-date a list of all UDIs that it has assigned.
p.000035:
p.000036: L 117/36 EN
p.000036: Official Journal of the European Union
p.000036: 5.5.2017
p.000036:
p.000036: 8. Economic operators shall store and keep, preferably by electronic means, the UDI of the devices
p.000036: which they have supplied or with which they have been supplied, if those devices belong to:
p.000036: — class III implantable devices;
p.000036: — the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
p.000036: 9. Health institutions shall store and keep preferably by electronic means the UDI of the devices
p.000036: which they have supplied or with which they have been supplied, if those devices belong to class III implantable
p.000036: devices.
p.000036:
p.000036: For devices other than class III implantable devices, Member States shall encourage, and may require,
p.000036: health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have
p.000036: been supplied.
p.000036:
p.000036: Member States shall encourage, and may require, healthcare professionals to store and keep preferably by
p.000036: electronic means, the UDI of the devices with which they have been supplied with.
p.000036:
p.000036: 10. The Commission is empowered to adopt delegated acts in accordance with Article 115:
p.000036: (a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and
p.000036: (b) amending Annex VI in the light of international developments and technical progress in the field of
p.000036: Unique Device Identification.
p.000036: 11. The Commission may, by means of implementing acts, specify the detailed arrangements and the
p.000036: procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the
p.000036: following:
...
p.000036: (c) the cost-effectiveness of the measures;
p.000036: (d) the convergence of UDI systems developed at international level;
p.000036: (e) the need to avoid duplications in the UDI system;
p.000036: (f) the needs of the healthcare systems of the Member States, and where possible, compatibility with
p.000036: other medical device identification systems that are used by stakeholders.
p.000036:
p.000036: Article 28
p.000036:
p.000036: UDI database
p.000036:
p.000036: 1. The Commission, after consulting the MDCG shall set up and manage a UDI database to validate,
p.000036: collate, process and make available to the public the information mentioned in Part B of Annex VI.
p.000036:
p.000036: 2. When designing the UDI database, the Commission shall take into account the general principles
p.000036: set out in Section 5 of Part C of Annex VI. The UDI database shall be designed in particular such
p.000036: that no UDI-PIs and no commercially confidential product information can be included therein.
p.000036:
p.000036: 3. The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be
p.000036: accessible to the public free of charge.
p.000036:
p.000036: 4. The technical design of the UDI database shall ensure maximum accessibility to information
p.000036: stored therein, including multi-user access and automatic uploads and downloads of that information. The
p.000036: Commission shall provide for technical and administrative support to manufacturers and other users of the UDI
p.000036: database.
p.000036:
p.000036: 5.5.2017 EN
p.000036: Official Journal of the European Union
p.000037: L 117/37
p.000037:
p.000037: Article 29
p.000037:
p.000037: Registration of devices
p.000037:
p.000037: 1. Before placing a device, other than a custom-made device, on the market, the manufacturer shall,
p.000037: in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in
p.000037: Part C of Annex VI to the device and shall provide it to the UDI database together with the other core
p.000037: data elements referred to in Part B of Annex VI related to that device.
p.000037:
p.000037: 2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3),
p.000037: that is not a custom- made device, the natural or legal person responsible shall assign to the system
p.000037: or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to
p.000037: the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system
p.000037: or procedure pack.
p.000037:
p.000037: 3. For devices that are the subject of a conformity assessment as referred to in Article 52(3)
p.000037: and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in
p.000037: paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
p.000037:
p.000037: For the devices referred to in the first subparagraph, the notified body shall include a reference to
p.000037: the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of
p.000037: Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex
...
p.000037: referred to in paragraph 1.
p.000037:
p.000037: Where applicable, importers shall inform the relevant authorised representative or manufacturer if the
p.000037: information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the
p.000037: relevant entry/entries.
p.000037:
p.000037:
p.000037: Article 31
p.000037:
p.000037: Registration of manufacturers, authorised representatives and importers
p.000037:
p.000037: 1. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised
p.000037: representatives and importers shall, in order to register, submit to the electronic system referred to in
p.000037: Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have
p.000037: not already registered in accordance with this Article. In cases where the conformity assessment procedure
p.000037: requires the involvement of a notified body pursuant to Article 52, the information referred to in
p.000037: Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000037: notified body.
p.000037:
p.000037: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000037: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and
p.000037: issue it to the manufacturer, the authorised representative or the importer.
p.000037:
p.000038: L 117/38 EN
p.000038: Official Journal of the European Union
p.000038: 5.5.2017
p.000038:
p.000038: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for
p.000038: accessing Eudamed in order to fulfil its obligations under Article 29.
p.000038:
p.000038: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000038: Article, the economic operator shall update the data in the electronic system referred to in Article 30.
p.000038:
p.000038: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000038: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the
p.000038: event of a failure to do so within six months of those deadlines, any Member State may take appropriate
p.000038: corrective measures within its territory until that economic operator complies with that obligation.
p.000038:
p.000038: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority
p.000038: shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000038:
p.000038: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in
p.000038: Article 30 shall be accessible to the public.
p.000038:
p.000038: 8. The competent authority may use the data to charge the manufacturer, the authorised
p.000038: representative or the importer a fee pursuant to Article 111.
p.000038:
p.000038: Article 32
p.000038:
p.000038: Summary of safety and clinical performance
p.000038:
...
p.000038: (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a
p.000038: description of the differences, as well as, where relevant, a description of any accessories, other devices and
p.000038: products, which are intended to be used in combination with the device;
p.000038: (d) possible diagnostic or therapeutic alternatives;
p.000038: (e) reference to any harmonised standards and CS applied;
p.000038: (f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on
p.000038: post-market clinical follow-up;
p.000038: (g) suggested profile and training for users;
p.000038: (h) information on any residual risks and any undesirable effects, warnings and precautions.
p.000038: 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data
p.000038: elements to be included in the summary of safety and clinical performance. Those implementing acts shall
p.000038: be adopted in accordance with the advisory procedure referred to in Article 114(2).
p.000038:
p.000038: Article 33
p.000038:
p.000038: European database on medical devices
p.000038:
p.000038: 1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European
p.000038: database on medical devices (‘Eudamed’) for the following purposes:
p.000038: (a) to enable the public to be adequately informed about devices placed on the market, the
p.000038: corresponding certificates issued by notified bodies and about the relevant economic operators;
p.000038:
p.000038: 5.5.2017 EN
p.000038: Official Journal of the European Union
p.000039: L 117/39
p.000039:
p.000039: (b) to enable unique identification of devices within the internal market and to facilitate their traceability;
p.000039:
p.000039: (c) to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical
p.000039: investi gations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to
p.000039: Article 81;
p.000039:
p.000039: (d) to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90
p.000039: or in any acts adopted pursuant to Article 91;
p.000039:
p.000039: (e) to enable the competent authorities of the Member States and the Commission to carry out their
p.000039: tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.
p.000039:
p.000039: 2. Eudamed shall include the following electronic systems:
p.000039:
p.000039: (a) the electronic system for registration of devices referred to in Article 29(4);
p.000039:
p.000039: (b) the UDI-database referred to in Article 28;
p.000039:
p.000039: (c) the electronic system on registration of economic operators referred to in Article 30;
p.000039:
p.000039: (d) the electronic system on notified bodies and on certificates referred to in Article 57;
p.000039:
p.000039: (e) the electronic system on clinical investigations referred to in Article 73;
p.000039:
p.000039: (f) the electronic system on vigilance and post-market surveillance referred to in Article 92;
p.000039:
p.000039: (g) the electronic system on market surveillance referred to in Article 100.
p.000039:
p.000039: 3. When designing Eudamed the Commission shall give due consideration to compatibility with national
p.000039: databases and national web-interfaces to allow for import and export of data.
...
p.000039: Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data
p.000039: subjects may effectively exercise the right of access to data relating to them, and the right to have
p.000039: inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission
p.000039: and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in
p.000039: accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as
p.000039: possible, but no later than 60 days after a request is made by a data subject.
p.000039:
p.000039: 8. The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary
p.000039: for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the
p.000039: examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission
p.000039: shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same
p.000039: information twice within the same module or in different modules of the system.
p.000039:
p.000039: 9. In relation to its responsibilities under this Article and the processing of personal data
p.000039: involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
p.000039:
p.000040: L 117/40 EN
p.000040: Official Journal of the European Union
p.000040: 5.5.2017
p.000040:
p.000040: Article 34
p.000040:
p.000040: Functionality of Eudamed
p.000040:
p.000040: 1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for
p.000040: Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May
p.000040: 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the
p.000040: Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that
p.000040: all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation
p.000040: (EU) 2017/746 are met.
p.000040:
p.000040: 2. The Commission shall, on the basis of an independent audit report, inform the MDCG when it has
p.000040: verified that Eudamed has achieved full functionality and Eudamed meets the functional
p.000040: specifications drawn up pursuant to paragraph 1.
p.000040:
p.000040: 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred
p.000040: to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
p.000040:
p.000040:
p.000040: CHAPTER IV
p.000040:
p.000040: NOTIFIED BODIES
p.000040:
p.000040: Article 35
p.000040:
p.000040: Authorities responsible for notified bodies
p.000040:
p.000040: 1. Any Member State that intends to designate a conformity assessment body as a notified body, or
p.000040: has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an
p.000040: authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities
p.000040: under national law and shall be responsible for setting up and carrying out the necessary procedures for
p.000040: the assessment, designation and notification of conformity assessment bodies and for the monitoring of
p.000040: notified bodies, including subcontractors and subsidiaries of those bodies.
p.000040:
p.000040: 2. The authority responsible for notified bodies shall be established, organised and operated so as
p.000040: to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with
p.000040: conformity assessment bodies.
p.000040:
p.000040: 3. The authority responsible for notified bodies shall be organised in a manner such that each
p.000040: decision relating to designation or notification is taken by personnel different from those who carried out the
p.000040: assessment.
p.000040:
p.000040: 4. The authority responsible for notified bodies shall not perform any activities that notified
...
p.000040: information it obtains. However, it shall exchange information on notified bodies with other Member States,
p.000040: the Commission and, when required, with other regulatory authorities.
p.000040:
p.000040: 6. The authority responsible for notified bodies shall have a sufficient number of competent
p.000040: personnel permanently available for the proper performance of its tasks.
p.000040:
p.000040: Where the authority responsible for notified bodies is a different authority from the national competent
p.000040: authority for medical devices, it shall ensure that the national authority responsible for medical devices
p.000040: is consulted on relevant matters.
p.000040:
p.000040: 7. Member States shall make publicly available general information on their measures governing the
p.000040: assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies,
p.000040: and on changes which have a significant impact on such tasks.
p.000040:
p.000040: 8. The authority responsible for notified bodies shall participate in the peer-review
p.000040: activities provided for in Article 48.
p.000040:
p.000040: 5.5.2017 EN
p.000040: Official Journal of the European Union
p.000041: L 117/41
p.000041:
p.000041: Article 36
p.000041:
p.000041: Requirements relating to notified bodies
p.000041:
p.000041: 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this
p.000041: Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and
p.000041: process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex
p.000041: VII.
p.000041:
p.000041: In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent
p.000041: availability of sufficient administrative, technical and scientific personnel in accordance with Section
p.000041: 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of
p.000041: Annex VII, where possible employed by the notified body itself.
p.000041:
p.000041: The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified
p.000041: body itself and shall not be external experts or subcontractors.
p.000041:
p.000041: 2. Notified bodies shall make available and submit upon request all relevant documentation, including
p.000041: the manufac turer's documentation, to the authority responsible for notified bodies to allow it to conduct its
p.000041: assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined
p.000041: in this Chapter.
p.000041:
p.000041: 3. In order to ensure the uniform application of the requirements set out in Annex VII, the
p.000041: Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent
...
p.000041: Article 38
p.000041:
p.000041: Application by conformity assessment bodies for designation
p.000041:
p.000041: 1. Conformity assessment bodies shall submit an application for designation to the authority
p.000041: responsible for notified bodies.
p.000041:
p.000041: 2. The application shall specify the conformity assessment activities as defined in this Regulation,
p.000041: and the types of devices for which the body is applying to be designated, and shall be supported by
p.000041: documentation demonstrating compliance with Annex VII.
p.000041:
p.000041: In respect of the organisational and general requirements and the quality management
p.000041: requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the
p.000041: corresponding evaluation report delivered by a national accreditation body in accordance with Regulation
p.000041: (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described
p.000041: in Article 39. However, the applicant shall make available all the documentation referred to in the first
p.000041: subparagraph to demonstrate compliance with those requirements upon request.
p.000041:
p.000041: 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant
p.000041: changes occur, in order to enable the authority responsible for notified bodies to monitor and verify
p.000041: continuous compliance with all the requirements set out in Annex VII.
p.000041:
p.000042: L 117/42 EN
p.000042: Official Journal of the European Union
p.000042: 5.5.2017
p.000042:
p.000042: Article 39
p.000042:
p.000042: Assessment of the application
p.000042:
p.000042: 1. The authority responsible for notified bodies shall within 30 days check that the application
p.000042: referred to in Article 38 is complete and shall request the applicant to provide any missing
p.000042: information. Once the application is complete that authority shall send it to the Commission.
p.000042:
p.000042: The authority responsible for notified bodies shall review the application and supporting documentation in
p.000042: accordance with its own procedures and shall draw up a preliminary assessment report.
p.000042:
p.000042: 2. The authority responsible for notified bodies shall submit the preliminary assessment report to
p.000042: the Commission which shall immediately transmit it to the MDCG.
p.000042:
p.000042: 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in
p.000042: conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the
p.000042: specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One
p.000042: of the experts shall be a representa tive of the Commission who shall coordinate the activities of the
p.000042: joint assessment team. The other two experts shall come from Member States other than the one in which the
p.000042: applicant conformity assessment body is established.
p.000042:
p.000042: The joint assessment team shall be comprised of experts who are competent to assess the conformity
p.000042: assessment activities and the types of devices which are the subject of the application or, in
p.000042: particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific
p.000042: concern can be appropriately assessed.
p.000042:
p.000042: 4. Within 90 days of its appointment, the joint assessment team shall review the documentation
p.000042: submitted with the application in accordance with Article 38. The joint assessment team may provide
p.000042: feedback to, or require clarification from, the authority responsible for notified bodies on the application and on
p.000042: the planned on-site assessment.
p.000042:
p.000042: The authority responsible for notified bodies together with the joint assessment team shall plan and
p.000042: conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or
p.000042: subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.
p.000042:
p.000042: The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
p.000042:
p.000042: 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements
p.000042: set out in Annex VII shall be raised during the assessment process and discussed between the authority
p.000042: responsible for notified bodies and the joint assessment team with a view to reaching consensus and
p.000042: resolving any diverging opinions, with respect to the assessment of the application.
p.000042:
p.000042: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the
p.000042: applicant conformity assessment body the non-compliances resulting from the assessment and summarise
p.000042: the assessment by the joint assessment team.
p.000042:
p.000042: Within a specified timeframe, the applicant conformity assessment body shall submit to the
p.000042: national authority a corrective and preventive action plan to address the non-compliances.
p.000042:
p.000042: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment
p.000042: within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000042:
p.000042: 7. The authority responsible for notified bodies shall following receipt of a corrective and preventive action
p.000042: plan from the applicant body assess whether non-compliances identified during the assessment have been
p.000042: appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and
p.000042: shall include a timeframe for implemen tation of the actions therein.
p.000042:
p.000042: The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward
p.000042: it and its opinion thereon to the joint assessment team. The joint assessment team may
p.000042: request of the authority responsible for notified bodies further clarification and modifications.
p.000042:
p.000042: 5.5.2017 EN
p.000042: Official Journal of the European Union
p.000043: L 117/43
p.000043:
p.000043: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000043: — the result of the assessment,
p.000043: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000043: required, implemented,
p.000043: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000043: — the recommended scope of designation.
p.000043: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000043: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000043:
p.000043: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared
p.000043: by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days
p.000043: of receipt of those documents to the Commission, which shall immediately submit that final opinion to
p.000043: the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue
p.000043: a recommendation with regard to the draft designation, which the authority responsible for notified bodies
...
p.000043: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000043: accordance with the examination procedure referred to in Article 114(3).
p.000043:
p.000043: Article 40
p.000043:
p.000043: Nomination of experts for joint assessment of applications for notification
p.000043:
p.000043: 1. The Member States and the Commission shall nominate experts qualified in the
p.000043: assessment of conformity assessment bodies in the field of medical devices to participate in the activities
p.000043: referred to in Articles 39 and 48.
p.000043:
p.000043: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this
p.000043: Article, together with information on their specific field of competence and expertise. That list shall
p.000043: be made available to Member States competent authorities through the electronic system referred to in Article 57.
p.000043:
p.000043: Article 41
p.000043:
p.000043: Language requirements
p.000043:
p.000043: All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages
p.000043: which shall be determined by the Member State concerned.
p.000043:
p.000043: Member States, in applying the first paragraph, shall consider accepting and using a commonly understood
p.000043: language in the medical field, for all or part of the documentation concerned.
p.000043:
p.000043: The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts
p.000043: thereof into an official Union language, such as is necessary for that documentation to be readily understood by the
p.000043: joint assessment team appointed in accordance with Article 39(3).
p.000043:
p.000043: Article 42
p.000043:
p.000043: Designation and notification procedure
p.000043:
p.000043: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to
p.000043: Article 39 was completed and which comply with Annex VII.
p.000043:
p.000043: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000043: have designated, using the electronic notification tool within the database of notified bodies developed
p.000043: and managed by the Commission (NANDO).
p.000043:
p.000043: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this
p.000043: Article, the scope of the designation indicating the conformity assessment activities as defined in this
p.000043: Regulation and the types of devices which the notified body is authorised to assess and, without
p.000043: prejudice to Article 44, any conditions associated with the designation.
p.000043:
p.000044: L 117/44 EN
p.000044: Official Journal of the European Union
p.000044: 5.5.2017
p.000044:
p.000044: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000044: for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and
p.000044: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of
p.000044: the MDCG, it shall provide a duly substantiated justification.
p.000044:
p.000044: 5. The notifying Member State shall, without prejudice to Article 44, inform the
p.000044: Commission and the other Member States of any conditions associated with the designation and provide
p.000044: documentary evidence regarding the arrangements in place to ensure that the notified body will be
p.000044: monitored regularly and will continue to satisfy the requirements set out in Annex VII.
p.000044:
p.000044: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the
p.000044: Commission may raise written objections, setting out its arguments, with regard either to the notified
p.000044: body or to its monitoring by the authority responsible for notified bodies. Where no objection is
p.000044: raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as
p.000044: referred to in paragraph 2.
p.000044:
p.000044: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
...
p.000044: the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and
p.000044: 8 of this Article.
p.000044:
p.000044: 11. The designation shall become valid the day after the notification is published in
p.000044: NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified
p.000044: body.
p.000044:
p.000044: 12. The conformity assessment body concerned may perform the activities of a notified
p.000044: body only after the designation has become valid in accordance with paragraph 11.
p.000044:
p.000044: 13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000044: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000044: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000044: referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list
p.000044: based, inter alia, on information arising from the coordination activities described in Article 48.
p.000044:
p.000044:
p.000044: Article 43
p.000044:
p.000044: Identification number and list of notified bodies
p.000044:
p.000044: 1. The Commission shall assign an identification number to each notified body for which the
p.000044: notification becomes valid in accordance with Article 42(11). It shall assign a single identification
p.000044: number even when the body is notified under several Union acts. If they are successfully designated in
p.000044: accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain
p.000044: the identification number assigned to them pursuant to those Directives.
p.000044:
p.000044: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000044: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000044: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000044: It shall also make this list available on the electronic system referred to in Article 57. The Commission shall
p.000044: ensure that the list is kept up to date.
p.000044:
p.000044: 5.5.2017 EN
p.000044: Official Journal of the European Union
p.000045: L 117/45
p.000045:
p.000045: Article 44
p.000045:
p.000045: Monitoring and re-assessment of notified bodies
p.000045:
p.000045: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority
p.000045: responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out
p.000045: in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they
p.000045: have been designated.
p.000045:
p.000045: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on
p.000045: their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the
p.000045: requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall,
p.000045: upon request by their authority responsible for notified bodies, supply all relevant information and
p.000045: documents, required to enable the authority, the Commission and other Member States to verify compliance.
p.000045:
p.000045: 3. Where the Commission or the authority of a Member State submits a request to a notified body established on
p.000045: the territory of another Member State relating to a conformity assessment carried out by that notified
p.000045: body, it shall send a copy of that request to the authority responsible for notified bodies of that
...
p.000045: of the obligations by a notified body or its deviation from common or best practice.
p.000045:
p.000045: 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments
p.000045: conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify
p.000045: compliance.
p.000045:
p.000045: 8. The authority responsible for notified bodies shall review the assessments by notified bodies of
p.000045: manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in
p.000045: Article 45.
p.000045:
p.000045: 9. The authority responsible for notified bodies shall document and record any findings regarding
p.000045: non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely
p.000045: implementation of corrective and preventive actions.
p.000045:
p.000045: 10. Three years after notification of a notified body, and again every fourth year thereafter, a
p.000045: complete re-assessment to determine whether the notified body still satisfies the requirements set out in
p.000045: Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the
p.000045: body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 38
p.000045: and 39.
p.000045:
p.000046: L 117/46 EN
p.000046: Official Journal of the European Union
p.000046: 5.5.2017
p.000046:
p.000046: 11. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to
p.000046: amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be
p.000046: carried out.
p.000046:
p.000046: 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on
p.000046: their monitoring and on-site assessment activities regarding notified bodies and, where applicable,
p.000046: subsidiaries and subcontractors. The report shall provide details of the outcome of those activities,
p.000046: including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the
p.000046: Commission; however it shall contain a summary which shall be made publicly available.
p.000046:
p.000046: The summary of the report shall be uploaded to the electronic system referred to in Article 57.
p.000046:
p.000046:
p.000046: Article 45
p.000046:
p.000046: Review of notified body assessment of technical documentation and clinical evaluation documentation
p.000046:
p.000046: 1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified
p.000046: bodies, shall review an appropriate number of notified body assessments of manufacturers' technical
p.000046: documentation, in particular the clinical evaluation documentation as referred to in points (c) and (d) of
p.000046: Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information
...
p.000046: surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or
p.000046: on the identification of concerns and emerging issues concerning the safety and performance of devices,
p.000046: the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser
p.000046: proportion of the technical documentation and clinical evaluation documen tation assessed by a notified body.
p.000046:
p.000046: 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000046: arrangements, associated documents for, and coordination of, the review of assessments of technical
p.000046: documentation and clinical evaluation documentation, as referred to in this Article. Those implementing
p.000046: acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000046:
p.000046:
p.000046: Article 46
p.000046:
p.000046: Changes to designations and notifications
p.000046:
p.000046: 1. The authority responsible for notified bodies shall notify the Commission and the other Member
p.000046: States of any relevant changes to the designation of a notified body.
p.000046:
p.000046: The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
p.000046:
p.000046: For changes to the designation other than extensions of its scope, the procedures laid down in the following
p.000046: paragraphs shall apply.
p.000046:
p.000046: 5.5.2017 EN
p.000046: Official Journal of the European Union
p.000047: L 117/47
p.000047:
p.000047: 2. The Commission shall immediately publish the amended notification in NANDO. The
p.000047: Commission shall immediately enter information on the changes to the designation of the notified body in
p.000047: the electronic system referred to in Article 57.
p.000047:
p.000047: 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority
p.000047: responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned
p.000047: cessation one year before ceasing its activities. The certificates may remain valid for a temporary period
p.000047: of nine months after cessation of the notified body's activities on condition that another notified body
p.000047: has confirmed in writing that it will assume responsibilities for the devices covered by those
p.000047: certificates. The new notified body shall complete a full assessment of the devices affected by the end
p.000047: of that period before issuing new certificates for those devices. Where the notified body has ceased its
p.000047: activity, the authority responsible for notified bodies shall withdraw the designation.
p.000047:
p.000047: 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer
p.000047: meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has
...
p.000047: restriction, and the authority responsible for notified bodies has outlined a timeline and actions
p.000047: anticipated to remedy the suspension or restriction; or
p.000047:
p.000047: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000047: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000047: whether the notified body has the capability of continuing to monitor and remain responsible for existing
p.000047: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000047: responsible for notified bodies determines that the notified body does not have the capability to support
p.000047: existing certificates issued, the manufacturer shall provide, to the competent authority for medical
p.000047: devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000047: registered place of business, within three months of the suspension or restriction, a written confirmation
p.000047: that another qualified notified body is temporarily assuming the functions of the notified body to
p.000047: monitor and remain responsible for the certificates during the period of suspension or restriction.
p.000047:
p.000048: L 117/48 EN
p.000048: Official Journal of the European Union
p.000048: 5.5.2017
p.000048:
p.000048: 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates
p.000048: shall remain valid for a period of nine months in the following circumstances:
p.000048:
p.000048: (a) where the competent authority for medical devices of the Member State in which the manufacturer of
p.000048: the device covered by the certificate has its registered place of business has confirmed that there is
p.000048: no safety issue associated with the devices in question; and
p.000048:
p.000048: (b) another notified body has confirmed in writing that it will assume immediate responsibilities for
p.000048: those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.
p.000048:
p.000048: In the circumstances referred to in the first subparagraph, the competent authority for
p.000048: medical devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000048: place of business may extend the provisional validity of the certificates for further periods of
p.000048: three months, which altogether shall not exceed twelve months.
p.000048:
p.000048: The authority or the notified body assuming the functions of the notified body affected by the change
p.000048: of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
p.000048:
p.000048:
p.000048: Article 47
p.000048:
p.000048: Challenge to the competence of notified bodies
p.000048:
...
p.000048: plan described in Article 44(4).
p.000048:
p.000048: 4. Where the Commission ascertains that a notified body no longer meets the requirements for its
p.000048: designation, it shall inform the notifying Member State accordingly and request it to take the necessary
p.000048: corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.
p.000048:
p.000048: Where the Member State fails to take the necessary corrective measures, the Commission may,
p.000048: by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing
p.000048: acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It
p.000048: shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in
p.000048: Article 57.
p.000048:
p.000048: 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is
p.000048: treated accordingly.
p.000048:
p.000048:
p.000048: Article 48
p.000048:
p.000048: Peer review and exchange of experience between authorities responsible for notified bodies
p.000048:
p.000048: 1. The Commission shall provide for the organisation of exchange of experience and coordination of
p.000048: administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements
p.000048: including:
p.000048: (a) development of best practice documents relating to the activities of the authorities responsible for notified
p.000048: bodies;
p.000048:
p.000048: 5.5.2017 EN
p.000048: Official Journal of the European Union
p.000049: L 117/49
p.000049:
p.000049: (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation;
p.000049: (c) training and qualification of the experts referred to in Article 40;
p.000049: (d) monitoring of trends relating to changes to notified body designations and notifications and trends
p.000049: in certificate withdrawals and transfers between notified bodies;
p.000049: (e) monitoring of the application and applicability of scope codes referred to in Article 42(13);
p.000049: (f) development of a mechanism for peer reviews between authorities and the Commission;
p.000049: (g) methods of communication to the public on the monitoring and surveillance activities of authorities
p.000049: and the Commission on notified bodies.
p.000049: 2. The authorities responsible for notified bodies shall participate in a peer review every third
p.000049: year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be
p.000049: conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority
p.000049: may make the choice of having such reviews take place as part of its monitoring activities referred to in
p.000049: Article 44.
p.000049:
p.000049: 3. The Commission shall participate in the organisation and provide support to the implementation of
p.000049: the peer review mechanism.
p.000049:
p.000049: 4. The Commission shall compile an annual summary report of the peer review activities, which shall
p.000049: be made publicly available.
p.000049:
p.000049: 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed
...
p.000049: referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in
p.000049: accordance with the examination procedure referred to in Article 114(3).
p.000049:
p.000049:
p.000049: Article 49
p.000049:
p.000049: Coordination of notified bodies
p.000049:
p.000049: The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and
p.000049: operated in the form of a coordination group of notified bodies in the field of medical devices,
p.000049: including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually.
p.000049:
p.000049: The bodies notified under this Regulation shall participate in the work of that group.
p.000049:
p.000049: The Commission may establish the specific arrangements for the functioning of the coordination group of
p.000049: notified bodies.
p.000049:
p.000049:
p.000049: Article 50
p.000049:
p.000049: List of standard fees
p.000049:
p.000049: Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they
p.000049: carry out and shall make those lists publicly available.
p.000049:
p.000049: CHAPTER V
p.000049: CLASSIFICATION AND CONFORMITY ASSESSMENT
p.000049:
p.000049: SECTION 1
p.000049: Classification
p.000049:
p.000049: Article 51
p.000049:
p.000049: Classification of devices
p.000049:
p.000049: 1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended
p.000049: purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.
p.000049:
p.000050: L 117/50 EN
p.000050: Official Journal of the European Union
p.000050: 5.5.2017
p.000050:
p.000050: 2. Any dispute between the manufacturer and the notified body concerned, arising from the
p.000050: application of Annex VIII, shall be referred for a decision to the competent authority of the Member
p.000050: State in which the manufacturer has its registered place of business. In cases where the manufacturer has no
p.000050: registered place of business in the Union and has not yet designated an authorised representative, the matter
p.000050: shall be referred to the competent authority of the Member State in which the authorised
p.000050: representative referred to in the last indent of point (b) of the second paragraph of Section
p.000050: 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established
p.000050: in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after
p.000050: consultation with the competent authority of the Member State that designated the notified body.
p.000050:
p.000050: The competent authority of the Member State in which the manufacturer has its registered place of business shall
p.000050: notify the MDCG and the Commission of its decision. The decision shall be made available upon request.
p.000050:
p.000050: 3. At the request of a Member State the Commission shall after consulting the MDCG,
p.000050: decide, by means of implementing acts, on the following:
p.000050:
p.000050: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the
p.000050: classifi cation of such devices;
p.000050:
p.000050: (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific
p.000050: evidence, or based on any information which becomes available in the course of the vigilance and market
p.000050: surveillance activities be reclassified, by way of derogation from Annex VIII.
p.000050:
...
p.000050: 2. Prior to putting into service a device that is not placed on the market,
p.000050: manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable
p.000050: conformity assessment procedures set out in Annexes IX to XI.
p.000050:
p.000050: 3. Manufacturers of class III devices, other than custom-made or investigational devices,
p.000050: shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer
p.000050: may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as
p.000050: specified in Annex XI.
p.000050:
p.000050: 4. Manufacturers of class IIb devices, other than custom-made or investigational devices,
p.000050: shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and
p.000050: including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one
p.000050: representative device per generic device group.
p.000050:
p.000050: However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth
p.000050: crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as
p.000050: specified in Section 4 of Annex IX shall apply for every device.
p.000050:
p.000050: Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in
p.000050: Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
p.000050:
p.000050: 5.5.2017 EN
p.000050: Official Journal of the European Union
p.000051: L 117/51
p.000051:
p.000051: 5. Where justified in view of well-established technologies, similar to those used in the exempted devices
p.000051: listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable
p.000051: devices, or where justified in order to protect the health and safety of patients, users or other persons
p.000051: or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance
p.000051: with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or
p.000051: removing devices therefrom.
p.000051:
p.000051: 6. Manufacturers of class IIa devices, other than custom-made or investigational devices,
p.000051: shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and
p.000051: including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one
p.000051: representative device for each category of devices.
p.000051:
p.000051: Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II
p.000051: and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The
p.000051: assessment of the technical documentation shall apply for at least one representative device for each category of
p.000051: devices.
p.000051:
p.000051: 7. Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the
p.000051: conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after
...
p.000051: Annex XI.
p.000051:
p.000051: 9. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article,
p.000051: in the case of devices referred to in the first subparagraph of Article 1(8), the procedure specified
p.000051: in Section 5.2 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
p.000051:
p.000051: 10. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of
p.000051: devices that are covered by this Regulation in accordance with point (f) or (g) of Article 1(6) and with
p.000051: the first subparagraph of Article 1(10), the procedure specified in Section 5.3 of Annex IX or Section
p.000051: 6 of Annex X, as applicable, shall also apply.
p.000051:
p.000051: 11. In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of
p.000051: devices that are composed of substances or of combinations of substances that are intended to be
p.000051: introduced into the human body via a body orifice or applied to the skin and that are absorbed by or
p.000051: locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X,
p.000051: as applicable, shall also apply.
p.000051:
p.000051: 12. The Member State in which the notified body is established may require that all or certain
p.000051: documents, including the technical documentation, audit, assessment and inspection reports, relating
p.000051: to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official
p.000051: Union language(s) determined by that Member State. In the absence of such requirement, those documents
p.000051: shall be available in any official Union language acceptable to the notified body.
p.000051:
p.000051: 13. Investigational devices shall be subject to the requirements set out in Articles 62 to 81.
p.000051:
p.000052: L 117/52 EN
p.000052: Official Journal of the European Union
p.000052: 5.5.2017
p.000052:
p.000052: 14. The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with
p.000052: a view to ensuring the harmonised application of the conformity assessment procedures by the notified
p.000052: bodies for any of the following aspects:
p.000052:
p.000052: (a) the frequency and the sampling basis of the assessment of the technical documentation on a
p.000052: representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX
p.000052: in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa
p.000052: devices;
p.000052:
p.000052: (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified
p.000052: bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
p.000052:
p.000052: (c) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample
p.000052: tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and
p.000052: 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
p.000052:
p.000052: The implementing acts referred to in the first subparagraph shall be adopted in accordance with the
p.000052: examination procedure referred to in Article 114(3).
p.000052:
p.000052:
p.000052: Article 53
p.000052:
p.000052: Involvement of notified bodies in conformity assessment procedures
p.000052:
p.000052: 1. Where the conformity assessment procedure requires the involvement of a notified body, the
...
p.000052:
p.000052: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment
p.000052: activities with the highest degree of professional integrity and the requisite technical and scientific
p.000052: competence in the specific field and shall be free from all pressures and inducements, particularly
p.000052: financial, which might influence their judgement or the results of their conformity assessment activities,
p.000052: especially as regards persons or groups with an interest in the results of those activities.
p.000052:
p.000052:
p.000052: Article 54
p.000052:
p.000052: Clinical evaluation consultation procedure for certain class III and class IIb devices
p.000052:
p.000052: 1. In addition to the procedures applicable pursuant to Article 52, a notified body shall also
p.000052: follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX
p.000052: or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the
p.000052: following devices:
p.000052:
p.000052: (a) class III implantable devices, and
p.000052:
p.000052: (b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to
p.000052: in Section 6.4 of Annex VIII (Rule 12).
p.000052:
p.000052: 2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
p.000052:
p.000052: (a) in the case of renewal of a certificate issued under this Regulation;
p.000052:
p.000052: 5.5.2017 EN
p.000052: Official Journal of the European Union
p.000053: L 117/53
p.000053:
p.000053: (b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same
p.000053: intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body
p.000053: that the modifications do not adversely affect the benefit-risk ratio of the device; or
p.000053:
p.000053: (c) where the principles of the clinical evaluation of the device type or category have been addressed in a CS
p.000053: referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer
p.000053: for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
p.000053:
p.000053: 3. The notified body shall notify the competent authorities, the authority responsible for notified
p.000053: bodies and the Commission through the electronic system referred to in Article 57 of whether or not the
p.000053: procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by
p.000053: the clinical evaluation assessment report.
p.000053:
p.000053: 4. The Commission shall draw up an annual overview of devices which have been subject to the
p.000053: procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall
p.000053: include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and
p.000053: a listing of the cases where the notified body did not follow the advice from the expert panel. The
...
p.000053:
p.000053: 1. A notified body shall notify the competent authorities of certificates it has granted to devices
p.000053: for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall
p.000053: take place through the electronic system referred to in Article 57 and shall include the summary of safety and
p.000053: clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions
p.000053: for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the
p.000053: expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the
p.000053: case of divergent views between the notified body and the expert panels, a full justifi cation shall
p.000053: also be included.
p.000053:
p.000053: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns
p.000053: apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate
p.000053: measures in accordance with Articles 95 and 97.
p.000053:
p.000053: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request
p.000053: scientific advice from the expert panels in relation to the safety and performance of any device.
p.000053:
p.000053:
p.000053: Article 56
p.000053:
p.000053: Certificates of conformity
p.000053:
p.000053: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000053: Union language determined by the Member State in which the notified body is established or otherwise in
p.000053: an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set
p.000053: out in Annex XII.
p.000053:
p.000053: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On
p.000053: application by the manufacturer, the validity of the certificate may be extended for further periods, each not
p.000053: exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment
p.000053: procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is
p.000053: valid.
p.000053:
p.000053: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups
p.000053: of patients or require manufacturers to undertake specific PMCF studies pursuant to Part B of Annex XIV.
p.000053:
p.000054: L 117/54 EN
p.000054: Official Journal of the European Union
p.000054: 5.5.2017
p.000054:
p.000054: 4. Where a notified body finds that the requirements of this Regulation are no longer met by the
p.000054: manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the
p.000054: certificate issued or impose any restrictions on it unless compliance with such requirements is ensured
p.000054: by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the
p.000054: notified body. The notified body shall give the reasons for its decision.
p.000054:
p.000054: 5. The notified body shall enter in the electronic system referred to in Article 57
p.000054: any information regarding certificates issued, including amendments and supplements thereto, and regarding
p.000054: suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information
p.000054: shall be accessible to the public.
p.000054:
p.000054: 6. In the light of technical progress, the Commission is empowered to adopt delegated acts in
p.000054: accordance with Article 115 amending the minimum content of the certificates set out in Annex XII.
p.000054:
p.000054:
p.000054: Article 57
p.000054:
p.000054: Electronic system on notified bodies and on certificates of conformity
p.000054:
p.000054: 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to collate
p.000054: and process the following information:
p.000054: (a) the list of subsidiaries referred to in Article 37(3);
p.000054: (b) the list of experts referred to in Article 40(2);
p.000054: (c) the information relating to the notification referred to in Article 42(10) and the amended notifications
p.000054: referred to in Article 46(2);
...
p.000054: provided elsewhere in this regulation or in Regulation (EU) 2017/746 to the public.
p.000054:
p.000054:
p.000054: Article 58
p.000054:
p.000054: Voluntary change of notified body
p.000054:
p.000054: 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with
p.000054: another notified body in respect of the conformity assessment of the same device, the detailed
p.000054: arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the
p.000054: incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the
p.000054: following aspects:
p.000054: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000054: (b) the date until which the identification number of the outgoing notified body may be indicated in
p.000054: the information supplied by the manufacturer, including any promotional material;
p.000054: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000054: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000054: the incoming notified body;
p.000054: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000054: 2. The outgoing notified body shall withdraw the certificates it has issued for the device
p.000054: concerned on the date on which they become invalid.
p.000054:
p.000054: 5.5.2017 EN
p.000054: Official Journal of the European Union
p.000055: L 117/55
p.000055:
p.000055: Article 59
p.000055:
p.000055: Derogation from the conformity assessment procedures
p.000055:
p.000055: 1. By way of derogation from Article 52, any competent authority may authorise, on a duly
p.000055: justified request, the placing on the market or putting into service within the territory of the Member State
p.000055: concerned, of a specific device for which the procedures referred to in that Article have not been carried
p.000055: out but use of which is in the interest of public health or patient safety or health.
p.000055:
p.000055: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000055: authorise the placing on the market or putting into service of a device in accordance with paragraph 1
p.000055: where such authorisation is granted for use other than for a single patient.
p.000055:
p.000055: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional
p.000055: cases relating to public health or patient safety or health, may, by means of implementing acts, extend
p.000055: for a limited period of time the validity of an authorisation granted by a Member State in accordance with
p.000055: paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may
p.000055: be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the
p.000055: examination procedure referred to in Article 114(3).
p.000055:
p.000055: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000055: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
p.000055: Article 114(4).
p.000055:
p.000055:
p.000055: Article 60
p.000055:
p.000055: Certificate of free sale
p.000055:
p.000055: 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the
p.000055: Member State in which the manufacturer or the authorised representative has its registered place of
p.000055: business shall issue a certificate of free sale declaring that the manufacturer or the authorised
p.000055: representative, as applicable, has its registered place of business on its territory and that the device in
p.000055: question bearing the CE marking in accordance with this Regulation may be marketed in the Union. The certificate
p.000055: of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under
p.000055: Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of
p.000055: free sale shall set out the unique number identifying the certificate issued by the notified body, as
p.000055: referred to in Section 3 of Chapter II of Annex XII.
p.000055:
p.000055: 2. The Commission may, by means of implementing acts, establish a model for certificates of free
p.000055: sale, taking into account international practice as regards the use of certificates of free sale. Those
p.000055: implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
p.000055:
p.000055:
p.000055: CHAPTER VI
p.000055:
p.000055: CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
p.000055:
p.000055: Article 61
p.000055:
p.000055: Clinical evaluation
p.000055:
p.000055: 1. Confirmation of conformity with relevant general safety and performance requirements set out in
p.000055: Annex I under the normal conditions of the intended use of the device, and the evaluation of the
p.000055: undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1
p.000055: and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where
p.000055: applicable relevant data as referred to in Annex III.
p.000055:
p.000055: The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate
p.000055: conformity with the relevant general safety and performance requirements. That level of clinical evidence
p.000055: shall be appropriate in view of the characteristics of the device and its intended purpose.
p.000055:
p.000055: To that end, manufacturers shall plan, conduct and document a clinical evaluation in accordance with
p.000055: this Article and Part A of Annex XIV.
p.000055:
p.000056: L 117/56 EN
p.000056: Official Journal of the European Union
p.000056: 5.5.2017
p.000056:
p.000056: 2. For all class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the
p.000056: manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in
p.000056: Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy and
p.000056: proposals for clinical investigation. The manufacturer shall give due consideration to the views
p.000056: expressed by the expert panel. Such consideration shall be documented in the clinical evaluation report
p.000056: referred to in paragraph 12 of this Article.
p.000056:
p.000056: The manufacturer may not invoke any rights to the views expressed by the expert panel with regard to
p.000056: any future conformity assessment procedure.
p.000056:
p.000056: 3. A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
p.000056:
p.000056: (a) a critical evaluation of the relevant scientific literature currently available relating to the
p.000056: safety, performance, design characteristics and intended purpose of the device, where the following conditions are
p.000056: satisfied:
p.000056:
p.000056: — it is demonstrated that the device subject to clinical evaluation for the intended purpose is
p.000056: equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and
p.000056:
p.000056: — the data adequately demonstrate compliance with the relevant general safety and performance requirements;
p.000056:
p.000056: (b) a critical evaluation of the results of all available clinical investigations, taking duly into
...
p.000056: manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation
p.000056: provided that the following conditions are fulfilled in addition to what is required in that paragraph:
p.000056:
p.000056: — the two manufacturers have a contract in place that explicitly allows the manufacturer of the second
p.000056: device full access to the technical documentation on an ongoing basis, and
p.000056:
p.000056: — the original clinical evaluation has been performed in compliance with the requirements of this Regulation, and the
p.000056: manufacturer of the second device provides clear evidence thereof to the notified body.
p.000056: 6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to
p.000056: implantable devices and class III devices:
p.000056:
p.000056: (a) which have been lawfully placed on the market or put into service in accordance with Directive
p.000056: 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
p.000056:
p.000056: — is based on sufficient clinical data, and
p.000056:
p.000056: — is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of
p.000056: device, where such a CS is available; or
p.000056:
p.000056: (b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates,
p.000056: wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in
p.000056: compliance with the relevant product-specific CS, where such a CS is available.
p.000056:
p.000056: 5.5.2017 EN
p.000056: Official Journal of the European Union
p.000057: L 117/57
p.000057:
p.000057: 7. Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the
p.000057: clinical evaluation report by the manufacturer and in the clinical evaluation assessment report by the notified body.
p.000057:
p.000057: 8. Where justified in view of well-established technologies, similar to those used in the exempted
p.000057: devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in
p.000057: order to protect the health and safety of patients, users or other persons or other aspects of public
p.000057: health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to
p.000057: amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and
p.000057: in point (b) of paragraph 6 of this Article, by adding other types of implantable or class III devices
p.000057: to that list or removing devices therefrom.
p.000057:
p.000057: 9. In the case of the products without an intended medical purpose listed in Annex XVI, the
p.000057: requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV
p.000057: shall be understood as a requirement to demonstrate the performance of the device. Clinical evaluations
p.000057: of those products shall be based on relevant data concerning safety, including data from post-market
p.000057: surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be
p.000057: performed for those products unless reliance on existing clinical data from an analogous medical device is duly
...
p.000057: documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for
p.000057: custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device
p.000057: concerned.
p.000057:
p.000057: 13. Where necessary to ensure the uniform application of Annex XIV, the Commission may, having due
p.000057: regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of
p.000057: divergent interpret ation and of practical application. Those implementing acts shall be adopted in
p.000057: accordance with the examination procedure referred to in Article 114(3).
p.000057:
p.000057:
p.000057:
p.000057: Article 62
p.000057:
p.000057: General requirements regarding clinical investigations conducted to demonstrate conformity of devices
p.000057:
p.000057: 1. Clinical investigations shall be designed, authorised, conducted, recorded and reported in
p.000057: accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to
p.000057: Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment
p.000057: purposes, for one or more of the following purposes:
p.000057:
p.000057: (a) to establish and verify that, under normal conditions of use, a device is designed, manufactured
p.000057: and packaged in such a way that it is suitable for one or more of the specific purposes listed in
p.000057: point (1) of Article 2, and achieves the performance intended as specified by its manufacturer;
p.000057:
p.000058: L 117/58 EN
p.000058: Official Journal of the European Union
p.000058: 5.5.2017
p.000058:
p.000058: (b) to establish and verify the clinical benefits of a device as specified by its manufacturer;
p.000058:
p.000058: (c) to establish and verify the clinical safety of the device and to determine any undesirable
p.000058: side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable
p.000058: risks when weighed against the benefits to be achieved by the device.
p.000058:
p.000058: 2. Where the sponsor of a clinical investigation is not established in the Union, that sponsor
p.000058: shall ensure that a natural or legal person is established in the Union as its legal representative.
p.000058: Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations
p.000058: pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided
p.000058: for in this Regulation. Any communication with that legal representative shall be deemed to be a communication
p.000058: with the sponsor.
p.000058:
p.000058: Member States may choose not to apply the first subparagraph to clinical investigations to be conducted
p.000058: solely on their territory, or on their territory and the territory of a third country, provided that they ensure that
p.000058: the sponsor establishes at least a contact person on their territory in respect of that clinical
p.000058: investigation who shall be the addressee for all communications with the sponsor provided for in this
p.000058: Regulation.
p.000058:
p.000058: 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and
p.000058: well-being of the subjects participating in a clinical investigation are protected and prevail over all
p.000058: other interests and the clinical data generated are scientifically valid, reliable and robust.
p.000058:
p.000058: Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an
p.000058: ethics committee in accordance with national law. Member States shall ensure that the procedures for
p.000058: review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the
p.000058: application for auth orisation of a clinical investigation. At least one lay person shall participate in the ethical
p.000058: review.
p.000058:
p.000058: 4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the
p.000058: following conditions are met:
p.000058:
p.000058: (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical
p.000058: investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000058:
p.000058: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion
p.000058: in relation to the clinical investigation, which is valid for that entire Member State under its national law;
p.000058:
p.000058: (c) the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the
p.000058: Union;
p.000058:
p.000058: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
p.000058:
p.000058: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000058: inconveniences and compliance with this condition is constantly monitored;
p.000058:
p.000058: (f) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative has given informed consent in accordance with Article 63;
p.000058:
p.000058: (g) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative, has been provided with the contact details of an entity where further information can be
p.000058: received in case of need;
p.000058:
p.000058: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of
p.000058: the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000058:
p.000058: (i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any
p.000058: other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of
p.000058: distress are specifically defined in the clinical investigation plan and constantly monitored;
p.000058:
p.000058: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor
p.000058: or, where appropriate, a qualified dental practitioner or any other person entitled by national law to
p.000058: provide the relevant patient care under clinical investigation conditions;
p.000058:
p.000058: (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where
p.000058: applicable, on his or her legally designated representatives, to participate in the clinical investigation;
p.000058:
p.000058: 5.5.2017 EN
p.000058: Official Journal of the European Union
p.000059: L 117/59
p.000059:
p.000059: (l) the investigational device(s) in question conform(s) to the applicable general safety and
p.000059: performance requirements set out in Annex I apart from the aspects covered by the clinical investigation
p.000059: and that, with regard to those aspects, every precaution has been taken to protect the health and
p.000059: safety of the subjects. This includes, where appropriate, technical and biological safety testing and
p.000059: pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention,
p.000059: taking into consideration the state of the art;
p.000059:
p.000059: (m) the requirements of Annex XV are fulfilled.
p.000059:
p.000059: 5. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000059: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000059: clinical investi gation at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC,
p.000059: the withdrawal of the informed consent shall not affect the activities already carried out and the use of
p.000059: data obtained based on informed consent before its withdrawal.
p.000059:
p.000059: 6. The investigator shall be a person exercising a profession which is recognised in the Member
p.000059: State concerned as qualifying for the role of investigator on account of having the necessary scientific
...
p.000059: his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
p.000059:
p.000059: (a) enable the subject or his or her legally designated representative to understand:
p.000059:
p.000059: (i) the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
p.000059:
p.000059: (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her
p.000059: right to refuse to participate in and the right to withdraw from the clinical investigation at any time
p.000059: without any resulting detriment and without having to provide any justification;
p.000059:
p.000059: (iii) the conditions under which the clinical investigations is to be conducted, including the expected duration of
p.000059: the subject's participation in the clinical investigation; and
p.000059:
p.000059: (iv) the possible treatment alternatives, including the follow-up measures if the participation of the
p.000059: subject in the clinical investigation is discontinued;
p.000059:
p.000059: (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her
p.000059: legally designated representative;
p.000059:
p.000059: (c) be provided in a prior interview with a member of the investigating team who is appropriately
p.000059: qualified under national law;
p.000059:
p.000060: L 117/60 EN
p.000060: Official Journal of the European Union
p.000060: 5.5.2017
p.000060:
p.000060: (d) include information about the applicable damage compensation system referred to in Article 69; and
p.000060: (e) include the Union-wide unique single identification number of the clinical investigation referred to
p.000060: in Article 70(1) and information about the availability of the clinical investigation results in
p.000060: accordance with paragraph 6 of this Article.
p.000060: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to
p.000060: the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000060: representative.
p.000060:
p.000060: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
p.000060: information needs of specific patient populations and of individual subjects, as well as to the methods used to give
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
...
p.000060: clinical investigation at any time, is respected by the investigator;
p.000060: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000060: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000060: the clinical investigation;
p.000060:
p.000060: (e) the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
p.000061: representative except for compensation for expenses and loss of earnings directly related to the participation in the
p.000061: clinical investigation;
p.000061: (e) the clinical investigation is intended to investigate treatments for a medical condition that only
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
...
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
p.000061: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious
p.000061: medical condition, the subject is unable to provide prior informed consent and to receive prior
p.000061: information on the clinical investi gation;
p.000061:
p.000062: L 117/62 EN
p.000062: Official Journal of the European Union
p.000062: 5.5.2017
p.000062:
p.000062: (b) there are scientific grounds to expect that participation of the subject in the clinical
p.000062: investigation will have the potential to produce a direct clinically relevant benefit for the subject
p.000062: resulting in a measurable health-related improvement alleviating the suffering and/or improving the
p.000062: health of the subject, or in the diagnosis of its condition;
p.000062: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
p.000062: prior informed consent from his or her legally designated representative;
p.000062: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000062: clinical investigation previously expressed by the subject;
p.000062: (e) the clinical investigation relates directly to the subject's medical condition because of which it
p.000062: is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her
p.000062: legally designated rep resentative and to supply prior information, and the clinical investigation is of
p.000062: such a nature that it may be conducted exclusively in emergency situations;
p.000062: (f) the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison
p.000062: with the standard treatment of the subject's condition.
...
p.000062:
p.000062: 3. If the subject or, where applicable, his or her legally designated representative does not give
p.000062: consent, he or she shall be informed of the right to object to the use of data obtained from the clinical
p.000062: investigation.
p.000062:
p.000062:
p.000062: Article 69
p.000062:
p.000062: Damage compensation
p.000062:
p.000062: 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from
p.000062: par ticipation in a clinical investigation conducted on their territory are in place in the form of
p.000062: insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is
p.000062: appropriate to the nature and the extent of the risk.
p.000062:
p.000062: 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in
p.000062: the form appropriate for the Member State in which the clinical investigation is conducted.
p.000062:
p.000062:
p.000062: Article 70
p.000062:
p.000062: Application for clinical investigations
p.000062:
p.000062: 1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in
p.000062: which the clinical investigation is to be conducted (referred to for the purposes of this Article as
p.000062: ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.
p.000062:
p.000062: The application shall be submitted by means of the electronic system referred to in Article 73, which
p.000062: shall generate a Union-wide unique single identification number for the clinical investigation, which shall
p.000062: be used for all relevant communication in relation to that clinical investigation. Within 10 days of it receiving
p.000062: the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation
p.000062: falls within the scope of this Regulation and as to whether the application dossier is complete in accordance
p.000062: with Chapter II of Annex XV.
p.000062:
p.000062: 5.5.2017 EN
p.000062: Official Journal of the European Union
p.000063: L 117/63
p.000063:
p.000063: 2. Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex
p.000063: XV, the sponsor shall update the relevant data in the electronic system referred to in Article 73 and make that change
p.000063: to the documentation clearly identifiable. The Member State concerned shall be notified of the update by
p.000063: means of that electronic system.
p.000063:
p.000063: 3. Where the Member State concerned finds that the clinical investigation applied for does not fall
p.000063: within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor
p.000063: thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the
p.000063: application by means of the electronic system referred to in Article 73. The Member State concerned may extend
p.000063: this period by a maximum of 20 days where appropriate.
p.000063:
p.000063: Where the sponsor has not provided comments nor completed the application within the time limit referred
p.000063: to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers the
p.000063: application does fall under the scope of this Regulation and/or is complete but the Member State concerned
p.000063: does not, the application shall be considered to have been rejected. The Member State concerned shall
p.000063: provide for an appeal procedure in respect of such refusal.
p.000063:
p.000063: The Member State concerned shall notify the sponsor within five days of receipt of the comments or of
p.000063: the requested additional information, whether the clinical investigation is considered as falling within the scope of
...
p.000063: committee in the Member State concerned in respect of the clinical investigation. The Member State shall
p.000063: notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph
p.000063: 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
p.000063:
p.000063: 8. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in
p.000063: the light of technical progress and global regulatory developments, the requirements laid down in Chapter II of Annex
p.000063: XV.
p.000063:
p.000063: 9. In order to ensure the uniform application of the requirements laid down in Chapter II of
p.000063: Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of
p.000063: divergent interpretation and of practical application. Those implementing acts shall be adopted in
p.000063: accordance with the examination procedure referred to in Article 114(3).
p.000063:
p.000063:
p.000063: Article 71
p.000063:
p.000063: Assessment by Member States
p.000063:
p.000063: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do
p.000063: not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural
p.000063: or legal persons financing the clinical investigation, as well as free of any other undue influence.
p.000063:
p.000064: L 117/64 EN
p.000064: Official Journal of the European Union
p.000064: 5.5.2017
p.000064:
p.000064: 2. Member States shall ensure that the assessment is done jointly by an appropriate number of
p.000064: persons who collectively have the necessary qualifications and experience.
p.000064:
p.000064: 3. Member States shall assess whether the clinical investigation is designed in such a way that
p.000064: potential remaining risks to subjects or third persons, after risk minimization, are justified, when
p.000064: weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or
p.000064: harmonised standards, examine in particular:
p.000064:
p.000064: (a) the demonstration of compliance of the investigational device(s) with the applicable general safety
p.000064: and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard
p.000064: to those aspects, every precaution has been taken to protect the health and safety of the subjects. This
p.000064: includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;
p.000064:
p.000064: (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards
p.000064: and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation
p.000064: solutions provide a level of protection that is equivalent to that provided by harmonised standards;
p.000064:
...
p.000064: brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in
p.000064: particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the
p.000064: device on subjects or patients,
p.000064:
p.000064: (c) the requirements of Article 62 are not met, or
p.000064:
p.000064: (d) any assessment under paragraph 3 is negative.
p.000064:
p.000064: Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
p.000064:
p.000064:
p.000064: Article 72
p.000064:
p.000064: Conduct of a clinical investigation
p.000064:
p.000064: 1. The sponsor and the investigator shall ensure that the clinical investigation is conducted in
p.000064: accordance with the approved clinical investigation plan.
p.000064:
p.000064: 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported
p.000064: data are reliable and robust, and that the conduct of the clinical investigation is in compliance with
p.000064: the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a
p.000064: clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis
p.000064: of an assessment that takes into consideration all character istics of the clinical investigation including the
p.000064: following:
p.000064:
p.000064: (a) the objective and methodology of the clinical investigation; and
p.000064:
p.000064: (b) the degree of deviation of the intervention from normal clinical practice.
p.000064:
p.000064: 5.5.2017 EN
p.000064: Official Journal of the European Union
p.000065: L 117/65
p.000065:
p.000065: 3. All clinical investigation information shall be recorded, processed, handled, and stored
p.000065: by the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
p.000065: interpreted and verified while the confiden tiality of records and the personal data of the subjects
p.000065: remain protected in accordance with the applicable law on personal data protection.
p.000065:
p.000065: 4. Appropriate technical and organisational measures shall be implemented to protect information and
p.000065: personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction
p.000065: or accidental loss, in particular where the processing involves transmission over a network.
p.000065:
p.000065: 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that
p.000065: clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved
p.000065: investigation plan.
p.000065:
p.000065: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate
p.000065: identification and, where necessary, an immediate recall of the devices used in the investigation.
p.000065:
p.000065:
p.000065: Article 73
p.000065:
p.000065: Electronic system on clinical investigations
p.000065:
...
p.000065: shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for
p.000065: human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European
p.000065: Parliament and of the Council (1) as concerns combined clinical investigations of devices with a clinical trial
p.000065: under that Regulation.
p.000065:
p.000065: 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member
p.000065: States and the Commission. The information referred to in the other points of that paragraph shall be
p.000065: accessible to the public, unless, for all or parts of that information, confidentiality of the information is
p.000065: justified on any of the following grounds:
p.000065:
p.000065: (a) protection of personal data in accordance with Regulation (EC) No 45/2001;
p.000065:
p.000065: (b) protection of commercially confidential information, especially in the investigators brochure, in
p.000065: particular through taking into account the status of the conformity assessment for the device, unless
p.000065: there is an overriding public interest in disclosure;
p.000065:
p.000065: (c) effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.
p.000065:
p.000065: 4. No personal data of subjects shall be publicly available.
p.000065:
p.000065: 5. The user interface of the electronic system referred to in paragraph 1 shall be available in
p.000065: all official languages of the Union.
p.000065:
p.000065: (1) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on
p.000065: medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
p.000065:
p.000066: L 117/66 EN
p.000066: Official Journal of the European Union
p.000066: 5.5.2017
p.000066:
p.000066: Article 74
p.000066:
p.000066: Clinical investigations regarding devices bearing the CE marking
p.000066:
p.000066: 1. Where a clinical investigation is to be conducted to further assess, within the scope of its
p.000066: intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF
p.000066: investigation’), and where the investigation would involve submitting subjects to procedures
p.000066: additional to those performed under the normal conditions of use of the device and those additional
p.000066: procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days
p.000066: prior to its commencement by means of the electronic system referred to in Article 73. The sponsor
p.000066: shall include the documentation referred to in Chapter II of Annex XV as part of the
p.000066: notification. Points (b) to (k) and (m) of Article 62(4), Article 75, Article 76, Article 77, Article
p.000066: 80(5) and the relevant provisions of Annex XV shall apply to PMCF investigations.
p.000066:
p.000066: 2. Where a clinical investigation is to be conducted to assess, outside the scope of its intended
p.000066: purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply.
p.000066:
p.000066:
p.000066: Article 75
p.000066:
p.000066: Substantial modifications to clinical investigations
p.000066:
p.000066: 1. If a sponsor intends to introduce modifications to a clinical investigation that are likely to
p.000066: have a substantial impact on the safety, health or rights of the subjects or on the robustness or
...
p.000066:
p.000066: (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification
p.000066: to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
p.000066:
p.000066: 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further
p.000066: seven days, for the purpose of consulting with experts.
p.000066:
p.000066:
p.000066: Article 76
p.000066:
p.000066: Corrective measures to be taken by Member States and information exchange between Member States
p.000066:
p.000066: 1. Where a Member State in which a clinical investigation is being or is to be conducted has grounds for
p.000066: considering that the requirements set out in this Regulation are not met, it may take at least any of
p.000066: the following measures on its territory:
p.000066: (a) revoke the authorisation for the clinical investigation;
p.000066: (b) suspend or terminate the clinical investigation;
p.000066: (c) require the sponsor to modify any aspect of the clinical investigation.
p.000066: 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it
p.000066: shall, except where immediate action is required, ask the sponsor or the investigator or both for their
p.000066: opinion. That opinion shall be delivered within seven days.
p.000066:
p.000066: 5.5.2017 EN
p.000066: Official Journal of the European Union
p.000067: L 117/67
p.000067:
p.000067: 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article or has
p.000067: refused a clinical investigation, or has been notified by the sponsor of the early termination of a
p.000067: clinical investigation on safety grounds, that Member State shall communicate the corresponding decision and the
p.000067: grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 73.
p.000067:
p.000067: 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that
p.000067: information shall be made available through the electronic system referred to in Article 73 to all Member States and
p.000067: the Commission.
p.000067:
p.000067:
p.000067: Article 77
p.000067:
p.000067: Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early
p.000067: termination
p.000067:
p.000067: 1. If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation
p.000067: early, it shall inform within 15 days the Member State in which that clinical investigation has been
p.000067: temporarily halted or terminated early, through the electronic system referred to in Article 73, of the
p.000067: temporary halt or early termination, providing a justification. In the event that the sponsor has
p.000067: temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all
p.000067: Member States in which that clinical investigation is being conducted thereof within 24 hours.
p.000067:
p.000067: 2. The end of a clinical investigation shall be deemed to coincide with the last visit of the last
...
p.000067: investigation plan referred to in Section 3 of Chapter II of Annex XV shall specify when the results of the clinical
p.000067: investigation are going to be available, together with a justification.
p.000067:
p.000067: 6. The Commission shall issue guidelines regarding the content and structure of the summary of the
p.000067: clinical investi gation report.
p.000067:
p.000067: In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases
p.000067: where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and
p.000067: adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
p.000067:
p.000067: 7. The summary and the clinical investigation report referred to in paragraph 5 of this Article
p.000067: shall become publicly accessible through the electronic system referred to in Article 73, at the
p.000067: latest when the device is registered in accordance with Article 29 and before it is placed on the
p.000067: market. In cases of early termination or temporary halt, the summary and the report shall become publicly
p.000067: accessible immediately after submission.
p.000067:
p.000067: If the device is not registered in accordance with Article 29 within one year of the summary and the report having
p.000067: been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become
p.000067: publicly accessible at that point in time.
p.000067:
p.000068: L 117/68 EN
p.000068: Official Journal of the European Union
p.000068: 5.5.2017
p.000068:
p.000068: Article 78
p.000068:
p.000068: Coordinated assessment procedure for clinical investigations
p.000068:
p.000068: 1. By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be
p.000068: conducted in more than one Member State may submit, for the purpose of Article 70, a single application
p.000068: that, upon receipt, is transmitted electronically to all Member States in which the clinical investigation is to be
p.000068: conducted.
p.000068:
p.000068: 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the
p.000068: Member States in which the clinical investigation is to be conducted acts as coordinating Member State.
p.000068: The Member States in which the clinical investigation is to be conducted shall, within six days of
p.000068: submission of the application, agree on one of them taking the role of the coordinating Member State. If they
p.000068: do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that
p.000068: role.
p.000068:
p.000068: 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member
p.000068: States concerned shall coordinate their assessment of the application, in particular of the documentation
p.000068: referred to in Chapter II of Annex XV.
p.000068:
p.000068: However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of
p.000068: Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1)
p.000068: to (5).
...
p.000068: additional information has been received.
p.000068:
p.000068: 6. For class IIb and class III devices, the coordinating Member State may also extend the periods
p.000068: referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
p.000068:
p.000068: 7. The Commission may, by means of implementing acts, further specify the procedures and
p.000068: timescales for coordinated assessments to be taken into account by Member States concerned when
p.000068: deciding on the sponsor's application. Such implementing acts may also set out the procedures and
p.000068: timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of
p.000068: this Article, in the case of reporting of adverse events pursuant to Article 80(4) and in the case of
p.000068: clinical investigations of combination products between medical devices and medicinal products, where the
p.000068: latter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No
p.000068: 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000068: 114(3).
p.000068:
p.000068: 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that
p.000068: the conduct of the clinical investigation is acceptable or acceptable subject to compliance with specific
p.000068: conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned.
p.000068:
p.000068: 5.5.2017 EN
p.000068: Official Journal of the European Union
p.000069: L 117/69
p.000069:
p.000069: Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of
p.000069: the coordinating Member State concerning the area of coordinated assessment on the following grounds:
p.000069: (a) when it considers that participation in the clinical investigation would lead to a subject
p.000069: receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
p.000069: (b) infringement of national law; or
p.000069: (c) considerations as regards subject safety and data reliability and robustness submitted under point (b) of
p.000069: paragraph 4.
p.000069: Where one of the Member States concerned disagrees with the conclusion on the basis of the second
p.000069: subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed
p.000069: justification, through the electronic system referred to in Article 73, to the Commission, to all other Member
p.000069: States concerned and to the sponsor.
p.000069:
p.000069: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that
p.000069: the clinical investigation is not acceptable, that conclusion shall be deemed to be the conclusion of
p.000069: all Member States concerned.
p.000069:
p.000069: 10. A Member State concerned shall refuse to authorise a clinical investigation if it disagrees
p.000069: with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second
p.000069: subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections
...
p.000069: paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State,
p.000069: except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2,
p.000069: 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
p.000069:
p.000069: 13. The Commission shall provide administrative support to the coordinating Member State in the
p.000069: accomplishment of its tasks under this Chapter.
p.000069:
p.000069: 14. The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member
p.000069: States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 May 2027, all
p.000069: Member States shall be required to apply that procedure.
p.000069:
p.000069:
p.000069: Article 79
p.000069:
p.000069: Review of coordinated assessment procedure
p.000069:
p.000069: By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on
p.000069: experience gained from the application of Article 78 and, if necessary, propose a review of Article
p.000069: 78(14) and point (h) of Article 123(3).
p.000069:
p.000069:
p.000069: Article 80
p.000069:
p.000069: Recording and reporting of adverse events that occur during clinical investigations
p.000069:
p.000069: 1. The sponsor shall fully record all of the following:
p.000069: (a) any adverse event of a type identified in the clinical investigation plan as being critical to
p.000069: the evaluation of the results of that clinical investigation;
p.000069: (b) any serious adverse event;
p.000069:
p.000070: L 117/70 EN
p.000070: Official Journal of the European Union
p.000070: 5.5.2017
p.000070:
p.000070: (c) any device deficiency that might have led to a serious adverse event if appropriate action had
p.000070: not been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000070: (d) any new findings in relation to any event referred to in points (a) to (c).
p.000070:
p.000070: 2. The sponsor shall report, without delay to all Member States in which the clinical investigation is being
p.000070: conducted, all of the following by means of the electronic system referred to in Article 73:
p.000070:
p.000070: (a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the
p.000070: investi gation procedure or where such causal relationship is reasonably possible;
p.000070:
p.000070: (b) any device deficiency that might have led to a serious adverse event if appropriate action had not
p.000070: been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000070: (c) any new findings in relation to any event referred to in points (a) and (b).
p.000070:
p.000070: The period for reporting shall take account of the severity of the event. Where necessary to ensure timely
p.000070: reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
p.000070:
p.000070: Upon request by any Member State in which the clinical investigation is being conducted, the sponsor
p.000070: shall provide all information referred to in paragraph 1.
p.000070:
p.000070: 3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any
p.000070: event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical
...
p.000070: health and patient safety. The coordinating Member State and the Commission shall be kept informed of
p.000070: the outcome of any such evaluation and the adoption of any such measures.
p.000070:
p.000070: 5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in
p.000070: Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article.
p.000070:
p.000070: 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the
p.000070: serious adverse event and the preceding investigational procedure has been established.
p.000070:
p.000070:
p.000070: Article 81
p.000070:
p.000070: Implementing acts
p.000070:
p.000070: The Commission may, by means of implementing acts, establish the detailed arrangements and procedural
p.000070: aspects necessary for the implementation of this Chapter as regards the following:
p.000070:
p.000070: (a) harmonised electronic forms for the application for clinical investigations and their assessment as
p.000070: referred to in Articles 70 and 78, taking into account specific categories or groups of devices;
p.000070: (b) the functioning of the electronic system referred to in Article 73;
p.000070:
p.000070: (c) harmonised electronic forms for the notification of PMCF investigations as referred to in Article
p.000070: 74(1), and of substantial modifications as referred to in Article 75;
p.000070: (d) the exchange of information between Member States as referred to in Article 76;
p.000070:
p.000070: 5.5.2017 EN
p.000070: Official Journal of the European Union
p.000071: L 117/71
p.000071:
p.000071: (e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as
p.000071: referred to in Article 80;
p.000071:
p.000071: (f) the timelines for the reporting of serious adverse events and device deficiencies, taking into
p.000071: account the severity of the event to be reported as referred to in Article 80;
p.000071:
p.000071: (g) uniform application of the requirements regarding the clinical evidence or data needed to
p.000071: demonstrate compliance with the general safety and performance requirements set out in Annex I.
p.000071: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000071: referred to in Article 114(3).
p.000071:
p.000071:
p.000071: Article 82
p.000071:
p.000071: Requirements regarding other clinical investigations
p.000071:
p.000071: 1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1),
p.000071: shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4)
p.000071: and Article 62(6).
p.000071:
p.000071: 2. In order to protect the rights, safety, dignity and well-being of subjects and the scientific
p.000071: and ethical integrity of clinical investigations not performed for any of the purposes listed in Article
p.000071: 62(1), each Member State shall define any additional requirements for such investigations, as appropriate for each
p.000071: Member State concerned.
p.000071:
p.000071:
p.000071: CHAPTER VII
p.000071:
p.000071: POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
p.000071:
p.000071: SECTION 1
p.000071:
p.000071: Post-market surveillance
...
p.000071: the type of device. That system shall be an integral part of the manufacturer's quality management system referred
p.000071: to in Article 10(9).
p.000071:
p.000071: 2. The post-market surveillance system shall be suited to actively and systematically
p.000071: gathering, recording and analysing relevant data on the quality, performance and safety of a device
p.000071: throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and
p.000071: monitoring any preventive and corrective actions.
p.000071:
p.000071: 3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
p.000071: (a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex
p.000071: I;
p.000071: (b) to update the design and manufacturing information, the instructions for use and the labelling;
p.000071: (c) to update the clinical evaluation;
p.000071: (d) to update the summary of safety and clinical performance referred to in Article 32;
p.000071: (e) for the identification of needs for preventive, corrective or field safety corrective action;
p.000071: (f) for the identification of options to improve the usability, performance and safety of the device;
p.000071: (g) when relevant, to contribute to the post-market surveillance of other devices; and
p.000071: (h) to detect and report trends in accordance with Article 88. The technical documentation shall be updated
p.000071: accordingly.
p.000071:
p.000072: L 117/72 EN
p.000072: Official Journal of the European Union
p.000072: 5.5.2017
p.000072:
p.000072: 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is
p.000072: identified, the manufacturer shall implement the appropriate measures and inform the competent authorities
p.000072: concerned and, where applicable, the notified body. Where a serious incident is identified or a field
p.000072: safety corrective action is implemented, it shall be reported in accordance with Article 87.
p.000072:
p.000072:
p.000072: Article 84
p.000072:
p.000072: Post-market surveillance plan
p.000072:
p.000072: The post-market surveillance system referred to in Article 83 shall be based on a post-market
p.000072: surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices
p.000072: other than custom-made devices, the post- market surveillance plan shall be part of the technical documentation
p.000072: specified in Annex II.
p.000072:
p.000072:
p.000072: Article 85
p.000072:
p.000072: Post-market surveillance report
p.000072:
p.000072: Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and
p.000072: conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000072: surveillance plan referred to in Article 84 together with a rationale and description of any preventive
p.000072: and corrective actions taken. The report shall be updated when necessary and made available to the competent
p.000072: authority upon request.
p.000072:
p.000072:
p.000072: Article 86
p.000072:
p.000072: Periodic safety update report
p.000072:
...
p.000072: characteristics of the population using the device and, where practicable, the usage frequency of the device.
p.000072:
p.000072: Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR
p.000072: shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II
p.000072: and III.
p.000072:
p.000072: Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
p.000072: That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in
p.000072: Annexes II and III.
p.000072:
p.000072: For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.
p.000072:
p.000072: 2. For class III devices or implantable devices, manufacturers shall submit PSURs by means of the
p.000072: electronic system referred to in Article 92 to the notified body involved in the conformity assessment in
p.000072: accordance with Article 52. The notified body shall review the report and add its evaluation to that
p.000072: electronic system with details of any action taken. Such PSURs and the evaluation by the notified body
p.000072: shall be made available to competent authorities through that electronic system.
p.000072:
p.000072: 3. For devices other than those referred to in paragraph 2, manufacturers shall make PSURs
p.000072: available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
p.000072:
p.000072: 5.5.2017 EN
p.000072: Official Journal of the European Union
p.000073: L 117/73
p.000073:
p.000073: SECTION 2
p.000073:
p.000073: Vigilance
p.000073:
p.000073: Article 87
p.000073:
p.000073: Reporting of serious incidents and field safety corrective actions
p.000073:
p.000073: 1. Manufacturers of devices made available on the Union market, other than investigational devices,
p.000073: shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
p.000073:
p.000073: (a) any serious incident involving devices made available on the Union market, except expected
p.000073: side-effects which are clearly documented in the product information and quantified in the technical
p.000073: documentation and are subject to trend reporting pursuant to Article 88;
p.000073:
p.000073: (b) any field safety corrective action in respect of devices made available on the Union market, including any field
p.000073: safety corrective action undertaken in a third country in relation to a device which is also legally
p.000073: made available on the Union market, if the reason for the field safety corrective action is not limited
p.000073: to the device made available in the third country.
p.000073:
p.000073: The reports referred to in the first subparagraph shall be submitted through the electronic system
p.000073: referred to in Article 92.
p.000073:
p.000073: 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account
p.000073: of the severity of the serious incident.
p.000073:
p.000073: 3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1
p.000073: immediately after they have established the causal relationship between that incident and their device or
p.000073: that such causal relationship is reasonably possible and not later than 15 days after they become aware of the
p.000073: incident.
p.000073:
p.000073: 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred
p.000073: to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of
p.000073: that threat.
p.000073:
p.000073: 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's
p.000073: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000073: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000073: after the date on which the manufacturer becomes aware of the serious incident.
p.000073:
...
p.000073: undertaken.
p.000073:
p.000073: 9. For similar serious incidents that occur with the same device or device type and for which the root cause
p.000073: has been identified or a field safety corrective action implemented or where the incidents are common and
p.000073: well documented, the manufacturer may provide periodic summary reports instead of individual serious
p.000073: incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in
p.000073: consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with
p.000073: the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single
p.000073: competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic
p.000073: summary reports following agreement with that competent authority.
p.000073:
p.000073: 10. The Member States shall take appropriate measures such as organising targeted information
p.000073: campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent
p.000073: authorities suspected serious incidents referred to in point (a) of paragraph 1.
p.000073:
p.000073: The competent authorities shall record centrally at national level reports they receive from healthcare
p.000073: professionals, users and patients.
p.000073:
p.000074: L 117/74 EN
p.000074: Official Journal of the European Union
p.000074: 5.5.2017
p.000074:
p.000074: 11. Where a competent authority of a Member State obtains such reports on suspected serious
p.000074: incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it
p.000074: shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the
p.000074: suspected serious incident without delay.
p.000074:
p.000074: Where the manufacturer of the device concerned considers that the incident is a serious incident, it
p.000074: shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the
p.000074: competent authority of the Member State in which that serious incident occurred and shall take the appropriate
p.000074: follow-up action in accordance with Article 89.
p.000074:
p.000074: Where the manufacturer of the device concerned considers that the incident is not a serious incident or
p.000074: is an expected undesirable side-effect, which will be covered by trend reporting in accordance with
p.000074: Article 88, it shall provide an explanatory statement. If the competent authority does not agree with
p.000074: the conclusion of the explanatory statement, it may require the manufacturer to provide a report in
p.000074: accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action
p.000074: is taken in accordance with Article 89.
p.000074:
p.000074:
p.000074:
p.000074: Article 88
p.000074:
p.000074: Trend reporting
p.000074:
...
p.000074:
p.000074: 1. Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer shall,
p.000074: without delay, perform the necessary investigations in relation to the serious incident and the devices
p.000074: concerned. This shall include a risk assessment of the incident and field safety corrective action
p.000074: taking into account criteria as referred to in paragraph 3 of this Article as appropriate.
p.000074:
p.000074: The manufacturer shall co-operate with the competent authorities and where relevant with the notified body
p.000074: concerned during the investigations referred to in the first subparagraph and shall not perform any
p.000074: investigation which involves altering the device or a sample of the batch concerned in a way which may
p.000074: affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of
p.000074: such action.
p.000074:
p.000074: 2. Member States shall take the necessary steps to ensure that any information regarding a serious
p.000074: incident that has occurred within their territory, or a field safety corrective action that has been or
p.000074: is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87
p.000074: is evaluated centrally at national level by their competent authority, if possible together with the manufacturer,
p.000074: and, where relevant, the notified body concerned.
p.000074:
p.000074: 5.5.2017 EN
p.000074: Official Journal of the European Union
p.000075: L 117/75
p.000075:
p.000075: 3. In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks
p.000075: arising from the reported serious incident and evaluate any related field safety corrective actions,
p.000075: taking into account the protection of public health and criteria such as causality, detectability and
p.000075: probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or
p.000075: indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and
p.000075: population affected. The competent authority shall also evaluate the adequacy of the field safety
p.000075: corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other
p.000075: corrective action, in particular taking into account the principle of inherent safety contained in Annex
p.000075: I.
p.000075:
p.000075: Upon request by the national competent authority, manufacturers shall provide all documents necessary for
p.000075: the risk assessment.
p.000075:
p.000075: 4. The competent authority shall monitor the manufacturer's investigation of a serious incident.
...
p.000075: where the serious incident or field safety corrective action may be related to the derivatives of
p.000075: tissues or cells of human origin utilised for the manufacture of the device, and in the case of
p.000075: devices falling under this Regulation pursuant to Article 1(10), the competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent
p.000075: authority for human tissues and cells that was consulted by the notified body in accordance with Article
p.000075: 52(10).
p.000075:
p.000075: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the
p.000075: evaluating competent authority shall, through the electronic system referred to in Article 92, inform,
p.000075: without delay, the other competent authorities of the corrective action taken or envisaged by the
p.000075: manufacturer or required of it to minimise the risk of recurrence of the serious incident, including
p.000075: information on the underlying events and the outcome of its assessment.
p.000075:
p.000075: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000075: brought without delay to the attention of users of the device in question by means of a field safety notice. The
p.000075: field safety notice shall be edited in an official Union language or languages determined by the Member
p.000075: State in which the field safety corrective action is taken. Except in cases of urgency, the content of
p.000075: the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases
p.000075: referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly
p.000075: justified by the situation of the individual Member State, the content of the field safety notice shall be consistent
p.000075: in all Member States.
p.000075:
p.000075: The field safety notice shall allow the correct identification of the device or devices involved, in
p.000075: particular by including the relevant UDIs, and the correct identification, in particular, by
p.000075: including the SRN, if already issued, of the manufacturer that has undertaken the field safety
p.000075: corrective action. The field safety notice shall explain, in a clear manner, without understating the
p.000075: level of risk, the reasons for the field safety corrective action with reference to the device
p.000075: malfunction and associated risks for patients, users or other persons, and shall clearly indicate all
p.000075: the actions to be taken by users.
p.000075:
p.000075: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which
p.000075: that notice shall be accessible to the public.
p.000075:
p.000075: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
p.000075: referred to in paragraph 3 in the following cases:
p.000075:
p.000075: (a) where there is concern regarding a particular serious incident or cluster of serious incidents
p.000075: relating to the same device or type of device of the same manufacturer in more than one Member State;
p.000075:
p.000076: L 117/76 EN
p.000076: Official Journal of the European Union
p.000076: 5.5.2017
p.000076:
p.000076: (b) where the appropriateness of a field safety corrective action that is proposed by a manufacturer in
p.000076: more than one Member State is in question.
p.000076: That coordinated procedure shall cover the following:
p.000076: — designation of a coordinating competent authority on a case by case basis, when required;
p.000076: — defining the coordinated assessment process, including the tasks and responsibilities of the
p.000076: coordinating competent authority and the involvement of other competent authorities.
p.000076: Unless otherwise agreed between the competent authorities, the coordinating competent authority
p.000076: shall be the competent authority of the Member State in which the manufacturer has its registered place of
p.000076: business.
p.000076:
p.000076: The coordinating competent authority shall, through the electronic system referred to in
p.000076: Article 92, inform the manufacturer, the other competent authorities and the Commission that it has
p.000076: assumed the role of coordinating authority.
p.000076:
p.000076: 10. The designation of a coordinating competent authority shall not affect the rights of
p.000076: the other competent authorities to perform their own assessment and to adopt measures in accordance
...
p.000076: (a) the typology of serious incidents and field safety corrective actions in relation to specific
p.000076: devices, or categories or groups of devices;
p.000076: (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and
p.000076: the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by
p.000076: manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
p.000076: (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting
p.000076: of suspected serious incidents by healthcare professionals, users and patients;
p.000076: (d) timelines for the reporting of field safety corrective actions, and for the provision by
p.000076: manufacturers of periodic summary reports and trend reports, taking into account the severity of the
p.000076: incident to be reported as referred to in Article 87;
p.000076: (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 89;
p.000076: (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process,
p.000076: including tasks and responsibilities of the coordinating competent authority and involvement of other competent
p.000076: authorities in this process.
p.000076: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000076: referred to in Article 114(3).
p.000076:
p.000076: 5.5.2017 EN
p.000076: Official Journal of the European Union
p.000077: L 117/77
p.000077:
p.000077: Article 92
p.000077:
p.000077: Electronic system on vigilance and on post-market surveillance
p.000077:
p.000077: 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to
p.000077: collate and process the following information:
p.000077:
p.000077: (a) the reports by manufacturers on serious incidents and field safety corrective actions referred to in
p.000077: Article 87(1) and Article 89(5);
p.000077:
p.000077: (b) the periodic summary reports by manufacturers referred to in Article 87(9);
p.000077:
p.000077: (c) the reports by manufacturers on trends referred to in Article 88;
p.000077:
p.000077: (d) the PSURs referred to in Article 86;
p.000077:
p.000077: (e) the field safety notices by manufacturers referred to in Article 89(8);
p.000077:
p.000077: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000077: them and the Commission in accordance with Article 89(7) and (9).
p.000077:
p.000077: That electronic system shall include relevant links to the UDI database.
p.000077:
p.000077: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000077: system to the competent authorities of the Member States and to the Commission. The notified bodies shall
p.000077: also have access to that information to the extent that it relates to devices for which they issued a certificate
p.000077: in accordance with Article 53.
p.000077:
p.000077: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels
p.000077: of access to the electronic system referred to in paragraph 1.
p.000077:
p.000077: 4. On the basis of arrangements between the Commission and competent authorities of third countries
p.000077: or internat ional organisations, the Commission may grant those competent authorities or international
p.000077: organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those
p.000077: arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent
p.000077: to those applicable in the Union.
p.000077:
p.000077: 5. The reports on serious incidents referred to in point (a) of Article 87(1) shall be
p.000077: automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of
p.000077: this Article, to the competent authority of the Member State in which the incident occurred.
p.000077:
p.000077: 6. The trend reports referred to in Article 88(1) shall be automatically transmitted upon receipt
p.000077: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000077: the Member State in which the incidents occurred.
p.000077:
p.000077: 7. The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall
p.000077: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000077: competent authorities of the following Member States:
p.000077:
p.000077: (a) the Member States in which the field safety corrective action is being or is to be undertaken;
p.000077:
p.000077: (b) the Member State in which the manufacturer has its registered place of business.
p.000077:
p.000077: 8. The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon
p.000077: receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
p.000077:
p.000077: (a) the Member State or Member States participating in the coordination procedure in accordance with
p.000077: Article 89(9) and which have agreed on the periodic summary report;
p.000077:
p.000077: (b) the Member State in which the manufacturer has its registered place of business.
p.000077:
p.000077: 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically
p.000077: transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to
p.000077: the notified body that issued the certificate for the device in question in accordance with Article 56.
p.000077:
p.000078: L 117/78 EN
p.000078: Official Journal of the European Union
p.000078: 5.5.2017
p.000078:
p.000078: SECTION 3
p.000078:
p.000078: Market surveillance
p.000078:
p.000078: Article 93
p.000078:
p.000078: Market surveillance activities
p.000078:
p.000078: 1. The competent authorities shall perform appropriate checks on the conformity characteristics and
p.000078: performance of devices including, where appropriate, a review of documentation and physical or laboratory
p.000078: checks on the basis of adequate samples. The competent authorities shall, in particular, take account of
p.000078: established principles regarding risk assessment and risk management, vigilance data and complaints.
p.000078:
p.000078: 2. The competent authorities shall draw up annual surveillance activity plans and allocate a
p.000078: sufficient number of material and competent human resources in order to carry out those activities taking into
p.000078: account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local
p.000078: circumstances.
p.000078:
p.000078: 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
p.000078:
p.000078: (a) may require economic operators to, inter alia, make available the documentation and information
p.000078: necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary
p.000078: samples of devices or access to devices free of charge; and
p.000078:
p.000078: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of
...
p.000078:
p.000078: 8. The Member States shall review and assess the functioning of their market surveillance activities. Such
p.000078: reviews and assessments shall be carried out at least every four years and the results thereof shall be
p.000078: communicated to the other Member States and the Commission. Each Member State shall make a summary of the results
p.000078: accessible to the public by means of the electronic system referred to in Article 100.
p.000078:
p.000078: 9. The competent authorities of the Member States shall coordinate their market surveillance
p.000078: activities, cooperate with each other and share with each other and with the Commission the results
p.000078: thereof, to provide for a harmonised and high level of market surveillance in all Member States.
p.000078:
p.000078: Where appropriate, the competent authorities of the Member States shall agree on work-sharing,
p.000078: joint market surveillance activities and specialisation.
p.000078:
p.000078: 10. Where more than one authority in a Member State is responsible for market surveillance and
p.000078: external border controls, those authorities shall cooperate with each other, by sharing information relevant to their
p.000078: role and functions.
p.000078:
p.000078: 11. Where appropriate, the competent authorities of the Member States shall cooperate with
p.000078: the competent authorities of third countries with a view to exchanging information and technical support
p.000078: and promoting activities relating to market surveillance.
p.000078:
p.000078: 5.5.2017 EN
p.000078: Official Journal of the European Union
p.000079: L 117/79
p.000079:
p.000079: Article 94
p.000079:
p.000079: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
p.000079:
p.000079: Where the competent authorities of a Member State, based on data obtained by vigilance or market
p.000079: surveillance activities or on other information, have reason to believe that a device:
p.000079: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or
p.000079: to other aspects of the protection of public health; or
p.000079: (b) otherwise does not comply with the requirements laid down in this Regulation,
p.000079: they shall carry out an evaluation of the device concerned covering all requirements laid down in this
p.000079: Regulation relating to the risk presented by the device, or to any other non-compliance of the device.
p.000079: The relevant economic operators shall cooperate with the competent authorities.
p.000079:
p.000079:
p.000079: Article 95
p.000079:
p.000079: Procedure for dealing with devices presenting an unacceptable risk to health and safety
p.000079:
p.000079: 1. Where, having performed an evaluation pursuant to Article 94, the competent authorities find that
p.000079: the device presents an unacceptable risk to the health or safety of patients, users or other persons,
p.000079: or to other aspects of the protection of public health, they shall without delay require the
p.000079: manufacturer of the devices concerned, its authorised representative and all other relevant economic
p.000079: operators to take all appropriate and duly justified corrective action to bring the device into
p.000079: compliance with the requirements of this Regulation relating to the risk presented by the device and, in
p.000079: a manner that is proportionate to the nature of the risk, to restrict the making available of the
p.000079: device on the market, to subject the making available of the device to specific requirements, to withdraw
p.000079: the device from the market, or to recall it, within a reasonable period that is clearly defined and communicated
p.000079: to the relevant economic operator.
p.000079:
p.000079: 2. The competent authorities shall, without delay, notify the Commission, the other Member States
p.000079: and, where a certificate has been issued in accordance with Article 56 for the device concerned, the
p.000079: notified body that issued that certificate, of the results of the evaluation and of the actions which
p.000079: they have required the economic operators to take, by means of the electronic system referred to in Article 100.
p.000079:
p.000079: 3. The economic operators as referred to in paragraph 1 shall, without delay, ensure that all
p.000079: appropriate corrective action is taken throughout the Union in respect of all the devices concerned that
p.000079: they have made available on the market.
p.000079:
p.000079: 4. Where the economic operator as referred to in paragraph 1 does not take adequate corrective
p.000079: action within the period referred to in paragraph 1, the competent authorities shall take all appropriate
p.000079: measures to prohibit or restrict the making available of the device on their national market, to withdraw the
p.000079: device from that market or to recall it.
p.000079:
p.000079: The competent authorities shall notify the Commission, the other Member States and the notified body
p.000079: referred to in paragraph 2 of this Article, without delay, of those measures, by means of the
p.000079: electronic system referred to in Article 100.
p.000079:
p.000079: 5. The notification referred to in paragraph 4 shall include all available details, in particular the data
p.000079: necessary for the identification and tracing of the non-compliant device, the origin of the device, the
p.000079: nature of and the reasons for the non-compliance alleged and the risk involved, the nature and
p.000079: duration of the national measures taken and the arguments put forward by the relevant economic operator.
p.000079:
p.000079: 6. Member States other than the Member State initiating the procedure shall, without delay, inform
p.000079: the Commission and the other Member States, by means of the electronic system referred to in Article
p.000079: 100, of any additional relevant information at their disposal relating to the non-compliance of the
p.000079: device concerned and of any measures adopted by them in relation to the device concerned.
p.000079:
p.000079: In the event of disagreement with the notified national measure, they shall, without delay, inform the
p.000079: Commission and the other Member States of their objections, by means of the electronic system referred to in Article
p.000079: 100.
p.000079:
p.000079: 7. Where, within two months of receipt of the notification referred to in paragraph 4, no
p.000079: objection has been raised by either a Member State or the Commission in respect of any measures taken by a
p.000079: Member State, those measures shall be deemed to be justified.
p.000079:
p.000080: L 117/80 EN
p.000080: Official Journal of the European Union
p.000080: 5.5.2017
p.000080:
p.000080: In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures,
p.000080: including withdrawing, recalling or limiting the availability of the device on their national market, are
p.000080: taken without delay in respect of the device concerned.
p.000080:
p.000080:
p.000080: Article 96
p.000080:
p.000080: Procedure for evaluating national measures at Union level
p.000080:
p.000080: 1. Where, within two months of receipt of the notification referred to in Article 95(4), objections
p.000080: are raised by a Member State against a measure taken by another Member State, or where the Commission
p.000080: considers the measure to be contrary to Union law, the Commission shall, after consulting the competent
p.000080: authorities concerned and, where necessary, the economic operators concerned, evaluate that national
p.000080: measure. On the basis of the results of that evaluation, the Commission may decide, by means of
p.000080: implementing acts, whether or not the national measure is justified. Those implementing acts shall be
p.000080: adopted in accordance with the examination procedure referred to in Article 114(3).
p.000080:
p.000080: 2. Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this
p.000080: Article, the second subparagraph of Article 95(7) shall apply. If the Commission considers the
p.000080: national measure to be unjustified, the Member State concerned shall withdraw the measure.
p.000080:
p.000080: Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt
p.000080: of the notification referred to in Article 95(4), the national measure shall be considered to be justified.
p.000080:
p.000080: 3. Where a Member State or the Commission considers that the risk to health and safety emanating
p.000080: from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or
p.000080: Member States concerned, the Commission, at the request of a Member State or on its own initiative, may
p.000080: take, by means of implementing acts, the necessary and duly justified measures to ensure the protection
p.000080: of health and safety, including measures restricting or prohibiting the placing on the market and putting
...
p.000080: recalled or withdrawn from the market. That Member State shall inform the Commission and the other
p.000080: Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
p.000080:
p.000080: 3. In order to ensure the uniform application of this Article, the Commission may, by means of
p.000080: implementing acts, specify appropriate measures to be taken by competent authorities to address given
p.000080: types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure
p.000080: referred to in Article 114(3).
p.000080:
p.000080:
p.000080: Article 98
p.000080:
p.000080: Preventive health protection measures
p.000080:
p.000080: 1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a
p.000080: device or a specific category or group of devices, considers that, in order to protect the health and
p.000080: safety of patients, users or other persons or other aspects of public health, the making available on the market or
p.000080: putting into service of a device or a specific category or group of devices should be prohibited, restricted
p.000080: or made subject to particular requirements or that such device or category or group of devices should
p.000080: be withdrawn from the market or recalled, it may take any necessary and justified measures.
p.000080:
p.000080: 5.5.2017 EN
p.000080: Official Journal of the European Union
p.000081: L 117/81
p.000081:
p.000081: 2. The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member
p.000081: States, giving the reasons for its decision, by means of the electronic system referred to in Article 100.
p.000081:
p.000081: 3. The Commission, in consultation with the MDCG and, where necessary, the economic operators
p.000081: concerned, shall assess the national measures taken. The Commission may decide, by means of implementing
p.000081: acts, whether the national measures are justified or not. In the absence of a Commission decision within
p.000081: six months of their notification, the national measures shall be considered to be justified. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000081:
p.000081: 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making
p.000081: available on the market or putting into service of a device, specific category or group of devices should be
p.000081: prohibited, restricted or made subject to particular requirements or that such device or category or group
p.000081: of devices should be withdrawn from the market or recalled in all Member States in order to protect
p.000081: the health and safety of patients, users or other persons or other aspects of public health, the
p.000081: Commission may adopt implementing acts to take the necessary and duly justified measures. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000081: 114(3).
p.000081:
p.000081:
...
p.000081: of this Regulation.
p.000081:
p.000081: 4. Where a measure adopted pursuant to Articles 95 to 98 concerns a device for which a notified
p.000081: body has been involved in the conformity assessment, the competent authorities shall by means of the
p.000081: electronic system referred to in Article 100 inform the relevant notified body and the authority responsible for
p.000081: the notified body of the measure taken.
p.000081:
p.000081:
p.000081: Article 100
p.000081:
p.000081: Electronic system on market surveillance
p.000081:
p.000081: 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to
p.000081: collate and process the following information:
p.000081: (a) summaries of the results of the surveillance activities referred to in Article 93(4);
p.000081: (b) the final inspection report referred to in Article 93(7);
p.000081: (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article
p.000081: 95(2),
p.000081: (4) and (6);
p.000081: (d) information in relation to non-compliance of products as referred to in Article 97(2);
p.000081: (e) information in relation to the preventive health protection measures referred to in Article 98(2);
p.000081: (f) summaries of the results of the reviews and assessments of the market surveillance activities of
p.000081: the Member States referred to in 93(8).
p.000081:
p.000082: L 117/82 EN
p.000082: Official Journal of the European Union
p.000082: 5.5.2017
p.000082:
p.000082: 2. The information referred to in paragraph 1 of this Article shall be immediately transmitted
p.000082: through the electronic system to all competent authorities concerned and, where applicable, to the
p.000082: notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible
p.000082: to the Member States and to the Commission.
p.000082:
p.000082: 3. Information exchanged between Member States shall not be made public where to do so might
p.000082: impair market surveillance activities and co-operation between Member States.
p.000082:
p.000082: CHAPTER VIII
p.000082:
p.000082: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT
p.000082: PANELS AND DEVICE REGISTERS
p.000082:
p.000082: Article 101
p.000082:
p.000082: Competent authorities
p.000082:
p.000082: The Member States shall designate the competent authority or authorities responsible for the
p.000082: implementation of this Regulation. They shall entrust their authorities with the powers, resources,
p.000082: equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation.
p.000082: The Member States shall communicate the names and contact details of the competent authorities to the Commission
p.000082: which shall publish a list of competent authorities.
p.000082:
p.000082:
p.000082: Article 102
p.000082:
p.000082: Cooperation
p.000082:
p.000082: 1. The competent authorities of the Member States shall cooperate with each other and with the
p.000082: Commission. The Commission shall provide for the organisation of exchanges of information necessary to
...
p.000082: expertise in the field of in vitro diagnostic medical devices. A Member State may choose to appoint only one
p.000082: member and one alternate, each with expertise in both fields.
p.000082:
p.000082: The members of the MDCG shall be chosen for their competence and experience in the field of medical
p.000082: devices and in vitro diagnostic medical devices. They shall represent the competent authorities of the
p.000082: Member States. The names and affiliation of members shall be made public by the Commission.
p.000082:
p.000082: The alternates shall represent and vote for the members in their absence.
p.000082:
p.000082: 3. The MDCG shall meet at regular intervals and, where the situation requires, upon request by the
p.000082: Commission or a Member State. The meetings shall be attended either by the members appointed for their role and
p.000082: expertise in the field of medical devices, or by the members appointed for their expertise in the field of in vitro
p.000082: diagnostic medical devices, or by the members appointed for their expertise in both fields, or their alternates, as
p.000082: appropriate.
p.000082:
p.000082: 4. The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be reached, the MDCG shall
p.000082: decide by a majority of its members. Members with diverging positions may request that their positions and the grounds
p.000082: on which they are based be recorded in the MDCG's position.
p.000082:
p.000082: 5. The MDCG shall be chaired by a representative of the Commission. The chair shall not take part
p.000082: in votes of the MDCG.
p.000082:
p.000082: 5.5.2017 EN
p.000082: Official Journal of the European Union
p.000083: L 117/83
p.000083:
p.000083: 6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend
p.000083: meetings or provide written contributions.
p.000083:
p.000083: 7. The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations
p.000083: representing the interests of the medical device industry, healthcare professionals, laboratories, patients
p.000083: and consumers at Union level shall be invited to such sub-groups in the capacity of observers.
p.000083:
p.000083: 8. The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the
p.000083: following:
p.000083: — the adoption of opinions or recommendations or other positions, including in cases of urgency;
p.000083: — the delegation of tasks to reporting and co-reporting members;
p.000083: — the implementation of Article 107 regarding conflict of interests;
p.000083: — the functioning of sub-groups.
p.000083: 9. The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of
p.000083: Regulation (EU) 2017/746.
p.000083:
p.000083:
p.000083: Article 104
p.000083:
p.000083: Support by the Commission
p.000083:
p.000083: The Commission shall support the functioning of the cooperation between national competent authorities. It
p.000083: shall, in particular, provide for the organisation of exchanges of experience between the competent
p.000083: authorities and provide technical, scientific and logistic support to the MDCG and its sub-groups. It
p.000083: shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure the
p.000083: appropriate follow-up.
p.000083:
p.000083:
p.000083: Article 105
p.000083:
p.000083: Tasks of the MDCG
p.000083:
p.000083: Under this Regulation, the MDCG shall have the following tasks:
p.000083: (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies
p.000083: pursuant to the provisions set out in Chapter IV;
p.000083: (b) to advise the Commission, at its request, in matters concerning the coordination group of notified
p.000083: bodies as established pursuant to Article 49;
p.000083: (c) to contribute to the development of guidance aimed at ensuring effective and harmonised
p.000083: implementation of this Regulation, in particular regarding the designation and monitoring of notified
p.000083: bodies, application of the general safety and performance requirements and conduct of clinical
p.000083: evaluations and investigations by manufacturers, assessment by notified bodies and vigilance activities;
p.000083: (d) to contribute to the continuous monitoring of technical progress and assessment of whether the
p.000083: general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to
p.000083: ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend
p.000083: Annex I to this Regulation;
p.000083: (e) to contribute to the development of device standards, of CS and of scientific guidelines, including
p.000083: product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class
p.000083: III devices;
p.000083: (f) to assist the competent authorities of the Member States in their coordination activities in
p.000083: particular in the fields of classification and the determination of the regulatory status of devices,
p.000083: clinical investigations, vigilance and market surveillance including the development and maintenance of
p.000083: a framework for a European market surveillance programme with the objective of achieving efficiency
p.000083: and harmonisation of market surveillance in the Union, in accordance with Article 93;
p.000083: (g) to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue
p.000083: related to the implementation of this Regulation;
p.000083: (h) to contribute to harmonised administrative practice with regard to devices in the Member States.
p.000083:
p.000084: L 117/84 EN
p.000084: Official Journal of the European Union
p.000084: 5.5.2017
p.000084:
p.000084: Article 106
p.000084:
p.000084: Provision of scientific, technical and clinical opinions and advice
p.000084:
p.000084: 1. The Commission shall, by means of implementing acts and in consultation with the MDCG, make
p.000084: provision for expert panels to be designated for the assessment of the clinical evaluation in relevant
p.000084: medical fields as referred to in paragraph 9 of this Article and to provide views in accordance with
p.000084: Article 48(6) of Regulation (EU) 2017/746 on the performance evaluation of certain in vitro diagnostic
p.000084: medical devices and, where necessary, for categories or groups of devices, or for specific hazards
p.000084: relating to categories or groups of devices, observing the principles of highest scientific competence,
p.000084: impartiality, independence and transparency. The same principles shall apply where the Commission
p.000084: decides to appoint expert laboratories in accordance with paragraph 7 of this Article.
p.000084:
p.000084: 2. Expert panels and expert laboratories may be designated in areas where the Commission, in
p.000084: consultation with the MDCG, has identified a need for the provision of consistent scientific, technical
p.000084: and/or clinical advice or laboratory expertise in relation to the implementation of this Regulation.
p.000084: Expert panels and expert laboratories may be appointed on a standing or temporary basis.
p.000084:
p.000084: 3. Expert panels shall consist of advisors appointed by the Commission on the basis of up-to-date
p.000084: clinical, scientific or technical expertise in the field and with a geographical distribution that
p.000084: reflects the diversity of scientific and clinical approaches in the Union. The Commission shall determine
p.000084: the number of members of each panel in accordance with the requisite needs.
p.000084:
p.000084: The members of expert panels shall perform their tasks with impartiality and objectivity. They shall
p.000084: neither seek nor take instructions from notified bodies or manufacturers. Each member shall draw up a
p.000084: declaration of interests, which shall be made publicly available.
p.000084:
p.000084: The Commission shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
p.000084:
p.000084: 4. Expert panels shall take into account relevant information provided by stakeholders including
p.000084: patients' organ isations and healthcare professionals when preparing their scientific opinions.
p.000084:
p.000084: 5. The Commission, following consultation with the MDCG, may appoint advisors to expert
p.000084: panels following publication in the Official Journal of the European Union and on the Commission website
p.000084: following a call for expressions of interest. Depending on the type of task and the need for specific
p.000084: expertise, advisors may be appointed to the expert panels for a maximum period of three years and their
p.000084: appointment may be renewed.
p.000084:
p.000084: 6. The Commission, following consultation with the MDCG, may include advisors on a central list of
p.000084: available experts who, whilst not being formally appointed to a panel, are available to provide advice and to
p.000084: support the work of the expert panel as needed. That list shall be published on the Commission website.
p.000084:
p.000084: 7. The Commission may, by means of implementing acts and following consultation with the MDCG,
p.000084: designate expert laboratories, on the basis of their expertise in:
p.000084: — physico-chemical characterisation, or
p.000084: — microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical biological and toxicological
p.000084: testing of specific devices, categories or groups of devices.
p.000084: The Commission shall only designate expert laboratories for which a Member State or the Joint Research
p.000084: Centre has submitted an application for designation.
p.000084:
p.000084: 8. Expert laboratories shall satisfy the following criteria:
p.000084:
p.000084: (a) have adequate and appropriately qualified staff with adequate knowledge and experience in the field
p.000084: of the devices for which they are designated;
p.000084: (b) possess the necessary equipment to carry out the tasks assigned to them;
p.000084: (c) have the necessary knowledge of international standards and best practices;
p.000084: (d) have an appropriate administrative organisation and structure;
p.000084: (e) ensure that their staff observe the confidentiality of information and data obtained in carrying out their
p.000084: tasks.
p.000084:
p.000084: 5.5.2017 EN
p.000084: Official Journal of the European Union
p.000085: L 117/85
p.000085:
p.000085: 9. Expert panels appointed for clinical evaluation in relevant medical fields shall fulfil the tasks
p.000085: provided for in Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or Section 6 of Annex X, as applicable.
p.000085:
p.000085: 10. Expert panels and expert laboratories may have the following tasks, depending on the requisite needs:
p.000085:
p.000085: (a) to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the
p.000085: implemen tation of this Regulation;
p.000085:
p.000085: (b) to contribute to the development and maintenance of appropriate guidance and CS for:
p.000085:
p.000085: — clinical investigations,
p.000085:
p.000085: — clinical evaluation and PMCF,
p.000085:
p.000085: — performance studies,
p.000085:
p.000085: — performance evaluation and post-market performance follow-up,
p.000085:
p.000085: — physico-chemical characterisation, and
p.000085:
p.000085: — microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing
p.000085:
p.000085: for specific devices, or a category or group of devices, or for specific hazards related to a category
p.000085: or group of devices;
p.000085:
p.000085: (c) to develop and review clinical evaluation guidance and performance evaluation guidance for
p.000085: performance of conformity assessment in line with the state of the art with regard to clinical
p.000085: evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility,
p.000085: mechanical, electrical, electronic or non- clinical toxicological testing;
p.000085:
p.000085: (d) to contribute to the development of standards at international level, ensuring that such standards reflect
...
p.000085: use their best endeavours to reach consensus. If consensus cannot be reached, the expert panels shall decide by a
p.000085: majority of their members, and the scientific opinion shall mention the divergent positions and the
p.000085: grounds on which they are based.
p.000085:
p.000085: The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9
p.000085: and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109.
p.000085: The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation
p.000085: with the MDCG.
p.000085:
p.000085: 13. The Commission may require manufacturers and notified bodies to pay fees for the advice
p.000085: provided by expert panels and expert laboratories. The structure and the level of fees as well as the
p.000085: scale and structure of recoverable costs shall be adopted by the Commission by means of implementing acts,
p.000085: taking into account the objectives of the adequate implementation of this Regulation, protection of health
p.000085: and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation
p.000085: in the expert panels. Those implementing acts shall be adopted in accordance with the examination procedure
p.000085: referred to in Article 114(3).
p.000085:
p.000086: L 117/86 EN
p.000086: Official Journal of the European Union
p.000086: 5.5.2017
p.000086:
p.000086: 14. The fees payable to the Commission in accordance with the procedure under paragraph 13 of this
p.000086: Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees
p.000086: payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance
p.000086: with point (c) of Section 5.1 of Annex IX involving a manufacturer who is a micro, small or
p.000086: medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
p.000086:
p.000086: 15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend
p.000086: the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article.
p.000086:
p.000086:
p.000086: Article 107
p.000086:
p.000086: Conflict of interests
p.000086:
p.000086: 1. Members of the MDCG, its sub-groups, and members of expert panels and expert laboratories shall
p.000086: not have financial or other interests in the medical device industry which could affect their
p.000086: impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare
p.000086: any direct or indirect interests they may have in the medical device industry and update that declaration
p.000086: whenever a relevant change occurs. The declaration of interests shall be made publicly available on the
p.000086: Commission website. This Article shall not apply to the representatives of stakeholder organisations
p.000086: participating in the sub-groups of the MDCG.
p.000086:
p.000086: 2. Experts and other third parties invited by the MDCG on a case-by-case basis shall declare any
...
p.000086: national provisions and practices in the Member States on confidentiality, all parties involved in the
p.000086: application of this Regulation shall respect the confidentiality of information and data obtained in carrying out
p.000086: their tasks in order to protect the following:
p.000086:
p.000086: (a) personal data, in accordance with Article 110;
p.000086:
p.000086: (b) commercially confidential information and trade secrets of a natural or legal person, including
p.000086: intellectual property rights; unless disclosure is in the public interest;
p.000086:
p.000086: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000086: audits.
p.000086:
p.000086: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent
p.000086: authorities and between competent authorities and the Commission shall not be disclosed without the prior
p.000086: agreement of the originating authority.
p.000086:
p.000086: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000086: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000086: obligations of the persons concerned to provide information under criminal law.
p.000086:
p.000086: 5.5.2017 EN
p.000086: Official Journal of the European Union
p.000087: L 117/87
p.000087:
p.000087: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000087: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000087:
p.000087: Article 110
p.000087:
p.000087: Data protection
p.000087:
p.000087: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the
p.000087: Member States pursuant to this Regulation.
p.000087:
p.000087: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000087: Commission pursuant to this Regulation.
p.000087:
p.000087: Article 111
p.000087:
p.000087: Levying of fees
p.000087:
p.000087: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the
p.000087: activities set out in this Regulation, provided that the level of the fees is set in a transparent
p.000087: manner and on the basis of cost-recovery principles.
p.000087:
p.000087: 2. Member States shall inform the Commission and the other Member States at least three months
p.000087: before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly
p.000087: available on request.
p.000087:
p.000087: Article 112
p.000087:
p.000087: Funding of activities related to designation and monitoring of notified bodies
p.000087:
p.000087: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
p.000087: shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other
...
p.000087:
p.000087: Article 113
p.000087:
p.000087: Penalties
p.000087:
p.000087: The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this
p.000087: Regulation and shall take all measures necessary to ensure that they are implemented. The penalties
p.000087: provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the
p.000087: Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any
p.000087: subsequent amendment affecting them.
p.000087:
p.000087: CHAPTER X
p.000087: FINAL PROVISIONS
p.000087:
p.000087: Article 114
p.000087:
p.000087: Committee procedure
p.000087:
p.000087: 1. The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a
p.000087: committee within the meaning of Regulation (EU) No 182/2011.
p.000087:
p.000087: 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and
p.000087: the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
p.000087: conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
p.000087:
p.000088: L 117/88 EN
p.000088: Official Journal of the European Union
p.000088: 5.5.2017
p.000088:
p.000088: Article 115
p.000088:
p.000088: Exercise of the delegation
p.000088:
p.000088: 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid
p.000088: down in this Article.
p.000088:
p.000088: 2. The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10),
p.000088: 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the Commission for a period of
p.000088: five years from 25 May 2017. The Commission shall draw up a report in respect of the delegation of
p.000088: power not later than nine months before the end of the five-year period. The delegation of power shall
p.000088: be tacitly extended for periods of an identical duration, unless the European Parliament or the Council
p.000088: opposes such extension not later than three months before the end of each period.
p.000088:
p.000088: 3. The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11),
p.000088: 52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European Parliament or by the Council. A
p.000088: decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect
p.000088: the day following the publication of the decision in the Official Journal of the European Union or at a
p.000088: later date specified therein. It shall not affect the validity of any delegated acts already in force.
p.000088:
p.000088: 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member
p.000088: State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better
p.000088: Law-Making.
p.000088:
p.000088: 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament
p.000088: and to the Council.
p.000088:
p.000088: 6. A delegated act adopted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6),
p.000088: 61(8), 70(8) and 106(15) shall enter into force only if no objection has been expressed either by the
p.000088: European Parliament or by the Council within a period of three months of notification of that act to
p.000088: the European Parliament and the Council or if, before the expiry of that period, the European Parliament
p.000088: and the Council have both informed the Commission that they will not object. That period shall be extended by
p.000088: three months at the initiative of the European Parliament or of the Council.
p.000088:
p.000088:
p.000088: Article 116
p.000088:
p.000088: Separate delegated acts for different delegated powers
p.000088:
p.000088: The Commission shall adopt a separate delegated act in respect of each power delegated to
p.000088: it pursuant to this Regulation.
p.000088:
p.000088:
p.000088: Article 117
p.000088:
p.000088: Amendment to Directive 2001/83/EC
p.000088:
p.000088: In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
...
p.000088: the marketing authorisation dossier shall include, where available, the results of the assessment of the
p.000088: conformity of the device part with the relevant general safety and performance requirements set out in
p.000088: Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant
p.000088: certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
p.000088: If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and
p.000088: where for the conformity assessment of the device, if used separately, the involvement of a notified
p.000088: body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to
p.000088: provide an opinion on the conformity of the device part with the relevant general safety and performance
p.000088: requirements set out in Annex I to that Regulation issued by a notified body designated in accordance
p.000088: with that Regulation for the type of device in question.
p.000088:
p.000088: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000088: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000088: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000088:
p.000088: 5.5.2017 EN
p.000088: Official Journal of the European Union
p.000089: L 117/89
p.000089:
p.000089: Article 118
p.000089:
p.000089: Amendment to Regulation (EC) No 178/2002
p.000089:
p.000089: In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
p.000089: ‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of
p.000089: the Council (*).
p.000089:
p.000089: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000089: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000089: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000089:
p.000089: Article 119
p.000089:
p.000089: Amendment to Regulation (EC) No 1223/2009
p.000089:
p.000089: In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
p.000089: ‘4. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures
p.000089: to determine whether or not a specific product or group of products falls within the definition
p.000089: ‘cosmetic product’. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article
p.000089: 32(2).’.
p.000089:
p.000089:
p.000089: Article 120
p.000089:
p.000089: Transitional provisions
p.000089:
p.000089: 1. From 26 May 2020, any publication of a notification in respect of a notified body
p.000089: in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
p.000089:
p.000089: 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC
p.000089: prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate,
...
p.000089: relating to post-market surveillance, market surveillance, vigilance, registration of economic operators
p.000089: and of devices shall apply in place of the corresponding requirements in those Directives.
p.000089:
p.000089: Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the
p.000089: certificate referred to in the first subparagraph shall continue to be responsible for the appropriate
p.000089: surveillance in respect of all of the applicable requirements relating to the devices it has certified.
p.000089:
p.000089: 4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to
p.000089: 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred
p.000089: to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27
p.000089: May 2025.
p.000089:
p.000089: 5. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may
p.000089: be placed on the market prior to 26 May 2020.
p.000089:
p.000089: 6. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which
p.000089: comply with this Regulation may be designated and notified prior 26 May 2020. Notified bodies which are
p.000089: designated and notified in accordance with this Regulation may carry out the conformity assessment
p.000089: procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May
p.000089: 2020.
p.000089:
p.000090: L 117/90 EN
p.000090: Official Journal of the European Union
p.000090: 5.5.2017
p.000090:
p.000090: 7. As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of
p.000090: this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made.
p.000090:
p.000090: 8. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC
p.000090: and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC,
p.000090: manufacturers, authorised representatives, importers and notified bodies which, during the period starting
p.000090: on the later of the dates referred to point (d) of Article 123(3) and ending 18 months later, comply
p.000090: with Article 29(4) and Article 56(5) of this Regulation shall be considered to comply with the laws
p.000090: and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive
p.000090: 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article
p.000090: 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as
p.000090: specified in Decision 2010/227/EU.
p.000090:
p.000090: 9. Authorisations granted by the competent authorities of the Member States in accordance with
p.000090: Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in
p.000090: the authorisation.
p.000090:
p.000090: 10. Devices falling within the scope of this Regulation in accordance with points (f) and (g) of
p.000090: Article 1(6) which have been legally placed on the market or put into service in accordance with the
...
p.000090: Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the
p.000090: obligations of the Member States and manufacturers as regards vigilance and to the obligations of
p.000090: manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC,
p.000090: those Directives are repealed with effect from 26 May 2020, with the exception of:
p.000090:
p.000090: — Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of
p.000090: Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the
p.000090: corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article
p.000090: 123(3) of this Regulation;
p.000090:
p.000090: — Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the obligations relating to
p.000090: registration of devices and economic operators, and to certificate notifications, provided for in the
p.000090: corresponding Annexes, which are repealed with effect from 18 months after the later of the dates
p.000090: referred to in point (d) of Article 123(3) of this Regulation;
p.000090:
p.000090: — Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of
p.000090: Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the
p.000090: corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article
p.000090: 123(3) of this Regulation; and
p.000090:
p.000090: 5.5.2017 EN
p.000090: Official Journal of the European Union
p.000091: L 117/91
p.000091:
p.000091: — Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and the
p.000091: obligations relating to registration of devices and economic operators, and to certificate notifications,
p.000091: provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later
p.000091: of the dates referred to in point (d) of Article 123(3) of this Regulation.
p.000091: As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives
p.000091: referred to in the first paragraph shall continue to apply until 27 May 2025 to the extent
p.000091: necessary for the application of those paragraphs.
p.000091:
p.000091: Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in
p.000091: force and continue to apply unless and until repealed by implementing acts adopted by the
p.000091: Commission pursuant to this Regulation.
p.000091:
p.000091: References to the repealed Directives shall be understood as references to this Regulation and shall be read in
p.000091: accordance with the correlation table laid down in Annex XVII to this Regulation.
p.000091:
p.000091: Article 123
p.000091: Entry into force and date of application
p.000091: 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official
p.000091: Journal of the European Union.
p.000091: 2. It shall apply from 26 May 2020.
p.000091: 3. By way of derogation from paragraph 2:
p.000091: (a) Articles 35 to 50 shall apply from 26 November 2017. However, from that date until 26 May 2020, the obligations
p.000091: on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an
p.000091: application for designation in accordance with Article 38;
p.000091: (b) Articles 101 and 103 shall apply from 26 November 2017;
p.000091: (c) Article 102 shall apply from 26 May 2018;
p.000091: (d) without prejudice to the obligations on the Commission pursuant to Article 34, where, due to
p.000091: circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article
p.000091: 34(1), Eudamed is not fully functional on 26 May 2020, the obligations and requirements that relate to
p.000091: Eudamed shall apply from the date corresponding to six months after the date of publication of the
p.000091: notice referred to in Article 34(3). The provisions referred to in the preceding sentence are:
p.000091: — Article 29,
p.000091: — Article 31,
p.000091: — Article 32,
p.000091: — Article 33(4),
p.000091: — the second sentence of Article 40(2),
p.000091: — Article 42(10),
p.000091: — Article 43(2),
p.000091: — the second subparagraph of Article 44(12),
p.000091: — points (d) and (e) of Article 46(7),
p.000091: — Article 53(2),
p.000091: — Article 54(3),
p.000091: — Article 55(1),
p.000091: — Articles 70 to 77,
p.000091: — paragraphs 1 to 13 of Article 78,
p.000091: — Articles 79 to 82,
p.000091: — Article 86(2),
p.000091: — Articles 87 and 88,
p.000091: — Article 89(5) and (7), and the third subparagraph of Article 89(8),
p.000091:
p.000092: L 117/92 EN
p.000092: Official Journal of the European Union
p.000092: 5.5.2017
p.000092:
p.000092: — Article 90,
p.000092:
p.000092: — Article 93(4), (7) and (8),
p.000092:
p.000092: — Article 95(2) and (4),
p.000092:
p.000092: — the last sentence of Article 97(2),
p.000092:
p.000092: — Article 99(4),
p.000092:
p.000092: — the second sentence of the first subparagraph of Article 120(3).
p.000092:
p.000092: Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC
p.000092: shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed
p.000092: in the first paragraph of this point regarding exchange of information including, and in particular,
p.000092: information regarding vigilance reporting, clinical investigations, registration of devices and economic
p.000092: operators, and certificate notifi cations.
p.000092:
p.000092: (e) Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates referred to in point (d);
p.000092:
p.000092: (f) for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For
p.000092: class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices
p.000092: Article 27(4) shall apply from 26 May 2025;
p.000092:
p.000092: (g) for reusable devices that shall bear the UDI carrier on the device itself, Article 27(4) shall apply from two
p.000092: years after the date referred to in point (f) of this paragraph for the respective class of devices in that point;
p.000092:
p.000092: (h) The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14);
p.000092:
p.000092: (i) Article 120(12) shall apply from 26 May 2019.
p.000092:
p.000092:
p.000092:
p.000092: This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 5
p.000092: April 2017.
p.000092:
p.000092: For the European Parliament The President
p.000092: A. TAJANI
p.000092: For the Council The President
p.000092: I. BORG
p.000092:
p.000092: 5.5.2017 EN
p.000092: Official Journal of the European Union
p.000093: L 117/93
p.000093:
p.000093: ANNEXES
p.000093:
p.000093: I General safety and performance requirements II Technical documentation
p.000093: III Technical documentation on post-market surveillance IV EU declaration of conformity
p.000093: V CE marking of conformity
p.000093:
p.000093: VI Information to be submitted upon the registration of devices and economic operators in
p.000093: accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together
p.000093: with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
p.000093:
p.000093: VII Requirements to be met by notified bodies VIII Classification rules
p.000093: IX Conformity assessment based on a quality management system and assessment of the technical documentation X
p.000093: Conformity assessment based on type examination
p.000093: XI Conformity assessment based on product conformity verification XII Certificates issued by a notified body
p.000093: XIII Procedure for custom-made devices
p.000093:
p.000093: XIV Clinical evaluation and post-market clinical follow-up XV Clinical investigations
p.000093: XVI List of groups of products without an intended medical purpose referred to in Article 1(2) XVII Correlation
p.000093: table
p.000093:
p.000094: L 117/94 EN
p.000094: Official Journal of the European Union
p.000094: 5.5.2017
p.000094:
p.000094: ANNEX I
p.000094:
p.000094: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000094:
p.000094: CHAPTER I
p.000094:
p.000094: GENERAL REQUIREMENTS
p.000094:
p.000094:
p.000094: 1. Devices shall achieve the performance intended by their manufacturer and shall be designed
p.000094: and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.
p.000094: They shall be safe and effective and shall not compromise the clinical condition or the safety of
p.000094: patients, or the safety and health of users or, where applicable, other persons, provided that any risks
p.000094: which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient
p.000094: and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged
p.000094: state of the art.
p.000094:
p.000094: 2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks
p.000094: as far as possible without adversely affecting the benefit-risk ratio.
p.000094:
p.000094: 3. Manufacturers shall establish, implement, document and maintain a risk management system.
p.000094:
p.000094: Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of
p.000094: a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:
p.000094:
...
p.000094: well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions,
p.000094: manufacturers shall, in the following order of priority:
p.000094:
p.000094: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000094:
p.000094: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000094: risks that cannot be eliminated; and
p.000094:
p.000094: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to
p.000094: users.
p.000094:
p.000094: Manufacturers shall inform users of any residual risks.
p.000094:
p.000094: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000094:
p.000094: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000094: environment in which the device is intended to be used (design for patient safety), and
p.000094:
p.000094: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000094: where applicable, and the medical and physical conditions of intended users (design for lay, professional,
p.000094: disabled or other users).
p.000094:
p.000094: 5.5.2017 EN
p.000094: Official Journal of the European Union
p.000095: L 117/95
p.000095:
p.000095: 6. The characteristics and performance of a device shall not be adversely affected to such a
p.000095: degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised
p.000095: during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the
p.000095: stresses which can occur during normal conditions of use and has been properly maintained in accordance
p.000095: with the manufacturer's instructions.
p.000095:
p.000095: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000095: performance during their intended use are not adversely affected during transport and storage,
p.000095: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000095: information provided by the manufacturer.
p.000095:
p.000095: 8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and
p.000095: be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the
p.000095: achieved performance of the device during normal conditions of use.
p.000095:
p.000095: 9. For the devices referred to in Annex XVI, the general safety requirements set out in
p.000095: Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for
p.000095: the purposes intended, does not present a risk at all or presents a risk that is no more than the
...
p.000095:
p.000095: (f) the mechanical properties of the materials used, reflecting, where appropriate, matters such as
p.000095: strength, ductility, fracture resistance, wear resistance and fatigue resistance;
p.000095:
p.000095: (g) surface properties; and
p.000095:
p.000095: (h) the confirmation that the device meets any defined chemical and/or physical specifications.
p.000095:
p.000095: 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk
p.000095: posed by contaminants and residues to patients, taking account of the intended purpose of the device,
p.000095: and to the persons involved in the transport, storage and use of the devices. Particular attention shall
p.000095: be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
p.000095:
p.000095: 10.3. Devices shall be designed and manufactured in such a way that they can be used safely with
p.000095: the materials and substances, including gases, with which they enter into contact during their intended
p.000095: use; if the devices are intended to administer medicinal products they shall be designed and manufactured
p.000095: in such a way as to be compatible with the medicinal products concerned in accordance with the
p.000095: provisions and restrictions governing those medicinal products and that the performance of both the
p.000095: medicinal products and of the devices is maintained in accordance with their respective indications and intended
p.000095: use.
p.000095:
p.000096: L 117/96 EN
p.000096: Official Journal of the European Union
p.000096: 5.5.2017
p.000096:
p.000096: 10.4. Substances
p.000096:
p.000096: 10.4.1. Design and manufacture of devices
p.000096:
p.000096: Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks
p.000096: posed by substances or particles, including wear debris, degradation products and processing residues, that
p.000096: may be released from the device.
p.000096: Devices, or those parts thereof or those materials used therein that:
p.000096: — are invasive and come into direct contact with the human body,
p.000096: — (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
p.000096: — transport or store such medicines, body fluids or substances, including gases, to be (re)administered
p.000096: to the body,
p.000096:
p.000096: shall only contain the following substances in a concentration that is above 0,1 % weight by weight
p.000096: (w/w) where justified pursuant to Section 10.4.2:
p.000096:
p.000096: (a) substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or
p.000096: 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
p.000096: and of the Council (1), or
p.000096:
p.000096: (b) substances having endocrine-disrupting properties for which there is scientific evidence of probable
p.000096: serious effects to human health and which are identified either in accordance with the procedure set out
p.000096: in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or,
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
...
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
...
p.000097: packaged to ensure that they remain in that state when placed on the market and remain so under the
p.000097: transport and storage conditions specified by the manufacturer.
p.000097:
p.000097: 11.4. Devices delivered in a sterile state shall be designed, manufactured and packaged
p.000097: in accordance with appropriate procedures, to ensure that they are sterile when placed on the
p.000097: market and that, unless the packaging which is intended to maintain their sterile condition is
p.000097: damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer,
p.000097: until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is
p.000097: clearly evident to the final user.
p.000097:
p.000097: 11.5. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means
p.000097: of appropriate, validated methods.
p.000097:
p.000097: 11.6. Devices intended to be sterilised shall be manufactured and packaged in appropriate and
p.000097: controlled conditions and facilities.
p.000097:
p.000097: 11.7. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product
p.000097: and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging
p.000097: system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
p.000097:
p.000098: L 117/98 EN
p.000098: Official Journal of the European Union
p.000098: 5.5.2017
p.000098:
p.000098: 11.8. The labelling of the device shall distinguish between identical or similar devices placed on
p.000098: the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are
p.000098: sterile.
p.000098:
p.000098: 12. Devices incorporating a substance considered to be a medicinal product and devices that are
p.000098: composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
p.000098:
p.000098: 12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality,
p.000098: safety and usefulness of the substance which, if used separately, would be considered to be a medicinal
p.000098: product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by
p.000098: analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable
p.000098: conformity assessment procedure under this Regulation.
p.000098:
p.000098: 12.2. Devices that are composed of substances or of combinations of substances that are intended to
p.000098: be introduced into the human body, and that are absorbed by or locally dispersed in the human body
p.000098: shall comply, where applicable and in a manner limited to the aspects not covered by this
p.000098: Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the
p.000098: evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with
...
p.000098: by manufacturers;
p.000098:
p.000098: (b) sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal
p.000098: origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where
p.000098: applicable, other persons. In particular safety with regard to viruses and other transmissible agents
p.000098: shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the
p.000098: manufacturing process, except when the use of such methods would lead to unacceptable degradation
p.000098: compromising the clinical benefit of the device;
p.000098:
p.000098: (c) in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as
p.000098: referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.
p.000098:
p.000098: 13.3. For devices manufactured utilising non-viable biological substances other than those
p.000098: referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those
p.000098: substances shall be carried out so as to provide safety for patients, users and, where applicable, other
p.000098: persons, including in the waste disposal chain. In particular, safety with regard to viruses and other
p.000098: transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated
p.000098: methods of elimination or inactivation in the course of the manufacturing process.
p.000098:
p.000098: 5.5.2017 EN
p.000098: Official Journal of the European Union
p.000099: L 117/99
p.000099:
p.000099: 14. Construction of devices and interaction with their environment
p.000099:
p.000099: 14.1. If the device is intended for use in combination with other devices or equipment the whole
p.000099: combination, including the connection system shall be safe and shall not impair the specified performance
p.000099: of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the
p.000099: instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical
p.000099: coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection.
p.000099:
p.000099: 14.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
p.000099:
p.000099: (a) the risk of injury, in connection with their physical features, including the
p.000099: volume/pressure ratio, dimensional and where appropriate ergonomic features;
p.000099:
p.000099: (b) risks connected with reasonably foreseeable external influences or environmental conditions,
p.000099: such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation
p.000099: associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in
p.000099: pressure and acceleration or radio signal interferences;
p.000099:
p.000099: (c) the risks associated with the use of the device when it comes into contact with materials,
p.000099: liquids, and substances, including gases, to which it is exposed during normal conditions of use;
p.000099:
...
p.000099:
p.000099: 14.6 Any measurement, monitoring or display scale shall be designed and manufactured in line with
p.000099: ergonomic principles, taking account of the intended purpose, users and the environmental conditions in
p.000099: which the devices are intended to be used.
p.000099:
p.000099: 14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe
p.000099: disposal and the safe disposal of related waste substances by the user, patient or other person. To
p.000099: that end, manufacturers shall identify and test procedures and measures as a result of which their
p.000099: devices can be safely disposed after use. Such procedures shall be described in the instructions for use.
p.000099:
p.000099: 15. Devices with a diagnostic or measuring function
p.000099:
p.000099: 15.1. Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way
p.000099: as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate
p.000099: scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer.
p.000099:
p.000099: 15.2. The measurements made by devices with a measuring function shall be expressed in legal units
p.000099: conforming to the provisions of Council Directive 80/181/EEC (1).
p.000099:
p.000099: (1) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member
p.000099: States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).
p.000099:
p.000100: L 117/100 EN
p.000100: Official Journal of the European Union
p.000100: 5.5.2017
p.000100:
p.000100: 16. Protection against radiation
p.000100:
p.000100: 16.1. General
p.000100:
p.000100: (a) Devices shall be designed, manufactured and packaged in such a way that exposure of patients,
p.000100: users and other persons to radiation is reduced as far as possible, and in a manner that is compatible
p.000100: with the intended purpose, whilst not restricting the application of appropriate specified levels for
p.000100: therapeutic and diagnostic purposes.
p.000100:
p.000100: (b) The operating instructions for devices emitting hazardous or potentially hazardous radiation shall
p.000100: contain detailed information as to the nature of the emitted radiation, the means of protecting the
p.000100: patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation
p.000100: as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance
p.000100: criteria, and the maintenance procedure shall also be specified.
p.000100:
p.000100: 16.2. Intended radiation
p.000100:
p.000100: (a) Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or
p.000100: non- ionizing radiation necessary for a specific medical purpose the benefit of which is considered to
p.000100: outweigh the risks inherent to the emission, it shall be possible for the user to control the
p.000100: emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable
p.000100: parameters within an acceptable tolerance.
p.000100:
...
p.000100: whilst minimising radiation exposure of the patient and user.
p.000100:
p.000100: (d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed
p.000100: and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the
p.000100: beam type, energy and, where appropriate, the quality of radiation.
p.000100:
p.000100: 17. Electronic programmable systems — devices that incorporate electronic programmable systems and
p.000100: software that are devices in themselves
p.000100:
p.000100: 17.1. Devices that incorporate electronic programmable systems, including software, or software that
p.000100: are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000100: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate
p.000100: or reduce as far as possible consequent risks or impairment of performance.
p.000100:
p.000100: 17.2. For devices that incorporate software or for software that are devices in themselves, the
p.000100: software shall be developed and manufactured in accordance with the state of the art taking into account
p.000100: the principles of development life cycle, risk management, including information security, verification and
p.000100: validation.
p.000100:
p.000100: 5.5.2017 EN
p.000100: Official Journal of the European Union
p.000101: L 117/101
p.000101:
p.000101: 17.3. Software referred to in this Section that is intended to be used in combination with mobile
p.000101: computing platforms shall be designed and manufactured taking into account the specific features of the
p.000101: mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their
p.000101: use (varying environment as regards level of light or noise).
p.000101:
p.000101: 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics
p.000101: and IT security measures, including protection against unauthorised access, necessary to run the software as
p.000101: intended.
p.000101:
p.000101: 18. Active devices and devices connected to them
p.000101:
p.000101: 18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be
p.000101: adopted to eliminate or reduce as far as possible consequent risks.
p.000101:
p.000101: 18.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means
p.000101: of determining the state of the power supply and an appropriate warning or indication for when the
p.000101: capacity of the power supply becomes critical. If necessary, such warning or indication shall be given
p.000101: prior to the power supply becoming critical.
p.000101:
p.000101: 18.3. Devices where the safety of the patient depends on an external power supply shall include an
p.000101: alarm system to signal any power failure.
...
p.000101: maintained as indicated by the manufacturer.
p.000101:
p.000101: 18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against
p.000101: unauthorised access that could hamper the device from functioning as intended.
p.000101:
p.000101: 19. Particular requirements for active implantable devices
p.000101:
p.000101: 19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or
p.000101: minimize as far as possible:
p.000101: (a) risks connected with the use of energy sources with particular reference, where electricity is
p.000101: used, to insulation, leakage currents and overheating of the devices,
p.000101: (b) risks connected with medical treatment, in particular those resulting from the use of defibrillators
p.000101: or high- frequency surgical equipment, and
p.000101: (c) risks which may arise where maintenance and calibration are impossible, including:
p.000101: — excessive increase of leakage currents,
p.000101: — ageing of the materials used,
p.000101: — excess heat generated by the device,
p.000101: — decreased accuracy of any measuring or control mechanism.
p.000101: 19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure
p.000101: — if applicable, the compatibility of the devices with the substances they are intended to administer, and
p.000101: — the reliability of the source of energy.
p.000101:
p.000102: L 117/102 EN
p.000102: Official Journal of the European Union
p.000102: 5.5.2017
p.000102:
p.000102: 19.3. Active implantable devices and, if appropriate, their component parts shall be
p.000102: identifiable to allow any necessary measure to be taken following the discovery of a potential risk
p.000102: in connection with the devices or their component parts.
p.000102:
p.000102: 19.4. Active implantable devices shall bear a code by which they and their manufacturer can be
p.000102: unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be
p.000102: possible to read this code, if necessary, without the need for a surgical operation.
p.000102:
p.000102: 20. Protection against mechanical and thermal risks
p.000102:
p.000102: 20.1. Devices shall be designed and manufactured in such a way as to protect patients and users
p.000102: against mechanical risks connected with, for example, resistance to movement, instability and moving parts.
p.000102:
p.000102: 20.2. Devices shall be designed and manufactured in such a way as to reduce to the lowest
p.000102: possible level the risks arising from vibration generated by the devices, taking account of technical progress and
p.000102: of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified
p.000102: performance.
p.000102:
p.000102: 20.3. Devices shall be designed and manufactured in such a way as to reduce to the lowest
p.000102: possible level the risks arising from the noise emitted, taking account of technical progress and of the means
...
p.000102: the patient and of the user.
p.000102:
p.000102: 21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in
p.000102: the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable
p.000102: means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances
p.000102: from an energy and/or substance source.
p.000102:
p.000102: 21.3. The function of the controls and indicators shall be clearly specified on the devices. Where
p.000102: a device bears instructions required for its operation or indicates operating or adjustment parameters by
p.000102: means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
p.000102:
p.000102: 22. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
p.000102:
p.000102: 22.1. Devices for use by lay persons shall be designed and manufactured in such a way
p.000102: that they perform appropriately for their intended purpose taking into account the skills and the
p.000102: means available to lay persons and the influence resulting from variation that can be reasonably
p.000102: anticipated in the lay person's technique and environment. The information and instructions provided by
p.000102: the manufacturer shall be easy for the lay person to understand and apply.
p.000102:
p.000102: 5.5.2017 EN
p.000102: Official Journal of the European Union
p.000103: L 117/103
p.000103:
p.000103: 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:
p.000103:
p.000103: — ensure that the device can be used safely and accurately by the intended user at all stages of the
p.000103: procedure, if necessary after appropriate training and/or information,
p.000103:
p.000103: — reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle
p.000103: stick injuries, and
p.000103:
p.000103: — reduce as far as possible the risk of error by the intended user in the handling of the device
p.000103: and, if applicable, in the interpretation of the results.
p.000103:
p.000103: 22.3. Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
p.000103:
p.000103: — can verify that, at the time of use, the device will perform as intended by the manufacturer, and
p.000103:
p.000103: — if applicable, is warned if the device has failed to provide a valid result.
p.000103:
p.000103: CHAPTER III
p.000103:
p.000103: REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
p.000103:
p.000103:
p.000103: 23. Label and instructions for use
p.000103:
p.000103: 23.1. General requirements regarding the information supplied by the manufacturer
p.000103:
p.000103: Each device shall be accompanied by the information needed to identify the device and its manufacturer,
p.000103: and by any safety and performance information relevant to the user, or any other person, as appropriate.
p.000103: Such information may appear on the device itself, on the packaging or in the instructions for use, and
...
p.000103: use shall not be required for class I and class IIa devices if such devices can be used safely
p.000103: without any such instructions and unless otherwise provided for elsewhere in this Section.
p.000103:
p.000103: (e) Where multiple devices are supplied to a single user and/or location, a single copy of the
p.000103: instructions for use may be provided if so agreed by the purchaser who in any case may request further
p.000103: copies to be provided free of charge.
p.000103:
p.000103: (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the
p.000103: extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent
p.000103: implementing rules adopted pursuant to this Regulation.
p.000103:
p.000103: (g) Residual risks which are required to be communicated to the user and/or other person shall be included
p.000103: as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000103:
p.000103: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000103: internationally recognised symbols. Any symbol or identification colour used shall conform to the
p.000103: harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours
p.000103: shall be described in the documentation supplied with the device.
p.000103:
p.000104: L 117/104 EN
p.000104: Official Journal of the European Union
p.000104: 5.5.2017
p.000104:
p.000104: 23.2. Information on the label
p.000104:
p.000104: The label shall bear all of the following particulars:
p.000104: (a) the name or trade name of the device;
p.000104: (b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it
p.000104: is not obvious for the user, the intended purpose of the device;
p.000104: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000104: its registered place of business;
p.000104: (d) if the manufacturer has its registered place of business outside the Union, the name of the
p.000104: authorised rep resentative and address of the registered place of business of the authorised representative;
p.000104: (e) where applicable, an indication that the device contains or incorporates:
p.000104: — a medicinal substance, including a human blood or plasma derivative, or
p.000104: — tissues or cells, or their derivatives, of human origin, or
p.000104: — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
p.000104: (f) where applicable, information labelled in accordance with Section 10.4.5.;
p.000104: (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL
p.000104: NUMBER or an equivalent symbol, as appropriate;
p.000104: (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
p.000104: (i) an unambiguous indication of t the time limit for using or implanting the device safely,
p.000104: expressed at least in terms of year and month, where this is relevant;
p.000104: (j) where there is no indication of the date until when it may be used safely, the date of
p.000104: manufacture. This date of manufacture may be included as part of the lot number or serial number,
p.000104: provided the date is clearly identifiable;
p.000104: (k) an indication of any special storage and/or handling condition that applies;
p.000104: (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
p.000104: (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the
p.000104: device, and to any other person. This information may be kept to a minimum in which case more detailed information
p.000104: shall appear in the instructions for use, taking into account the intended users;
p.000104: (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication
p.000104: of single use shall be consistent across the Union;
p.000104: (o) if the device is a single-use device that has been reprocessed, an indication of that fact, the
p.000104: number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
p.000104: (p) if the device is custom-made, the words ‘custom-made device’;
p.000104: (q) an indication that the device is a medical device. If the device is intended for clinical investigation only,
p.000104: the words ‘exclusively for clinical investigation’;
p.000104: (r) in the case of devices that are composed of substances or of combinations of substances that are
p.000104: intended to be introduced into the human body via a body orifice or applied to the skin and that are
p.000104: absorbed by or locally dispersed in the human body, the overall qualitative composition of the device
p.000104: and quantitative information on the main constituent or constituents responsible for achieving the
p.000104: principal intended action;
p.000104: (s) for active implantable devices, the serial number, and for other implantable devices, the serial
p.000104: number or the lot number.
p.000104: 23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
p.000104:
p.000104: The following particulars shall appear on the sterile packaging:
p.000104: (a) an indication permitting the sterile packaging to be recognised as such,
p.000104: (b) a declaration that the device is in a sterile condition,
p.000104:
p.000104: 5.5.2017 EN
p.000104: Official Journal of the European Union
p.000105: L 117/105
p.000105:
p.000105: (c) the method of sterilisation,
p.000105:
p.000105: (d) the name and address of the manufacturer,
p.000105:
p.000105: (e) a description of the device,
p.000105:
p.000105: (f) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
p.000105:
p.000105: (g) if the device is custom-made, the words ‘custom-made device’,
p.000105:
p.000105: (h) the month and year of manufacture,
p.000105:
p.000105: (i) an unambiguous indication of the time limit for using or implanting the device safely expressed at
p.000105: least in terms of year and month, and
p.000105:
p.000105: (j) an instruction to check the instructions for use for what to do if the sterile packaging is
p.000105: damaged or unintentionally opened before use.
p.000105:
p.000105: 23.4. Information in the instructions for use
p.000105:
p.000105: The instructions for use shall contain all of the following particulars:
p.000105:
p.000105: (a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;
p.000105:
p.000105: (b) the device's intended purpose with a clear specification of indications, contra-indications, the patient target
p.000105: group or groups, and of the intended users, as appropriate;
p.000105:
p.000105: (c) where applicable, a specification of the clinical benefits to be expected.
p.000105:
p.000105: (d) where applicable, links to the summary of safety and clinical performance referred to in Article 32;
p.000105:
p.000105: (e) the performance characteristics of the device;
p.000105:
p.000105: (f) where applicable, information allowing the healthcare professional to verify if the device is
p.000105: suitable and select the corresponding software and accessories;
p.000105:
...
p.000105: (h) specifications the user requires to use the device appropriately, e.g. if the device has a measuring function,
p.000105: the degree of accuracy claimed for it;
p.000105:
p.000105: (i) details of any preparatory treatment or handling of the device before it is ready for use or
p.000105: during its use, such as sterilisation, final assembly, calibration, etc., including the levels of
p.000105: disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
p.000105:
p.000105: (j) any requirements for special facilities, or special training, or particular qualifications of the
p.000105: device user and/or other persons;
p.000105:
p.000105: (k) the information needed to verify whether the device is properly installed and is ready to perform
p.000105: safely and as intended by the manufacturer, together with, where relevant:
p.000105:
p.000105: — details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory
p.000105: cleaning or disinfection,
p.000105:
p.000105: — identification of any consumable components and how to replace them,
p.000105:
p.000105: — information on any necessary calibration to ensure that the device operates properly and safely during its
p.000105: intended lifetime, and
p.000105:
p.000105: — methods for eliminating the risks encountered by persons involved in installing, calibrating
p.000105: or servicing devices;
p.000105:
p.000105: (l) if the device is supplied sterile, instructions in the event of the sterile packaging being
p.000105: damaged or unintentionally opened before use;
p.000105:
p.000106: L 117/106 EN
p.000106: Official Journal of the European Union
p.000106: 5.5.2017
p.000106:
p.000106: (m) if the device is supplied non-sterile with the intention that it is sterilised before use, the
p.000106: appropriate instructions for sterilisation;
p.000106:
p.000106: (n) if the device is reusable, information on the appropriate processes for allowing reuse, including
p.000106: cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation
p.000106: appropriate to the Member State or Member States in which the device has been placed on the market.
p.000106: Information shall be provided to identify when the device should no longer be reused, e.g. signs of
p.000106: material degradation or the maximum number of allowable reuses;
p.000106:
p.000106: (o) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility
p.000106: of the manufacturer to comply with the general safety and performance requirements;
p.000106:
p.000106: (p) if the device bears an indication that it is for single use, information on known
p.000106: characteristics and technical factors known to the manufacturer that could pose a risk if the device
p.000106: were to be re-used. This information shall be based on a specific section of the manufacturer's risk
p.000106: management documentation, where such characteristics and technical factors shall be addressed in detail. If in
p.000106: accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be
p.000106: made available to the user upon request;
p.000106:
...
p.000106: changes in its performance that may affect safety,
p.000106:
p.000106: — warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable
p.000106: external influences or environmental conditions, such as magnetic fields, external electrical and electro magnetic
p.000106: effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity,
p.000106: or temperature,
p.000106:
p.000106: — warnings, precautions and/or measures to be taken as regards the risks of interference posed by the
p.000106: reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or
p.000106: therapeutic treatment or other procedures such as electromagnetic interference emitted by the device
p.000106: affecting other equipment,
p.000106:
p.000106: — if the device is intended to administer medicinal products, tissues or cells of human or animal
p.000106: origin, or their derivatives, or biological substances, any limitations or incompatibility in the
p.000106: choice of substances to be delivered,
p.000106:
p.000106: — warnings, precautions and/or limitations related to the medicinal substance or biological material that
p.000106: is incorporated into the device as an integral part of the device; and
p.000106:
p.000106: — precautions related to materials incorporated into the device that contain or consist of CMR substances or
p.000106: endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the
p.000106: patient or user;
p.000106:
p.000106: 5.5.2017 EN
p.000106: Official Journal of the European Union
p.000107: L 117/107
p.000107:
p.000107: (t) in the case of devices that are composed of substances or of combinations of substances that are intended to
p.000107: be introduced into the human body and that are absorbed by or locally dispersed in the human body,
p.000107: warnings and precautions, where appropriate, related to the general profile of interaction of the device and its
p.000107: products of metabolism with other devices, medicinal products and other substances as well as contra-
p.000107: indications, undesirable side-effects and risks relating to overdose;
p.000107:
p.000107: (u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and
p.000107: substances to which patients can be exposed;
p.000107:
p.000107: (v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories
p.000107: and the consumables used with it, if any. This information shall cover, where appropriate:
p.000107:
p.000107: — infection or microbial hazards such as explants, needles or surgical equipment contaminated with
p.000107: potentially infectious substances of human origin, and
p.000107:
p.000107: — physical hazards such as from sharps.
p.000107:
p.000107: If in accordance with the point (d) of Section 23.1 no instructions for use are required, this
p.000107: information shall be made available to the user upon request;
p.000107:
p.000107: (w) for devices intended for use by lay persons, the circumstances in which the user
p.000107: should consult a healthcare professional;
p.000107:
p.000107: (x) for the devices covered by this Regulation pursuant to Article 1(2), information regarding the
p.000107: absence of a clinical benefit and the risks related to use of the device;
p.000107:
p.000107: (y) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000107: identifier of the latest revision of the instructions for use;
p.000107:
p.000107: (z) a notice to the user and/or patient that any serious incident that has occurred in relation to
p.000107: the device should be reported to the manufacturer and the competent authority of the Member State in
p.000107: which the user and/or patient is established;
p.000107:
p.000107: (aa) information to be supplied to the patient with an implanted device in accordance with Article 18;
p.000107:
p.000107: (ab) for devices that incorporate electronic programmable systems, including software, or software that
p.000107: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000107: security measures, including protection against unauthorised access, necessary to run the software as
p.000107: intended.
p.000107:
p.000108: L 117/108 EN
p.000108: Official Journal of the European Union
p.000108: 5.5.2017
p.000108:
p.000108: ANNEX II
p.000108:
p.000108: TECHNICAL DOCUMENTATION
p.000108:
p.000108: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000108: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in
p.000108: particular the elements listed in this Annex.
p.000108:
p.000108: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000108:
p.000108: 1.1. Device description and specification
p.000108:
p.000108: (a) product or trade name and a general description of the device including its intended purpose and
p.000108: intended users;
p.000108: (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device
p.000108: in question, as soon as identification of this device becomes based on a UDI system, or otherwise a
p.000108: clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
p.000108: (c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored and
p.000108: other considerations such as patient selection criteria, indications, contra-indications, warnings;
p.000108: (d) principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
p.000108: (e) the rationale for the qualification of the product as a device;
p.000108: (f) the risk class of the device and the justification for the classification rule(s) applied in
p.000108: accordance with Annex VIII;
p.000108: (g) an explanation of any novel features;
p.000108: (h) a description of the accessories for a device, other devices and other products that are not
p.000108: devices, which are intended to be used in combination with it;
p.000108: (i) a description or complete list of the various configurations/variants of the device that are
p.000108: intended to be made available on the market;
p.000108: (j) a general description of the key functional elements, e.g. its parts/components (including
p.000108: software if appropriate), its formulation, its composition, its functionality and, where
p.000108: relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled
p.000108: pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key
p.000108: parts/components, including sufficient explanation to understand the drawings and diagrams;
p.000108: (k) a description of the raw materials incorporated into key functional elements and those making
p.000108: either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal
p.000108: circulation of body fluids;
p.000108: (l) technical specifications, such as features, dimensions and performance attributes, of the
p.000108: device and any variants/configurations and accessories that would typically appear in the product
p.000108: specification made available to the user, for example in brochures, catalogues and similar publications.
p.000108:
p.000108: 1.2. Reference to previous and similar generations of the device
p.000108:
p.000108: (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such
p.000108: devices exist;
p.000108: (b) an overview of identified similar devices available on the Union or international markets, where
p.000108: such devices exist.
p.000108:
p.000108: 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
p.000108:
p.000108: A complete set of:
p.000108: — the label or labels on the device and on its packaging, such as single unit packaging, sales
p.000108: packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member
p.000108: States where the device is envisaged to be sold; and
p.000108:
p.000108: 5.5.2017 EN
p.000108: Official Journal of the European Union
p.000109: L 117/109
p.000109:
p.000109: — the instructions for use in the languages accepted in the Member States where the device is
p.000109: envisaged to be sold.
p.000109:
p.000109: 3. DESIGN AND MANUFACTURING INFORMATION
p.000109:
p.000109: (a) information to allow the design stages applied to the device to be understood;
p.000109:
p.000109: (b) complete information and specifications, including the manufacturing processes and their validation,
p.000109: their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the
p.000109: technical documentation;
p.000109:
p.000109: (c) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities
p.000109: are performed.
p.000109:
p.000109: 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000109:
p.000109: The documentation shall contain information for the demonstration of conformity with the general safety
p.000109: and performance requirements set out in Annex I that are applicable to the device taking into account
p.000109: its intended purpose, and shall include a justification, validation and verification of the solutions
p.000109: adopted to meet those requirements. The demonstration of conformity shall include:
p.000109:
p.000109: (a) the general safety and performance requirements that apply to the device and an explanation as to
p.000109: why others do not apply;
p.000109:
p.000109: (b) the method or methods used to demonstrate conformity with each applicable general safety and
p.000109: performance requirement;
p.000109: (c) the harmonised standards, CS or other solutions applied; and
p.000109: (d) the precise identity of the controlled documents offering evidence of conformity with each
...
p.000109: The documentation shall contain information on:
p.000109: (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
p.000109: (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
p.000109:
p.000109: 6. PRODUCT VERIFICATION AND VALIDATION
p.000109:
p.000109: The documentation shall contain the results and critical analyses of all verifications and validation
p.000109: tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this
p.000109: Regulation and in particular the applicable general safety and performance requirements.
p.000109:
p.000109: 6.1. Pre-clinical and clinical data
p.000109:
p.000109: (a) results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation
p.000109: of published literature applicable to the device, taking into account its intended purpose, or to similar
p.000109: devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
p.000109:
p.000109: (b) detailed information regarding test design, complete test or study protocols, methods of data
p.000109: analysis, in addition to data summaries and test conclusions regarding in particular:
p.000109:
p.000109: — the biocompatibility of the device including the identification of all materials in direct or indirect
p.000109: contact with the patient or user;
p.000109: — physical, chemical and microbiological characterisation;
p.000109: — electrical safety and electromagnetic compatibility;
p.000109:
p.000110: L 117/110 EN
p.000110: Official Journal of the European Union
p.000110: 5.5.2017
p.000110:
p.000110: — software verification and validation (describing the software design and development process and
p.000110: evidence of the validation of the software, as used in the finished device. This information shall
p.000110: typically include the summary results of all verification, validation and testing performed both in-house
p.000110: and in a simulated or actual user environment prior to final release. It shall also address all of the
p.000110: different hardware config urations and, where applicable, operating systems identified in the
p.000110: information supplied by the manufacturer);
p.000110:
p.000110: — stability, including shelf life; and
p.000110:
p.000110: — performance and safety.
p.000110:
p.000110: Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and
p.000110: of the Council (1) shall be demonstrated.
p.000110:
p.000110: Where no new testing has been undertaken, the documentation shall incorporate a rationale for that
p.000110: decision. An example of such a rationale would be that biocompatibility testing on identical materials
p.000110: was conducted when those materials were incorporated in a previous version of the device that has been
p.000110: legally placed on the market or put into service;
p.000110:
p.000110: (c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in
p.000110: Article 61(12) and Part A of Annex XIV;
p.000110:
p.000110: (d) the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not
p.000110: applicable.
p.000110:
p.000110: 6.2. Additional information required in specific cases
p.000110:
...
p.000110: human body, detailed information, including test design, complete test or study protocols, methods
p.000110: of data analysis, and data summaries and test conclusions, regarding studies in relation to:
p.000110:
p.000110: — absorption, distribution, metabolism and excretion;
p.000110:
p.000110: — possible interactions of those substances, or of their products of metabolism in the human body, with other
p.000110: devices, medicinal products or other substances, considering the target population, and its
p.000110: associated medical conditions;
p.000110:
p.000110: — local tolerance; and
p.000110:
p.000110: — toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and
p.000110: reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device.
p.000110:
p.000110: In the absence of such studies, a justification shall be provided.
p.000110:
p.000110: (d) In the case of devices containing CMR or endocrine-disrupting substances referred to in Section
p.000110: 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
p.000110:
p.000110: (1) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of
p.000110: laws, regulations and administrative provisions relating to the application of the principles of good
p.000110: laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50,
p.000110: 20.2.2004, p. 44).
p.000110:
p.000110: 5.5.2017 EN
p.000110: Official Journal of the European Union
p.000111: L 117/111
p.000111:
p.000111: (e) In the case of devices placed on the market in a sterile or defined microbiological condition, a
p.000111: description of the environmental conditions for the relevant manufacturing steps. In the case of devices
p.000111: placed on the market in a sterile condition, a description of the methods used, including the validation
p.000111: reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report
p.000111: shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
p.000111:
p.000111: (f) In the case of devices placed on the market with a measuring function, a description of the
p.000111: methods used in order to ensure the accuracy as given in the specifications.
p.000111:
p.000111: (g) If the device is to be connected to other device(s) in order to operate as intended, a
p.000111: description of this combination/configuration including proof that it conforms to the general
p.000111: safety and performance requirements when connected to any such device(s) having regard to the
p.000111: characteristics specified by the manufacturer.
p.000111:
p.000112: L 117/112 EN
p.000112: Official Journal of the European Union
p.000112: 5.5.2017
p.000112:
p.000112: ANNEX III
p.000112:
p.000112: TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
p.000112:
p.000112: The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance
p.000112: with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and
p.000112: shall include in particular the elements described in this Annex.
p.000112:
p.000112: 1.1. The post-market surveillance plan drawn up in accordance with Article 84.
p.000112: The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation
p.000112: referred to in Article 83.
p.000112: (a) The post-market surveillance plan shall address the collection and utilization of available
p.000112: information, in particular:
p.000112: — information concerning serious incidents, including information from PSURs, and field safety corrective
p.000112: actions;
p.000112: — records referring to non-serious incidents and data on any undesirable side-effects;
p.000112: — information from trend reporting;
p.000112: — relevant specialist or technical literature, databases and/or registers;
p.000112: — information, including feedbacks and complaints, provided by users, distributors and importers; and
p.000112: — publicly available information about similar medical devices.
p.000112: (b) The post-market surveillance plan shall cover at least:
p.000112: — a proactive and systematic process to collect any information referred to in point (a). The process
p.000112: shall allow a correct characterisation of the performance of the devices and shall also allow a
p.000112: comparison to be made between the device and similar products available on the market;
p.000112: — effective and appropriate methods and processes to assess the collected data;
p.000112: — suitable indicators and threshold values that shall be used in the continuous reassessment of the
p.000112: benefit- risk analysis and of the risk management as referred to in Section 3 of Annex I;
p.000112: — effective and appropriate methods and tools to investigate complaints and analyse
p.000112: market-related experience collected in the field;
p.000112: — methods and protocols to manage the events subject to the trend report as provided for in Article
p.000112: 88, including the methods and protocols to be used to establish any statistically significant increase in
p.000112: the frequency or severity of incidents as well as the observation period;
p.000112: — methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and
p.000112: users;
p.000112: — reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
p.000112: — systematic procedures to identify and initiate appropriate measures including corrective actions;
p.000112: — effective tools to trace and identify devices for which corrective actions might be necessary; and
p.000112: — a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
p.000112: 1.2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
p.000112:
p.000112: 5.5.2017 EN
p.000112: Official Journal of the European Union
p.000113: L 117/113
p.000113:
p.000113: ANNEX IV
p.000113:
p.000113: EU DECLARATION OF CONFORMITY
p.000113:
p.000113: The EU declaration of conformity shall contain all of the following information:
p.000113:
p.000113: 1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in
p.000113: Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of
p.000113: their registered place of business where they can be contacted and their location be established;
p.000113:
p.000113: 2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
p.000113:
p.000113: 3. The Basic UDI-DI as referred to in Part C of Annex VI;
p.000113:
p.000113: 4. Product and trade name, product code, catalogue number or other unambiguous reference allowing
p.000113: identification and traceability of the device covered by the EU declaration of conformity, such
p.000113: as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the
p.000113: information allowing identifi cation and traceability may be provided by the Basic UDI-DI referred to in point 3;
p.000113:
p.000113: 5. Risk class of the device in accordance with the rules set out in Annex VIII;
p.000113:
p.000113: 6. A statement that the device that is covered by the present declaration is in conformity with this
p.000113: Regulation and, if applicable, with any other relevant Union legislation that provides for the
p.000113: issuing of an EU declaration of conformity;
p.000113:
p.000113: 7. References to any CS used and in relation to which conformity is declared;
p.000113:
p.000113: 8. Where applicable, the name and identification number of the notified body, a description of the
p.000113: conformity assessment procedure performed and identification of the certificate or certificates issued;
p.000113:
p.000113: 9. Where applicable, additional information;
p.000113:
p.000113: 10. Place and date of issue of the declaration, name and function of the person who signed it as
p.000113: well as an indication for, and on behalf of whom, that person signed, signature.
p.000113:
p.000114: L 117/114 EN
p.000114: Official Journal of the European Union
p.000114: 5.5.2017
p.000114:
p.000114: ANNEX V
p.000114:
p.000114: CE MARKING OF CONFORMITY
p.000114:
p.000114: 1. The CE marking shall consist of the initials ‘CE’ taking the following form:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
p.000114:
p.000114: 3. The various components of the CE marking shall have substantially the same vertical dimension, which
p.000114: may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
p.000114:
p.000114: 5.5.2017 EN
p.000114: Official Journal of the European Union
p.000115: L 117/115
p.000115:
p.000115: ANNEX VI
p.000115:
p.000115: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000115: WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN
p.000115: ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
p.000115:
p.000115: PART A
p.000115:
p.000115: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000115: WITH ARTICLES 29(4) AND 31
p.000115:
p.000115: Manufacturers or, when applicable, authorised representatives, and, when applicable, importers
p.000115: shall submit the information referred to in Section 1 and shall ensure that the information on their
p.000115: devices referred to in Section 2 is complete, correct and updated by the relevant party.
p.000115:
p.000115: 1. Information relating to the economic operator
p.000115:
p.000115: 1.1. type of economic operator(manufacturer, authorised representative, or importer),
p.000115: 1.2. name, address and contact details of the economic operator,
p.000115:
p.000115: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000115: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000115:
p.000115: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000115: referred to in Article 15.
p.000115:
p.000115: 2. Information relating to the device
p.000115:
p.000115: 2.1. Basic UDI-DI,
p.000115:
p.000115: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000115: identification number of that notified body and the link to the information that appears on the
p.000115: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000115: 2.3. Member State in which the device is to or has been placed on the market in the Union,
p.000115: 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made
p.000115: available,
p.000115: 2.5. risk class of the device,
p.000115: 2.6. reprocessed single-use device (y/n),
p.000115:
p.000115: 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of
p.000115: that substance,
p.000115:
p.000115: 2.8. presence of a substance which, if used separately, may be considered to be a medicinal
p.000115: product derived from human blood or human plasma and name of this substance,
p.000115: 2.9. presence of tissues or cells of human origin, or their derivatives (y/n),
p.000115:
p.000115: 2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in
p.000115: Regulation (EU) No 722/2012 (y/n),
p.000115:
p.000115: 2.11. where applicable, the single identification number of the clinical investigation or investigations
p.000115: conducted in relation to the device or a link to the clinical investigation registration in the electronic system on
p.000115: clinical investi gations,
p.000115:
p.000115: 2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose
p.000115: of the device is other than a medical purpose,
p.000115:
p.000115: 2.13. in the case of devices designed and manufactured by another legal or natural person
p.000115: as referred in Article 10(15), the name, address and contact details of that legal or natural person,
p.000115:
p.000116: L 117/116 EN
p.000116: Official Journal of the European Union
p.000116: 5.5.2017
p.000116:
p.000116: 2.14. in the case of class III or implantable devices, the summary of safety and clinical performance,
p.000116:
p.000116: 2.15. status of the device (on the market, no longer placed on the market, recalled, field safety
p.000116: corrective action initiated).
p.000116:
p.000116: PART B
p.000116:
p.000116: CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH
p.000116: ARTICLES 28 AND 29
p.000116:
p.000116:
p.000116: The manufacturer shall provide to the UDI database the UDI-DI and all of the following information
p.000116: relating to the manufacturer and the device:
p.000116:
p.000116: 1. quantity per package configuration,
p.000116:
p.000116: 2. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
p.000116:
p.000116: 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot
p.000116: number, serial number),
p.000116:
p.000116: 4. if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use,
p.000116: a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
p.000116:
p.000116: 5. name and address of the manufacturer (as indicated on the label),
p.000116:
p.000116: 6. the SRN issued in accordance with Article 31(2),
p.000116:
p.000116: 7. if applicable, name and address of the authorised representative (as indicated on the label),
p.000116:
p.000116: 8. the medical device nomenclature code as provided for in Article 26,
p.000116:
p.000116: 9. risk class of the device,
p.000116:
p.000116: 10. if applicable, name or trade name,
p.000116:
p.000116: 11. if applicable, device model, reference, or catalogue number,
p.000116:
p.000116: 12. if applicable, clinical size (including volume, length, gauge, diameter),
p.000116:
p.000116: 13. additional product description (optional),
p.000116:
p.000116: 14. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
p.000116:
p.000116: 15. if applicable, additional trade names of the device,
p.000116:
p.000116: 16. labelled as a single-use device (y/n),
p.000116:
p.000116: 17. if applicable, the maximum number of reuses,
p.000116:
p.000116: 18. device labelled sterile (y/n),
p.000116:
p.000116: 19. need for sterilisation before use (y/n),
p.000116:
p.000116: 20. containing latex (y/n),
p.000116:
p.000116: 21. where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
p.000116:
p.000116: 22. URL for additional information, such as electronic instructions for use (optional),
p.000116:
p.000116: 23. if applicable, critical warnings or contra-indications,
p.000116:
p.000116: 24. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action
p.000116: initiated).
p.000116:
p.000116: 5.5.2017 EN
p.000116: Official Journal of the European Union
p.000117: L 117/117
p.000117:
p.000117: PART C
p.000117:
p.000117: THE UDI SYSTEM
p.000117:
p.000117: 1. Definitions
p.000117:
p.000117: Automatic identification and data capture (‘AIDC’)
p.000117:
p.000117: AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart
p.000117: cards, biometrics and RFID.
p.000117:
p.000117: Basic UDI-DI
p.000117:
p.000117: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of
p.000117: the device unit of use. It is the main key for records in the UDI database and is referenced in
p.000117: relevant certificates and EU declarations of conformity.
p.000117:
p.000117: Unit of Use DI
p.000117:
p.000117: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000117: UDI is not labelled on the individual device at the level of its unit of use, for example in the
p.000117: event of several units of the same device being packaged together.
p.000117:
p.000117: Configurable device
p.000117:
p.000117: A configurable device is a device that consists of several components which can be
p.000117: assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
p.000117:
p.000117: Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia
p.000117: systems, physiological Monitoring systems, radiology information systems (RIS).
p.000117:
p.000117: Configuration
p.000117:
p.000117: Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a
p.000117: device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to
p.000117: meet specific needs.
p.000117: Configurations include inter alia:
p.000117: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an
p.000117: intended function in computed tomography.
p.000117: — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia. UDI-DI
p.000117: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the
p.000117: ‘access key’ to information stored in a UDI database.
p.000117:
p.000117: Human Readable Interpretation (‘HRI’)
p.000117:
p.000117: HRI is a legible interpretation of the data characters encoded in the UDI carrier.
p.000117:
p.000117: Packaging levels
p.000117:
p.000117: Packaging levels means the various levels of device packaging that contain a defined quantity of devices,
p.000117: such as a carton or case.
p.000117:
p.000117: UDI-PI
p.000117:
p.000117: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
p.000117:
p.000117: The different types of UDI-PIs include serial number, lot number, software identification and
p.000117: manufacturing or expiry date or both types of date.
p.000117:
p.000118: L 117/118 EN
p.000118: Official Journal of the European Union
p.000118: 5.5.2017
p.000118:
p.000118: Radio Frequency Identification RFID
p.000118:
p.000118: RFID is a technology that uses communication through the use of radio waves to exchange data between a
p.000118: reader and an electronic tag attached to an object, for the purpose of identification.
p.000118:
p.000118: Shipping containers
p.000118:
p.000118: A shipping container is a container in relation to which traceability is controlled by a process specific to logistics
p.000118: systems.
p.000118:
p.000118: Unique Device Identifier (‘UDI’)
p.000118:
p.000118: The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted
p.000118: device identification and coding standard. It allows the unambiguous identification of a specific device
p.000118: on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
p.000118:
p.000118: The word ‘Unique’ does not imply serialisation of individual production units.
p.000118:
p.000118: UDI carrier
p.000118:
p.000118: The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include,
p.000118: inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
p.000118: 2. General requirements
p.000118:
p.000118: 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking
p.000118: or labelling requirements laid down in Annex I to this Regulation.
p.000118:
p.000118: 2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
p.000118:
p.000118: 2.3. Only the manufacturer may place the UDI on the device or its packaging.
p.000118:
p.000118: 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2)
p.000118: may be used.
p.000118:
p.000118: 3. The UDI
...
p.000118: own UDI.
p.000118:
p.000118: 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI
p.000118: shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the
p.000118: UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or
p.000118: to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
p.000118:
p.000118: 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.
p.000118:
p.000118: 3.4. The UDI-DI shall be unique at each level of device packaging.
p.000118:
p.000118: 3.5. If a lot number, serial number, software identification or expiry date appears on the label,
p.000118: it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need
p.000118: to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the
p.000118: UDI-PI.
p.000118:
p.000118: 3.6. Each component that is considered to be a device and is commercially available on its own
p.000118: shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own
p.000118: UDI.
p.000118:
p.000118: 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.
p.000118:
p.000118: 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.
p.000118:
p.000118: 5.5.2017 EN
p.000118: Official Journal of the European Union
p.000119: L 117/119
p.000119:
p.000119: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to
p.000119: misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the
p.000119: following UDI database data elements shall require a new UDI-DI:
p.000119: (a) name or trade name,
p.000119: (b) device version or model,
p.000119: (c) labelled as single use,
p.000119: (d) packaged sterile,
p.000119: (e) need for sterilization before use,
p.000119: (f) quantity of devices provided in a package,
p.000119: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.
p.000119: 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record
p.000119: of the original device manufacturer's UDI.
p.000119:
p.000119: 4. UDI carrier
p.000119:
p.000119: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on
p.000119: the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000119:
p.000119: 4.2. In the event of there being significant space constraints on the unit of use packaging, the
p.000119: UDI carrier may be placed on the next higher packaging level.
p.000119:
p.000119: 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be
p.000119: required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton
p.000119: containing several individually packaged devices. However, when the healthcare provider is not expected to
...
p.000119:
p.000119: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000119: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000119: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000119: results in there being no space for the AIDC.
p.000119:
p.000119: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000119:
p.000119: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000119: standard provided by the issuing entities shall also be provided on the label.
p.000119:
p.000119: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000119: reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses
p.000119: shall be permanent and readable after each process performed to make the device ready for the subsequent
p.000119: use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in
p.000119: the following circumstances:
p.000119: (a) any type of direct marking would interfere with the safety or performance of the device;
p.000119: (b) the device cannot be directly marked because it is not technologically feasible.
p.000119: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000119:
p.000120: L 117/120 EN
p.000120: Official Journal of the European Union
p.000120: 5.5.2017
p.000120:
p.000120: 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the
p.000120: device's packaging, the placing of the UDI carrier on the packaging shall not be required.
p.000120:
p.000120: 4.13. In the case of single finished devices made up of multiple parts that must be assembled
p.000120: before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
p.000120:
p.000120: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal
p.000120: operation or storage.
p.000120:
p.000120: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for
p.000120: the device to operate or other data.
p.000120:
p.000120: 5. General principles of the UDI database
p.000120:
p.000120: 5.1. The UDI database shall support the use of all core UDI database data elements referred to in
p.000120: Part B of this Annex.
p.000120:
p.000120: 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying
p.000120: information and other device data elements in the UDI database.
p.000120:
p.000120: 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.
p.000120:
p.000120: 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices
p.000120: they have placed on the market, except for devices that are no longer available on the market.
p.000120:
p.000120: 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the
p.000120: device is in conformity with this Regulation.
p.000120:
p.000120: 5.6. The database shall allow for the linking of all the packaging levels of the device.
p.000120:
p.000120: 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.
p.000120:
p.000120: 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being
p.000120: made to an element, which does not require a new UDI-DI.
p.000120:
p.000120: 5.9. Internationally-accepted standards for data submission and updates shall, wherever possible, be
p.000120: used by the UDI database.
p.000120:
p.000120: 5.10. The user interface of the UDI database shall be available in all official languages of the
p.000120: Union. The use of free- text fields shall, however, be minimized in order to reduce translations.
p.000120:
p.000120: 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.
p.000120:
p.000120: 6. Rules for specific device types
p.000120:
p.000120: 6.1. Implantable devices:
p.000120: 6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or
p.000120: marked using AIDC, with a UDI (UDI-DI + UDI-PI);
p.000120: 6.1.2. The UDI-PI shall have at least the following characteristics:
p.000120: (a) the serial number for active implantable devices,
p.000120: (b) the serial number or lot number for other implantable devices.
p.000120: 6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.
p.000120:
p.000120: 6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
p.000120:
p.000120: 6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure
p.000120: to make the device ready for the next use.
p.000120:
p.000120: 6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
p.000120:
p.000120: 5.5.2017 EN
p.000120: Official Journal of the European Union
p.000121: L 117/121
p.000121:
p.000121: 6.3. Systems and procedure packs as referred to in Article 22
p.000121:
p.000121: 6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system
p.000121: or procedure pack with a UDI including both UDI-DI and UDI-PI.
p.000121:
p.000121: 6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device
p.000121: itself. Exemptions:
p.000121: (a) individual single-use disposable devices, the uses of which are generally known to the persons by whom they are
p.000121: intended to be used, which are contained within a system or procedure pack, and which are not intended for individual
p.000121: use outside the context of the system or procedure pack, shall not be required to bear their own UDI
p.000121: carrier;
p.000121: (b) devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to
p.000121: bear a UDI carrier when included within a system or procedure pack.
p.000121: 6.3.3. Placement of the UDI carrier on systems or procedure packs
p.000121: (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
p.000121: (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the
p.000121: outside of the packaging of the system or procedure pack or inside transparent packaging.
p.000121:
p.000121: 6.4. Configurable devices:
p.000121:
p.000121: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable
p.000121: device UDI.
p.000121:
p.000121: 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per
...
p.000121:
p.000121: 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a
p.000121: separate UDI.
p.000121:
p.000121: 6.5. Device Software
p.000121:
p.000121: 6.5.1. UDI assignment Criteria
p.000121:
p.000121: The UDI shall be assigned at the system level of the software. Only software which is commercially available on
p.000121: its own and software which constitutes a device in itself shall be subject to that requirement.
p.000121:
p.000121: The software identification shall be considered to be the manufacturing control mechanism and
p.000121: shall be displayed in the UDI-PI.
p.000121:
p.000121: 6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:
p.000121: (a) the original performance;
p.000121: (b) the safety or the intended use of the software;
p.000121: (c) interpretation of data.
p.000121: Such modifications include new or modified algorithms, database structures, operating platform, architecture
p.000121: or new user interfaces or new channels for interoperability.
p.000121:
p.000121: 6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
p.000121:
p.000121: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for
p.000121: safety purposes, security patches or operating efficiency.
p.000121:
p.000121: Minor software revisions shall be identified by a manufacturer-specific form of identification.
p.000121:
p.000122: L 117/122 EN
p.000122: Official Journal of the European Union
p.000122: 5.5.2017
p.000122:
p.000122: 6.5.4. UDI placement criteria for software
p.000122: (a) where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall
p.000122: bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the
p.000122: physical medium containing the software and its packaging shall be identical to the UDI assigned to the
p.000122: system level software;
p.000122: (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable
p.000122: plain-text format, such as an ‘about’ file, or included on the start-up screen;
p.000122: (c) software lacking a user interface such as middleware for image conversion, shall be capable of
p.000122: transmitting the UDI through an application programming interface (API);
p.000122: (d) only the human readable portion of the UDI shall be required in electronic displays of the
p.000122: software. The marking of UDI using AIDC shall not be required in the electronic displays, such as
p.000122: ‘about’ menu, splash screen etc.;
p.000122: (e) the human readable format of the UDI for the software shall include the Application Identifiers
p.000122: (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI
p.000122: and determining which standard is being used to create the UDI.
p.000122:
p.000122: 5.5.2017 EN
p.000122: Official Journal of the European Union
p.000123: L 117/123
p.000123:
p.000123: ANNEX VII
p.000123:
p.000123: REQUIREMENTS TO BE MET BY NOTIFIED BODIES
p.000123:
p.000123: 1. ORGANISATIONAL AND GENERAL REQUIREMENTS
p.000123:
p.000123: 1.1. Legal status and organisational structure
p.000123:
p.000123: 1.1.1. Each notified body shall be established under the national law of a Member State, or under the
p.000123: law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and
p.000123: status shall be fully documented. Such documentation shall include information about ownership and the legal
p.000123: or natural persons exercising control over the notified body.
p.000123:
p.000123: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of
p.000123: that organisation as well as its organisational structure and governance, and the relationship with the
p.000123: notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable
p.000123: to both the notified body and the organisation to which it belongs.
p.000123:
p.000123: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a
p.000123: third country or is owned by another legal entity, the activities and responsibilities of those entities,
p.000123: as well as their legal and operational relationships with the notified body, shall be clearly defined
p.000123: and documented. Personnel of those entities performing conformity assessment activities under this
p.000123: Regulation shall be subject to the applicable requirements of this Regulation.
p.000123:
p.000123: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000123: body shall be such that they ensure that there is confidence in the performance by the notified body
p.000123: and in the results of the conformity assessment activities it conducts.
p.000123:
p.000123: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
...
p.000123: and responsi bility for each of the following:
p.000123:
p.000123: — the provision of adequate resources for conformity assessment activities;
p.000123:
p.000123: — the development of procedures and policies for the operation of the notified body;
p.000123:
p.000123: — the supervision of implementation of the procedures, policies and quality management systems of the notified body;
p.000123:
p.000123: — the supervision of the notified body's finances;
p.000123:
p.000123: — the activities and decisions taken by the notified body, including contractual agreements;
p.000123:
p.000123: — the delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000123: defined activities;
p.000123:
p.000123: — the interaction with the authority responsible for notified bodies and the obligations regarding
p.000123: communi cations with other competent authorities, the Commission and other notified bodies.
p.000123:
p.000123: 1.2. Independence and impartiality
p.000123:
p.000123: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in
p.000123: relation to which it performs conformity assessment activities. The notified body shall also be independent
p.000123: of any other economic operator having an interest in the device as well as of any competitors of the
p.000123: manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for
p.000123: competing manufacturers.
p.000123:
p.000124: L 117/124 EN
p.000124: Official Journal of the European Union
p.000124: 5.5.2017
p.000124:
p.000124: 1.2.2. The notified body shall be organised and operated so as to safeguard the
p.000124: independence, objectivity and impartiality of its activities. The notified body shall document and
p.000124: implement a structure and procedures for safeguarding impartiality and for promoting and applying
p.000124: the principles of impartiality throughout its organisation, personnel and assessment activities. Such
p.000124: procedures shall provide for the identification, investi gation and resolution of any case in which a
p.000124: conflict of interest may arise, including involvement in consultancy services in the field of devices prior
p.000124: to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented.
p.000124:
p.000124: 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the
p.000124: conformity assessment tasks shall not:
p.000124:
p.000124: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess,
p.000124: nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use
p.000124: of assessed devices that are necessary for the operations of the notified body and the conduct of the
p.000124: conformity assessment, or the use of such devices for personal purposes;
p.000124:
p.000124: (b) be involved in the design, manufacture or construction, marketing, installation and use, or
p.000124: maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
p.000124:
...
p.000124: bodies and/or the competent authority and, on the other hand, the notified body.
p.000124:
p.000124: 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or
p.000124: subcontractors, or of any associated body, including the activities of its owners do not affect
p.000124: its independence, impartiality or the objectivity of its conformity assessment activities.
p.000124:
p.000124: 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable
p.000124: terms and conditions, taking into account the interests of small and medium-sized
p.000124: enterprises as defined in Recommen dation 2003/361/EC in relation to fees.
p.000124:
p.000124: 1.2.9. The requirements laid down in this Section in no way preclude exchanges of technical information and
p.000124: regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
p.000124:
p.000124: 1.3. Confidentiality
p.000124:
p.000124: 1.3.1. The notified body shall have documented procedures in place ensuring that its
p.000124: personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect
p.000124: the confidentiality of the information which comes into its possession during the performance of conformity
p.000124: assessment activities, except when disclosure is required by law.
p.000124:
p.000124: 5.5.2017 EN
p.000124: Official Journal of the European Union
p.000125: L 117/125
p.000125:
p.000125: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
p.000125: under this Regulation or any provision of national law giving effect to it, except in relation to the authorities
p.000125: responsible for notified bodies, competent authorities for medical devices in the Member States or the
p.000125: Commission. Proprietary rights shall be protected. The notified body shall have documented
p.000125: procedures in place in respect of the requirements of this Section.
p.000125:
p.000125: 1.4. Liability
p.000125:
p.000125: 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment
p.000125: activities, unless liability is assumed by the Member State in question in accordance with national law
p.000125: or that Member State is directly responsible for the conformity assessment.
p.000125:
p.000125: 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic
p.000125: scope of activities of the notified body and be commensurate with the risk profile of the devices
p.000125: certified by the notified body. The liability insurance shall cover cases where the notified body may be
p.000125: obliged to withdraw, restrict or suspend certificates.
p.000125:
p.000125: 1.5. Financial requirements
p.000125:
p.000125: The notified body shall have at its disposal the financial resources required to conduct its conformity
p.000125: assessment activities within its scope of designation and related business operations. It shall document
...
p.000125: relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
p.000125:
p.000125: 1.6.2. The notified body shall take into consideration guidance and best practice documents.
p.000125:
p.000125: 2. QUALITY MANAGEMENT REQUIREMENTS
p.000125:
p.000125: 2.1. The notified body shall establish, document, implement, maintain and operate a quality management
p.000125: system that is appropriate to the nature, area and scale of its conformity assessment activities and is
p.000125: capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.
p.000125:
p.000125: 2.2. The quality management system of the notified body shall address at least the following:
p.000125: — management system structure and documentation, including policies and objectives for its activities;
p.000125: — policies for assignment of activities and responsibilities to personnel;
p.000125: — assessment and decision-making processes in accordance with the tasks, responsibilities and role of
p.000125: the notified body's personnel and top-level management;
p.000125: — the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
p.000125: — control of documents;
p.000125: — control of records;
p.000125: — management reviews;
p.000125: — internal audits;
p.000125: — corrective and preventive actions;
p.000125: — complaints and appeals; and
p.000125: — continuous training.
p.000125: Where documents are used in various languages, the notified body shall ensure and control that they
p.000125: have the same content.
p.000125:
p.000126: L 117/126 EN
p.000126: Official Journal of the European Union
p.000126: 5.5.2017
p.000126:
p.000126: 2.3. The top-level management of the notified body shall ensure that the quality
p.000126: management system is fully understood, implemented and maintained throughout the notified body
p.000126: organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this
p.000126: Regulation.
p.000126:
p.000126: 2.4. The notified body shall require all personnel to formally commit themselves by a signature or
p.000126: equivalent to comply with the procedures defined by the notified body. That commitment shall cover
p.000126: aspects relating to confidentiality and to independence from commercial and other interests, and any
p.000126: existing or prior association with clients. The personnel shall be required to complete written statements
p.000126: indicating their compliance with confidentiality, independence and impartiality principles.
p.000126:
p.000126: 3. RESOURCE REQUIREMENTS
p.000126:
p.000126: 3.1. General
p.000126:
p.000126: 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this
p.000126: Regulation with the highest degree of professional integrity and the requisite competence in the specific field,
p.000126: whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
p.000126:
p.000126: In particular, notified bodies shall have the necessary personnel and possess or have access to all
p.000126: equipment, facilities and competence needed to perform properly the technical, scientific and administrative
...
p.000126: bility for all conformity assessment activities in relation to devices.
p.000126:
p.000126: 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain
p.000126: their qualifi cation and expertise by implementing a system for exchange of experience and a continuous
p.000126: training and education programme.
p.000126:
p.000126: 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of
p.000126: auth orisation of the personnel, including any subcontractors and external experts, involved in conformity
p.000126: assessment activities and inform those personnel accordingly.
p.000126:
p.000126: 3.2. Qualification criteria in relation to personnel
p.000126:
p.000126: 3.2.1. The Notified Body shall establish and document qualification criteria and procedures for selection
p.000126: and authoris ation of persons involved in conformity assessment activities, including as regards
p.000126: knowledge, experience and other competence required, and the required initial and ongoing training. The
p.000126: qualification criteria shall address the various functions within the conformity assessment process, such
p.000126: as auditing, product evaluation or testing, technical documentation review and decision-making, as well as
p.000126: the devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and
p.000126: animal origin and clinical evaluation, covered by the scope of designation.
p.000126:
p.000126: 5.5.2017 EN
p.000126: Official Journal of the European Union
p.000127: L 117/127
p.000127:
p.000127: 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified
p.000127: body's designation in accordance with the scope description used by the Member State for the notification
p.000127: referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the
p.000127: subdivisions of the scope description.
p.000127: Specific qualification criteria shall be defined at least for the assessment of:
p.000127: — the pre-clinical evaluation,
p.000127: — clinical evaluation,
p.000127: — tissues and cells of human and animal origin,
p.000127: — functional safety,
p.000127: — software,
p.000127: — packaging,
p.000127: — devices that incorporate as an integral part a medicinal product,
p.000127:
p.000127: — devices that are composed of substances or of combinations of substances that are absorbed by or
p.000127: locally dispersed in the human body and
p.000127: — the different types of sterilisation processes.
p.000127:
p.000127: 3.2.3. The personnel responsible for establishing qualification criteria and for authorising other
p.000127: personnel to perform specific conformity assessment activities shall be employed by the notified body
p.000127: itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all
p.000127: of the following:
p.000127: — Union devices legislation and relevant guidance documents;
p.000127: — the conformity assessment procedures provided for in this Regulation;
p.000127: — a broad base of knowledge of device technologies and the design and manufacture of devices;
p.000127: — the notified body's quality management system, related procedures and the required qualification criteria;
p.000127: — training relevant to personnel involved in conformity assessment activities in relation to devices;
p.000127:
p.000127: — adequate experience in conformity assessments under this Regulation or previously applicable law within
p.000127: a notified body.
p.000127:
p.000127: 3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise
p.000127: and where possible such personnel shall be employed by the notified body itself. Such
p.000127: personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
p.000127:
p.000127: — identify when specialist input is required for the assessment of the clinical evaluation conducted by
p.000127: the manufacturer and identify appropriately qualified experts;
p.000127:
p.000127: — appropriately train external clinical experts in the relevant requirements of this Regulation, CS,
p.000127: guidance and harmonised standards and ensure that the external clinical experts are fully aware
p.000127: of the context and implications of their assessment and the advice they provide;
p.000127:
p.000127: — be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any
p.000127: associated clinical investigations, and appropriately guide external clinical experts in the assessment of
p.000127: the clinical evaluation presented by the manufacturer;
p.000127:
p.000127: — be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results
p.000127: of the external clinical experts' assessment of the manufacturer's clinical evaluation;
p.000127:
p.000127: — be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by
p.000127: clinical experts;
p.000127:
p.000127: — be able to make an assessment of the manufacturer's clinical evaluation and a clinical judgement of
p.000127: the opinion provided by any external expert and make a recommendation to the notified body's decision
p.000127: maker; and
p.000127:
p.000127: — be able to draw up records and reports demonstrating that the relevant conformity assessment activities
p.000127: have been appropriately carried out.
p.000127:
p.000128: L 117/128 EN
p.000128: Official Journal of the European Union
p.000128: 5.5.2017
p.000128:
p.000128: 3.2.5. The personnel responsible for carrying out product-related reviews (product reviewers),
p.000128: such as technical documentation reviews or type examination, including aspects such as clinical evaluation,
p.000128: biological safety, sterili sation and software validation, shall have all of the following proven qualifications:
p.000128:
p.000128: — successful completion of a university or a technical college degree or equivalent qualification in
p.000128: relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
p.000128:
p.000128: — four years' professional experience in the field of healthcare products or related activities, such as in manufac
p.000128: turing, auditing or research, of which two years shall be in the design, manufacture, testing or use
p.000128: of the device or technology to be assessed or related to the scientific aspects to be assessed;
p.000128:
p.000128: — knowledge of device legislation, including the general safety and performance requirements set
p.000128: out in Annex I;
p.000128:
p.000128: — appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
p.000128:
p.000128: — appropriate knowledge and experience of risk management and related device standards and
p.000128: guidance documents;
p.000128:
p.000128: — appropriate knowledge and experience of clinical evaluation;
p.000128:
p.000128: — appropriate knowledge of the devices which they are assessing;
p.000128:
p.000128: — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to
...
p.000128: guidance documents;
p.000128:
p.000128: — appropriate knowledge of quality management systems and related standards and guidance documents;
p.000128:
p.000128: — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to
p.000128: XI, in particular of the aspects of those procedures for which they are responsible, and adequate
p.000128: authoris ation for carrying out those audits;
p.000128:
p.000128: — training in auditing techniques enabling them to challenge quality management systems;
p.000128:
p.000128: — the ability to draw up records and reports demonstrating that the relevant conformity assessment
p.000128: activities have been appropriately carried out.
p.000128:
p.000128: 3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be
p.000128: employed by the notified body itself and shall not be external experts or be subcontracted. Those
p.000128: personnel shall, as a group, have proven knowledge and comprehensive experience of all of the following:
p.000128:
p.000128: — devices legislation and relevant guidance documents;
p.000128:
p.000128: — the device conformity assessments relevant to this Regulation;
p.000128:
p.000128: — the types of qualifications, experience and expertise relevant to device conformity assessment;
p.000128:
p.000128: — a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of
p.000128: devices being reviewed for certification, the device industry and the design and manufacture of devices;
p.000128:
p.000128: 5.5.2017 EN
p.000128: Official Journal of the European Union
p.000129: L 117/129
p.000129:
p.000129: — the notified body's quality management system, related procedures and the required
p.000129: qualifications for personnel involved;
p.000129: — the ability to draw up records and reports demonstrating that the conformity assessment activities have
p.000129: been appropriately carried out.
p.000129:
p.000129: 3.3. Documentation of qualification, training and authorisation of personnel
p.000129:
p.000129: 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each
p.000129: member of personnel involved in conformity assessment activities and the satisfaction of the qualification
p.000129: criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the
p.000129: qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall
p.000129: justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry
p.000129: out specific conformity assessment activities.
p.000129:
p.000129: 3.3.2. For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and
p.000129: maintain up to date:
p.000129: — a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment
p.000129: activities; and
p.000129: — records attesting to the required knowledge and experience for the conformity assessment activity for
p.000129: which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for
p.000129: each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
p.000129:
...
p.000129: — final review and decision making functions.
p.000129: 3.4.2. Where a notified body subcontracts certain conformity assessment activities either to an
p.000129: organisation or an individual, it shall have a policy describing the conditions under which subcontracting
p.000129: may take place, and shall ensure that:
p.000129: — the subcontractor meets the relevant requirements of this Annex;
p.000129: — subcontractors and external experts do not further subcontract work to organisations or personnel; and
p.000129: — the natural or legal person that applied for conformity assessment has been informed of the
p.000129: requirements referred to in the first and second indent.
p.000129: Any subcontracting or consultation of external personnel shall be properly documented, shall not involve
p.000129: any intermediaries and shall be subject to a written agreement covering, among other things,
p.000129: confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks
p.000129: performed by subcon tractors.
p.000129:
p.000129: 3.4.3. Where subcontractors or external experts are used in the context of a conformity assessment, in
p.000129: particular regarding novel, invasive and implantable devices or technologies, the notified body in
p.000129: question shall have internal competence in each product area for which it is designated that is adequate
p.000129: for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity
p.000129: of expert opinions and making decisions on certification.
p.000129:
p.000130: L 117/130 EN
p.000130: Official Journal of the European Union
p.000130: 5.5.2017
p.000130:
p.000130: 3.5. Monitoring of competences, training and exchange of experience
p.000130:
p.000130: 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going
p.000130: monitoring of the competence, conformity assessment activities and performance of all internal and external
p.000130: personnel, and subcon tractors, involved in conformity assessment activities.
p.000130:
p.000130: 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify
p.000130: training needs and draw up a training plan to maintain the required level of qualification and knowledge
p.000130: of individual personnel. That review shall at a minimum, verify that personnel:
p.000130:
p.000130: — are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance
p.000130: documents and the results of the coordination activities referred to in Section 1.6; and
p.000130:
p.000130: — take part in the internal exchange of experience and the continuous training and education programme
p.000130: referred to in Section 3.1.2.
p.000130:
p.000130: 4. PROCESS REQUIREMENTS
p.000130:
p.000130: 4.1. General
p.000130:
p.000130: The notified body shall have in place documented processes and sufficiently detailed procedures for the
p.000130: conduct of each conformity assessment activity for which it is designated, comprising the individual steps
p.000130: from pre- application activities up to decision making and surveillance and taking into account, when
p.000130: necessary, the respective specificities of the devices.
p.000130:
p.000130: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the
p.000130: internal activities of notified bodies and shall not be subcontracted.
p.000130: 4.2. Notified body quotations and pre-application activities The notified body shall:
p.000130:
p.000130: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000130: obtain certification from it. That description shall include which languages are acceptable for
p.000130: submission of documentation and for any related correspondence;
p.000130:
p.000130: (b) have documented procedures relating to, and documented details about, fees charged for specific
p.000130: conformity assessment activities and any other financial conditions relating to notified bodies' assessment
p.000130: activities for devices;
...
p.000130:
p.000130: (d) have documented procedures requiring the review of pre-application information, including the
p.000130: preliminary verification that the product is covered by this Regulation and its classification, prior to issuing any
p.000130: quotation to the manufacturer relating to a specific conformity assessment; and
p.000130:
p.000130: (e) ensure that all contracts relating to the conformity assessment activities covered by this
p.000130: Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation.
p.000130:
p.000130: 4.3. Application review and contract
p.000130:
p.000130: The notified body shall require a formal application signed by a manufacturer or an authorised
p.000130: representative containing all of the information and the manufacturer's declarations required by
p.000130: the relevant conformity assessment as referred to in Annexes IX to XI.
p.000130:
p.000130: The contract between a notified body and a manufacturer shall take the form of a written agreement
p.000130: signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions
p.000130: and contain obligations that enable the notified body to act as required under this Regulation, including
p.000130: an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the
p.000130: notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its
p.000130: information obligations.
p.000130:
p.000130: 5.5.2017 EN
p.000130: Official Journal of the European Union
p.000131: L 117/131
p.000131:
p.000131: The notified body shall have documented procedures to review applications, addressing:
p.000131:
p.000131: (a) the completeness of those applications with respect to the requirements of the relevant
p.000131: conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought,
p.000131:
p.000131: (b) the verification of the qualification of products covered by those applications as devices and their
p.000131: respective classifications,
p.000131:
p.000131: (c) whether the conformity assessment procedures chosen by the applicant are applicable to the device
p.000131: in question under this Regulation,
p.000131: (d) the ability of the notified body to assess the application based on its designation, and
p.000131: (e) the availability of sufficient and appropriate resources.
p.000131:
p.000131: The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be
p.000131: notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.
p.000131:
p.000131: 4.4. Allocation of resources
p.000131:
p.000131: The notified body shall have documented procedures to ensure that all conformity assessment activities
p.000131: are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the
p.000131: evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment.
p.000131:
p.000131: For each application, the notified body shall determine the resources needed and identify one
p.000131: individual responsible for ensuring that the assessment of that application is conducted in accordance
...
p.000131: designated, taking account of the relevant requirements set out in Annexes IX to XI, and in
p.000131: particular all of the following requirements:
p.000131: — appropriately plan the conduct of each individual project,
p.000131:
p.000131: — ensure that the composition of the assessment teams is such that there is sufficient experience in
p.000131: relation to the technology concerned, and that there is continuous objectivity and independence, and to
p.000131: provide for rotation of the members of the assessment team at appropriate intervals,
p.000131: — specify the rationale for fixing time limits for completion of conformity assessment activities,
p.000131:
p.000131: — assess the manufacturer's technical documentation and the solutions adopted to meet the requirements
p.000131: laid down in Annex I,
p.000131: — review the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects,
p.000131: — review the manufacturer's procedures and documentation relating to clinical evaluation,
p.000131:
p.000131: — address the interface between the manufacturer's risk management process and its appraisal and analysis
p.000131: of the pre-clinical and clinical evaluation and to evaluate their relevance for the demonstration of
p.000131: conformity with the relevant requirements in Annex I,
p.000131: — carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX,
p.000131:
p.000131: — in the case of class IIa or class IIb devices, assess the technical documentation of devices selected on a represen
p.000131: tative basis,
p.000131:
p.000132: L 117/132 EN
p.000132: Official Journal of the European Union
p.000132: 5.5.2017
p.000132:
p.000132: — plan and periodically carry out appropriate surveillance audits and assessments, carry out or request
p.000132: certain tests to verify the proper functioning of the quality management system and to perform unannounced on site
p.000132: audits,
p.000132:
p.000132: — relating to the sampling of devices, verify that the manufactured device is in conformity with the
p.000132: technical documentation; such requirements shall define the relevant sampling criteria and testing procedure
p.000132: prior to sampling,
p.000132:
p.000132: — evaluate and verify a manufacturer's compliance with relevant Annexes.
p.000132:
p.000132: The notified body shall, where relevant, take into consideration available CS, guidance and
p.000132: best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance.
p.000132:
p.000132:
p.000132: 4.5.2. Quality management system auditing
p.000132:
p.000132: (a) As part of the assessment of the quality management system, a notified body shall prior to an
p.000132: audit and in accordance with its documented procedures:
p.000132:
p.000132: — assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw
p.000132: up an audit programme which clearly identifies the number and sequence of activities required to
p.000132: demonstrate complete coverage of a manufacturer's quality management system and to determine whether it meets the
p.000132: requirements of this Regulation,
p.000132:
p.000132: — identify links between, and allocation of responsibilities among, the various manufacturing sites, and
p.000132: identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to
...
p.000132: The respective roles, responsibilities and authorities of the team members shall be clearly defined and
p.000132: documented.
p.000132:
p.000132: (b) Based on the audit programme it has drawn up, the notified body shall, in accordance with its
p.000132: documented procedures:
p.000132:
p.000132: — audit the manufacturer's quality management system, in order to verify that the quality management
p.000132: system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices
p.000132: at every stage, from design through final quality control to ongoing surveillance, and shall determine
p.000132: whether the requirements of this Regulation are met,
p.000132:
p.000132: — based on relevant technical documentation and in order to determine whether the manufacturer meets the
p.000132: requirements referred to in the relevant conformity assessment Annex, review and audit the manufac turer's
p.000132: processes and subsystems, in particular for:
p.000132:
p.000132: — design and development,
p.000132:
p.000132: — production and process controls,
p.000132:
p.000132: — product documentation,
p.000132:
p.000132: — purchasing controls including verification of purchased devices,
p.000132:
p.000132: — corrective and preventive actions, including for post-market surveillance, and
p.000132:
p.000132: — PMCF,
p.000132:
p.000132: and review and audit requirements and provisions adopted by the manufacturer, including those in relation
p.000132: to fulfilling the general safety and performance requirements set out in Annex I.
p.000132:
p.000132: 5.5.2017 EN
p.000132: Official Journal of the European Union
p.000133: L 117/133
p.000133:
p.000133: The documentation shall be sampled in such a manner as to reflect the risks associated with the intended use of the
p.000133: device, the complexity of the manufacturing technologies, the range and classes of devices produced and any
p.000133: available post-market surveillance information,
p.000133:
p.000133: — if not already covered by the audit programme, audit the control of processes on the premises of
p.000133: the manufacturer's suppliers, when the conformity of finished devices is significantly influenced
p.000133: by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient
p.000133: control over its suppliers,
p.000133:
p.000133: — conduct assessments of the technical documentation based on its sampling plan and taking account of
p.000133: Sections 4.5.4. and 4.5.5. for pre-clinical and clinical evaluations, and
p.000133:
p.000133: — the notified body shall ensure that audit findings are appropriately and consistently
p.000133: classified in accordance with the requirements of this Regulation and with relevant standards, or with
p.000133: best practice documents developed or adopted by the MDCG.
p.000133:
p.000133: 4.5.3. Product verification
p.000133:
p.000133: Assessment of the technical documentation
p.000133:
p.000133: For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX,
p.000133: notified bodies shall have sufficient expertise, facilities and documented procedures for:
p.000133:
p.000133: — the allocation of appropriately qualified and authorised personnel for the examination of individual
...
p.000133:
p.000133: — examine and assess the technical documentation taking account of Sections 4.5.4. to 4.5.6., and verify
p.000133: that the type has been manufactured in conformity with that documentation;
p.000133:
p.000133: — establish a test plan identifying all relevant and critical parameters which need to be tested by
p.000133: the notified body or under its responsibility;
p.000133:
p.000133: — document its rationale for the selection of those parameters;
p.000133:
p.000133: — carry out the appropriate examinations and tests in order to verify that the solutions
p.000133: adopted by the manufacturer meet the general safety and performance requirements set out in Annex I.
p.000133: Such examinations and tests shall include all tests necessary to verify that the manufacturer has in
p.000133: fact applied the relevant standards it has opted to use;
p.000133:
p.000133: — agree with the applicant as to where the necessary tests will be performed if they are not to be
p.000133: carried out directly by the notified body; and
p.000133:
p.000133: — assume full responsibility for test results. Test reports submitted by the manufacturer shall only be
p.000133: taken into account if they have been issued by conformity assessment bodies which are competent and
p.000133: independent of the manufacturer.
p.000133: Verification by examination and testing of every product The notified body shall:
p.000133:
p.000133: (a) have documented procedures, sufficient expertise and facilities for the verification by examination and
p.000133: testing of every product in accordance with Part B of Annex XI;
p.000133:
p.000134: L 117/134 EN
p.000134: Official Journal of the European Union
p.000134: 5.5.2017
p.000134:
p.000134: (b) establish a test plan identifying all relevant and critical parameters which need to be tested by
p.000134: the notified body or under its responsibility in order to:
p.000134: — verify, for class IIb devices, the conformity of the device with the type described in the EU
p.000134: type-exami nation certificate and with the requirements of this Regulation which apply to those devices,
p.000134: — confirm, for class IIa devices, the conformity with the technical documentation referred to in Annexes
p.000134: II and III and with the requirements of this Regulation which apply to those devices;
p.000134: (c) document its rationale for the selection of the parameters referred to in point (b);
p.000134: (d) have documented procedures to carry out the appropriate assessments and tests in order to verify
p.000134: the conformity of the device with the requirements of this Regulation by examining and testing every product
p.000134: as specified in Section 15 of Annex XI;
p.000134: (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and
p.000134: where necessary tests that are not to be carried out by the notified body itself are to be performed; and
p.000134: (f) assume full responsibility for test results in accordance with documented procedures; test reports
p.000134: submitted by the manufacturer shall only be taken into account if they have been issued by conformity
p.000134: assessment bodies which are competent and independent of the manufacturer.
p.000134:
p.000134: 4.5.4. Pre-clinical evaluation assessment
p.000134:
p.000134: The notified body shall have documented procedures in place for the review of the manufacturer's
...
p.000134: results of literature searches and all validation, verification and testing performed and conclusions
p.000134: drawn, and shall typically include considering the use of alternative materials and substances and take
p.000134: account of the packaging, stability, including shelf life, of the finished device. Where no new testing has been
p.000134: undertaken by a manufacturer or where there are deviations from procedures, the notified body in question
p.000134: shall critically examine the justifi cation presented by the manufacturer.
p.000134:
p.000134: 4.5.5. Clinical evaluation assessment
p.000134:
p.000134: The notified body shall have documented procedures in place relating to the assessment of a
p.000134: manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity
p.000134: assessment and on an ongoing basis. The notified body shall examine, validate and verify that manufacturers'
p.000134: procedures and documen tation adequately address:
p.000134: — the planning, conduct, assessment, reporting and updating of the clinical evaluation as
p.000134: referred to in Annex XIV,
p.000134: — post-market surveillance and PMCF,
p.000134: — the interface with the risk management process,
p.000134: — the appraisal and analysis of the available data and its relevance with regard to demonstrating
p.000134: conformity with the relevant requirements in Annex I, and
p.000134: — the conclusions drawn with regard to the clinical evidence and drawing up of the clinical evaluation report.
p.000134:
p.000134: 5.5.2017 EN
p.000134: Official Journal of the European Union
p.000135: L 117/135
p.000135:
p.000135: These procedures referred to in the first paragraph shall take into consideration available CS, guidance
p.000135: and best practice documents.
p.000135:
p.000135: The notified body's assessment of clinical evaluations as referred to in Annex XIV shall cover:
p.000135:
p.000135: — the intended use specified by the manufacturer and claims for the device defined by it,
p.000135:
p.000135: — the planning of the clinical evaluation,
p.000135:
p.000135: — the methodology for the literature search,
p.000135:
p.000135: — relevant documentation from the literature search,
p.000135:
p.000135: — the clinical investigation,
p.000135:
p.000135: — validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the
p.000135: suitability and conclusions data from equivalent and similar devices,
p.000135:
p.000135: — post-market surveillance and PMCF,
p.000135:
p.000135: — the clinical evaluation report, and
p.000135:
p.000135: — justifications in relation to non-performance of clinical investigations or PMCF.
p.000135:
p.000135: In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in
p.000135: question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the
p.000135: approved clinical investigation plan.
p.000135:
p.000135: The notified body shall ensure that the clinical evaluation adequately addresses the relevant
p.000135: safety and performance requirements provided for in Annex I, that it is appropriately aligned with the
p.000135: risk management requirements, that it is conducted in accordance with Annex XIV and that it is
...
p.000135: they are designated.
p.000135:
p.000135: In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives,
p.000135: such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have
p.000135: documented procedures in place that fulfil the requirements laid down in that Regulation, including for
p.000135: the preparation of a summary evaluation report for the relevant competent authority.
p.000135:
p.000135:
p.000135: 4.6. Reporting
p.000135:
p.000135: The notified body shall:
p.000135:
p.000135: — ensure that all steps of the conformity assessment are documented so that the conclusions of the
p.000135: assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent
p.000135: objective evidence of such compliance to persons that are not themselves involved in the assessment, for
p.000135: example personnel in designating authorities,
p.000135:
p.000135: — ensure that records that are sufficient to provide a discernible audit trail are available for quality
p.000135: management system audits,
p.000135:
p.000135: — clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation
p.000135: assessment report, and
p.000135:
p.000135: — for each specific project, provide a detailed report which shall be based on a standard format
p.000135: containing a minimum set of elements determined by the MDCG.
p.000135:
p.000136: L 117/136 EN
p.000136: Official Journal of the European Union
p.000136: 5.5.2017
p.000136:
p.000136: The report of the notified body shall:
p.000136:
p.000136: — clearly document the outcome of its assessment and draw clear conclusions from the verification of
p.000136: the manufacturer's conformity with the requirements of this Regulation,
p.000136:
p.000136: — make a recommendation for a final review and for a final decision to be taken by the notified
p.000136: body; this recommendation shall be signed off by the member of personnel responsible in the notified body, and
p.000136:
p.000136: — be provided to the manufacturer in question.
p.000136:
p.000136:
p.000136: 4.7. Final review
p.000136:
p.000136: The notified body shall prior to making a final decision:
p.000136:
p.000136: — ensure that the personnel assigned for the final review and decision-making on specific
p.000136: projects are appropriately authorised and are different from the personnel who have conducted the assessments,
p.000136:
p.000136: — verify that the report or reports and supporting documentation needed for decision making,
p.000136: including concerning resolution of non-conformities noted during assessment, are complete and sufficient
p.000136: with respect to the scope of the application, and
p.000136:
p.000136: — verify whether there are any unresolved non-conformities preventing issuance of a certificate.
p.000136:
p.000136:
p.000136: 4.8. Decisions and Certifications
p.000136:
p.000136: The notified body shall have documented procedures for decision-making including as regards the allocation
p.000136: of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those
p.000136: procedures shall include the notification requirements laid down in Chapter V of this Regulation. The
...
p.000136:
p.000136: — decide whether specific conditions or provisions need to be defined for the certification,
p.000136:
p.000136: — decide, based on the novelty, risk classification, clinical evaluation and conclusions from the risk
p.000136: analysis of the device, on a period of certification not exceeding five years,
p.000136:
p.000136: — clearly document decision making and approval steps including approval by signature of the members of
p.000136: personnel responsible,
p.000136:
p.000136: — clearly document responsibilities and mechanisms for communication of decisions, in particular, where
p.000136: the final signatory of a certificate differs from the decision maker or decision makers or does not
p.000136: fulfil the requirements laid down in Section 3.2.7,
p.000136:
p.000136: — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex
p.000136: XII for a period of validity not exceeding five years and shall indicate whether there are specific
p.000136: conditions or limitations associated with the certification,
p.000136:
p.000136: — issue a certificate or certificates for the applicant alone and shall not issue certificates covering
p.000136: multiple entities, and
p.000136:
p.000136: — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that
p.000136: they are entered into the electronic system referred to in Article 57.
p.000136:
p.000136: 5.5.2017 EN
p.000136: Official Journal of the European Union
p.000137: L 117/137
p.000137:
p.000137: 4.9. Changes and modifications
p.000137:
p.000137: The notified body shall have documented procedures and contractual arrangements with manufacturers in
p.000137: place relating to the manufacturers' information obligations and the assessment of changes to:
p.000137:
p.000137: — the approved quality management system or systems or to the product-range covered,
p.000137:
p.000137: — the approved design of a device,
p.000137:
p.000137: — the intended use of or claims made for the device,
p.000137:
p.000137: — the approved type of a device, and
p.000137:
p.000137: — any substance incorporated in or utilised for the manufacturing of a device and being subject to the
p.000137: specific procedures in accordance with Section 4.5.6.
p.000137:
p.000137: The procedures and contractual arrangements referred to in the first paragraph shall include measures for
p.000137: checking the significance of the changes referred to in the first paragraph.
p.000137:
p.000137: In accordance with its documented procedures, the notified body in question shall:
p.000137:
p.000137: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and
p.000137: relevant information relating to such changes,
p.000137:
p.000137: — assess the changes proposed and verify whether, after these changes, the quality management system, or
p.000137: the design of a device or type of a device, still meets the requirements of this Regulation, and
p.000137:
p.000137: — notify the manufacturer of its decision and provide a report or as applicable a supplementary report,
p.000137: which shall contain the justified conclusions of its assessment.
...
p.000137: activities, and
p.000137:
p.000137: — to review vigilance data to which they have access under Article 92(2) in order to estimate its
p.000137: impact, if any, on the validity of existing certificates. The results of the evaluation and
p.000137: any decisions taken shall be thoroughly documented.
p.000137:
p.000137: The notified body in question shall, upon receipt of information about vigilance cases from a
p.000137: manufacturer or competent authorities, decide which of the following options to apply:
p.000137:
p.000137: — not to take action on the basis that the vigilance case is clearly not related to the certification granted,
p.000137:
p.000137: — observe the manufacturer's and competent authority's activities and the results of the manufacturer's
p.000137: investi gation so as to determine whether the certification granted is at risk or whether adequate
p.000137: corrective action has been taken,
p.000137:
p.000137: — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits
p.000137: and product testing, where it is likely that the certification granted is at risk,
p.000137:
p.000137: — increase the frequency of surveillance audits,
p.000137:
p.000137: — review specific products or processes on the occasion of the next audit of the manufacturer, or
p.000137:
p.000137: — take any other relevant measure.
p.000137:
p.000138: L 117/138 EN
p.000138: Official Journal of the European Union
p.000138: 5.5.2017
p.000138:
p.000138: In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
p.000138:
p.000138: — conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned
p.000138: and conducted in line with the relevant requirements in Section 4.5,
p.000138:
p.000138: — ensure adequate assessment of the manufacturer's documentation on, and application of the provisions
p.000138: on, vigilance, the post-market surveillance, and PMCF,
p.000138:
p.000138: — sample and test devices and technical documentation, during audits, according to pre-defined
p.000138: sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved
p.000138: quality management system,
p.000138:
p.000138: — ensure that the manufacturer complies with the documentation and information obligations laid down in
p.000138: the relevant Annexes and that its procedures take into account best practices in the implementation of
p.000138: quality management systems,
p.000138:
p.000138: — ensure that the manufacturer does not use quality management system or device approvals in a
p.000138: misleading manner,
p.000138:
p.000138: — gather sufficient information to determine if the quality management system continues to comply with
p.000138: the requirements of this Regulation,
p.000138:
p.000138: — ask the manufacturer, if non-conformities are detected, for corrections, corrective actions
p.000138: and, where applicable, preventive actions, and
p.000138:
p.000138: — where necessary, impose specific restrictions on the relevant certificate, or suspend or withdraw it. The notified
p.000138: body shall, if listed as part of the conditions for certification:
...
p.000138:
p.000138: 4.11. Re-certification
p.000138:
p.000138: The notified body shall have documented procedures in place relating to the re-certification reviews and
p.000138: the renewal of certificates. Re-certification of approved quality management systems or EU technical
p.000138: documentation assessment certificates or EU type-examination certificates shall occur at least every five years.
p.000138:
p.000138: The notified body shall have documented procedures relating to renewals of EU technical
p.000138: documentation assessment certificates and EU type-examination certificates and those procedures shall require
p.000138: the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
p.000138:
p.000138: (a) all changes to the originally approved device, including changes not yet notified,
p.000138:
p.000138: (b) experience gained from post-market surveillance,
p.000138:
p.000138: (c) experience from risk management,
p.000138:
p.000138: (d) experience from updating the proof of compliance with the general safety and performance requirements
p.000138: set out in Annex I,
p.000138:
p.000138: (e) experience from reviews of the clinical evaluation, including the results of any clinical
p.000138: investigations and PMCF,
p.000138:
p.000138: (f) changes to the requirements, to components of the device or to the scientific or regulatory environment,
p.000138:
p.000138: (g) changes to applied or new harmonised standards, CS or equivalent documents, and
p.000138:
p.000138: 5.5.2017 EN
p.000138: Official Journal of the European Union
p.000139: L 117/139
p.000139:
p.000139: (h) changes in medical, scientific and technical knowledge, such as:
p.000139:
p.000139: — new treatments,
p.000139:
p.000139: — changes in test methods,
p.000139:
p.000139: — new scientific findings on materials and components, including findings on their biocompatibility,
p.000139:
p.000139: — experience from studies on comparable devices,
p.000139:
p.000139: — data from registers and registries,
p.000139:
p.000139: — experience from clinical investigations with comparable devices.
p.000139:
p.000139: The notified body shall have documented procedures to assess the information referred to in
p.000139: the second paragraph and shall pay particular attention to clinical data from post-market surveillance
p.000139: and PMCF activities undertaken since the previous certification or re-certification, including appropriate
p.000139: updates to manufacturers' clinical evaluation reports.
p.000139:
p.000139: For the decision on re-certification, the notified body in question shall use the same methods and
p.000139: principles as for the initial certification decision. If necessary, separate forms shall be established for
p.000139: re-certification taking into account the steps taken for certification such as application and application review.
p.000139:
p.000140: L 117/140 EN
p.000140: Official Journal of the European Union
p.000140: 5.5.2017
p.000140:
p.000140: ANNEX VIII
p.000140:
p.000140: CLASSIFICATION RULES
p.000140:
p.000140: CHAPTER I
p.000140:
p.000140: DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
p.000140:
p.000140: 1. DURATION OF USE
p.000140:
p.000140: 1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
p.000140:
p.000140: 1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
p.000140:
p.000140: 1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
p.000140:
p.000140: 2. INVASIVE AND ACTIVE DEVICES
p.000140:
p.000140: 2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the
p.000140: eyeball, or any permanent artificial opening, such as a stoma.
p.000140:
p.000140: 2.2. ‘Surgically invasive device’ means:
p.000140: (a) an invasive device which penetrates inside the body through the surface of the body, including
p.000140: through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
p.000140: (b) a device which produces penetration other than through a body orifice.
p.000140: 2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting,
p.000140: drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection
p.000140: to an active device and which is intended by the manufacturer to be reused after appropriate
p.000140: procedures such as cleaning, disinfection and sterilisation have been carried out.
p.000140:
p.000140: 2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with
...
p.000140:
p.000140: 2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus
p.000140: aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria
p.000140: carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae
p.000140: pulmonales, vena cava superior and vena cava inferior.
p.000140:
p.000140: 2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.
p.000140:
p.000140: 2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a
p.000140: pathological change or change following disease or a wound.
p.000140:
p.000140: CHAPTER II
p.000140:
p.000140: IMPLEMENTING RULES
p.000140:
p.000140: 3.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.000140:
p.000140: 3.2. If the device in question is intended to be used in combination with another device, the
p.000140: classification rules shall apply separately to each of the devices. Accessories for a medical device and
p.000140: for a product listed in Annex XVI shall be classified in their own right separately from the device with which
p.000140: they are used.
p.000140:
p.000140: 3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the
p.000140: device.
p.000140:
p.000140: If the software is independent of any other device, it shall be classified in its own right.
p.000140:
p.000140: 5.5.2017 EN
p.000140: Official Journal of the European Union
p.000141: L 117/141
p.000141:
p.000141: 3.4. If the device is not intended to be used solely or principally in a specific part of the
p.000141: body, it shall be considered and classified on the basis of the most critical specified use.
p.000141:
p.000141: 3.5. If several rules, or if, within the same rule, several sub-rules, apply to the same device
p.000141: based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall
p.000141: apply.
p.000141:
p.000141: 3.6. In calculating the duration referred to in Section 1, continuous use shall mean:
p.000141: (a) the entire duration of use of the same device without regard to temporary interruption of use
p.000141: during a procedure or temporary removal for purposes such as cleaning or disinfection of the device.
p.000141: Whether the interruption of use or the removal is temporary shall be established in relation to the
p.000141: duration of the use prior to and after the period when the use is interrupted or the device removed; and
p.000141: (b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of
p.000141: the same type.
p.000141: 3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease
p.000141: or condition in question by itself or when it provides decisive information for the diagnosis.
p.000141:
p.000141: CHAPTER III
p.000141:
p.000141: CLASSIFICATION RULES
p.000141:
p.000141: 4. NON-INVASIVE DEVICES
p.000141:
p.000141: 4.1. Rule 1
p.000141:
p.000141: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
p.000141:
p.000141: 4.2. Rule 2
p.000141:
...
p.000141: — if they are intended for use for channelling or storing blood or other body liquids or for storing organs,
p.000141: parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
p.000141: In all other cases, such devices are classified as class I.
p.000141:
p.000141: 4.3. Rule 3
p.000141:
p.000141: All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells,
p.000141: blood, other body liquids or other liquids intended for implantation or administration into the body are classified as
p.000141: class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of
p.000141: gas, heat, in which case they are classified as class IIa.
p.000141:
p.000141: All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct
p.000141: contact with human cells, tissues or organs taken from the human body or used in vitro with human
p.000141: embryos before their implantation or administration into the body are classified as class III.
p.000141:
p.000141: 4.4. Rule 4
p.000141:
p.000141: All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
p.000141: — class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
p.000141: — class IIb if they are intended to be used principally for injuries to skin which have breached the
p.000141: dermis or mucous membrane and can only heal by secondary intent;
p.000141:
p.000142: L 117/142 EN
p.000142: Official Journal of the European Union
p.000142: 5.5.2017
p.000142:
p.000142: — class IIa if they are principally intended to manage the micro-environment of injured skin
p.000142: or mucous membrane; and
p.000142: — class IIa in all other cases.
p.000142: This rule applies also to the invasive devices that come into contact with injured mucous membrane.
p.000142:
p.000142: 5. INVASIVE DEVICES
p.000142:
p.000142: 5.1. Rule 5
p.000142:
p.000142: All invasive devices with respect to body orifices, other than surgically invasive devices, which are
p.000142: not intended for connection to an active device or which are intended for connection to a class I active device are
p.000142: classified as:
p.000142: — class I if they are intended for transient use;
p.000142: — class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx,
p.000142: in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and
p.000142: — class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the
p.000142: pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be
p.000142: absorbed by the mucous membrane, in which case they are classified as class IIa.
p.000142: All invasive devices with respect to body orifices, other than surgically invasive devices, intended for
p.000142: connection to a class IIa, class IIb or class III active device, are classified as class IIa.
p.000142:
p.000142: 5.2. Rule 6
p.000142:
p.000142: All surgically invasive devices intended for transient use are classified as class IIa unless they:
...
p.000142: — are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
p.000142: — have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or
p.000142: — are intended to administer medicinal products by means of a delivery system, if such administration
p.000142: of a medicinal product is done in a manner that is potentially hazardous taking account of the mode
p.000142: of application, in which case they are classified as class IIb.
p.000142:
p.000142: 5.3. Rule 7
p.000142:
p.000142: All surgically invasive devices intended for short-term use are classified as class IIa unless they:
p.000142: — are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the
p.000142: central circulatory system through direct contact with those parts of the body, in which case they are
p.000142: classified as class III;
p.000142: — are intended specifically for use in direct contact with the heart or central circulatory system or
p.000142: the central nervous system, in which case they are classified as class III;
p.000142: — are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;
p.000142: — have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;
p.000142: — are intended to undergo chemical change in the body in which case they are classified as class IIb,
p.000142: except if the devices are placed in the teeth; or
p.000142: — are intended to administer medicines, in which case they are classified as class IIb.
p.000142:
p.000142: 5.5.2017 EN
p.000142: Official Journal of the European Union
p.000143: L 117/143
p.000143:
p.000143: 5.4. Rule 8
p.000143:
p.000143: All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
p.000143: — are intended to be placed in the teeth, in which case they are classified as class IIa;
p.000143:
p.000143: — are intended to be used in direct contact with the heart, the central circulatory system or the
p.000143: central nervous system, in which case they are classified as class III;
p.000143:
p.000143: — have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;
p.000143:
p.000143: — are intended to undergo chemical change in the body in which case they are classified as class III, except if the
p.000143: devices are placed in the teeth;
p.000143:
p.000143: — are intended to administer medicinal products, in which case they are classified as class III;
p.000143: — are active implantable devices or their accessories, in which cases they are classified as class III;
p.000143: — are breast implants or surgical meshes, in which cases they are classified as class III;
p.000143:
p.000143: — are total or partial joint replacements, in which case they are classified as class III, with the
p.000143: exception of ancillary components such as screws, wedges, plates and instruments; or
p.000143:
p.000143: — are spinal disc replacement implants or are implantable devices that come into contact with the
p.000143: spinal column, in which case they are classified as class III with the exception of components such as
p.000143: screws, wedges, plates and instruments.
p.000143:
p.000143: 6. ACTIVE DEVICES
p.000143:
p.000143: 6.1. Rule 9
p.000143:
p.000143: All active therapeutic devices intended to administer or exchange energy are classified as class IIa
...
p.000143: All active devices that are intended for controlling, monitoring or directly influencing the performance
p.000143: of active implantable devices are classified as class III.
p.000143:
p.000143:
p.000143: 6.2. Rule 10
p.000143:
p.000143: Active devices intended for diagnosis and monitoring are classified as class IIa:
p.000143:
p.000143: — if they are intended to supply energy which will be absorbed by the human body, except for devices
p.000143: intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
p.000143:
p.000143: — if they are intended to image in vivo distribution of radiopharmaceuticals; or
p.000143:
p.000143: — if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless
p.000143: they are specifically intended for monitoring of vital physiological parameters and the nature of
p.000143: variations of those parameters is such that it could result in immediate danger to the patient, for
p.000143: instance variations in cardiac performance, respiration, activity of the central nervous system, or they
p.000143: are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they
p.000143: are classified as class IIb.
p.000143:
p.000143: Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology,
p.000143: including interventional radiology devices and devices which control or monitor such devices, or which
p.000143: directly influence their performance, are classified as class IIb.
p.000143:
p.000144: L 117/144 EN
p.000144: Official Journal of the European Union
p.000144: 5.5.2017
p.000144:
p.000144: 6.3. Rule 11
p.000144:
p.000144: Software intended to provide information which is used to take decisions with diagnosis or therapeutic
p.000144: purposes is classified as class IIa, except if such decisions have an impact that may cause:
p.000144: — death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
p.000144: — a serious deterioration of a person's state of health or a surgical intervention, in which case it
p.000144: is classified as class IIb.
p.000144:
p.000144: Software intended to monitor physiological processes is classified as class IIa, except if it
p.000144: is intended for monitoring of vital physiological parameters, where the nature of variations of those
p.000144: parameters is such that it could result in immediate danger to the patient, in which case it is classified as
p.000144: class IIb.
p.000144:
p.000144: All other software is classified as class I.
p.000144:
p.000144: 6.4. Rule 12
p.000144:
p.000144: All active devices intended to administer and/or remove medicinal products, body liquids or other
p.000144: substances to or from the body are classified as class IIa, unless this is done in a manner that is
p.000144: potentially hazardous, taking account of the nature of the substances involved, of the part of the body
p.000144: concerned and of the mode of application in which case they are classified as class IIb.
p.000144:
p.000144: 6.5. Rule 13
p.000144:
p.000144: All other active devices are classified as class I.
p.000144:
p.000144: 7. SPECIAL RULES
p.000144:
p.000144: 7.1. Rule 14
p.000144:
...
p.000144: to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a
p.000144: medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of
p.000144: that Directive, and that has an action ancillary to that of the devices, are classified as class III.
p.000144:
p.000144: 7.2. Rule 15
p.000144:
p.000144: All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified
p.000144: as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class
p.000144: III.
p.000144:
p.000144: 7.3. Rule 16
p.000144:
p.000144: All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate,
p.000144: hydrating contact lenses are classified as class IIb.
p.000144:
p.000144: All devices intended specifically to be used for disinfecting or sterilising medical devices are
p.000144: classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended
p.000144: specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are
p.000144: classified as class IIb.
p.000144:
p.000144: This rule does not apply to devices that are intended to clean devices other than contact lenses by
p.000144: means of physical action only.
p.000144:
p.000144: 7.4. Rule 17
p.000144:
p.000144: Devices specifically intended for recording of diagnostic images generated by X-ray radiation are
p.000144: classified as class IIa.
p.000144:
p.000144: 5.5.2017 EN
p.000144: Official Journal of the European Union
p.000145: L 117/145
p.000145:
p.000145: 7.5. Rule 18
p.000145:
p.000145: All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives,
p.000145: which are non- viable or rendered non-viable, are classified as class III, unless such devices are
p.000145: manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or
p.000145: rendered non-viable and are devices intended to come into contact with intact skin only.
p.000145:
p.000145: 7.6. Rule 19
p.000145:
p.000145: All devices incorporating or consisting of nanomaterial are classified as:
p.000145:
p.000145: — class III if they present a high or medium potential for internal exposure;
p.000145:
p.000145: — class IIb if they present a low potential for internal exposure; and
p.000145:
p.000145: — class IIa if they present a negligible potential for internal exposure.
p.000145:
p.000145: 7.7. Rule 20
p.000145:
p.000145: All invasive devices with respect to body orifices, other than surgically invasive devices, which are
p.000145: intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has
p.000145: an essential impact on the efficacy and safety of the administered medicinal product or they are intended
p.000145: to treat life- threatening conditions, in which case they are classified as class IIb.
p.000145:
p.000145: 7.8. Rule 21
p.000145:
p.000145: Devices that are composed of substances or of combinations of substances that are intended to be
p.000145: introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed
p.000145: in the human body are classified as:
p.000145:
p.000145: — class III if they, or their products of metabolism, are systemically absorbed by the human body in
p.000145: order to achieve the intended purpose;
p.000145:
p.000145: — class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or
p.000145: their products of metabolism, are systemically absorbed by the human body;
p.000145:
p.000145: — class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as
p.000145: far as the pharynx, and achieve their intended purpose on those cavities; and
p.000145:
p.000145: — class IIb in all other cases.
p.000145:
p.000145: 7.9. Rule 22
p.000145:
p.000145: Active therapeutic devices with an integrated or incorporated diagnostic function which significantly
p.000145: determines the patient management by the device, such as closed loop systems or automated external
p.000145: defibrillators, are classified as class III.
p.000145:
p.000146: L 117/146 EN
p.000146: Official Journal of the European Union
p.000146: 5.5.2017
p.000146:
p.000146: ANNEX IX
p.000146:
p.000146: CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
p.000146:
p.000146: CHAPTER I
p.000146:
p.000146: QUALITY MANAGEMENT SYSTEM
p.000146:
p.000146: 1. The manufacturer shall establish, document and implement a quality management system
p.000146: as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices
p.000146: concerned. The manufacturer shall ensure the application of the quality management system as specified in
p.000146: Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified
p.000146: in Section 3.
p.000146:
p.000146:
p.000146: 2. Quality management system assessment
p.000146:
p.000146: 2.1. The manufacturer shall lodge an application for assessment of its quality management system
p.000146: with a notified body. The application shall include:
p.000146:
p.000146: — the name of the manufacturer and address of its registered place of business and any additional
p.000146: manufactur ing site covered by the quality management system, and, if the manufacturer's application is
p.000146: lodged by its authorised representative, the name of the authorised representative and the address
p.000146: of the authorised representative's registered place of business,
p.000146:
p.000146: — all relevant information on the device or group of devices covered by the quality management system,
p.000146:
p.000146: — a written declaration that no application has been lodged with any other notified body for the same
...
p.000146: apply those procedures,
p.000146:
p.000146: — a description of the procedures in place to ensure that the quality management system remains adequate and
p.000146: effective, and the undertaking by the manufacturer to apply those procedures,
p.000146:
p.000146: — the documentation on the manufacturer's post-market surveillance system and, where applicable, on the
p.000146: PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the
p.000146: provisions on vigilance set out in Articles 87 to 92,
p.000146:
p.000146: — a description of the procedures in place to keep up to date the post-market surveillance system,
p.000146: and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations
p.000146: resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the
p.000146: manufacturer to apply those procedures,
p.000146:
p.000146: — documentation on the clinical evaluation plan, and
p.000146:
p.000146: — a description of the procedures in place to keep up to date the clinical evaluation plan, taking
p.000146: into account the state of the art.
p.000146:
p.000146: 2.2. Implementation of the quality management system shall ensure compliance with this
p.000146: Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality
p.000146: management system shall be documented in a systematic and orderly manner in the form of a quality
p.000146: manual and written policies and procedures such as quality programmes, quality plans and quality records.
p.000146:
p.000146: 5.5.2017 EN
p.000146: Official Journal of the European Union
p.000147: L 117/147
p.000147:
p.000147: Moreover, the documentation to be submitted for the assessment of the quality management system shall include an
p.000147: adequate description of, in particular:
p.000147: (a) the manufacturer's quality objectives;
p.000147: (b) the organisation of the business and in particular:
p.000147:
p.000147: — the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the
p.000147: responsibilities of the managerial staff and their organisational authority,
p.000147:
p.000147: — the methods of monitoring whether the operation of the quality management system is efficient and in
p.000147: particular the ability of that system to achieve the desired design and device quality, including control
p.000147: of devices which fail to conform,
p.000147:
p.000147: — where the design, manufacture and/or final verification and testing of the devices, or parts of any
p.000147: of those processes, is carried out by another party, the methods of monitoring the efficient operation of the
p.000147: quality management system and in particular the type and extent of control applied to the other party,
p.000147: and
p.000147:
p.000147: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000147: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000147: representative to accept the mandate;
p.000147:
p.000147: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
...
p.000147: relevant documents at every stage of manufacture, and
p.000147: — management of design or quality management system changes; and
p.000147:
p.000147: (d) the verification and quality assurance techniques at the manufacturing stage and in particular the
p.000147: processes and procedures which are to be used, particularly as regards sterilisation and the relevant documents; and
p.000147:
p.000147: (e) the appropriate tests and trials which are to be carried out before, during and after
p.000147: manufacture, the frequency with which they are to take place, and the test equipment to be used; it
p.000147: shall be possible to trace back adequately the calibration of that test equipment.
p.000147:
p.000147: In addition, the manufacturer shall grant the notified body access to the technical documentation
p.000147: referred to in Annexes II and III.
p.000147:
p.000147: 2.3. Audit
p.000147:
p.000147: The notified body shall audit the quality management system to determine whether it meets the
p.000147: requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related
p.000147: to a quality management system, the notified body shall assess conformity with those standards or CS.
p.000147: The notified body shall assume that a quality management system which satisfies the relevant
p.000147: harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly
p.000147: substantiates not doing so.
p.000147:
p.000148: L 117/148 EN
p.000148: Official Journal of the European Union
p.000148: 5.5.2017
p.000148:
p.000148: The audit team of the notified body shall include at least one member with past experience of assessments of the
p.000148: technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such
p.000148: experience is not immediately obvious or applicable, the notified body shall provide a documented
p.000148: rationale for the composition of that team. The assessment procedure shall include an audit on the
p.000148: manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to
p.000148: verify the manufac turing and other relevant processes.
p.000148:
p.000148: Moreover, in the case of class IIa and class IIb devices, the quality management system assessment
p.000148: shall be accompanied by the assessment of technical documentation for devices selected on a representative
p.000148: basis in accordance with Sections 4.4 to 4.8. In choosing representative samples, the notified body
p.000148: shall take into account the published guidance developed by the MDCG pursuant to Article 105 and in particular the
p.000148: novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the
p.000148: intended purpose and the results of any previous relevant assessments such as with regard to physical,
p.000148: chemical, biological or clinical properties, that have been carried out in accordance with this
p.000148: Regulation. The notified body in question shall document its rationale for the samples taken.
p.000148:
p.000148: If the quality management system conforms to the relevant provisions of this Regulation, the notified body
...
p.000148:
p.000148: — the data stipulated in the part of the quality management system relating to manufacture, such as
p.000148: quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned.
p.000148:
p.000148: 3.3. Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and
p.000148: assessments to make sure that the manufacturer in question applies the approved quality management system
p.000148: and the post- market surveillance plan. Those audits and assessments shall include audits on the premises
p.000148: of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time
p.000148: of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to
p.000148: check that the quality management system is working properly. It shall provide the manufacturer with a
p.000148: surveillance audit report and, if a test has been carried out, with a test report.
p.000148:
p.000148: 3.4. The notified body shall randomly perform at least once every five years unannounced audits on
p.000148: the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors,
p.000148: which may be combined with the periodic surveillance assessment referred to in Section 3.3. or be
p.000148: performed in addition to that surveillance assessment. The notified body shall establish a plan for such
p.000148: unannounced on-site audits but shall not disclose it to the manufacturer.
p.000148:
p.000148: 5.5.2017 EN
p.000148: Official Journal of the European Union
p.000149: L 117/149
p.000149:
p.000149: Within the context of such unannounced on-site audits, the notified body shall test an adequate sample
p.000149: of the devices produced or an adequate sample from the manufacturing process to verify that the
p.000149: manufactured device is in conformity with the technical documentation, with the exception of the devices
p.000149: referred to in the second subparagraph of Article 52(8). Prior to unannounced on-site audits, the
p.000149: notified body shall specify the relevant sampling criteria and testing procedure.
p.000149:
p.000149: Instead of, or in addition to, sampling referred to in the second paragraph, the notified body shall
p.000149: take samples of devices from the market to verify that the manufactured device is in conformity with the
p.000149: technical documen tation, with the exception of the devices referred to in the second subparagraph of
p.000149: Article 52(8). Prior to the sampling, the notified body in question shall specify the relevant sampling criteria
p.000149: and testing procedure.
p.000149:
p.000149: The notified body shall provide the manufacturer in question with an on-site audit report which shall
p.000149: include, if applicable, the result of the sample test.
p.000149:
p.000149: 3.5. In the case of class IIa and class IIb devices, the surveillance assessment shall also
p.000149: include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or
p.000149: devices concerned on the basis of further representative samples chosen in accordance with the rationale
p.000149: documented by the notified body in accordance with the second paragraph of Section 2.3.
p.000149:
...
p.000149: it plans to place on the market or put into service and which is covered by the quality management system referred
p.000149: to in Section 2.
p.000149:
p.000149: 4.2. The application shall describe the design, manufacture and performance of the device in question. It shall
p.000149: include the technical documentation as referred to in Annexes II and III.
p.000149:
p.000149: 4.3. The notified body shall examine the application by using staff, employed by it, with proven
p.000149: knowledge and experience regarding the technology concerned and its clinical application. The notified body
p.000149: may require the application to be completed by having further tests carried out or requesting further
p.000149: evidence to be provided to allow assessment of conformity with the relevant requirements of the
p.000149: Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the
p.000149: device or request the manufacturer to carry out such tests.
p.000149:
p.000149: 4.4. The notified body shall review the clinical evidence presented by the manufacturer in the
p.000149: clinical evaluation report and the related clinical evaluation that was conducted. The notified body shall
p.000149: employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical
p.000149: experts with direct and current experience relating to the device in question or the clinical condition in which
p.000149: it is utilised, for the purposes of that review.
p.000149:
p.000150: L 117/150 EN
p.000150: Official Journal of the European Union
p.000150: 5.5.2017
p.000150:
p.000150: 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or
p.000150: totally on data from devices which are claimed to be equivalent to the device under assessment, assess
p.000150: the suitability of using such data, taking into account factors such as new indications and
p.000150: innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and
p.000150: on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the
p.000150: device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what
p.000150: extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
p.000150:
p.000150: 4.6. The notified body shall verify that the clinical evidence and the clinical evaluation are
p.000150: adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant
p.000150: general safety and performance requirements. That verification shall include consideration of the adequacy
p.000150: of the benefit-risk determination, the risk management, the instructions for use, the user training and
p.000150: the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the
p.000150: PMCF plan proposed, where applicable.
p.000150:
p.000150: 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the
...
p.000150:
p.000150:
p.000150: 5. Specific additional procedures
p.000150:
p.000150: 5.1. Assessment procedure for certain class III and class IIb devices
p.000150:
p.000150: (a) For class III implantable devices, and for class IIb active devices intended to administer and/or
p.000150: remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body
p.000150: shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer
p.000150: referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its
p.000150: conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the
p.000150: benefit-risk determination, the consistency of that evidence with the intended purpose, including the
p.000150: medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
p.000150:
p.000150: The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's
p.000150: clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to
p.000150: the Commission.
p.000150:
p.000150: The Commission shall immediately transmit those documents to the relevant expert panel referred to in
p.000150: Article 106.
p.000150:
p.000150: (b) The notified body may be requested to present its conclusions as referred to in point (a) to the
p.000150: expert panel concerned.
p.000150:
p.000150: 5.5.2017 EN
p.000150: Official Journal of the European Union
p.000151: L 117/151
p.000151:
p.000151: (c) The expert panel shall decide, under the supervision of the Commission, on the basis of all of
p.000151: the following criteria:
p.000151:
p.000151: (i) the novelty of the device or of the related clinical procedure involved, and the possible major
p.000151: clinical or health impact thereof;
p.000151:
p.000151: (ii) a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to
p.000151: scientifically valid health concerns in respect of components or source material or in respect of the
p.000151: impact on health in the case of failure of the device;
p.000151:
p.000151: (iii) a significantly increased rate of serious incidents reported in accordance with Article 87 in
p.000151: respect of a specific category or group of devices,
p.000151:
p.000151: whether to provide a scientific opinion on the clinical evaluation assessment report of the notified
p.000151: body based on the clinical evidence provided by the manufacturer, in particular concerning the
p.000151: benefit-risk deter mination, the consistency of that evidence with the medical indication or indications
p.000151: and the PMCF plan. That scientific opinion shall be provided within a period of 60 days, starting on
p.000151: the day of receipt of the documents from the Commission as referred to in point (a). The reasons for
...
p.000151: the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as
p.000151: appropriate. The notified body shall provide a full justification where it has not followed the advice of
p.000151: the expert panel in its conformity assessment report and the Commission shall without prejudice to
p.000151: Article 109 make both the scientific opinion of the expert panel and the written justification provided by the
p.000151: notified body publicly available via Eudamed.
p.000151:
p.000151: (h) The Commission, after consultation with the Member States and relevant scientific experts shall
p.000151: provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
p.000151:
p.000151:
p.000151: 5.2. Procedure in the case of devices incorporating a medicinal substance
p.000151:
p.000151:
p.000151: (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.000151: considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive
p.000151: 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action
p.000151: ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by
p.000151: analogy with the methods specified in Annex I to Directive 2001/83/EC.
p.000151:
p.000152: L 117/152 EN
p.000152: Official Journal of the European Union
p.000152: 5.5.2017
p.000152:
p.000152: (b) Before issuing an EU technical documentation assessment certificate, the notified body shall, having
p.000152: verified the usefulness of the substance as part of the device and taking account of the intended
p.000152: purpose of the device, seek a scientific opinion from one of the competent authorities designated by the
p.000152: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred
p.000152: to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under
p.000152: this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the
p.000152: substance into the device. Where the device incorporates a human blood or plasma derivative or a substance
p.000152: that, if used separately, may be considered to be a medicinal product falling exclusively within the
p.000152: scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
p.000152:
p.000152: (c) When issuing its opinion, the medicinal products authority consulted shall take into account the manufactur ing
...
p.000152: human or animal origin, or their derivatives, that are non-viable or rendered non-viable
p.000152:
p.000152:
p.000152:
p.000152: 5.3.1. Tissues or cells of human origin or their derivatives
p.000152:
p.000152:
p.000152: (a) For devices manufactured utilising derivatives of tissues or cells of human origin that are covered
p.000152: by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as
p.000152: an integral part, tissues or cells of human origin, or their derivatives, covered by Directive
p.000152: 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to
p.000152: issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the
p.000152: competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human
p.000152: tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing
p.000152: of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of
p.000152: the preliminary conformity assessment which provides, among other things, information about the
p.000152: non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk
p.000152: or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
p.000152:
p.000152: 5.5.2017 EN
p.000152: Official Journal of the European Union
p.000153: L 117/153
p.000153:
p.000153: (b) Within 120 days of receipt of all the necessary documentation, the human tissues and cells
p.000153: competent authority shall provide to the notified body its opinion.
p.000153:
p.000153: (c) The scientific opinion of the human tissues and cells competent authority, and any possible update,
p.000153: shall be included in the documentation of the notified body concerning the device. The notified body
p.000153: shall give due consideration to the views expressed in the scientific opinion of the human tissues and
p.000153: cells competent authority when making its decision. The notified body shall not deliver the certificate
p.000153: if that scientific opinion is unfavourable. It shall convey its final decision to the human tissues and
p.000153: cells competent authority concerned.
p.000153:
p.000153: (d) Before any change is made with respect to non-viable tissues or cells of human origin or their
p.000153: derivatives incorporated in a device, in particular relating to their donation, testing or procurement,
p.000153: the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority
...
p.000153:
p.000153: (c) The opinion of the medicinal products authority consulted shall be drawn up within 150 days of
p.000153: receipt of all the necessary documentation.
p.000153:
p.000153: (d) The scientific opinion of the medicinal products authority consulted, and any possible update, shall
p.000153: be included in the documentation of the notified body concerning the device. The notified body shall
p.000153: give due consideration to the views expressed in the scientific opinion when making its decision and
p.000153: shall convey its final decision to the medicinal products authority consulted.
p.000153:
p.000153: 6. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000153: substance which, if used separately, would be considered to be a medicinal product derived from human
p.000153: blood or human plasma as referred to in Article 1(8)
p.000153:
p.000153: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000153: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000153: human blood
p.000153:
p.000154: L 117/154 EN
p.000154: Official Journal of the European Union
p.000154: 5.5.2017
p.000154:
p.000154: or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform
p.000154: the notified body of the release of the batch of devices and send it the official certificate
p.000154: concerning the release of the batch of human blood or plasma derivative used in the device, issued by
p.000154: a Member State laboratory or a laboratory designated for that purpose by a Member State in
p.000154: accordance with Article 114(2) of Directive 2001/83/EC.
p.000154:
p.000154: CHAPTER III
p.000154:
p.000154: ADMINISTRATIVE PROVISIONS
p.000154:
p.000154: 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000154: its authorised representative shall, for a period ending no sooner than 10 years, and in the case of
p.000154: implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at
p.000154: the disposal of the competent authorities:
p.000154:
p.000154: — the EU declaration of conformity,
p.000154:
p.000154: — the documentation referred to in the fifth indent of Section 2.1 and in particular the data and records arising
p.000154: from the procedures referred to in point (c) of the second paragraph of Section 2.2,
p.000154:
p.000154: — information on the changes referred to in Section 2.4,
p.000154:
p.000154: — the documentation referred to in Section 4.2, and
p.000154:
p.000154: — the decisions and reports from the notified body as referred to in this Annex.
p.000154:
p.000154: 8. Each Member State shall require that the documentation referred to in Section 7 is kept at
p.000154: the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or
p.000154: its authorised represen tative, established within its territory goes bankrupt or ceases its business activity
p.000154: prior to the end of that period.
p.000154:
p.000154: 5.5.2017 EN
p.000154: Official Journal of the European Union
p.000155: L 117/155
p.000155:
p.000155: ANNEX X
p.000155:
p.000155: CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
p.000155:
p.000155: 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a
p.000155: device, including its technical documentation and relevant life cycle processes and a corresponding
p.000155: representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation.
p.000155:
p.000155:
p.000155: 2. Application
p.000155:
p.000155: The manufacturer shall lodge an application for assessment with a notified body. The application shall include:
p.000155:
p.000155: — the name of the manufacturer and address of the registered place of business of the manufacturer
p.000155: and, if the application is lodged by the authorised representative, the name of the authorised
p.000155: representative and the address of its registered place of business,
p.000155:
p.000155: — the technical documentation referred to in Annexes II and III. The applicant shall make a representative
p.000155: sample of the device production envisaged (‘type’) available to the notified body. The notified body may
p.000155: request other samples as necessary, and
p.000155:
p.000155: — a written declaration that no application has been lodged with any other notified body for the same
p.000155: type, or information about any previous application for the same type that was refused by another notified body or
p.000155: was withdrawn by the manufacturer or its authorised representative before that other notified body made
p.000155: its final assessment.
p.000155:
p.000155: 3. Assessment
p.000155:
p.000155: The notified body shall:
p.000155:
...
p.000155: the device in question or to the clinical condition in which it is utilised, for the purposes of that review;
p.000155:
p.000155: (d) in circumstances in which the clinical evidence is based partly or totally on data from devices
p.000155: which are claimed to be similar or equivalent to the device under assessment, assess the suitability of
p.000155: using such data, taking into account factors such as new indications and innovation. The notified body
p.000155: shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of
p.000155: the data for demonstrating conformity;
p.000155:
p.000155: (e) clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment
p.000155: report as part of the EU type examination report referred to in point (i);
p.000155:
p.000155: (f) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary
p.000155: to verify whether the solutions adopted by the manufacturer meet the general safety and performance
p.000155: requirements laid down in this Regulation, in the event that the standards referred to in Article 8 or
p.000155: the CS have not been applied. Where the device has to be connected to another device or devices in
p.000155: order to operate as intended, proof shall be provided that it conforms to the general safety and
p.000155: performance requirements when connected to any such device or devices having the characteristics specified by the
p.000155: manufacturer;
p.000155:
p.000156: L 117/156 EN
p.000156: Official Journal of the European Union
p.000156: 5.5.2017
p.000156:
p.000156: (g) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary
p.000156: to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised
p.000156: standards, those standards have actually been applied;
p.000156:
p.000156: (h) agree with the applicant on the place where the necessary assessments and tests are to be carried out; and
p.000156:
p.000156: (i) draw up an EU type-examination report on the results of the assessments and tests carried out under points (a)
p.000156: to (g).
p.000156:
p.000156: 4. Certificate
p.000156:
p.000156: If the type conforms to this Regulation, the notified body shall issue an EU type-examination
p.000156: certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of
p.000156: the type examination assessment, the conditions of the certificate's validity and the data needed for
p.000156: identification of the type approved. The certificate shall be drawn up in accordance with Annex XII. The
p.000156: relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
p.000156:
p.000156: 5. Changes to the type
p.000156:
p.000156: 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of
p.000156: any planned change to the approved type or of its intended purpose and conditions of use.
p.000156:
p.000156: 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use
p.000156: shall require approval from the notified body which issued the EU type-examination certificate where such
...
p.000156: manufacturer of its decision and provide him with a supplement to the EU type-examination report. The
p.000156: approval of any change to the approved type shall take the form of a supplement to the EU type-examination
p.000156: certificate.
p.000156:
p.000156: 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations
p.000156: of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment.
p.000156:
p.000156: 6. Specific additional procedures
p.000156:
p.000156: Section 5 of Annex IX shall apply with the proviso that any reference to an EU
p.000156: technical documentation assessment certificate shall be understood as a reference to an EU type-examination
p.000156: certificate.
p.000156:
p.000156: 7. Administrative provisions
p.000156:
p.000156: The manufacturer or, where the manufacturer does not have a registered place of business in a Member
p.000156: State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of
p.000156: implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal
p.000156: of the competent authorities:
p.000156:
p.000156: — the documentation referred to in the second indent of Section 2,
p.000156:
p.000156: — information on the changes referred to in Section 5, and
p.000156:
p.000156: — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section
p.000156: 8 of Annex IX shall apply.
p.000156:
p.000156: 5.5.2017 EN
p.000156: Official Journal of the European Union
p.000157: L 117/157
p.000157:
p.000157: ANNEX XI
p.000157:
p.000157: CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
p.000157:
p.000157: 1. The objective of the conformity assessment based on product conformity verification is to
p.000157: ensure that devices conform to the type for which an EU type-examination certificate has been issued,
p.000157: and that they meet the provisions of this Regulation which apply to them.
p.000157:
p.000157: 2. Where an EU type-examination certificate has been issued in accordance with Annex X, the
p.000157: manufacturer may either apply the procedure set out in Part A (production quality assurance) or the
p.000157: procedure set out in Part B (product verification) of this Annex.
p.000157:
p.000157: 3. By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with
p.000157: the drawing up of technical documentation as set out in Annexes II and III may also be applied by
p.000157: manufacturers of class IIa devices.
p.000157:
p.000157:
p.000157: PART A
p.000157:
p.000157: PRODUCTION QUALITY ASSURANCE
p.000157:
p.000157: 4. The manufacturer shall ensure that the quality management system approved for the manufacture
p.000157: of the devices concerned is implemented, shall carry out a final verification, as specified in Section
p.000157: 6, and shall be subject to the surveillance referred to in Section 7.
p.000157:
p.000157: 5. When the manufacturer fulfils the obligations laid down in Section 4, it shall draw
p.000157: up and keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the
...
p.000157: application is lodged, a reference to the technical documentation and its updates and the certificates issued shall
p.000157: also be included in the application.
p.000157:
p.000157: 6.2. Implementation of the quality management system shall be such as to ensure that there is
p.000157: compliance with the type described in the EU type-examination certificate and with the provisions of this
p.000157: Regulation which apply to the devices at each stage. All the elements, requirements and provisions
p.000157: adopted by the manufacturer for its quality management system shall be documented in a systematic and
p.000157: orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes,
p.000157: quality plans and quality records.
p.000157:
p.000157: That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d)
p.000157: and (e) of Section 2.2 of Annex IX.
p.000157:
p.000157: 6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply.
p.000157:
p.000157: If the quality management system is such that it ensures that the devices conform to the type described in the EU
p.000157: type-examination certificate and that it conforms to the relevant provisions of this Regulation, the
p.000157: notified body shall issue an EU quality assurance certificate. The notified body shall notify the
p.000157: manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the
p.000157: notified body's audit and a reasoned assessment.
p.000157:
p.000158: L 117/158 EN
p.000158: Official Journal of the European Union
p.000158: 5.5.2017
p.000158:
p.000158: 6.4. Section 2.4 of Annex IX shall apply.
p.000158:
p.000158:
p.000158: 7. Surveillance
p.000158:
p.000158: Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of
p.000158: Annex IX shall apply.
p.000158:
p.000158: In the case of class III devices, surveillance shall also include a check that the quantities of
p.000158: produced or purchased raw material or crucial components approved for the type and correspond to the
p.000158: quantities of finished devices.
p.000158:
p.000158: 8. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000158: substance which, if used separately, would be considered to be a medicinal product derived from human blood or human
p.000158: plasma referred to in Article 1(8).
p.000158:
p.000158: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000158: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000158: human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the
p.000158: notified body of the release of the batch of devices and send it the official certificate concerning the
p.000158: release of the batch of human blood or plasma derivative used in the device, issued by a Member State
p.000158: laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of
p.000158: Directive 2001/83/EC.
p.000158:
p.000158:
p.000158: 9. Administrative provisions
p.000158:
...
p.000158:
p.000158: — information on the changes referred to in Section 2.4 of Annex IX, and
p.000158:
p.000158: — the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX. Section 8
p.000158: of Annex IX shall apply.
p.000158:
p.000158: 10. Application to class IIa devices
p.000158:
p.000158: 10.1. By way of derogation from Section 5, by virtue of the EU declaration of conformity the
p.000158: manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are
p.000158: manufactured in conformity with the technical documentation referred to in Annexes II and III and meet
p.000158: the requirements of this Regulation which apply to them.
p.000158:
p.000158: 10.2. For class IIa devices the notified body shall assess, as part of the assessment referred to in
p.000158: Section 6.3, whether the technical documentation as referred to in Annexes II and III for the devices selected on
p.000158: a representative basis is compliant with this Regulation.
p.000158:
p.000158: In choosing a representative sample or samples of devices, the notified body shall take into account
p.000158: the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods,
p.000158: the intended use and the results of any previous relevant assessments (e.g. with regard to physical,
p.000158: chemical, biological or clinical properties) that have been carried out in accordance with this
p.000158: Regulation. The notified body shall document its rationale for the sample or samples of devices taken.
p.000158:
p.000158: 5.5.2017 EN
p.000158: Official Journal of the European Union
p.000159: L 117/159
p.000159:
p.000159: 10.3. Where the assessment under Section 10.2. confirms that the class IIa devices in question conform
p.000159: to the technical documentation referred to in Annexes II and III and meet the requirements of this
p.000159: Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
p.000159:
p.000159: 10.4. Samples additional to those taken for the initial conformity assessment of devices shall be
p.000159: assessed by the notified body as part of the surveillance assessment referred to in Section 7.
p.000159:
p.000159: 10.5. By way of derogation from Section 6, the manufacturer or its authorised representative shall, for a period
p.000159: ending no sooner than 10 years after the last device has been placed on the market, keep at the
p.000159: disposal of the competent authorities:
p.000159:
p.000159: — the EU declaration of conformity,
p.000159:
p.000159: — the technical documentation referred to in Annexes II and III, and
p.000159:
p.000159: — the certificate referred to in Section 10.3. Section 8 of Annex IX shall apply.
p.000159:
p.000159: PART B
p.000159:
p.000159: PRODUCT VERIFICATION
p.000159:
p.000159: 11. Product verification shall be understood to be the procedure whereby after examination of every
p.000159: manufactured device, the manufacturer, by issuing an EU declaration of conformity in accordance
p.000159: with Article 19 and Annex IV, shall be deemed to ensure and to declare that the devices which have been subject
p.000159: to the procedure set out in Sections 14 and 15 conform to the type described in the EU type-examination
p.000159: certificate and meet the requirements of this Regulation which apply to them.
p.000159:
...
p.000159: ing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of
p.000159: Sections 6 and 7.
p.000159:
p.000159: 13. The manufacturer shall undertake to institute and keep up to date a post-market surveillance
p.000159: plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the
p.000159: manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.
p.000159:
p.000159: 14. The notified body shall carry out the appropriate examinations and tests in order to verify the conformity
p.000159: of the device with the requirements of the Regulation by examining and testing every product
p.000159: as specified in Section 15.
p.000159:
p.000159: The examinations and tests referred to in the first paragraph of this Section shall not apply to
p.000159: aspects of the manufacturing process designed to secure sterility.
p.000159:
p.000159:
p.000159: 15. Verification by examination and testing of every product
p.000159:
p.000159: 15.1. Every device shall be examined individually and the appropriate physical or laboratory tests as
p.000159: defined in the relevant standard or standards referred to in Article 8, or equivalent tests and assessments, shall be
p.000159: carried out in order to verify, where appropriate, the conformity of the devices with the type described
p.000159: in the EU type- examination certificate and with the requirements of this Regulation which apply to them.
p.000159:
p.000160: L 117/160 EN
p.000160: Official Journal of the European Union
p.000160: 5.5.2017
p.000160:
p.000160: 15.2. The notified body shall affix, or have affixed, its identification number to each approved
p.000160: device and shall draw up an EU product verification certificate relating to the tests and assessments carried out.
p.000160:
p.000160: 16. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000160: substance which, if used separately, would be considered to be a medicinal product derived from human blood or human
p.000160: plasma referred to in Article 1(8).
p.000160:
p.000160: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000160: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000160: human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the
p.000160: notified body of the release of the batch of devices and send it the official certificate concerning the
p.000160: release of the batch of human blood or plasma derivative used in the device, issued by a Member State
p.000160: laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of
p.000160: Directive 2001/83/EC.
p.000160:
p.000160: 17. Administrative provisions
p.000160:
p.000160: The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years,
p.000160: and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the
p.000160: market, keep at the disposal of the competent authorities:
p.000160:
...
p.000160:
p.000160: 18.1. By way of derogation from Section 11, by virtue of the EU declaration of conformity the
p.000160: manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are
p.000160: manufactured in conformity with the technical documentation referred to in Annexes II and III and meet
p.000160: the requirements of this Regulation which apply to them.
p.000160:
p.000160: 18.2. The verification conducted by the notified body in accordance with Section 14 is intended to
p.000160: confirm the conformity of the class IIa devices in question with the technical documentation referred to in Annexes
p.000160: II and III and with the requirements of this Regulation which apply to them.
p.000160:
p.000160: 18.3. If the verification referred to in Section 18.2 confirms that the class IIa devices in question
p.000160: conform to the technical documentation referred to in Annexes II and III and meet the requirements of
p.000160: this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
p.000160:
p.000160: 18.4. By way of derogation from Section 17, the manufacturer or its authorised representative shall,
p.000160: for a period ending no sooner than 10 years after the last device has been placed on the market, keep
p.000160: at the disposal of the competent authorities:
p.000160:
p.000160: — the EU declaration of conformity,
p.000160:
p.000160: — the technical documentation referred to in Annexes II and III, and
p.000160:
p.000160: — the certificate referred to in Section 18.3. Section 8 of Annex IX shall apply.
p.000160:
p.000160: 5.5.2017 EN
p.000160: Official Journal of the European Union
p.000161: L 117/161
p.000161:
p.000161: ANNEX XII
p.000161:
p.000161: CERTIFICATES ISSUED BY A NOTIFIED BODY
p.000161:
p.000161: CHAPTER I
p.000161:
p.000161: GENERAL REQUIREMENTS
p.000161:
p.000161: 1. Certificates shall be drawn up in one of the official languages of the Union.
p.000161:
p.000161: 2. Each certificate shall refer to only one conformity assessment procedure.
p.000161:
p.000161: 3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer
p.000161: included in the certificate shall be the same as that registered in the electronic system referred to in Article 30.
p.000161:
p.000161: 4. The scope of the certificates shall unambiguously identify the device or devices covered:
p.000161:
p.000161: (a) EU technical documentation assessment certificates, EU type-examination certificates and EU product
p.000161: verification certificates shall include a clear identification, including the name, model and type, of the
p.000161: device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in
p.000161: relation to which the device has been assessed in the conformity assessment procedure, risk classification
p.000161: and the Basic UDI-DI as referred to in Article 27(6);
p.000161:
p.000161: (b) EU quality management system certificates and EU quality assurance certificates shall include the identification
p.000161: of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.
p.000161:
p.000161: 5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by
p.000161: the certificate. The notified body shall set up a system that enables the determination of the devices,
p.000161: including their classification, covered by the certificate.
p.000161:
p.000161: 6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device
p.000161: or devices it covers, another certificate issued in accordance with this Regulation is required.
p.000161:
p.000161: 7. EU quality management system certificates and EU quality assurance certificates for class I devices
p.000161: for which the involvement of a notified body is required pursuant to Article 52(7) shall include a
p.000161: statement that the audit by the notified body of the quality management system was limited to the aspects required
p.000161: under that paragraph.
p.000161:
p.000161: 8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a
p.000161: reference to the preceding certificate and its date of issue with identification of the changes.
p.000161:
p.000161:
p.000161: CHAPTER II
p.000161:
p.000161: MINIMUM CONTENT OF THE CERTIFICATES
p.000161:
p.000161: 1. name, address and identification number of the notified body;
p.000161:
p.000161: 2. name and address of the manufacturer and, if applicable, of the authorised representative;
p.000161:
p.000161: 3. unique number identifying the certificate;
p.000161:
p.000161: 4. if already issued, the SRN of the manufacturer referred to in to Article 31(2);
p.000161:
p.000161: 5. date of issue;
p.000161:
p.000161: 6. date of expiry;
p.000161:
p.000161: 7. data needed for the unambiguous identification of the device or devices where applicable as specified
p.000161: in Section 4 of Part I;
p.000161:
p.000162: L 117/162 EN
p.000162: Official Journal of the European Union
p.000162: 5.5.2017
p.000162:
p.000162: 8. if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
p.000162:
p.000162: 9. reference to this Regulation and the relevant Annex in accordance with which the conformity
p.000162: assessment has been carried out;
p.000162:
p.000162: 10. examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports
p.000162: and audit report(s);
p.000162:
p.000162: 11. if applicable, reference to the relevant parts of the technical documentation or other certificates
p.000162: required for the placing on the market of the device or devices covered;
p.000162:
p.000162: 12. if applicable, information about the surveillance by the notified body;
p.000162:
p.000162: 13. conclusions of the notified body's conformity assessment with regard to the relevant Annex;
p.000162:
p.000162: 14. conditions for or limitations to the validity of the certificate;
p.000162:
p.000162: 15. legally binding signature of the notified body in accordance with the applicable national law.
p.000162:
p.000162: 5.5.2017 EN
p.000162: Official Journal of the European Union
p.000163: L 117/163
p.000163:
p.000163: ANNEX XIII
p.000163:
p.000163: PROCEDURE FOR CUSTOM-MADE DEVICES
p.000163:
p.000163: 1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement
p.000163: containing all of the following information:
p.000163:
p.000163: — the name and address of the manufacturer, and of all manufacturing sites,
p.000163:
p.000163: — if applicable, the name and address of the authorised representative,
p.000163:
p.000163: — data allowing identification of the device in question,
p.000163:
p.000163: — a statement that the device is intended for exclusive use by a particular patient or user,
p.000163: identified by name, an acronym or a numerical code,
p.000163:
p.000163: — the name of the person who made out the prescription and who is authorised by national law by virtue
p.000163: of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
p.000163:
p.000163: — the specific characteristics of the product as indicated by the prescription,
p.000163:
p.000163: — a statement that the device in question conforms to the general safety and performance requirements
p.000163: set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been
p.000163: fully met, together with the grounds,
p.000163:
p.000163: — where applicable, an indication that the device contains or incorporates a medicinal substance, including a human
p.000163: blood or plasma derivative, or tissues or cells of human origin, or of animal origin as
p.000163: referred to in Regulation (EU) No 722/2012.
p.000163:
p.000163: 2. The manufacturer shall undertake to keep available for the competent national authorities
p.000163: documentation that indicates its manufacturing site or sites and allows an understanding to be formed of
p.000163: the design, manufacture and performance of the device, including the expected performance, so as to allow
p.000163: assessment of conformity with the requirements of this Regulation.
p.000163:
p.000163: 3. The manufacturer shall take all the measures necessary to ensure that the manufacturing process
p.000163: produces devices which are manufactured in accordance with the documentation referred to in Section 2.
p.000163:
p.000163: 4. The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years
p.000163: after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15
p.000163: years.
p.000163:
p.000163: Section 8 of Annex IX shall apply.
p.000163:
p.000163: 5. The manufacturer shall review and document experience gained in the post-production phase, including
p.000163: from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective
p.000163: action, In that context, it shall report in accordance with Article 87(1) to the competent authorities
p.000163: any serious incidents or field safety corrective actions or both as soon as it learns of them.
p.000163:
p.000164: L 117/164 EN
p.000164: Official Journal of the European Union
p.000164: 5.5.2017
p.000164:
p.000164: ANNEX XIV
p.000164:
p.000164: CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
p.000164:
p.000164: PART A
p.000164:
p.000164: CLINICAL EVALUATION
p.000164:
p.000164: 1. To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
p.000164:
p.000164: (a) establish and update a clinical evaluation plan, which shall include at least:
p.000164:
p.000164: — an identification of the general safety and performance requirements that require support from relevant
p.000164: clinical data;
p.000164:
p.000164: — a specification of the intended purpose of the device;
p.000164:
p.000164: — a clear specification of intended target groups with clear indications and contra-indications;
p.000164:
p.000164: — a detailed description of intended clinical benefits to patients with relevant and specified clinical
p.000164: outcome parameters;
p.000164:
p.000164: — a specification of methods to be used for examination of qualitative and quantitative aspects of
p.000164: clinical safety with clear reference to the determination of residual risks and side-effects;
p.000164:
p.000164: — an indicative list and specification of parameters to be used to determine, based on the state of
p.000164: the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended
p.000164: purpose or purposes of the device;
p.000164:
p.000164: — an indication how benefit-risk issues relating to specific components such as use of pharmaceutical,
p.000164: non- viable animal or human tissues, are to be addressed; and
p.000164:
...
p.000164: performance of the device including its clinical benefits.
p.000164:
p.000164: 2. The clinical evaluation shall be thorough and objective, and take into account both favourable
p.000164: and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature,
p.000164: classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in
p.000164: respect of the device.
p.000164:
p.000164: 3. A clinical evaluation may be based on clinical data relating to a device for which equivalence
p.000164: to the device in question can be demonstrated. The following technical, biological and clinical
p.000164: characteristics shall be taken into consideration for the demonstration of equivalence:
p.000164:
p.000164: — Technical: the device is of similar design; is used under similar conditions of use; has similar
p.000164: specifications and properties including physicochemical properties such as intensity of energy, tensile
p.000164: strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment
p.000164: methods, where relevant; has similar principles of operation and critical performance requirements;
p.000164:
p.000164: — Biological: the device uses the same materials or substances in contact with the same human tissues
p.000164: or body fluids for a similar kind and duration of contact and similar release characteristics of
p.000164: substances, including degradation products and leachables;
p.000164:
p.000164: 5.5.2017 EN
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p.000165: L 117/165
p.000165:
p.000165: — Clinical: the device is used for the same clinical condition or purpose, including similar severity
p.000165: and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and
p.000165: physiology; has the same kind of user; has similar relevant critical performance in view of the expected
p.000165: clinical effect for a specific intended purpose.
p.000165:
p.000165: The characteristics listed in the first paragraph shall be similar to the extent that there would be
p.000165: no clinically significant difference in the safety and clinical performance of the device. Considerations
p.000165: of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that
p.000165: manufacturers have sufficient levels of access to the data relating to devices with which they are
p.000165: claiming equivalence in order to justify their claims of equivalence.
p.000165:
p.000165: 4. The results of the clinical evaluation and the clinical evidence on which it is based shall be
p.000165: documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
p.000165:
p.000165: The clinical evidence together with non-clinical data generated from non-clinical testing methods
p.000165: and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general
p.000165: safety and performance requirements and shall be part of the technical documentation for the device in question.
p.000165:
...
p.000165:
p.000165: 6.1. The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating
p.000165: clinical data with the aim of:
p.000165:
p.000165: (a) confirming the safety and performance of the device throughout its expected lifetime,
p.000165:
p.000165: (b) identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
p.000165:
p.000165: (c) identifying and analysing emergent risks on the basis of factual evidence,
p.000165:
p.000165: (d) ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
p.000165:
p.000165: (e) identifying possible systematic misuse or off-label use of the device, with a view to verifying
p.000165: that the intended purpose is correct.
p.000165:
p.000165: 6.2. The PMCF plan shall include at least:
p.000165:
p.000165: (a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained,
p.000165: feedback from users, screening of scientific literature and of other sources of clinical data;
p.000165:
p.000165: (b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers
p.000165: or PMCF studies;
p.000165:
p.000165: (c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
p.000165:
p.000165: (d) a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and
p.000165: to the risk management referred to in Section 3 of Annex I;
p.000165:
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p.000166: 5.5.2017
p.000166:
p.000166: (e) the specific objectives to be addressed by the PMCF;
p.000166:
p.000166: (f) an evaluation of the clinical data relating to equivalent or similar devices;
p.000166:
p.000166: (g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant
p.000166: guidance on PMCF; and
p.000166:
p.000166: (h) a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data
p.000166: and reporting) to be undertaken by the manufacturer.
p.000166:
p.000166: 7. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF
p.000166: evaluation report that shall be part of the clinical evaluation report and the technical documentation.
p.000166:
p.000166: 8. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation
p.000166: referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3
p.000166: of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been
p.000166: identified, the manufacturer shall implement them.
p.000166:
p.000166: 5.5.2017 EN
p.000166: Official Journal of the European Union
p.000167: L 117/167
p.000167:
p.000167: ANNEX XV
p.000167:
p.000167: CLINICAL INVESTIGATIONS
p.000167:
p.000167: CHAPTER I
p.000167: GENERAL REQUIREMENTS
p.000167:
p.000167: 1. Ethical principles
p.000167:
p.000167: Each step in the clinical investigation, from the initial consideration of the need for and justification of the study
p.000167: to the publication of the results, shall be carried out in accordance with recognised ethical principles.
p.000167:
p.000167: 2. Methods
p.000167:
p.000167: 2.1. Clinical investigations shall be performed on the basis of an appropriate plan of
p.000167: investigation reflecting the latest scientific and technical knowledge and defined in such a way as to
p.000167: confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating
p.000167: to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall
p.000167: include an adequate number of observations to guarantee the scientific validity of the conclusions. The
p.000167: rationale for the design and chosen statistical methodology shall be presented as further described in Section
p.000167: 3.6 of Chapter II of this Annex.
p.000167:
p.000167: 2.2. The procedures used to perform the clinical investigation shall be appropriate to the device under
p.000167: investigation.
p.000167:
p.000167: 2.3. The research methodologies used to perform the clinical investigation shall be appropriate to
p.000167: the device under investigation.
p.000167:
p.000167: 2.4. Clinical investigations shall be performed in accordance with the clinical investigation plan
...
p.000167: performance and safety of the device. The endpoints shall be determined and assessed using scientifically
p.000167: valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant.
p.000167:
p.000167: 2.7. Investigators shall have access to the technical and clinical data regarding the device.
p.000167: Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the
p.000167: proper use of the investigational device, and as regards the clinical investigation plan and good
p.000167: clinical practice. This training shall be verified and where necessary arranged by the sponsor and documented
p.000167: appropriately.
p.000167:
p.000167: 2.8. The clinical investigation report, signed by the investigator, shall contain a critical
p.000167: evaluation of all the data collected during the clinical investigation, and shall include any negative findings.
p.000167:
p.000167: CHAPTER II
p.000167: DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
p.000167:
p.000167: For investigational devices covered by Article 62, the sponsor shall draw up and submit the application
p.000167: in accordance with Article 70 accompanied by the following documents:
p.000167:
p.000167: 1. Application form
p.000167:
p.000167: The application form shall be duly filled in, containing information regarding:
p.000167: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and
p.000167: contact details of its contact person or legal representative in accordance with Article 62(2) established in the
p.000167: Union;
p.000167:
p.000168: L 117/168 EN
p.000168: Official Journal of the European Union
p.000168: 5.5.2017
p.000168:
p.000168: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
p.000168: of the device intended for clinical investigation and, if applicable, of its authorised representative;
p.000168:
p.000168: 1.3. title of the clinical investigation;
p.000168:
p.000168: 1.4. status of the clinical investigation application (i.e. first submission, resubmission, significant
p.000168: amendment);
p.000168:
p.000168: 1.5. details and/or reference to the clinical evaluation plan;
p.000168:
p.000168: 1.6. If the application is a resubmission with regard to a device for which an application has been already
p.000168: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000168: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000168: changes from the previous application together with a rationale for those changes, in particular, whether
p.000168: any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000168:
p.000168: 1.7. if the application is submitted in parallel with an application for a clinical
p.000168: trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the
p.000168: clinical trial;
p.000168:
p.000168: 1.8. identification of the Member States and third countries in which the clinical investigation is
p.000168: to be conducted as part of a multicentre or multinational study at the time of application;
p.000168:
...
p.000168:
p.000168: 1.14. details of the anticipated start date and duration of the investigation;
p.000168:
p.000168: 1.15. details to identify the notified body, if already involved at the stage of application for a clinical
p.000168: investigation;
p.000168:
p.000168: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics
p.000168: committee that is assessing or has assessed the application; and
p.000168:
p.000168: 1.17. the statement referred to in Section 4.1.
p.000168:
p.000168:
p.000168: 2. Investigator's Brochure
p.000168:
p.000168:
p.000168: The investigator's brochure (IB) shall contain the clinical and non-clinical information on the
p.000168: investigational device that is relevant for the investigation and available at the time of application.
p.000168: Any updates to the IB or other relevant information that is newly available shall be brought to the
p.000168: attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular
p.000168: the following information:
p.000168:
p.000168: 2.1. Identification and description of the device, including information on the intended purpose,
p.000168: the risk classifi cation and applicable classification rule pursuant to Annex VIII, design and
p.000168: manufacturing of the device and reference to previous and similar generations of the device.
p.000168:
p.000168: 5.5.2017 EN
p.000168: Official Journal of the European Union
p.000169: L 117/169
p.000169:
p.000169: 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for
p.000169: use, including storage and handling requirements, as well as, to the extent that such information is available,
p.000169: information to be placed on the label, and instructions for use to be provided with the device when
p.000169: placed on the market. In addition, information relating to any relevant training required.
p.000169:
p.000169: 2.3. Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in
p.000169: particular regarding in- design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or
p.000169: electrical tests, reliability tests, sterili sation validation, software verification and validation,
p.000169: performance tests, evaluation of biocompatibility and biological safety, as applicable.
p.000169:
p.000169: 2.4. Existing clinical data, in particular:
p.000169:
p.000169: — from relevant scientific literature available relating to the safety, performance, clinical benefits to
p.000169: patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices;
p.000169:
p.000169: — other relevant clinical data available relating to the safety, performance, clinical benefits to
p.000169: patients, design characteristics and intended purpose of equivalent or similar devices of the same
p.000169: manufacturer, including length of time on the market and a review of performance, clinical benefit and
p.000169: safety-related issues and any corrective actions taken.
p.000169:
...
p.000169:
p.000169: 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements
p.000169: set out in Annex I, including the standards and CS applied, in full or in part, as well as a
p.000169: description of the solutions for fulfilling the relevant general safety and performance requirements, in so
p.000169: far as those standards and CS have not or have only been partly fulfilled or are lacking.
p.000169:
p.000169: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000169: the clinical investi gation and in particular information on any deviation from normal clinical practice.
p.000169:
p.000169:
p.000169: 3. Clinical Investigation Plan
p.000169:
p.000169: The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology,
p.000169: monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall
p.000169: contain in particular the information as laid down in this Annex. If part of this information is
p.000169: submitted in a separate document, it shall be referenced in the CIP.
p.000169:
p.000169:
p.000169: 3.1. General
p.000169:
p.000169: 3.1.1. Single identification number of the clinical investigation, as referred to in Article 70(1).
p.000169:
p.000169: 3.1.2. Identification of the sponsor — name, address and contact details of the sponsor and, where
p.000169: applicable, the name, address and contact details of the sponsor's contact person or legal representative
p.000169: in accordance with Article 62(2) established in the Union.
p.000169:
p.000169: 3.1.3. Information on the principal investigator at each investigational site, the coordinating
p.000169: investigator for the investigation, the address details for each investigational site and the emergency
p.000169: contact details for the principal investigator at each site. The roles, responsibilities and qualifications
p.000169: of the various kinds of investigators shall be specified in the CIP.
p.000169:
p.000170: L 117/170 EN
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p.000170: 5.5.2017
p.000170:
p.000170: 3.1.4. A brief description of how the clinical investigation is financed and a brief description of
p.000170: the agreement between the sponsor and the site.
p.000170:
p.000170: 3.1.5. Overall synopsis of the clinical investigation, in an official Union language determined by the
p.000170: Member State concerned.
p.000170:
p.000170: 3.2. Identification and description of the device, including its intended purpose, its manufacturer,
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
...
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
p.000170: 3.13. Description of the Informed consent process.
p.000170:
p.000170: 3.14. Safety reporting, including definitions of adverse events and serious adverse events,
p.000170: device deficiencies, procedures and timelines for reporting.
p.000170:
p.000170: 5.5.2017 EN
p.000170: Official Journal of the European Union
p.000171: L 117/171
p.000171:
p.000171: 3.15. Criteria and procedures for follow-up of subjects following the end, temporary halt or early
p.000171: termination of an investigation, for follow-up of subjects who have withdrawn their consent and procedures
p.000171: for subjects lost to follow-up. Such procedures shall for implantable devices, cover as a minimum traceability.
p.000171:
p.000171: 3.16. A description of the arrangements for taking care of the subjects after their participation in
p.000171: the clinical investi gation has ended, where such additional care is necessary because of the subjects'
p.000171: participation in the clinical investigation and where it differs from that normally expected for the medical
p.000171: condition in question.
p.000171:
p.000171: 3.17. Policy as regards the establishment of the clinical investigation report and publication of
p.000171: results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I.
p.000171:
p.000171: 3.18. List of the technical and functional features of the device, with specific mention of those covered by
p.000171: the investi gation.
p.000171:
p.000171: 3.19. Bibliography.
p.000171:
p.000171:
p.000171: 4. Other information
p.000171:
p.000171: 4.1. A signed statement by the natural or legal person responsible for the manufacture of the
p.000171: investigational device that the device in question conforms to the general safety and performance requirements apart
p.000171: from the aspects covered by the clinical investigation and that, with regard to those aspects, every
...
p.000171: confidentiality of personal data, in particular:
p.000171:
p.000171: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000171: dissemination, alteration or loss of information and personal data processed;
p.000171:
p.000171: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000171: subjects; and
p.000171:
p.000171: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000171: possible adverse effects.
p.000171:
p.000171: 4.6. Full details of the available technical documentation, for example detailed risk
p.000171: analysis/management documen tation or specific test reports, shall, upon request, be submitted to the
p.000171: competent authority reviewing an application.
p.000171:
p.000171:
p.000171: CHAPTER III
p.000171:
p.000171: OTHER OBLIGATIONS OF THE SPONSOR
p.000171:
p.000171: 1. The sponsor shall undertake to keep available for the competent national authorities
p.000171: any documentation necessary to provide evidence for the documentation referred to in Chapter II of
p.000171: this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the
p.000171: investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000171:
p.000172: L 117/172 EN
p.000172: Official Journal of the European Union
p.000172: 5.5.2017
p.000172:
p.000172: 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or
p.000172: any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in
p.000172: a timely manner.
p.000172:
p.000172: 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years
p.000172: after the clinical investigation with the device in question has ended, or, in the event that the
p.000172: device is subsequently placed on the market, at least 10 years after the last device has been placed
p.000172: on the market. In the case of implantable devices, the period shall be at least 15 years.
p.000172:
p.000172: Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the
p.000172: period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative
p.000172: as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity
p.000172: prior to the end of this period.
p.000172:
p.000172: 4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the
p.000172: investi gation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
p.000172:
p.000172: 5. The Sponsor shall complete the follow-up of investigation subjects.
p.000172:
p.000172: 6. The Sponsor shall provide evidence that the investigation is being conducted in line with
p.000172: good clinical practice, for instance through internal or external inspection.
p.000172:
...
p.000172: of the investigation. The completion date of the investigation, and in particular details of
p.000172: early termination, temporary halts or suspensions of investigations.
p.000172:
p.000172: — Investigational device description, in particular clearly defined intended purpose.
p.000172:
p.000172: — A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring
p.000172: and quality measures, selection criteria, target patient populations, sample size, treatment schedules,
p.000172: follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation
p.000172: and analysis methods, as well as a justification.
p.000172:
p.000172: — Results of the clinical investigation covering, with rationale and justification, subject demographics,
p.000172: analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with
p.000172: the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical
p.000172: investigation, or lost to follow-up.
p.000172:
p.000172: — Summary of serious adverse events, adverse device effects, device deficiencies and any relevant
p.000172: corrective actions.
p.000172:
p.000172: — Discussion and overall conclusions covering safety and performance results, assessment of risks and
p.000172: clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any
p.000172: specific precautions for specific patient populations, implications for the investigational device, limitations of
p.000172: the investigation.
p.000172:
p.000172: 5.5.2017 EN
p.000172: Official Journal of the European Union
p.000173: L 117/173
p.000173:
p.000173: ANNEX XVI
p.000173:
p.000173: LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
p.000173:
p.000173: 1. Contact lenses or other items intended to be introduced into or onto the eye.
p.000173:
p.000173: 2. Products intended to be totally or partially introduced into the human body through surgically
p.000173: invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of
p.000173: tattooing products and piercings.
p.000173:
p.000173: 3. Substances, combinations of substances, or items intended to be used for facial or other
p.000173: dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other
p.000173: introduction, excluding those for tattooing.
p.000173:
p.000173: 4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for
p.000173: liposuction, lipolysis or lipoplasty.
p.000173:
p.000173: 5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting
p.000173: equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad
p.000173: spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin
p.000173: treatment.
p.000173:
p.000173: 6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic
p.000173: fields that penetrate the cranium to modify neuronal activity in the brain.
p.000173:
p.000174: L 117/174 EN
p.000174: Official Journal of the European Union
p.000174: 5.5.2017
p.000174:
p.000174: ANNEX XVII
p.000174:
p.000174: CORRELATION TABLE
p.000174:
p.000174:
p.000174: Council Directive 90/385/EEC
p.000174:
p.000174: Article 1(1)
p.000174: Article 1(2)
p.000174: Council Directive 93/42/EEC
p.000174:
p.000174: Article 1(1)
p.000174: Article 1(2)
p.000174:
p.000174:
p.000174: Article 1(1)
p.000174: Article 2
p.000174: This Regulation
p.000174:
p.000174: Article 1(3)
p.000174: —
p.000174: Article 1(4) and (4a) Article 1(5)
p.000174: Article 1(6)
p.000174: —
p.000174: —
p.000174: Article 2
p.000174: Article 3 first paragraph Article 3 second paragraph Article 4(1)
p.000174: Article 4(2)
p.000174: Article 4(3)
p.000174: Article 4(4) Article 4(5)(a) Article 4(5)(b) Article 5(1)
p.000174: Article 5(2)
p.000174: Article 6(1)
p.000174: Article 6(2)
p.000174: Article 7
p.000174: —
p.000174: Article 8(1)
p.000174: Article 8(2)
p.000174:
p.000174: Article 8(3)
p.000174: Article 8(4)
p.000174: Article 9(1)
p.000174: —
p.000174: —
p.000174: —
p.000174: —
p.000174: Article 1(3) first subparagraph Article 1(3) second subparagraph Article 1(4) and (4a)
p.000174: Article 1(7)
p.000174: Article 1(5)
p.000174: Article 1(6)
p.000174: Article 1(8)
p.000174: Article 2
p.000174: Article 3 first paragraph Article 3 second paragraph Article 4(1)
p.000174: Article 4(2)
p.000174: Article 4(3)
p.000174: Article 4(4)
p.000174: Article 4(5) first subparagraph Article 4(5) second subparagraph Article 5(1)
p.000174: Article 5(2)
p.000174: Articles 5(3) and 6
p.000174: Article 7(1)
p.000174: Article 8
p.000174: Article 9
p.000174: Article 10(1)
p.000174: Article 10(2)
p.000174:
p.000174: Article 10(3)
p.000174: Article 10(4)
p.000174: Article 11(1)
p.000174: Article 11(2)
p.000174: Article 11(3)
p.000174: Article 11(4)
p.000174: Article 11(5)
p.000174: Article 1(9) first subparagraph Article 1(9) second subparagraph Article 1(8) first subparagraph Article 1(11)
p.000174: Article 1(6)
p.000174: —
p.000174: Article 1(13)
p.000174: Article 5(1)
p.000174: Article 5(2)
p.000174: Article 1(12)
p.000174: Article 24
p.000174: Article 21(1) and (2)
p.000174: Article 21(3)
p.000174: Article 10(11)
p.000174: Article 20(6)
p.000174: —
p.000174: Article 8(1)
p.000174: Article 8(2)
p.000174: —
p.000174: Article 114
p.000174: Articles 94 to 97
p.000174: Article 51
p.000174: Articles 87(1) and 89 (2)
p.000174: Article 87(10) and Article 87(11) first subparagraph
p.000174: Article 89(7)
p.000174: Article 91
p.000174: Article 52(3)
p.000174: Article 52(6)
p.000174: Article 52(4) and (5)
p.000174: —
p.000174: Article 52(7)
p.000174:
p.000174: 5.5.2017 EN
p.000174: Official Journal of the European Union
p.000175: L 117/175
p.000175:
p.000175:
p.000175: Council Directive 90/385/EEC
p.000175:
p.000175: Article 9(2)
p.000175: Article 9(3)
p.000175: Article 9(4)
p.000175: Article 9(5)
p.000175: Article 9(6)
p.000175: Article 9(7)
p.000175: Article 9(8)
p.000175: Article 9(9)
p.000175: Article 9(10)
p.000175:
p.000175: —
p.000175: —
p.000175: Article 9a(1) first indent Article 9a(1) second indent
p.000175: —
p.000175: —
p.000175: Article 10
p.000175: Article 10a(1), second sentence of Article 10a(2) and Article 10a(3)
p.000175: Article 10a(2), first sentence Article 10b
p.000175: Article 10c Article 11(1)
p.000175: Article 11(2)
p.000175: Article 11(3)
p.000175: Article 11(4)
p.000175: Article 11(5)
p.000175: Article 11(6)
p.000175: Article 11(7)
p.000175: Article 12
p.000175: Article 13
p.000175: Article 14
p.000175: Article 15 Article 15a Article 16
p.000175: Article 17
p.000175: —
p.000175: Council Directive 93/42/EEC
p.000175:
p.000175: Article 11 (6)
p.000175: Article 11(8)
p.000175: Article 11(12)
p.000175: Article 11(7)
p.000175: Article 11(9)
p.000175: Article 11(10)
p.000175: Article 11(11)
p.000175: Article 11(13)
p.000175: Article 11(14)
p.000175:
p.000175: Article 12 Article 12a Article 13(1)(c) Article 13(1)(d) Article 13(1)(a) Article 13(1)(b) Article 15
p.000175: Article 14(1), second sentence of Article 14(2) and Article 14(3)
p.000175: Article 14(2) first sentence Article 14a
p.000175: Article 14b Article 16(1)
p.000175: Article 16(2)
p.000175: Article 16(3)
p.000175: Article 16(4)
p.000175: Article 16(5)
p.000175: Article 16(6)
p.000175: Article 16(7)
p.000175: Article 17
p.000175: Article 18
p.000175: Article 19
p.000175: Article 20 Article 20a Article 22
p.000175: Article 23
p.000175: Article 21
p.000175: This Regulation
p.000175:
p.000175: Article 52(8)
p.000175: Article 11(3)
p.000175: Article 52(12)
p.000175: —
...
Social / Women
Searching for indicator women:
(return to top)
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
p.000009: subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
p.000009:
p.000009:
p.000009: (70) The sponsor of a clinical investigation should submit a summary of results of the clinical
p.000009: investigation that is easily understandable for the intended user together with the clinical investigation
p.000009: report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to
p.000009: submit the summary of the results within the defined timelines for scientific reasons, the sponsor should
p.000009: justify this and specify when the results will be submitted.
p.000009:
p.000009:
p.000009: (71) This Regulation should cover clinical investigations intended to gather clinical evidence for
p.000009: the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and
p.000009: scientific assessments for other types of clinical investigations of medical devices.
p.000009:
p.000010: L 117/10 EN
p.000010: Official Journal of the European Union
p.000010: 5.5.2017
p.000010:
p.000010: (72) Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection
p.000010: measures. However, it should be left to Member States to determine the legally designated representatives
p.000010: of incapacitated subjects and minors.
p.000010:
p.000010: (73) The principles of replacement, reduction and refinement in the area of animal experimentation
p.000010: laid down in the Directive 2010/63/EU of the European Parliament and of the Council (1) should be
p.000010: observed. In particular, the unnecessary duplication of tests and studies should be avoided.
p.000010:
p.000010: (74) Manufacturers should play an active role during the post-market phase by systematically and
p.000010: actively gathering information from post-market experience with their devices in order to update their technical
p.000010: documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000010: activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000010: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000010: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000010: preventive and/or corrective actions, should be used to update any relevant part of technical
p.000010: documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the
p.000010: purpose of transparency.
p.000010:
...
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
...
p.000096: once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article
p.000096: 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with
p.000096: the criteria that are relevant to human health amongst the criteria established therein.
p.000096: 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
p.000096:
p.000096: The justification for the presence of such substances shall be based upon:
p.000096: (a) an analysis and estimation of potential patient or user exposure to the substance;
p.000096: (b) an analysis of possible alternative substances, materials or designs, including, where available,
p.000096: information about independent research, peer-reviewed studies, scientific opinions from relevant scientific
p.000096: committees and an analysis of the availability of such alternatives;
p.000096: (c) argumentation as to why possible substance and/ or material substitutes, if available, or design
p.000096: changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the
p.000096: benefit-risk ratios of the product; including taking into account if the intended use of such devices
p.000096: includes treatment of children or treatment of pregnant or breastfeeding women or treatment of
p.000096: other patient groups considered particularly vulnerable to such substances and/or materials; and
p.000096: (d) where applicable and available, the latest relevant scientific committee guidelines in
p.000096: accordance with Sections 10.4.3. and 10.4.4.
p.000096: 10.4.3. Guidelines on phthalates
p.000096:
p.000096: For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant
p.000096: scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the
p.000096: committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong
p.000096: to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The
p.000096: benefit-risk assessment shall take into account the intended purpose and context of the use of the
p.000096: device, as well as any available alternative substances and alternative materials, designs or medical
p.000096: treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every
p.000096: five years, the guidelines shall be updated.
p.000096:
p.000096: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000096: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
p.000096: and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
p.000096: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
p.000096: concerning the Registration,
p.000096: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
p.000096: (3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making
p.000096: available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
p.000096:
p.000096: 5.5.2017 EN
p.000096: Official Journal of the European Union
p.000097: L 117/97
p.000097:
p.000097: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances
p.000097:
p.000097: Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred
p.000097: to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1.,
p.000097: where appropriate.
p.000097:
p.000097: 10.4.5. Labelling
p.000097:
p.000097: Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain
p.000097: substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight
p.000097: by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the
p.000097: packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
p.000097: If the intended use of such devices includes treatment of children or treatment of pregnant or
p.000097: breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances
p.000097: and/or materials, information on residual risks for those patient groups and, if applicable, on
p.000097: appropriate precautionary measures shall be given in the instructions for use.
p.000097:
p.000097: 10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by
p.000097: the unintentional ingress of substances into the device taking into account the device and the nature of
p.000097: the environment in which it is intended to be used.
p.000097:
p.000097: 10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked
p.000097: to the size and the properties of particles which are or can be released into the patient's or user's
p.000097: body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
p.000097:
p.000097: 11. Infection and microbial contamination
p.000097:
p.000097: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as
p.000097: far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
p.000097:
p.000097: (a) reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as
p.000097: needle stick injuries,
p.000097:
p.000097: (b) allow easy and safe handling,
p.000097:
p.000097: (c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
p.000097:
...
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
p.000170: 3.6. Design of the clinical investigation with evidence of its scientific robustness and validity.
p.000170:
p.000170: 3.6.1. General information such as type of investigation with rationale for choosing it, for its
p.000170: endpoints and for its variables as set out in the clinical evaluation plan.
p.000170:
p.000170: 3.6.2. Information on the investigational device, on any comparator and on any other device or medication to be
p.000170: used in the clinical investigation.
p.000170:
p.000170: 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness
p.000170: of investigation population in relation to target population and, if applicable, information on vulnerable
p.000170: subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
p.000170:
p.000170: 3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
p.000170: management of potential confounding factors.
p.000170:
p.000170: 3.6.5. Description of the clinical procedures and diagnostic methods relating to the clinical
p.000170: investigation and in particular highlighting any deviation from normal clinical practice.
p.000170:
p.000170: 3.6.6. Monitoring plan.
p.000170:
p.000170: 3.7. Statistical considerations, with justification, including a power calculation for the sample size, if
p.000170: applicable.
p.000170:
p.000170: 3.8. Data management.
p.000170:
p.000170: 3.9. Information about any amendments to the CIP.
p.000170:
p.000170: 3.10. Policy regarding follow-up and management of any deviations from the CIP at the investigational
p.000170: site and clear prohibition of use of waivers from the CIP.
p.000170:
p.000170: 3.11. Accountability regarding the device, in particular control of access to the device, follow-up
p.000170: in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning
p.000170: devices.
p.000170:
p.000170: 3.12. Statement of compliance with the recognised ethical principles for medical research involving
p.000170: humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as
p.000170: with the applicable regulatory requirements.
p.000170:
p.000170: 3.13. Description of the Informed consent process.
p.000170:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000060: in Article 70(1) and information about the availability of the clinical investigation results in
p.000060: accordance with paragraph 6 of this Article.
p.000060: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to
p.000060: the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000060: representative.
p.000060:
p.000060: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
p.000060: information needs of specific patient populations and of individual subjects, as well as to the methods used to give
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
p.000060: consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing
p.000060: the information given to him or her, shall also assent in order to participate in a clinical investigation.
p.000060:
p.000060:
p.000060: Article 64
p.000060:
p.000060: Clinical investigations on incapacitated subjects
p.000060:
p.000060: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent
p.000060: before the onset of their incapacity, a clinical investigation may be conducted only where, in addition
p.000060: to the conditions set out in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060: (b) the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in
p.000060: view of their capacity to understand it;
p.000060: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000060: the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the
p.000060: clinical investigation at any time, is respected by the investigator;
...
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
p.000061: representative except for compensation for expenses and loss of earnings directly related to the participation in the
p.000061: clinical investigation;
p.000061: (e) the clinical investigation is intended to investigate treatments for a medical condition that only
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
...
p.000121: 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per
p.000121: configuration within the group. A group of configurations is defined as the collection of possible
p.000121: configurations for a given device as described in the technical documentation.
p.000121:
p.000121: 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.
p.000121:
p.000121: 6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be
p.000121: exchanged during the lifetime of the system and shall be identified as the configurable device UDI.
p.000121:
p.000121: 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a
p.000121: separate UDI.
p.000121:
p.000121: 6.5. Device Software
p.000121:
p.000121: 6.5.1. UDI assignment Criteria
p.000121:
p.000121: The UDI shall be assigned at the system level of the software. Only software which is commercially available on
p.000121: its own and software which constitutes a device in itself shall be subject to that requirement.
p.000121:
p.000121: The software identification shall be considered to be the manufacturing control mechanism and
p.000121: shall be displayed in the UDI-PI.
p.000121:
p.000121: 6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:
p.000121: (a) the original performance;
p.000121: (b) the safety or the intended use of the software;
p.000121: (c) interpretation of data.
p.000121: Such modifications include new or modified algorithms, database structures, operating platform, architecture
p.000121: or new user interfaces or new channels for interoperability.
p.000121:
p.000121: 6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
p.000121:
p.000121: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for
p.000121: safety purposes, security patches or operating efficiency.
p.000121:
p.000121: Minor software revisions shall be identified by a manufacturer-specific form of identification.
p.000121:
p.000122: L 117/122 EN
p.000122: Official Journal of the European Union
p.000122: 5.5.2017
p.000122:
p.000122: 6.5.4. UDI placement criteria for software
p.000122: (a) where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall
p.000122: bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the
p.000122: physical medium containing the software and its packaging shall be identical to the UDI assigned to the
p.000122: system level software;
p.000122: (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable
p.000122: plain-text format, such as an ‘about’ file, or included on the start-up screen;
p.000122: (c) software lacking a user interface such as middleware for image conversion, shall be capable of
p.000122: transmitting the UDI through an application programming interface (API);
p.000122: (d) only the human readable portion of the UDI shall be required in electronic displays of the
p.000122: software. The marking of UDI using AIDC shall not be required in the electronic displays, such as
p.000122: ‘about’ menu, splash screen etc.;
p.000122: (e) the human readable format of the UDI for the software shall include the Application Identifiers
p.000122: (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI
p.000122: and determining which standard is being used to create the UDI.
p.000122:
p.000122: 5.5.2017 EN
...
Social / education
Searching for indicator education:
(return to top)
p.000017: refurbished device;
p.000017:
p.000018: L 117/18 EN
p.000018: Official Journal of the European Union
p.000018: 5.5.2017
p.000018:
p.000018: (32) ‘authorised representative’ means any natural or legal person established within the Union who has
p.000018: received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's
p.000018: behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
p.000018:
p.000018: (33) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000018: country on the Union market;
p.000018:
p.000018: (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer
p.000018: or the importer, that makes a device available on the market, up until the point of putting into service;
p.000018:
p.000018: (35) ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or
p.000018: the person referred to in Article 22(1) and 22(3);
p.000018:
p.000018: (36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of
p.000018: patients or the promotion of public health;
p.000018:
p.000018: (37) ‘user’ means any healthcare professional or lay person who uses a device;
p.000018:
p.000018: (38) ‘lay person’ means an individual who does not have formal education in a relevant field of
p.000018: healthcare or medical discipline;
p.000018:
p.000018: (39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse
p.000018: including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the
p.000018: technical and functional safety of the used device;
p.000018:
p.000018: (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation
p.000018: relating to a device have been fulfilled;
p.000018:
p.000018: (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000018: including calibration, testing, certification and inspection;
p.000018:
p.000018: (42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000018:
p.000018: (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000018: conformity with the applicable requirements set out in this Regulation and other applicable Union
p.000018: harmonisation legislation providing for its affixing;
p.000018:
p.000018: (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect,
p.000018: analyse and assess the clinical data pertaining to a device in order to verify the safety and
p.000018: performance, including clinical benefits, of the device when used as intended by the manufacturer;
p.000018:
p.000018: (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects,
p.000018: undertaken to assess the safety or performance of a device;
...
p.000059: and that, with regard to those aspects, every precaution has been taken to protect the health and
p.000059: safety of the subjects. This includes, where appropriate, technical and biological safety testing and
p.000059: pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention,
p.000059: taking into consideration the state of the art;
p.000059:
p.000059: (m) the requirements of Annex XV are fulfilled.
p.000059:
p.000059: 5. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000059: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000059: clinical investi gation at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC,
p.000059: the withdrawal of the informed consent shall not affect the activities already carried out and the use of
p.000059: data obtained based on informed consent before its withdrawal.
p.000059:
p.000059: 6. The investigator shall be a person exercising a profession which is recognised in the Member
p.000059: State concerned as qualifying for the role of investigator on account of having the necessary scientific
p.000059: knowledge and experience in patient care. Other personnel involved in conducting a clinical investigation shall be
p.000059: suitably qualified, by education, training or experience in the relevant medical field and in clinical research
p.000059: methodology, to perform their tasks.
p.000059:
p.000059: 7. The facilities where the clinical investigation is to be conducted shall be suitable for the
p.000059: clinical investigation and shall be similar to the facilities where the device is intended to be used.
p.000059:
p.000059:
p.000059:
p.000059: Article 63
p.000059:
p.000059: Informed consent
p.000059:
p.000059: 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in
p.000059: point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed
p.000059: consent, his or her legally designated representative after having been duly informed in accordance with
p.000059: paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate
p.000059: alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and
p.000059: date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her
p.000059: legally designated representative shall be provided with a copy of the document or the record, as appropriate,
p.000059: by which informed consent has been given. The informed consent shall be documented. Adequate time shall
...
p.000094:
p.000094: 4. Risk control measures adopted by manufacturers for the design and manufacture of the
p.000094: devices shall conform to safety principles, taking account of the generally acknowledged state of the
p.000094: art. To reduce risks, Manufac turers shall manage risks so that the residual risk associated with each hazard as
p.000094: well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions,
p.000094: manufacturers shall, in the following order of priority:
p.000094:
p.000094: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000094:
p.000094: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000094: risks that cannot be eliminated; and
p.000094:
p.000094: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to
p.000094: users.
p.000094:
p.000094: Manufacturers shall inform users of any residual risks.
p.000094:
p.000094: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000094:
p.000094: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000094: environment in which the device is intended to be used (design for patient safety), and
p.000094:
p.000094: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000094: where applicable, and the medical and physical conditions of intended users (design for lay, professional,
p.000094: disabled or other users).
p.000094:
p.000094: 5.5.2017 EN
p.000094: Official Journal of the European Union
p.000095: L 117/95
p.000095:
p.000095: 6. The characteristics and performance of a device shall not be adversely affected to such a
p.000095: degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised
p.000095: during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the
p.000095: stresses which can occur during normal conditions of use and has been properly maintained in accordance
p.000095: with the manufacturer's instructions.
p.000095:
p.000095: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000095: performance during their intended use are not adversely affected during transport and storage,
p.000095: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000095: information provided by the manufacturer.
p.000095:
p.000095: 8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and
p.000095: be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the
p.000095: achieved performance of the device during normal conditions of use.
p.000095:
p.000095: 9. For the devices referred to in Annex XVI, the general safety requirements set out in
...
p.000103: stick injuries, and
p.000103:
p.000103: — reduce as far as possible the risk of error by the intended user in the handling of the device
p.000103: and, if applicable, in the interpretation of the results.
p.000103:
p.000103: 22.3. Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
p.000103:
p.000103: — can verify that, at the time of use, the device will perform as intended by the manufacturer, and
p.000103:
p.000103: — if applicable, is warned if the device has failed to provide a valid result.
p.000103:
p.000103: CHAPTER III
p.000103:
p.000103: REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
p.000103:
p.000103:
p.000103: 23. Label and instructions for use
p.000103:
p.000103: 23.1. General requirements regarding the information supplied by the manufacturer
p.000103:
p.000103: Each device shall be accompanied by the information needed to identify the device and its manufacturer,
p.000103: and by any safety and performance information relevant to the user, or any other person, as appropriate.
p.000103: Such information may appear on the device itself, on the packaging or in the instructions for use, and
p.000103: shall, if the manufacturer has a website, be made available and kept up to date on the website,
p.000103: taking into account the following:
p.000103:
p.000103: (a) The medium, format, content, legibility, and location of the label and instructions for
p.000103: use shall be appropriate to the particular device, its intended purpose and the technical
p.000103: knowledge, experience, education or training of the intended user(s). In particular, instructions for use
p.000103: shall be written in terms readily understood by the intended user and, where appropriate,
p.000103: supplemented with drawings and diagrams.
p.000103:
p.000103: (b) The information required on the label shall be provided on the device itself. If this is not
p.000103: practicable or appropriate, some or all of the information may appear on the packaging for each unit,
p.000103: and/or on the packaging of multiple devices.
p.000103:
p.000103: (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable
p.000103: information, such as radio-frequency identification (‘RFID’) or bar codes.
p.000103:
p.000103: (d) Instructions for use shall be provided together with devices. By way of exception, instructions for
p.000103: use shall not be required for class I and class IIa devices if such devices can be used safely
p.000103: without any such instructions and unless otherwise provided for elsewhere in this Section.
p.000103:
p.000103: (e) Where multiple devices are supplied to a single user and/or location, a single copy of the
p.000103: instructions for use may be provided if so agreed by the purchaser who in any case may request further
p.000103: copies to be provided free of charge.
p.000103:
p.000103: (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the
p.000103: extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent
p.000103: implementing rules adopted pursuant to this Regulation.
p.000103:
...
p.000126: devices, for which it has been designated, having regard to the requirements of this Regulation, in particular,
p.000126: those set out in Annex I.
p.000126:
p.000126: A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which
p.000126: it is designated. The notified body shall have sufficient internal competence to critically evaluate
p.000126: assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting
p.000126: are set out in Section 4.1.
p.000126:
p.000126: Personnel involved in the management of the operation of a notified body's conformity assessment
p.000126: activities for devices shall have appropriate knowledge to set up and operate a system for the selection
p.000126: of assessment and verification staff, for verification of their competence, for authorisation and
p.000126: allocation of their tasks, for organisation of their initial and ongoing training and for the
p.000126: assignment of their duties and the monitoring of those staff, in order to ensure that personnel who
p.000126: carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
p.000126:
p.000126: The notified body shall identify at least one individual within its top-level management as having overall responsi
p.000126: bility for all conformity assessment activities in relation to devices.
p.000126:
p.000126: 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain
p.000126: their qualifi cation and expertise by implementing a system for exchange of experience and a continuous
p.000126: training and education programme.
p.000126:
p.000126: 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of
p.000126: auth orisation of the personnel, including any subcontractors and external experts, involved in conformity
p.000126: assessment activities and inform those personnel accordingly.
p.000126:
p.000126: 3.2. Qualification criteria in relation to personnel
p.000126:
p.000126: 3.2.1. The Notified Body shall establish and document qualification criteria and procedures for selection
p.000126: and authoris ation of persons involved in conformity assessment activities, including as regards
p.000126: knowledge, experience and other competence required, and the required initial and ongoing training. The
p.000126: qualification criteria shall address the various functions within the conformity assessment process, such
p.000126: as auditing, product evaluation or testing, technical documentation review and decision-making, as well as
p.000126: the devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and
p.000126: animal origin and clinical evaluation, covered by the scope of designation.
p.000126:
p.000126: 5.5.2017 EN
p.000126: Official Journal of the European Union
p.000127: L 117/127
p.000127:
p.000127: 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified
p.000127: body's designation in accordance with the scope description used by the Member State for the notification
p.000127: referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the
p.000127: subdivisions of the scope description.
...
p.000129: particular regarding novel, invasive and implantable devices or technologies, the notified body in
p.000129: question shall have internal competence in each product area for which it is designated that is adequate
p.000129: for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity
p.000129: of expert opinions and making decisions on certification.
p.000129:
p.000130: L 117/130 EN
p.000130: Official Journal of the European Union
p.000130: 5.5.2017
p.000130:
p.000130: 3.5. Monitoring of competences, training and exchange of experience
p.000130:
p.000130: 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going
p.000130: monitoring of the competence, conformity assessment activities and performance of all internal and external
p.000130: personnel, and subcon tractors, involved in conformity assessment activities.
p.000130:
p.000130: 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify
p.000130: training needs and draw up a training plan to maintain the required level of qualification and knowledge
p.000130: of individual personnel. That review shall at a minimum, verify that personnel:
p.000130:
p.000130: — are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance
p.000130: documents and the results of the coordination activities referred to in Section 1.6; and
p.000130:
p.000130: — take part in the internal exchange of experience and the continuous training and education programme
p.000130: referred to in Section 3.1.2.
p.000130:
p.000130: 4. PROCESS REQUIREMENTS
p.000130:
p.000130: 4.1. General
p.000130:
p.000130: The notified body shall have in place documented processes and sufficiently detailed procedures for the
p.000130: conduct of each conformity assessment activity for which it is designated, comprising the individual steps
p.000130: from pre- application activities up to decision making and surveillance and taking into account, when
p.000130: necessary, the respective specificities of the devices.
p.000130:
p.000130: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the
p.000130: internal activities of notified bodies and shall not be subcontracted.
p.000130: 4.2. Notified body quotations and pre-application activities The notified body shall:
p.000130:
p.000130: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000130: obtain certification from it. That description shall include which languages are acceptable for
p.000130: submission of documentation and for any related correspondence;
p.000130:
p.000130: (b) have documented procedures relating to, and documented details about, fees charged for specific
p.000130: conformity assessment activities and any other financial conditions relating to notified bodies' assessment
p.000130: activities for devices;
p.000130:
p.000130: (c) have documented procedures in relation to advertising of their conformity assessment
p.000130: services. Those procedures shall ensure that advertising or promotional activities in no way imply or
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
p.000061: (i) if during a clinical investigation the minor reaches the age of legal competence to give informed
p.000061: consent as defined in national law, his or her express informed consent shall be obtained before that subject can
p.000061: continue to participate in the clinical investigation.
p.000061:
p.000061: Article 66
p.000061:
p.000061: Clinical investigations on pregnant or breastfeeding women
p.000061:
p.000061: A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
...
Social / employees
Searching for indicator employees:
(return to top)
p.000028: not be required to have the person responsible for regulatory compliance within their organisation but
p.000028: shall have such person permanently and continuously at their disposal.
p.000028:
p.000028: (1) Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized
p.000028: enterprises (OJ L 124, 20.5.2003, p. 36).
p.000028:
p.000028: 5.5.2017 EN
p.000028: Official Journal of the European Union
p.000029: L 117/29
p.000029:
p.000029: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000029: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
p.000029: system under which the devices are manufactured, before a device is released;
p.000029: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
p.000029: (c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
p.000029: (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
p.000029: (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is
p.000029: issued.
p.000029: 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2
p.000029: and 3, their respective areas of responsibility shall be stipulated in writing.
p.000029:
p.000029: 5. The person responsible for regulatory compliance shall suffer no disadvantage within the
p.000029: manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or
p.000029: not they are employees of the organisation.
p.000029:
p.000029: 6. Authorised representatives shall have permanently and continuously at their disposal at
p.000029: least one person responsible for regulatory compliance who possesses the requisite expertise regarding
p.000029: the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by
p.000029: either of the following qualifications:
p.000029: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a
p.000029: university degree or of a course of study recognised as equivalent by the Member State concerned, in law,
p.000029: medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of
p.000029: professional experience in regulatory affairs or in quality management systems relating to medical devices;
p.000029: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000029: to medical devices.
p.000029:
p.000029:
p.000029: Article 16
p.000029:
p.000029: Cases in which obligations of manufacturers apply to importers, distributors or other persons
p.000029:
p.000029: 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent
p.000029: on manufacturers if it does any of the following:
p.000029: (a) makes available on the market a device under its name, registered trade name or registered trade
p.000029: mark, except in cases where a distributor or importer enters into an agreement with a manufacturer
p.000029: whereby the manufacturer is identified as such on the label and is responsible for meeting the
...
Social / gender
Searching for indicator gender:
(return to top)
p.000168: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000168: changes from the previous application together with a rationale for those changes, in particular, whether
p.000168: any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000168:
p.000168: 1.7. if the application is submitted in parallel with an application for a clinical
p.000168: trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the
p.000168: clinical trial;
p.000168:
p.000168: 1.8. identification of the Member States and third countries in which the clinical investigation is
p.000168: to be conducted as part of a multicentre or multinational study at the time of application;
p.000168:
p.000168: 1.9. a brief description of the investigational device, its classification and other information necessary for
p.000168: the identifi cation of the device and device type;
p.000168:
p.000168: 1.10. information as to whether the device incorporates a medicinal substance, including a human
p.000168: blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal
p.000168: origin, or their derivatives;
p.000168:
p.000168: 1.11. summary of the clinical investigation plan including the objective or objectives of the clinical
p.000168: investigation, the number and gender of subjects, criteria for subject selection, whether there are
p.000168: subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies,
p.000168: planned dates of commencement and of completion of the clinical investigation;
p.000168:
p.000168: 1.12. if applicable, information regarding a comparator device, its classification and other
p.000168: information necessary for the identification of the comparator device;
p.000168:
p.000168: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are
p.000168: capable of conducting the clinical investigation in accordance with the clinical investigation plan;
p.000168:
p.000168: 1.14. details of the anticipated start date and duration of the investigation;
p.000168:
p.000168: 1.15. details to identify the notified body, if already involved at the stage of application for a clinical
p.000168: investigation;
p.000168:
p.000168: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics
p.000168: committee that is assessing or has assessed the application; and
p.000168:
p.000168: 1.17. the statement referred to in Section 4.1.
p.000168:
p.000168:
p.000168: 2. Investigator's Brochure
p.000168:
p.000168:
p.000168: The investigator's brochure (IB) shall contain the clinical and non-clinical information on the
p.000168: investigational device that is relevant for the investigation and available at the time of application.
p.000168: Any updates to the IB or other relevant information that is newly available shall be brought to the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000001: 5.5.2017 EN
p.000001: Official Journal of the European Union
p.000001: L 117/1
p.000001:
p.000001:
p.000001: I
p.000001:
p.000001: (Legislative acts)
p.000001:
p.000001:
p.000001:
p.000001: REGULATIONS
p.000001:
p.000001: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.000001: of 5 April 2017
p.000001: on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC)
p.000001: No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
p.000001:
p.000001: (Text with EEA relevance)
p.000001:
p.000001: THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
p.000001:
p.000001: Having regard to the Treaty on the Functioning of the European Union, and in particular
p.000001: Article 114 and Article 168(4)(c) thereof,
p.000001:
p.000001: Having regard to the proposal from the European Commission,
p.000001:
p.000001: After transmission of the draft legislative act to the national parliaments,
p.000001:
p.000001: Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the
p.000001: Regions,
p.000001: Acting in accordance with the ordinary legislative procedure (2), Whereas:
p.000001: (1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory
p.000001: framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental
p.000001: revision of those Directives is needed to establish a robust, transparent, predictable and sustainable
p.000001: regulatory framework for medical devices which ensures a high level of safety and health whilst supporting
p.000001: innovation.
p.000001:
p.000001: (2) This Regulation aims to ensure the smooth functioning of the internal market as regards
p.000001: medical devices, taking as a base a high level of protection of health for patients and users, and
p.000001: taking into account the small- and medium-sized enterprises that are active in this sector. At the same
p.000001: time, this Regulation sets high standards of quality and safety for medical devices in order to meet
p.000001: common safety concerns as regards such products. Both objectives are being pursued simultaneously and are
p.000001: inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on
p.000001: the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on
p.000001: the market and putting into service of medical devices and their accessories on the Union market thus
p.000001: allowing them to benefit from the principle of free movement of goods.
p.000001:
p.000001: (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
p.000001: (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of
p.000001: the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
p.000001: (3) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
p.000001: active implantable
p.000001: medical devices (OJ L 189, 20.7.1990, p. 17).
p.000001: (4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
p.000001:
p.000002: L 117/2 EN
p.000002: Official Journal of the European Union
p.000002: 5.5.2017
p.000002:
p.000002: As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
p.000002: ensuring, among other things, that data generated in clinical investigations are reliable and robust and
p.000002: that the safety of the subjects participating in a clinical investigation is protected.
p.000002:
p.000002:
p.000002: (3) This Regulation does not seek to harmonise rules relating to the further making available on
p.000002: the market of medical devices after they have already been put into service such as in the context of second-hand
p.000002: sales.
p.000002:
p.000002:
p.000002: (4) Key elements of the existing regulatory approach, such as the supervision of
p.000002: notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation,
p.000002: vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and
p.000002: traceability regarding medical devices should be introduced, to improve health and safety.
...
p.000010: subgroups in order to have access to necessary in-depth
p.000010:
p.000010: (1) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the
p.000010: protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
p.000010: (2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
p.000010: medical devices and
p.000010: repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).
p.000010:
p.000010: 5.5.2017 EN
p.000010: Official Journal of the European Union
p.000011: L 117/11
p.000011:
p.000011: technical expertise in the field of medical devices including in vitro diagnostic medical devices. When
p.000011: establishing subgroups, appropriate consideration should be given to the possibility of involving existing
p.000011: groups at Union level in the field of medical devices.
p.000011:
p.000011:
p.000011: (83) Expert panels and expert laboratories should be designated by the Commission on the basis of
p.000011: their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific,
p.000011: technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in
p.000011: relation to the implementation of this Regulation. Moreover, expert panels should fulfil the
p.000011: tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of
p.000011: certain high-risk devices.
p.000011:
p.000011: (84) Closer coordination between national competent authorities through information exchange and
p.000011: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000011: consistently high level of health and safety protection within the internal market, in particular in the
p.000011: areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment
p.000011: should also apply across other authority activities described in this Regulation, such as the designation of
p.000011: notified bodies and should be encouraged in the area of market surveillance of devices. Joint working,
p.000011: coordination and communication of activities should also lead to more efficient use of resources and expertise at
p.000011: national level.
p.000011:
p.000011: (85) The Commission should provide scientific, technical and corresponding logistical support
p.000011: to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000011: implemented at Union level based on sound scientific evidence.
p.000011:
p.000011:
p.000011: (86) The Union and, where appropriate, the Member States should actively participate in international
...
p.000012: (1) Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L
p.000012: 72, 10.3.2012, p. 28).
p.000012: (2) Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the
p.000012: requirements laid down
p.000012: in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices
p.000012: manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
p.000012:
p.000012: 5.5.2017 EN
p.000012: Official Journal of the European Union
p.000013: L 117/13
p.000013:
p.000013: Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also
p.000013: remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely,
p.000013: no such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC
p.000013: (2) and Commission Implementing Regulation (EU) No 920/2013 (3).
p.000013:
p.000013: (99) The requirements of this Regulation should be applicable to all devices placed on the market
p.000013: or put into service from the date of application of this Regulation. However, in order to provide for a smooth
p.000013: transition it should be possible, for a limited period of time from that date, for devices to be placed on the market
p.000013: or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive
p.000013: 93/42/EEC.
p.000013:
p.000013: (100) The European Data Protection Supervisor has given an opinion (4) pursuant to Article
p.000013: 28(2) of Reg ulation (EC) No 45/2001.
p.000013:
p.000013: (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal
p.000013: market as regards medical devices and to ensure high standards of quality and safety for medical
p.000013: devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot
p.000013: be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be
p.000013: better achieved at Union level, the Union may adopt measures, in accordance with the principle of
p.000013: subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of
p.000013: proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve
p.000013: those objectives,
p.000013:
p.000013:
p.000013:
p.000013: HAVE ADOPTED THIS REGULATION:
p.000013:
p.000013:
p.000013: CHAPTER I
p.000013:
p.000013: SCOPE AND DEFINITIONS
p.000013:
p.000013: Article 1
p.000013:
p.000013: Subject matter and scope
p.000013:
p.000013: 1. This Regulation lays down rules concerning the placing on the market, making available on the
p.000013: market or putting into service of medical devices for human use and accessories for such devices in the Union. This
p.000013: Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the
...
p.000042: resolving any diverging opinions, with respect to the assessment of the application.
p.000042:
p.000042: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the
p.000042: applicant conformity assessment body the non-compliances resulting from the assessment and summarise
p.000042: the assessment by the joint assessment team.
p.000042:
p.000042: Within a specified timeframe, the applicant conformity assessment body shall submit to the
p.000042: national authority a corrective and preventive action plan to address the non-compliances.
p.000042:
p.000042: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment
p.000042: within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000042:
p.000042: 7. The authority responsible for notified bodies shall following receipt of a corrective and preventive action
p.000042: plan from the applicant body assess whether non-compliances identified during the assessment have been
p.000042: appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and
p.000042: shall include a timeframe for implemen tation of the actions therein.
p.000042:
p.000042: The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward
p.000042: it and its opinion thereon to the joint assessment team. The joint assessment team may
p.000042: request of the authority responsible for notified bodies further clarification and modifications.
p.000042:
p.000042: 5.5.2017 EN
p.000042: Official Journal of the European Union
p.000043: L 117/43
p.000043:
p.000043: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000043: — the result of the assessment,
p.000043: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000043: required, implemented,
p.000043: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000043: — the recommended scope of designation.
p.000043: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000043: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000043:
p.000043: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared
p.000043: by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days
p.000043: of receipt of those documents to the Commission, which shall immediately submit that final opinion to
p.000043: the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue
p.000043: a recommendation with regard to the draft designation, which the authority responsible for notified bodies
p.000043: shall duly take into consideration for its decision on the designation of the notified body.
p.000043:
p.000043: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000043: arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the
p.000043: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000043: accordance with the examination procedure referred to in Article 114(3).
p.000043:
p.000043: Article 40
p.000043:
p.000043: Nomination of experts for joint assessment of applications for notification
p.000043:
p.000043: 1. The Member States and the Commission shall nominate experts qualified in the
p.000043: assessment of conformity assessment bodies in the field of medical devices to participate in the activities
p.000043: referred to in Articles 39 and 48.
p.000043:
p.000043: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this
p.000043: Article, together with information on their specific field of competence and expertise. That list shall
p.000043: be made available to Member States competent authorities through the electronic system referred to in Article 57.
p.000043:
p.000043: Article 41
p.000043:
p.000043: Language requirements
p.000043:
...
p.000043: thereof into an official Union language, such as is necessary for that documentation to be readily understood by the
p.000043: joint assessment team appointed in accordance with Article 39(3).
p.000043:
p.000043: Article 42
p.000043:
p.000043: Designation and notification procedure
p.000043:
p.000043: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to
p.000043: Article 39 was completed and which comply with Annex VII.
p.000043:
p.000043: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000043: have designated, using the electronic notification tool within the database of notified bodies developed
p.000043: and managed by the Commission (NANDO).
p.000043:
p.000043: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this
p.000043: Article, the scope of the designation indicating the conformity assessment activities as defined in this
p.000043: Regulation and the types of devices which the notified body is authorised to assess and, without
p.000043: prejudice to Article 44, any conditions associated with the designation.
p.000043:
p.000044: L 117/44 EN
p.000044: Official Journal of the European Union
p.000044: 5.5.2017
p.000044:
p.000044: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000044: for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and
p.000044: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of
p.000044: the MDCG, it shall provide a duly substantiated justification.
p.000044:
p.000044: 5. The notifying Member State shall, without prejudice to Article 44, inform the
p.000044: Commission and the other Member States of any conditions associated with the designation and provide
p.000044: documentary evidence regarding the arrangements in place to ensure that the notified body will be
p.000044: monitored regularly and will continue to satisfy the requirements set out in Annex VII.
p.000044:
p.000044: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the
p.000044: Commission may raise written objections, setting out its arguments, with regard either to the notified
p.000044: body or to its monitoring by the authority responsible for notified bodies. Where no objection is
p.000044: raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as
p.000044: referred to in paragraph 2.
p.000044:
p.000044: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
p.000044: bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph
p.000044: 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days
p.000044: of the matter having been brought before it. Where the MDCG is of the opinion that the notification
p.000044: can be accepted, the Commission shall publish in NANDO the notification within 14 days.
p.000044:
p.000044: 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or
p.000044: raises another objection, the notifying Member State shall provide a written response to the MDCG
p.000044: opinion within 40 days of its receipt. The response shall address the objections raised in the opinion,
p.000044: and set out the reasons for the notifying Member State's decision to designate or not designate the conformity
p.000044: assessment body.
p.000044:
p.000044: 9. Where the notifying Member State decides to uphold its decision to designate the conformity
p.000044: assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in
p.000044: NANDO the notification within 14 days of being informed thereof.
p.000044:
p.000044: 10. When publishing the notification in NANDO, the Commission shall also add to the electronic system
p.000044: referred to in Article 57 the information relating to the notification of the notified body along with
p.000044: the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and
p.000044: 8 of this Article.
p.000044:
p.000044: 11. The designation shall become valid the day after the notification is published in
p.000044: NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified
p.000044: body.
p.000044:
p.000044: 12. The conformity assessment body concerned may perform the activities of a notified
p.000044: body only after the designation has become valid in accordance with paragraph 11.
p.000044:
p.000044: 13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000044: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000044: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000044: referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list
p.000044: based, inter alia, on information arising from the coordination activities described in Article 48.
p.000044:
p.000044:
p.000044: Article 43
p.000044:
p.000044: Identification number and list of notified bodies
p.000044:
p.000044: 1. The Commission shall assign an identification number to each notified body for which the
p.000044: notification becomes valid in accordance with Article 42(11). It shall assign a single identification
p.000044: number even when the body is notified under several Union acts. If they are successfully designated in
...
p.000053: 4. The Commission shall draw up an annual overview of devices which have been subject to the
p.000053: procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall
p.000053: include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and
p.000053: a listing of the cases where the notified body did not follow the advice from the expert panel. The
p.000053: Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
p.000053:
p.000053: 5. The Commission shall by 27 May 2025 draw up a report on the operation of this Article and
p.000053: submit it to the European Parliament and to the Council. The report shall take into account the annual
p.000053: overviews and any available relevant recommendations from the MDCG. On the basis of that report the
p.000053: Commission shall, if appropriate, make proposals for amendments to this Regulation.
p.000053:
p.000053:
p.000053: Article 55
p.000053:
p.000053: Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
p.000053:
p.000053: 1. A notified body shall notify the competent authorities of certificates it has granted to devices
p.000053: for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall
p.000053: take place through the electronic system referred to in Article 57 and shall include the summary of safety and
p.000053: clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions
p.000053: for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the
p.000053: expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the
p.000053: case of divergent views between the notified body and the expert panels, a full justifi cation shall
p.000053: also be included.
p.000053:
p.000053: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns
p.000053: apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate
p.000053: measures in accordance with Articles 95 and 97.
p.000053:
p.000053: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request
p.000053: scientific advice from the expert panels in relation to the safety and performance of any device.
p.000053:
p.000053:
p.000053: Article 56
p.000053:
p.000053: Certificates of conformity
p.000053:
p.000053: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000053: Union language determined by the Member State in which the notified body is established or otherwise in
p.000053: an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set
p.000053: out in Annex XII.
p.000053:
p.000053: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On
p.000053: application by the manufacturer, the validity of the certificate may be extended for further periods, each not
...
p.000058: investigation who shall be the addressee for all communications with the sponsor provided for in this
p.000058: Regulation.
p.000058:
p.000058: 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and
p.000058: well-being of the subjects participating in a clinical investigation are protected and prevail over all
p.000058: other interests and the clinical data generated are scientifically valid, reliable and robust.
p.000058:
p.000058: Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an
p.000058: ethics committee in accordance with national law. Member States shall ensure that the procedures for
p.000058: review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the
p.000058: application for auth orisation of a clinical investigation. At least one lay person shall participate in the ethical
p.000058: review.
p.000058:
p.000058: 4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the
p.000058: following conditions are met:
p.000058:
p.000058: (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical
p.000058: investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000058:
p.000058: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion
p.000058: in relation to the clinical investigation, which is valid for that entire Member State under its national law;
p.000058:
p.000058: (c) the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the
p.000058: Union;
p.000058:
p.000058: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
p.000058:
p.000058: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000058: inconveniences and compliance with this condition is constantly monitored;
p.000058:
p.000058: (f) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative has given informed consent in accordance with Article 63;
p.000058:
p.000058: (g) the subject or, where the subject is not able to give informed consent, his or her legally
p.000058: designated representative, has been provided with the contact details of an entity where further information can be
p.000058: received in case of need;
p.000058:
p.000058: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of
p.000058: the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000058:
p.000058: (i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any
...
p.000060: in Article 70(1) and information about the availability of the clinical investigation results in
p.000060: accordance with paragraph 6 of this Article.
p.000060: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to
p.000060: the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000060: representative.
p.000060:
p.000060: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
p.000060: information needs of specific patient populations and of individual subjects, as well as to the methods used to give
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
p.000060: consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing
p.000060: the information given to him or her, shall also assent in order to participate in a clinical investigation.
p.000060:
p.000060:
p.000060: Article 64
p.000060:
p.000060: Clinical investigations on incapacitated subjects
p.000060:
p.000060: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent
p.000060: before the onset of their incapacity, a clinical investigation may be conducted only where, in addition
p.000060: to the conditions set out in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060: (b) the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in
p.000060: view of their capacity to understand it;
p.000060: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000060: the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the
p.000060: clinical investigation at any time, is respected by the investigator;
p.000060: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000060: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000060: the clinical investigation;
p.000060:
p.000060: (e) the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
p.000061: representative except for compensation for expenses and loss of earnings directly related to the participation in the
p.000061: clinical investigation;
p.000061: (e) the clinical investigation is intended to investigate treatments for a medical condition that only
p.000061: occurs in minors or the clinical investigation is essential with respect to minors to validate data
p.000061: obtained in clinical investigations on persons able to give informed consent or by other research methods;
p.000061: (f) the clinical investigation either relates directly to a medical condition from which the minor
p.000061: concerned suffers or is of such a nature that it can only be carried out on minors;
p.000061: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000061: produce a direct benefit to the minor subject outweighing the risks and burdens involved;
p.000061: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000061: maturity;
...
p.000063: provide for an appeal procedure in respect of such refusal.
p.000063:
p.000063: The Member State concerned shall notify the sponsor within five days of receipt of the comments or of
p.000063: the requested additional information, whether the clinical investigation is considered as falling within the scope of
p.000063: this Regulation and the application is complete.
p.000063:
p.000063: 4. The Member State concerned may also extend the period referred to in paragraph 1 and 3 each
p.000063: by a further five days.
p.000063:
p.000063: 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with
p.000063: paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the
p.000063: validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
p.000063:
p.000063: 6. During the period when the application is being assessed, the Member State may request
p.000063: additional information from the sponsor. The expiry of the period laid down in point (b) of paragraph 7
p.000063: shall be suspended from the date of the first request until such time as the additional information has been
p.000063: received.
p.000063:
p.000063: 7. The sponsor may start the clinical investigation in the following circumstances:
p.000063:
p.000063: (a) in the case of investigational class I devices or in the case of non-invasive class IIa and
p.000063: class IIb devices, unless otherwise stated by national law, immediately after the validation date of the
p.000063: application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire
p.000063: Member State, under national law, has not been issued by an ethics committee in the Member State concerned in
p.000063: respect of the clinical investigation;
p.000063:
p.000063: (b) in the case of investigational devices, other than those referred to in point (a), as soon as the
p.000063: Member State concerned has notified the sponsor of its authorisation, and provided that a negative
p.000063: opinion which is valid for the entire Member State, under national law, has not been issued by an ethics
p.000063: committee in the Member State concerned in respect of the clinical investigation. The Member State shall
p.000063: notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph
p.000063: 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
p.000063:
p.000063: 8. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in
p.000063: the light of technical progress and global regulatory developments, the requirements laid down in Chapter II of Annex
p.000063: XV.
p.000063:
p.000063: 9. In order to ensure the uniform application of the requirements laid down in Chapter II of
p.000063: Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of
p.000063: divergent interpretation and of practical application. Those implementing acts shall be adopted in
p.000063: accordance with the examination procedure referred to in Article 114(3).
p.000063:
p.000063:
p.000063: Article 71
p.000063:
p.000063: Assessment by Member States
p.000063:
p.000063: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do
p.000063: not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural
p.000063: or legal persons financing the clinical investigation, as well as free of any other undue influence.
p.000063:
p.000064: L 117/64 EN
...
p.000066: Substantial modifications to clinical investigations
p.000066:
p.000066: 1. If a sponsor intends to introduce modifications to a clinical investigation that are likely to
p.000066: have a substantial impact on the safety, health or rights of the subjects or on the robustness or
p.000066: reliability of the clinical data generated by the investigation, it shall notify, within one week, by
p.000066: means of the electronic system referred to in Article 73 the Member State(s) in which the clinical
p.000066: investigation is being or is to be conducted of the reasons for and the nature of those modifications.
p.000066: The sponsor shall include an updated version of the relevant documentation referred to in
p.000066: Chapter II of Annex XV as part of the notification. Changes to the relevant documentation shall be clearly
p.000066: identifiable.
p.000066:
p.000066: 2. The Member State shall assess any substantial modification to the clinical investigation in
p.000066: accordance with the procedure laid down in Article 71.
p.000066:
p.000066: 3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days
p.000066: after the notification referred to in that paragraph, unless:
p.000066:
p.000066: (a) the Member State in which the clinical investigation is being or is to be conducted has notified
p.000066: the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of
p.000066: public health, subject and user safety or health, of public policy, or
p.000066:
p.000066: (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification
p.000066: to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
p.000066:
p.000066: 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further
p.000066: seven days, for the purpose of consulting with experts.
p.000066:
p.000066:
p.000066: Article 76
p.000066:
p.000066: Corrective measures to be taken by Member States and information exchange between Member States
p.000066:
p.000066: 1. Where a Member State in which a clinical investigation is being or is to be conducted has grounds for
p.000066: considering that the requirements set out in this Regulation are not met, it may take at least any of
p.000066: the following measures on its territory:
p.000066: (a) revoke the authorisation for the clinical investigation;
p.000066: (b) suspend or terminate the clinical investigation;
p.000066: (c) require the sponsor to modify any aspect of the clinical investigation.
p.000066: 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it
p.000066: shall, except where immediate action is required, ask the sponsor or the investigator or both for their
p.000066: opinion. That opinion shall be delivered within seven days.
p.000066:
p.000066: 5.5.2017 EN
p.000066: Official Journal of the European Union
p.000067: L 117/67
p.000067:
p.000067: 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article or has
p.000067: refused a clinical investigation, or has been notified by the sponsor of the early termination of a
p.000067: clinical investigation on safety grounds, that Member State shall communicate the corresponding decision and the
p.000067: grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 73.
p.000067:
p.000067: 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that
p.000067: information shall be made available through the electronic system referred to in Article 73 to all Member States and
p.000067: the Commission.
p.000067:
p.000067:
p.000067: Article 77
p.000067:
p.000067: Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early
p.000067: termination
p.000067:
p.000067: 1. If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation
p.000067: early, it shall inform within 15 days the Member State in which that clinical investigation has been
p.000067: temporarily halted or terminated early, through the electronic system referred to in Article 73, of the
p.000067: temporary halt or early termination, providing a justification. In the event that the sponsor has
p.000067: temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all
...
p.000069: the coordinating Member State concerning the area of coordinated assessment on the following grounds:
p.000069: (a) when it considers that participation in the clinical investigation would lead to a subject
p.000069: receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
p.000069: (b) infringement of national law; or
p.000069: (c) considerations as regards subject safety and data reliability and robustness submitted under point (b) of
p.000069: paragraph 4.
p.000069: Where one of the Member States concerned disagrees with the conclusion on the basis of the second
p.000069: subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed
p.000069: justification, through the electronic system referred to in Article 73, to the Commission, to all other Member
p.000069: States concerned and to the sponsor.
p.000069:
p.000069: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that
p.000069: the clinical investigation is not acceptable, that conclusion shall be deemed to be the conclusion of
p.000069: all Member States concerned.
p.000069:
p.000069: 10. A Member State concerned shall refuse to authorise a clinical investigation if it disagrees
p.000069: with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second
p.000069: subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections
p.000069: 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV are not complied with, or where an ethics committee has
p.000069: issued a negative opinion in relation to that clinical investigation, which is valid, in accordance with
p.000069: national law, for that entire Member State. That Member State shall provide for an appeal procedure in
p.000069: respect of such refusal.
p.000069:
p.000069: 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in
p.000069: Article 73 as to whether the clinical investigation is authorised, whether it is authorised subject to
p.000069: conditions, or whether authoris ation has been refused. Notification shall be done by way of one single
p.000069: decision within five days of the transmission, pursuant to point (d) of paragraph 4, by the coordinating Member
p.000069: State of the final assessment report. Where an author isation of a clinical investigation is subject to
p.000069: conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of
p.000069: that authorisation.
p.000069:
p.000069: 12. Any substantial modifications as referred to in Article 75 shall be notified to the Member
p.000069: States concerned by means of the electronic system referred to in Article 73. Any assessment
p.000069: as to whether there are grounds for disagreement as referred to in the second subparagraph of
p.000069: paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State,
p.000069: except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2,
p.000069: 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
p.000069:
...
p.000075: the risk assessment.
p.000075:
p.000075: 4. The competent authority shall monitor the manufacturer's investigation of a serious incident.
p.000075: Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent
p.000075: investigation.
p.000075:
p.000075: 5. The manufacturer shall provide a final report to the competent authority setting out its
p.000075: findings from the investi gation by means of the electronic system referred to in Article 92. The
p.000075: report shall set out conclusions and where relevant indicate corrective actions to be taken.
p.000075:
p.000075: 6. In the case of devices referred to in the first subparagraph of Article 1(8) and where the
p.000075: serious incident or field safety corrective action may be related to a substance which, if used
p.000075: separately, would be considered to be a medicinal product, the evaluating competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national
p.000075: competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article
p.000075: 52(9), of that serious incident or field safety corrective action.
p.000075:
p.000075: In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and
p.000075: where the serious incident or field safety corrective action may be related to the derivatives of
p.000075: tissues or cells of human origin utilised for the manufacture of the device, and in the case of
p.000075: devices falling under this Regulation pursuant to Article 1(10), the competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent
p.000075: authority for human tissues and cells that was consulted by the notified body in accordance with Article
p.000075: 52(10).
p.000075:
p.000075: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the
p.000075: evaluating competent authority shall, through the electronic system referred to in Article 92, inform,
p.000075: without delay, the other competent authorities of the corrective action taken or envisaged by the
p.000075: manufacturer or required of it to minimise the risk of recurrence of the serious incident, including
p.000075: information on the underlying events and the outcome of its assessment.
p.000075:
p.000075: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
...
p.000085: performance of conformity assessment in line with the state of the art with regard to clinical
p.000085: evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility,
p.000085: mechanical, electrical, electronic or non- clinical toxicological testing;
p.000085:
p.000085: (d) to contribute to the development of standards at international level, ensuring that such standards reflect
p.000085: the state of the art;
p.000085:
p.000085: (e) to provide opinions in response to consultations by manufacturers in accordance with Article 61(2),
p.000085: notified bodies and Member States in accordance with paragraphs 11 to 13 of this Article.
p.000085:
p.000085: (f) to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;
p.000085:
p.000085: (g) to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performance
p.000085: evaluation of certain in vitro diagnostic medical devices.
p.000085:
p.000085: 11. The Commission, shall facilitate the access of Member States and notified bodies and
p.000085: manufacturers to advice provided by expert panels and expert laboratories concerning, inter alia, the
p.000085: criteria for an appropriate data set for assessment of the conformity of a device, in particular with
p.000085: regard to the clinical data required for clinical evaluation, with regard to physico-chemical
p.000085: characterisation, and with regard to microbiological, biocompatibility, mechanical, electrical, electronic and
p.000085: non-clinical toxicological testing.
p.000085:
p.000085: 12. When adopting its scientific opinion in accordance with paragraph 9, the members of the expert panels shall
p.000085: use their best endeavours to reach consensus. If consensus cannot be reached, the expert panels shall decide by a
p.000085: majority of their members, and the scientific opinion shall mention the divergent positions and the
p.000085: grounds on which they are based.
p.000085:
p.000085: The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9
p.000085: and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109.
p.000085: The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation
p.000085: with the MDCG.
p.000085:
p.000085: 13. The Commission may require manufacturers and notified bodies to pay fees for the advice
p.000085: provided by expert panels and expert laboratories. The structure and the level of fees as well as the
p.000085: scale and structure of recoverable costs shall be adopted by the Commission by means of implementing acts,
p.000085: taking into account the objectives of the adequate implementation of this Regulation, protection of health
p.000085: and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation
p.000085: in the expert panels. Those implementing acts shall be adopted in accordance with the examination procedure
p.000085: referred to in Article 114(3).
p.000085:
p.000086: L 117/86 EN
p.000086: Official Journal of the European Union
p.000086: 5.5.2017
p.000086:
p.000086: 14. The fees payable to the Commission in accordance with the procedure under paragraph 13 of this
p.000086: Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees
p.000086: payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance
p.000086: with point (c) of Section 5.1 of Annex IX involving a manufacturer who is a micro, small or
...
p.000087:
p.000087: Article 112
p.000087:
p.000087: Funding of activities related to designation and monitoring of notified bodies
p.000087:
p.000087: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
p.000087: shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other
p.000087: necessary implementing rules. Those implementing acts shall be adopted in accordance with the
p.000087: examination procedure referred to in Article 114(3).
p.000087:
p.000087: Article 113
p.000087:
p.000087: Penalties
p.000087:
p.000087: The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this
p.000087: Regulation and shall take all measures necessary to ensure that they are implemented. The penalties
p.000087: provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the
p.000087: Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any
p.000087: subsequent amendment affecting them.
p.000087:
p.000087: CHAPTER X
p.000087: FINAL PROVISIONS
p.000087:
p.000087: Article 114
p.000087:
p.000087: Committee procedure
p.000087:
p.000087: 1. The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a
p.000087: committee within the meaning of Regulation (EU) No 182/2011.
p.000087:
p.000087: 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and
p.000087: the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
p.000087:
p.000087: 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
p.000087: conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
p.000087:
p.000088: L 117/88 EN
p.000088: Official Journal of the European Union
p.000088: 5.5.2017
p.000088:
p.000088: Article 115
p.000088:
p.000088: Exercise of the delegation
p.000088:
p.000088: 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid
p.000088: down in this Article.
p.000088:
p.000088: 2. The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10),
p.000088: 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the Commission for a period of
p.000088: five years from 25 May 2017. The Commission shall draw up a report in respect of the delegation of
p.000088: power not later than nine months before the end of the five-year period. The delegation of power shall
p.000088: be tacitly extended for periods of an identical duration, unless the European Parliament or the Council
p.000088: opposes such extension not later than three months before the end of each period.
p.000088:
p.000088: 3. The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11),
p.000088: 52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European Parliament or by the Council. A
p.000088: decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect
...
p.000088: three months at the initiative of the European Parliament or of the Council.
p.000088:
p.000088:
p.000088: Article 116
p.000088:
p.000088: Separate delegated acts for different delegated powers
p.000088:
p.000088: The Commission shall adopt a separate delegated act in respect of each power delegated to
p.000088: it pursuant to this Regulation.
p.000088:
p.000088:
p.000088: Article 117
p.000088:
p.000088: Amendment to Directive 2001/83/EC
p.000088:
p.000088: In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
p.000088: ‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of
p.000088: Regulation (EU) 2017/745 of the European Parliament and of the Council (*), a product is governed by this Directive,
p.000088: the marketing authorisation dossier shall include, where available, the results of the assessment of the
p.000088: conformity of the device part with the relevant general safety and performance requirements set out in
p.000088: Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant
p.000088: certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
p.000088: If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and
p.000088: where for the conformity assessment of the device, if used separately, the involvement of a notified
p.000088: body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to
p.000088: provide an opinion on the conformity of the device part with the relevant general safety and performance
p.000088: requirements set out in Annex I to that Regulation issued by a notified body designated in accordance
p.000088: with that Regulation for the type of device in question.
p.000088:
p.000088: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000088: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000088: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000088:
p.000088: 5.5.2017 EN
p.000088: Official Journal of the European Union
p.000089: L 117/89
p.000089:
p.000089: Article 118
p.000089:
p.000089: Amendment to Regulation (EC) No 178/2002
p.000089:
p.000089: In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
p.000089: ‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of
p.000089: the Council (*).
p.000089:
p.000089: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000089: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000089: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000089:
p.000089: Article 119
p.000089:
p.000089: Amendment to Regulation (EC) No 1223/2009
p.000089:
p.000089: In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
p.000089: ‘4. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures
...
p.000127: a notified body.
p.000127:
p.000127: 3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise
p.000127: and where possible such personnel shall be employed by the notified body itself. Such
p.000127: personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
p.000127:
p.000127: — identify when specialist input is required for the assessment of the clinical evaluation conducted by
p.000127: the manufacturer and identify appropriately qualified experts;
p.000127:
p.000127: — appropriately train external clinical experts in the relevant requirements of this Regulation, CS,
p.000127: guidance and harmonised standards and ensure that the external clinical experts are fully aware
p.000127: of the context and implications of their assessment and the advice they provide;
p.000127:
p.000127: — be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any
p.000127: associated clinical investigations, and appropriately guide external clinical experts in the assessment of
p.000127: the clinical evaluation presented by the manufacturer;
p.000127:
p.000127: — be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results
p.000127: of the external clinical experts' assessment of the manufacturer's clinical evaluation;
p.000127:
p.000127: — be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by
p.000127: clinical experts;
p.000127:
p.000127: — be able to make an assessment of the manufacturer's clinical evaluation and a clinical judgement of
p.000127: the opinion provided by any external expert and make a recommendation to the notified body's decision
p.000127: maker; and
p.000127:
p.000127: — be able to draw up records and reports demonstrating that the relevant conformity assessment activities
p.000127: have been appropriately carried out.
p.000127:
p.000128: L 117/128 EN
p.000128: Official Journal of the European Union
p.000128: 5.5.2017
p.000128:
p.000128: 3.2.5. The personnel responsible for carrying out product-related reviews (product reviewers),
p.000128: such as technical documentation reviews or type examination, including aspects such as clinical evaluation,
p.000128: biological safety, sterili sation and software validation, shall have all of the following proven qualifications:
p.000128:
p.000128: — successful completion of a university or a technical college degree or equivalent qualification in
p.000128: relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
p.000128:
p.000128: — four years' professional experience in the field of healthcare products or related activities, such as in manufac
p.000128: turing, auditing or research, of which two years shall be in the design, manufacture, testing or use
p.000128: of the device or technology to be assessed or related to the scientific aspects to be assessed;
p.000128:
p.000128: — knowledge of device legislation, including the general safety and performance requirements set
p.000128: out in Annex I;
p.000128:
p.000128: — appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
p.000128:
...
p.000150:
p.000150: The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's
p.000150: clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to
p.000150: the Commission.
p.000150:
p.000150: The Commission shall immediately transmit those documents to the relevant expert panel referred to in
p.000150: Article 106.
p.000150:
p.000150: (b) The notified body may be requested to present its conclusions as referred to in point (a) to the
p.000150: expert panel concerned.
p.000150:
p.000150: 5.5.2017 EN
p.000150: Official Journal of the European Union
p.000151: L 117/151
p.000151:
p.000151: (c) The expert panel shall decide, under the supervision of the Commission, on the basis of all of
p.000151: the following criteria:
p.000151:
p.000151: (i) the novelty of the device or of the related clinical procedure involved, and the possible major
p.000151: clinical or health impact thereof;
p.000151:
p.000151: (ii) a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to
p.000151: scientifically valid health concerns in respect of components or source material or in respect of the
p.000151: impact on health in the case of failure of the device;
p.000151:
p.000151: (iii) a significantly increased rate of serious incidents reported in accordance with Article 87 in
p.000151: respect of a specific category or group of devices,
p.000151:
p.000151: whether to provide a scientific opinion on the clinical evaluation assessment report of the notified
p.000151: body based on the clinical evidence provided by the manufacturer, in particular concerning the
p.000151: benefit-risk deter mination, the consistency of that evidence with the medical indication or indications
p.000151: and the PMCF plan. That scientific opinion shall be provided within a period of 60 days, starting on
p.000151: the day of receipt of the documents from the Commission as referred to in point (a). The reasons for
p.000151: the decision to provide a scientific opinion on the basis of the criteria in points (i), (ii) and
p.000151: (iii) shall be included in the scientific opinion. Where the information submitted is not sufficient for
p.000151: the expert panel to reach a conclusion, this shall be stated in the scientific opinion.
p.000151:
p.000151: (d) The expert panel may decide, under the supervision of the Commission, on the basis of the criteria
p.000151: laid down in point (c) not to provide a scientific opinion, in which case it shall inform the notified body
p.000151: as soon as possible and in any event within 21 days of receipt of the documents as referred to in point
p.000151: (a) from the Commission. The expert panel shall within that time limit provide the notified body and
p.000151: the Commission with the reasons for its decision, whereupon the notified body may proceed with the
p.000151: certification procedure of that device.
p.000151:
p.000151: (e) The expert panel shall within 21 days of receipt of the documents from the Commission
p.000151: notify the Commission, through Eudamed whether it intends to provide a scientific opinion, pursuant to
p.000151: point (c), or whether it intends not to provide a scientific opinion, pursuant to point (d).
p.000151:
p.000151: (f) Where no opinion has been delivered within a period of 60 days, the notified body may proceed
p.000151: with the certification procedure of the device in question.
p.000151:
p.000151: (g) The notified body shall give due consideration to the views expressed in the scientific opinion of
p.000151: the expert panel. Where the expert panel finds that the level of clinical evidence is not sufficient or
p.000151: otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that
p.000151: evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the
p.000151: notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to
p.000151: certain groups of patients or certain medical indications and/or to impose a limit on the duration of
p.000151: validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or
p.000151: the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as
p.000151: appropriate. The notified body shall provide a full justification where it has not followed the advice of
p.000151: the expert panel in its conformity assessment report and the Commission shall without prejudice to
p.000151: Article 109 make both the scientific opinion of the expert panel and the written justification provided by the
p.000151: notified body publicly available via Eudamed.
p.000151:
p.000151: (h) The Commission, after consultation with the Member States and relevant scientific experts shall
p.000151: provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
p.000151:
p.000151:
p.000151: 5.2. Procedure in the case of devices incorporating a medicinal substance
p.000151:
p.000151:
p.000151: (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.000151: considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive
p.000151: 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action
p.000151: ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by
p.000151: analogy with the methods specified in Annex I to Directive 2001/83/EC.
p.000151:
p.000152: L 117/152 EN
p.000152: Official Journal of the European Union
p.000152: 5.5.2017
p.000152:
p.000152: (b) Before issuing an EU technical documentation assessment certificate, the notified body shall, having
p.000152: verified the usefulness of the substance as part of the device and taking account of the intended
p.000152: purpose of the device, seek a scientific opinion from one of the competent authorities designated by the
p.000152: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred
p.000152: to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under
p.000152: this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the
p.000152: substance into the device. Where the device incorporates a human blood or plasma derivative or a substance
p.000152: that, if used separately, may be considered to be a medicinal product falling exclusively within the
p.000152: scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
p.000152:
p.000152: (c) When issuing its opinion, the medicinal products authority consulted shall take into account the manufactur ing
p.000152: process and the data relating to the usefulness of incorporation of the substance into the device as
p.000152: determined by the notified body.
p.000152:
p.000152: (d) The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of
p.000152: receipt of all the necessary documentation.
p.000152:
p.000152: (e) The scientific opinion of the medicinal products authority consulted, and any possible
p.000152: update of that opinion, shall be included in the documentation of the notified body concerning the
p.000152: device. The notified body shall give due consideration to the views expressed in the scientific opinion
p.000152: when making its decision. The notified body shall not deliver the certificate if the scientific opinion is
p.000152: unfavourable and shall convey its final decision to the medicinal products authority consulted.
p.000152:
p.000152: (f) Before any change is made with respect to an ancillary substance incorporated in a device, in
p.000152: particular related to its manufacturing process, the manufacturer shall inform the notified body of the
p.000152: changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order
p.000152: to confirm that the quality and safety of the ancillary substance remain unchanged. The
p.000152: medicinal products authority consulted shall take into account the data relating to the usefulness of
p.000152: incorporation of the substance into the device as determined by the notified body, in order to ensure
p.000152: that the changes have no negative impact on the risk or benefit previously established concerning the
p.000152: incorporation of the substance into the device. The medicinal products authority consulted shall provide
p.000152: its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The
p.000152: notified body shall not deliver the supplement to the EU technical documentation assessment certificate
p.000152: if the scientific opinion provided by the medicinal products authority consulted is
p.000152: unfavourable. The notified body shall convey its final decision to the medicinal products authority
p.000152: consulted.
p.000152:
p.000152: (g) Where the medicinal products authority consulted obtains information on the ancillary substance,
p.000152: which could have an impact on the risk or benefit previously established concerning the incorporation of
p.000152: the substance into the device, it shall advise the notified body as to whether this information has an
p.000152: impact on the risk or benefit previously established concerning the incorporation of the substance into
p.000152: the device. The notified body shall take that advice into account in reconsidering its assessment of the conformity
p.000152: assessment procedure.
p.000152:
p.000152:
p.000152: 5.3. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of
p.000152: human or animal origin, or their derivatives, that are non-viable or rendered non-viable
p.000152:
p.000152:
p.000152:
p.000152: 5.3.1. Tissues or cells of human origin or their derivatives
p.000152:
p.000152:
p.000152: (a) For devices manufactured utilising derivatives of tissues or cells of human origin that are covered
p.000152: by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as
p.000152: an integral part, tissues or cells of human origin, or their derivatives, covered by Directive
p.000152: 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to
p.000152: issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the
p.000152: competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human
p.000152: tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing
p.000152: of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of
p.000152: the preliminary conformity assessment which provides, among other things, information about the
p.000152: non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk
p.000152: or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
p.000152:
p.000152: 5.5.2017 EN
p.000152: Official Journal of the European Union
p.000153: L 117/153
p.000153:
p.000153: (b) Within 120 days of receipt of all the necessary documentation, the human tissues and cells
p.000153: competent authority shall provide to the notified body its opinion.
p.000153:
p.000153: (c) The scientific opinion of the human tissues and cells competent authority, and any possible update,
p.000153: shall be included in the documentation of the notified body concerning the device. The notified body
p.000153: shall give due consideration to the views expressed in the scientific opinion of the human tissues and
p.000153: cells competent authority when making its decision. The notified body shall not deliver the certificate
p.000153: if that scientific opinion is unfavourable. It shall convey its final decision to the human tissues and
p.000153: cells competent authority concerned.
p.000153:
p.000153: (d) Before any change is made with respect to non-viable tissues or cells of human origin or their
p.000153: derivatives incorporated in a device, in particular relating to their donation, testing or procurement,
p.000153: the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority
p.000153: that was involved in the initial consultation, in order to confirm that the quality and safety of the
p.000153: tissues or cells of human origin or their derivatives incorporated in the device are maintained. The
p.000153: human tissues and cells competent authority concerned shall take into account the data relating to the usefulness
p.000153: of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the
p.000153: notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of
p.000153: the addition of the tissues or cells of human origin or their derivatives in the device. It shall
p.000153: provide its opinion within 60 days of receipt of all the necessary documentation regarding the intended changes. The
p.000153: notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the
p.000153: scientific opinion is unfavourable and shall convey its final decision to the human tissues and
p.000153: cells competent authority concerned.
p.000153:
p.000153: 5.3.2. Tissues or cells of animal origin or their derivatives
p.000153:
p.000153: In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising
p.000153: non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the
p.000153: notified body shall apply the relevant requirements laid down in that Regulation.
p.000153:
p.000153:
p.000153: 5.4. Procedure in the case of devices that are composed of substances or of combinations of
p.000153: substances that are absorbed by or locally dispersed in the human body
p.000153:
p.000153: (a) The quality and safety of devices that are composed of substances or of combinations of substances
p.000153: that are intended to be introduced into the human body via a body orifice or applied to the skin and
p.000153: that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and
p.000153: only in respect of the requirements not covered by this Regulation, in accordance with the relevant
p.000153: requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution,
p.000153: metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or
p.000153: other substances and potential for adverse reactions.
p.000153:
p.000153: (b) In addition, for devices, or their products of metabolism, that are systemically absorbed by the
p.000153: human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion
p.000153: from one of the competent authorities designated by the Member States in accordance with Directive
p.000153: 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal
p.000153: products authority consulted’ depending on which has been consulted under this point, on the compliance
p.000153: of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
p.000153:
p.000153: (c) The opinion of the medicinal products authority consulted shall be drawn up within 150 days of
p.000153: receipt of all the necessary documentation.
p.000153:
p.000153: (d) The scientific opinion of the medicinal products authority consulted, and any possible update, shall
p.000153: be included in the documentation of the notified body concerning the device. The notified body shall
p.000153: give due consideration to the views expressed in the scientific opinion when making its decision and
p.000153: shall convey its final decision to the medicinal products authority consulted.
p.000153:
p.000153: 6. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000153: substance which, if used separately, would be considered to be a medicinal product derived from human
p.000153: blood or human plasma as referred to in Article 1(8)
p.000153:
p.000153: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000153: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000153: human blood
p.000153:
p.000154: L 117/154 EN
p.000154: Official Journal of the European Union
p.000154: 5.5.2017
p.000154:
p.000154: or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform
p.000154: the notified body of the release of the batch of devices and send it the official certificate
p.000154: concerning the release of the batch of human blood or plasma derivative used in the device, issued by
p.000154: a Member State laboratory or a laboratory designated for that purpose by a Member State in
p.000154: accordance with Article 114(2) of Directive 2001/83/EC.
p.000154:
p.000154: CHAPTER III
p.000154:
p.000154: ADMINISTRATIVE PROVISIONS
p.000154:
p.000154: 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
...
p.000171: for subjects lost to follow-up. Such procedures shall for implantable devices, cover as a minimum traceability.
p.000171:
p.000171: 3.16. A description of the arrangements for taking care of the subjects after their participation in
p.000171: the clinical investi gation has ended, where such additional care is necessary because of the subjects'
p.000171: participation in the clinical investigation and where it differs from that normally expected for the medical
p.000171: condition in question.
p.000171:
p.000171: 3.17. Policy as regards the establishment of the clinical investigation report and publication of
p.000171: results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I.
p.000171:
p.000171: 3.18. List of the technical and functional features of the device, with specific mention of those covered by
p.000171: the investi gation.
p.000171:
p.000171: 3.19. Bibliography.
p.000171:
p.000171:
p.000171: 4. Other information
p.000171:
p.000171: 4.1. A signed statement by the natural or legal person responsible for the manufacture of the
p.000171: investigational device that the device in question conforms to the general safety and performance requirements apart
p.000171: from the aspects covered by the clinical investigation and that, with regard to those aspects, every
p.000171: precaution has been taken to protect the health and safety of the subject.
p.000171:
p.000171: 4.2. Where applicable according to national law, copy of the opinion or opinions of the ethics
p.000171: committee or committees concerned. Where according to national law the opinion or opinions of the ethics
p.000171: committee or committees is not required at the time of the submission of the application, a copy of the
p.000171: opinion or opinions shall be submitted as soon as available.
p.000171:
p.000171: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to
p.000171: Article 69 and the corresponding national law.
p.000171:
p.000171: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and
p.000171: the informed consent document.
p.000171:
p.000171: 4.5. Description of the arrangements to comply with the applicable rules on the protection and
p.000171: confidentiality of personal data, in particular:
p.000171:
p.000171: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000171: dissemination, alteration or loss of information and personal data processed;
p.000171:
p.000171: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000171: subjects; and
p.000171:
p.000171: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000171: possible adverse effects.
p.000171:
p.000171: 4.6. Full details of the available technical documentation, for example detailed risk
p.000171: analysis/management documen tation or specific test reports, shall, upon request, be submitted to the
p.000171: competent authority reviewing an application.
p.000171:
p.000171:
p.000171: CHAPTER III
p.000171:
p.000171: OTHER OBLIGATIONS OF THE SPONSOR
p.000171:
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000029: pack size, if the repackaging is necessary in order to market the device in the relevant Member State
p.000029: and if it is carried out in such conditions that the original condition of the device cannot be
p.000029: affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed
p.000029: that the original condition of the device is adversely affected if the packaging that is necessary for
p.000029: maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
p.000029:
p.000030: L 117/30 EN
p.000030: Official Journal of the European Union
p.000030: 5.5.2017
p.000030:
p.000030: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of
p.000030: paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a
p.000030: document accompanying the device, the activity carried out together with its name, registered trade name
p.000030: or registered trade mark, registered place of business and the address at which it can be contacted, so that its
p.000030: location can be established.
p.000030:
p.000030: Distributors and importers shall ensure that they have in place a quality management system that
p.000030: includes procedures which ensure that the translation of information is accurate and up-to-date, and that
p.000030: the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that
p.000030: preserve the original condition of the device and that the packaging of the repackaged device is not
p.000030: defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures
p.000030: ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer
p.000030: in relation to the device in question in order to respond to safety issues or to bring it into conformity
p.000030: with this Regulation.
p.000030:
p.000030: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000030: distributors or importers carrying out any of the activities mentioned in points (a) and (b)
p.000030: of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in
p.000030: which they plan to make the device available of the intention to make the relabelled or repackaged
p.000030: device available and, upon request, shall provide the manufacturer and the competent authority with a sample
p.000030: or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
p.000030: Within the same period of 28 days, the distributor or importer shall submit to the competent authority
p.000030: a certificate, issued by a notified body designated for the type of devices that are subject to
p.000030: activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system
p.000030: of the distributer or importer complies with the requirements laid down in paragraph 3.
p.000030:
p.000030:
p.000030: Article 17
p.000030:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000005: down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may
p.000005: have been injured by a defective device.
p.000005:
p.000005:
p.000005: (32) To ensure that devices manufactured in series production continue to be in conformity with the
p.000005: requirements of this Regulation and that experience from the use of the devices they manufacture is
p.000005: taken into account for the production process, all manufacturers should have a quality management system
p.000005: and a post-market surveillance system in place which should be proportionate to the risk class and the
p.000005: type of the device in question. In addition, in order to minimize risks or prevent incidents related to
p.000005: devices, manufacturers should establish a system for risk management and a system for reporting of incidents and
p.000005: field safety corrective actions.
p.000005:
p.000005:
p.000005: (33) The risk management system should be carefully aligned with and reflected in the clinical
p.000005: evaluation for the device, including the clinical risks to be addressed as part of clinical
p.000005: investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical
p.000005: evaluation processes should be inter-dependent and should be regularly updated.
p.000005:
p.000005:
p.000005: (34) It should be ensured that supervision and control of the manufacture of devices, and the post-market
p.000005: surveillance and vigilance activities concerning them, are carried out within the manufacturer's
p.000005: organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
p.000005:
p.000005:
p.000005: (35) For manufacturers who are not established in the Union, the authorised representative plays a
p.000005: pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as
p.000005: their contact person established in the Union. Given that pivotal role, for the purposes of enforcement
p.000005: it is appropriate to make the authorised representative legally liable for defective devices in the event
p.000005: that a manufacturer established outside the Union has not complied with its general obligations. The
p.000005: liability of the authorised representative provided for in this Regulation is without prejudice to the
p.000005: provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally
p.000005: liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a
p.000005: written mandate. Considering the role of authorised representatives, the minimum requirements they
p.000005: should meet should be clearly defined, including the requirement of having available a person who
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000009:
p.000009: (69) Sponsors should report certain adverse events and device deficiencies that occur during clinical
p.000009: investigations to the Member States in which those clinical investigations are being conducted. Member
p.000009: States should have the possibility of terminating or suspending the investigations or revoking the
p.000009: authorisation for those investigations, if considered necessary to ensure a high level of protection of the
p.000009: subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
p.000009:
p.000009:
p.000009: (70) The sponsor of a clinical investigation should submit a summary of results of the clinical
p.000009: investigation that is easily understandable for the intended user together with the clinical investigation
p.000009: report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to
p.000009: submit the summary of the results within the defined timelines for scientific reasons, the sponsor should
p.000009: justify this and specify when the results will be submitted.
p.000009:
p.000009:
p.000009: (71) This Regulation should cover clinical investigations intended to gather clinical evidence for
p.000009: the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and
p.000009: scientific assessments for other types of clinical investigations of medical devices.
p.000009:
p.000010: L 117/10 EN
p.000010: Official Journal of the European Union
p.000010: 5.5.2017
p.000010:
p.000010: (72) Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection
p.000010: measures. However, it should be left to Member States to determine the legally designated representatives
p.000010: of incapacitated subjects and minors.
p.000010:
p.000010: (73) The principles of replacement, reduction and refinement in the area of animal experimentation
p.000010: laid down in the Directive 2010/63/EU of the European Parliament and of the Council (1) should be
p.000010: observed. In particular, the unnecessary duplication of tests and studies should be avoided.
p.000010:
p.000010: (74) Manufacturers should play an active role during the post-market phase by systematically and
p.000010: actively gathering information from post-market experience with their devices in order to update their technical
p.000010: documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000010: activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000010: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000010: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000010: preventive and/or corrective actions, should be used to update any relevant part of technical
p.000010: documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the
p.000010: purpose of transparency.
p.000010:
p.000010: (75) In order to better protect health and safety regarding devices on the market, the electronic
p.000010: system on vigilance for devices should be made more effective by creating a central portal at Union
p.000010: level for reporting serious incidents and field safety corrective actions.
...
p.000019: L 117/19
p.000019:
p.000019: (51) ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a
p.000019: sufficient amount and quality to allow a qualified assessment of whether the device is safe and
p.000019: achieves the intended clinical benefit(s), when used as intended by the manufacturer;
p.000019:
p.000019: (52) ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects
p.000019: which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve
p.000019: its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients,
p.000019: when used as intended by the manufacturer;
p.000019:
p.000019: (53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed
p.000019: in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s)
p.000019: related to diagnosis, or a positive impact on patient management or public health;
p.000019:
p.000019: (54) ‘investigator’ means an individual responsible for the conduct of a clinical investigation at a
p.000019: clinical investigation site;
p.000019:
p.000019: (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000019: participate in a particular clinical investigation, after having been informed of all aspects of the
p.000019: clinical investigation that are relevant to the subject's decision to participate or, in the case of
p.000019: minors and of incapacitated subjects, an authoris ation or agreement from their legally designated representative
p.000019: to include them in the clinical investigation;
p.000019:
p.000019: (56) ‘ethics committee’ means an independent body established in a Member State in accordance with the
p.000019: law of that Member State and empowered to give opinions for the purposes of this Regulation, taking
p.000019: into account the views of laypersons, in particular patients or patients' organisations;
p.000019:
p.000019: (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward
p.000019: clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the
p.000019: context of a clinical investigation, whether or not related to the investigational device;
p.000019:
p.000019: (58) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000019:
p.000019: (a) death,
p.000019:
p.000019: (b) serious deterioration in the health of the subject, that resulted in any of the following:
p.000019:
p.000019: (i) life-threatening illness or injury,
p.000019:
p.000019: (ii) permanent impairment of a body structure or a body function,
p.000019:
p.000019: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000019:
p.000019: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent
p.000019: impairment to a body structure or a body function,
p.000019:
p.000019: (v) chronic disease,
p.000019:
...
p.000060: the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000060: representative.
p.000060:
p.000060: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
p.000060: information needs of specific patient populations and of individual subjects, as well as to the methods used to give
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
p.000060: consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing
p.000060: the information given to him or her, shall also assent in order to participate in a clinical investigation.
p.000060:
p.000060:
p.000060: Article 64
p.000060:
p.000060: Clinical investigations on incapacitated subjects
p.000060:
p.000060: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent
p.000060: before the onset of their incapacity, a clinical investigation may be conducted only where, in addition
p.000060: to the conditions set out in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060: (b) the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in
p.000060: view of their capacity to understand it;
p.000060: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000060: the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the
p.000060: clinical investigation at any time, is respected by the investigator;
p.000060: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000060: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000060: the clinical investigation;
p.000060:
p.000060: (e) the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
p.000060: (f) the clinical investigation relates directly to a medical condition from which the subject suffers;
p.000060: (g) there are scientific grounds for expecting that participation in the clinical investigation will
p.000060: produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
p.000060: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000060:
p.000060:
p.000060: Article 65
p.000060:
p.000060: Clinical investigations on minors
p.000060:
p.000060: A clinical investigation on minors may be conducted only where, in addition to the conditions set out
p.000060: in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060:
p.000060: 5.5.2017 EN
p.000060: Official Journal of the European Union
p.000061: L 117/61
p.000061:
p.000061: (b) the minors have received the information referred to in Article 63(2) in a way adapted to their
p.000061: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000061: experienced in working with children;
p.000061: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000061: referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation
p.000061: at any time, is respected by the investigator;
p.000061: (d) no incentives or financial inducements are given to the subject or his or her legally designated
...
p.000062: health of the subject, or in the diagnosis of its condition;
p.000062: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
p.000062: prior informed consent from his or her legally designated representative;
p.000062: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000062: clinical investigation previously expressed by the subject;
p.000062: (e) the clinical investigation relates directly to the subject's medical condition because of which it
p.000062: is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her
p.000062: legally designated rep resentative and to supply prior information, and the clinical investigation is of
p.000062: such a nature that it may be conducted exclusively in emergency situations;
p.000062: (f) the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison
p.000062: with the standard treatment of the subject's condition.
p.000062: 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with
p.000062: Article 63 shall be sought to continue the participation of the subject in the clinical investigation,
p.000062: and information on the clinical investigation shall be given, in accordance with the following requirements:
p.000062: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the
p.000062: investigator from his or her legally designated representative without undue delay and the information
p.000062: referred to in Article 63(2) shall be given as soon as possible to the subject and to his or her legally
p.000062: designated representative;
p.000062: (b) regarding other subjects, the informed consent shall be sought by the investigator without undue
p.000062: delay from the subject or his or her legally designated representative, whichever can be done sooner, and the
p.000062: information referred to in Article 63(2) shall be given as soon as possible to the subject or his or
p.000062: her legally designated representative, as applicable.
p.000062: For the purposes of point (b) where informed consent has been obtained from the legally designated
p.000062: representative, informed consent to continue the participation in the clinical investigation shall be obtained from the
p.000062: subject as soon as he or she is capable of giving informed consent.
p.000062:
p.000062: 3. If the subject or, where applicable, his or her legally designated representative does not give
p.000062: consent, he or she shall be informed of the right to object to the use of data obtained from the clinical
p.000062: investigation.
p.000062:
p.000062:
p.000062: Article 69
p.000062:
p.000062: Damage compensation
p.000062:
...
Searching for indicator incapacity:
(return to top)
p.000060: the information.
p.000060:
p.000060: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000060: subject has understood the information.
p.000060:
p.000060: 6. The subject shall be informed that a clinical investigation report and a summary presented in terms
p.000060: understandable to the intended user will be made available pursuant to Article 77(5) in the electronic
p.000060: system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical
p.000060: investigation, and shall be informed, to the extent possible, when they have become available.
p.000060:
p.000060: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed
p.000060: consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing
p.000060: the information given to him or her, shall also assent in order to participate in a clinical investigation.
p.000060:
p.000060:
p.000060: Article 64
p.000060:
p.000060: Clinical investigations on incapacitated subjects
p.000060:
p.000060: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent
p.000060: before the onset of their incapacity, a clinical investigation may be conducted only where, in addition
p.000060: to the conditions set out in Article 62(4), all of the following conditions are met:
p.000060: (a) the informed consent of their legally designated representative has been obtained;
p.000060: (b) the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in
p.000060: view of their capacity to understand it;
p.000060: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000060: the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the
p.000060: clinical investigation at any time, is respected by the investigator;
p.000060: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000060: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000060: the clinical investigation;
p.000060:
p.000060: (e) the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity
p.000060: cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000014: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000014: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000014:
p.000014: 5.5.2017 EN
p.000014: Official Journal of the European Union
p.000015: L 117/15
p.000015:
p.000015: 10. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000015: part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to
p.000015: that of the device shall be assessed and authorised in accordance with this Regulation. In that case,
p.000015: the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
p.000015:
p.000015: However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the
p.000015: device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive
p.000015: 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to
p.000015: this Regulation shall apply as far as the safety and performance of the device part are concerned.
p.000015:
p.000015: 11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
p.000015:
p.000015: 12. Devices that are also machinery within the meaning of point (a) of the second paragraph of
p.000015: Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a
p.000015: hazard relevant under that Directive exists, also meet the essential health and safety requirements set out
p.000015: in Annex I to that Directive to the extent to which those requirements are more specific than the
p.000015: general safety and performance requirements set out in Chapter II of Annex I to this Regulation.
p.000015:
p.000015: 13. This Regulation shall not affect the application of Directive 2013/59/Euratom.
p.000015:
p.000015: 14. This Regulation shall not affect the right of a Member State to restrict the use of any
p.000015: specific type of device in relation to aspects not covered by this Regulation.
p.000015:
p.000015: 15. This Regulation shall not affect national law concerning the organisation, delivery or financing
p.000015: of health services and medical care, such as the requirement that certain devices may only be supplied
p.000015: on a medical prescription, the requirement that only certain health professionals or healthcare institutions
p.000015: may dispense or use certain devices or that their use be accompanied by specific professional counselling.
p.000015:
p.000015: 16. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the
p.000015: media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular
p.000015: under Article 11 of the Charter of Fundamental Rights of the European Union.
p.000015:
p.000015:
p.000015: Article 2
p.000015:
p.000015: Definitions
p.000015:
p.000015: For the purposes of this Regulation, the following definitions apply:
...
p.000094:
p.000094: (a) establish and document a risk management plan for each device;
p.000094:
p.000094: (b) identify and analyse the known and foreseeable hazards associated with each device;
p.000094:
p.000094: (c) estimate and evaluate the risks associated with, and occurring during, the intended use
p.000094: and during reasonably foreseeable misuse;
p.000094:
p.000094: (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
p.000094:
p.000094: (e) evaluate the impact of information from the production phase and, in particular, from the
p.000094: post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their
p.000094: associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
p.000094:
p.000094: (f) based on the evaluation of the impact of the information referred to in point (e), if necessary
p.000094: amend control measures in line with the requirements of Section 4.
p.000094:
p.000094: 4. Risk control measures adopted by manufacturers for the design and manufacture of the
p.000094: devices shall conform to safety principles, taking account of the generally acknowledged state of the
p.000094: art. To reduce risks, Manufac turers shall manage risks so that the residual risk associated with each hazard as
p.000094: well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions,
p.000094: manufacturers shall, in the following order of priority:
p.000094:
p.000094: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000094:
p.000094: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000094: risks that cannot be eliminated; and
p.000094:
p.000094: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to
p.000094: users.
p.000094:
p.000094: Manufacturers shall inform users of any residual risks.
p.000094:
p.000094: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000094:
p.000094: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000094: environment in which the device is intended to be used (design for patient safety), and
p.000094:
p.000094: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000094: where applicable, and the medical and physical conditions of intended users (design for lay, professional,
p.000094: disabled or other users).
p.000094:
p.000094: 5.5.2017 EN
p.000094: Official Journal of the European Union
p.000095: L 117/95
p.000095:
p.000095: 6. The characteristics and performance of a device shall not be adversely affected to such a
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000061: addition to the conditions set out in Article 62(4), all of the following conditions are met:
p.000061: (a) the clinical investigation has the potential to produce a direct benefit for the pregnant or
p.000061: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000061: (b) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse
p.000061: impact on the health of the child;
p.000061: (c) no incentives or financial inducements are given to the subject except for compensation for
p.000061: expenses and loss of earnings directly related to the participation in the clinical investigation.
p.000061:
p.000061: Article 67
p.000061:
p.000061: Additional national measures
p.000061:
p.000061: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000061: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical
p.000061: investigations, or persons in residential care institutions.
p.000061:
p.000061:
p.000061: Article 68
p.000061:
p.000061: Clinical investigations in emergency situations
p.000061:
p.000061: 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article
p.000061: 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical
p.000061: investigation may be obtained, and information on the clinical investigation may be given, after the decision to
p.000061: include the subject in the clinical investigation, provided that that decision is taken at the time of the
p.000061: first intervention on the subject, in accordance with the clinical investigation plan for that clinical
p.000061: investigation and that all of the following conditions are fulfilled:
p.000061: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious
p.000061: medical condition, the subject is unable to provide prior informed consent and to receive prior
p.000061: information on the clinical investi gation;
p.000061:
p.000062: L 117/62 EN
p.000062: Official Journal of the European Union
p.000062: 5.5.2017
p.000062:
p.000062: (b) there are scientific grounds to expect that participation of the subject in the clinical
p.000062: investigation will have the potential to produce a direct clinically relevant benefit for the subject
p.000062: resulting in a measurable health-related improvement alleviating the suffering and/or improving the
p.000062: health of the subject, or in the diagnosis of its condition;
p.000062: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
p.000062: prior informed consent from his or her legally designated representative;
p.000062: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000062: clinical investigation previously expressed by the subject;
p.000062: (e) the clinical investigation relates directly to the subject's medical condition because of which it
p.000062: is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her
p.000062: legally designated rep resentative and to supply prior information, and the clinical investigation is of
p.000062: such a nature that it may be conducted exclusively in emergency situations;
p.000062: (f) the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison
p.000062: with the standard treatment of the subject's condition.
p.000062: 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with
p.000062: Article 63 shall be sought to continue the participation of the subject in the clinical investigation,
p.000062: and information on the clinical investigation shall be given, in accordance with the following requirements:
p.000062: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the
p.000062: investigator from his or her legally designated representative without undue delay and the information
p.000062: referred to in Article 63(2) shall be given as soon as possible to the subject and to his or her legally
p.000062: designated representative;
p.000062: (b) regarding other subjects, the informed consent shall be sought by the investigator without undue
p.000062: delay from the subject or his or her legally designated representative, whichever can be done sooner, and the
p.000062: information referred to in Article 63(2) shall be given as soon as possible to the subject or his or
p.000062: her legally designated representative, as applicable.
p.000062: For the purposes of point (b) where informed consent has been obtained from the legally designated
...
p.000064: following:
p.000064:
p.000064: (a) the objective and methodology of the clinical investigation; and
p.000064:
p.000064: (b) the degree of deviation of the intervention from normal clinical practice.
p.000064:
p.000064: 5.5.2017 EN
p.000064: Official Journal of the European Union
p.000065: L 117/65
p.000065:
p.000065: 3. All clinical investigation information shall be recorded, processed, handled, and stored
p.000065: by the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
p.000065: interpreted and verified while the confiden tiality of records and the personal data of the subjects
p.000065: remain protected in accordance with the applicable law on personal data protection.
p.000065:
p.000065: 4. Appropriate technical and organisational measures shall be implemented to protect information and
p.000065: personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction
p.000065: or accidental loss, in particular where the processing involves transmission over a network.
p.000065:
p.000065: 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that
p.000065: clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved
p.000065: investigation plan.
p.000065:
p.000065: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate
p.000065: identification and, where necessary, an immediate recall of the devices used in the investigation.
p.000065:
p.000065:
p.000065: Article 73
p.000065:
p.000065: Electronic system on clinical investigations
p.000065:
p.000065: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000065: electronic system:
p.000065:
p.000065: (a) to create the single identification numbers for clinical investigations referred to in Article 70(1);
p.000065:
p.000065: (b) to be used as an entry point for the submission of all applications or notifications for clinical
p.000065: investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data
p.000065: in this context;
p.000065:
p.000065: (c) for the exchange of information relating to clinical investigations in accordance with this
p.000065: Regulation between the Member States and between them and the Commission including the exchange of
p.000065: information referred to in Articles 70 and 76;
p.000065:
p.000065: (d) for information to be provided by the sponsor in accordance with Article 77, including the clinical
p.000065: investigation report and its summary as required in paragraph 5 of that Article;
p.000065:
p.000065: (e) for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.
p.000065:
p.000065: 2. When setting up the electronic system referred in paragraph 1 of this Article, the Commission
p.000065: shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for
...
p.000169: far as those standards and CS have not or have only been partly fulfilled or are lacking.
p.000169:
p.000169: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000169: the clinical investi gation and in particular information on any deviation from normal clinical practice.
p.000169:
p.000169:
p.000169: 3. Clinical Investigation Plan
p.000169:
p.000169: The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology,
p.000169: monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall
p.000169: contain in particular the information as laid down in this Annex. If part of this information is
p.000169: submitted in a separate document, it shall be referenced in the CIP.
p.000169:
p.000169:
p.000169: 3.1. General
p.000169:
p.000169: 3.1.1. Single identification number of the clinical investigation, as referred to in Article 70(1).
p.000169:
p.000169: 3.1.2. Identification of the sponsor — name, address and contact details of the sponsor and, where
p.000169: applicable, the name, address and contact details of the sponsor's contact person or legal representative
p.000169: in accordance with Article 62(2) established in the Union.
p.000169:
p.000169: 3.1.3. Information on the principal investigator at each investigational site, the coordinating
p.000169: investigator for the investigation, the address details for each investigational site and the emergency
p.000169: contact details for the principal investigator at each site. The roles, responsibilities and qualifications
p.000169: of the various kinds of investigators shall be specified in the CIP.
p.000169:
p.000170: L 117/170 EN
p.000170: Official Journal of the European Union
p.000170: 5.5.2017
p.000170:
p.000170: 3.1.4. A brief description of how the clinical investigation is financed and a brief description of
p.000170: the agreement between the sponsor and the site.
p.000170:
p.000170: 3.1.5. Overall synopsis of the clinical investigation, in an official Union language determined by the
p.000170: Member State concerned.
p.000170:
p.000170: 3.2. Identification and description of the device, including its intended purpose, its manufacturer,
p.000170: its traceability, the target population, materials coming into contact with the human body, the medical
p.000170: or surgical procedures involved in its use and the necessary training and experience for its use,
p.000170: background literature review, the current state of the art in clinical care in the relevant field of
p.000170: application and the proposed benefits of the new device.
p.000170:
p.000170: 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding
p.000170: expected clinical outcomes in the clinical investigation plan.
p.000170:
p.000170: 3.4. Description of the relevance of the clinical investigation in the context of the state of the art of
p.000170: clinical practice.
p.000170:
p.000170: 3.5. Objectives and hypotheses of the clinical investigation.
p.000170:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: devices.
p.000002:
p.000002:
p.000002: (7) The scope of application of this Regulation should be clearly delimited from other
p.000002: Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal
p.000002: products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of
p.000002: the Council (1) should be amended to exclude medical devices from its scope.
p.000002:
p.000002:
p.000002: (8) It should be the responsibility of the Member States to decide on a case-by-case basis
p.000002: whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification
p.000002: decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should
p.000002: be allowed to, on its own initiative or at the duly substantiated request of a Member State,
p.000002: having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether
p.000002: or not a specific product, category or group of products falls within the scope of this Regulation.
p.000002: When deliberating on the regulatory status of products in borderline cases involving medicinal products,
p.000002: human tissues and cells, biocidal products or food products, the Commission should ensure an
p.000002: appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency
p.000002: and the European Food Safety Authority, as relevant.
p.000002:
p.000002:
p.000002: (9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the
p.000002: possibility of taking a Union-wide decision regarding the regulatory status of a product should
p.000002: also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
p.000002:
p.000002:
p.000002: (10) Products which combine a medicinal product or substance and a medical device are regulated
p.000002: either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3)
p.000002: The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market
p.000002: assessment, and of exchange of information in the context of vigilance activities involving such combination
p.000002: products. For medicinal products that integrate a medical device part, compliance with the general safety
p.000002: and performance requirements laid down in this Regulation for the device part should be adequately
p.000002: assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should
p.000002: therefore be amended.
p.000002:
p.000002: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the
p.000002: general principles and requirements of food law, establishing the European Food Safety Authority and laying
p.000002: down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
p.000002: (2) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic
p.000002: products (OJ L 342,
p.000002: 22.12.2009, p. 59).
p.000002: (3) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000002: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000002:
p.000002: 5.5.2017 EN
p.000002: Official Journal of the European Union
p.000003: L 117/3
p.000003:
p.000003: (11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the
p.000003: Council (1) and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplete in
p.000003: respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are
p.000003: non-viable or are rendered non-viable. Such products should come under the scope of this Regulation,
p.000003: provided they comply with the definition of a medical device or are covered by this Regulation.
p.000003:
p.000003:
p.000003: (12) Certain groups of products for which a manufacturer claims only an aesthetic or another
p.000003: non-medical purpose but which are similar to medical devices in terms of functioning and risks profile
p.000003: should be covered by this Regulation. In order for manufacturers to be able to demonstrate the
p.000003: conformity of such products, the Commission should adopt common specifications at least with regard
...
p.000005: In that context, it is appropriate to provide that certain rules of this Regulation, as regards
p.000005: medical devices manufactured and used only within health institutions, including hospitals as well as
p.000005: institutions, such as laboratories and public health institutes that support the healthcare system and/or
p.000005: address patient needs, but which do not treat or care for patients directly, should not apply, since
p.000005: the aims of this Regulation would still be met in a proportionate manner. It should be noted that the
p.000005: concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests
p.000005: or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption
p.000005: applicable to health institutions does not apply to such establishments.
p.000005:
p.000005:
p.000005: (31) In view of the fact that natural or legal persons can claim compensation for damage caused by a
p.000005: defective device in accordance with applicable Union and national law, it is appropriate to
p.000005: require manufacturers to have measures in place to provide sufficient financial coverage in respect of
p.000005: their potential liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to
p.000005: the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay
p.000005: down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may
p.000005: have been injured by a defective device.
p.000005:
p.000005:
p.000005: (32) To ensure that devices manufactured in series production continue to be in conformity with the
p.000005: requirements of this Regulation and that experience from the use of the devices they manufacture is
p.000005: taken into account for the production process, all manufacturers should have a quality management system
p.000005: and a post-market surveillance system in place which should be proportionate to the risk class and the
p.000005: type of the device in question. In addition, in order to minimize risks or prevent incidents related to
p.000005: devices, manufacturers should establish a system for risk management and a system for reporting of incidents and
p.000005: field safety corrective actions.
p.000005:
p.000005:
p.000005: (33) The risk management system should be carefully aligned with and reflected in the clinical
p.000005: evaluation for the device, including the clinical risks to be addressed as part of clinical
p.000005: investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical
p.000005: evaluation processes should be inter-dependent and should be regularly updated.
p.000005:
p.000005:
p.000005: (34) It should be ensured that supervision and control of the manufacture of devices, and the post-market
...
p.000007: under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC)
p.000007: No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic
p.000007: systems.
p.000007:
p.000007: (48) For implantable devices and for class III devices, manufacturers should summarise the
p.000007: main safety and performance aspects of the device and the outcome of the clinical evaluation in a
p.000007: document that should be publicly available.
p.000007:
p.000007: (49) The summary of safety and clinical performance for a device should include in particular the
p.000007: place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation
p.000007: of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which
p.000007: that device and its alternatives can be considered.
p.000007:
p.000007: (50) The proper functioning of notified bodies is crucial for ensuring a high level of health and
p.000007: safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by
p.000007: the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at
p.000007: Union level.
p.000007:
p.000007: (51) Notified bodies' assessments of manufacturers' technical documentation, in particular documentation
p.000007: on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies.
p.000007: That evaluation should be part of the risk-based approach to the oversight and monitoring activities of
p.000007: notified bodies and should be based on sampling of the relevant documentation.
p.000007:
p.000007: (52) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with
p.000007: regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests
p.000007: on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
p.000007:
p.000007: (1) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102,
p.000007: 23.4.2010, p. 45).
p.000007: (2) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of
p.000007: individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995,
p.000007: p. 31).
p.000007: (3) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of
p.000007: individuals with
p.000007: regard to the processing of personal data by the Community institutions and bodies and on the free movement of such
p.000007: data (OJ L 8, 12.1.2001, p. 1).
p.000007:
p.000008: L 117/8 EN
p.000008: Official Journal of the European Union
p.000008: 5.5.2017
p.000008:
p.000008: (53) To increase transparency with regard to the oversight of notified bodies by national
...
p.000008: investigations that have been carried out under the responsibility of a sponsor. It should be possible both for
p.000008: the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical
p.000008: investigation.
p.000008:
p.000008: 5.5.2017 EN
p.000008: Official Journal of the European Union
p.000009: L 117/9
p.000009:
p.000009: (64) The rules on clinical investigations should be in line with well-established international
p.000009: guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical
p.000009: investigations of medical devices for human subjects, so as to make it easier for the results of clinical
p.000009: investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for
p.000009: the results of clinical investi gations conducted outside the Union in accordance with international guidelines to be
p.000009: accepted within the Union. In addition, the rules should be in line with the most recent
p.000009: version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research
p.000009: Involving Human Subjects.
p.000009:
p.000009:
p.000009: (65) It should be left to the Member State where a clinical investigation is to be conducted
p.000009: to determine the appropriate authority to be involved in the assessment of the application to conduct
p.000009: a clinical investigation and to organise the involvement of ethics committees within the timelines for the
p.000009: authorisation of that clinical investi gation as set out in this Regulation. Such decisions are a matter
p.000009: of internal organisation for each Member State. In that context, Member States should ensure the
p.000009: involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the
p.000009: necessary expertise is available.
p.000009:
p.000009:
p.000009: (66) Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
p.000009: or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in
p.000009: such cases, including issues of causality and the level of damages and sanctions, should remain governed by
p.000009: national law.
p.000009:
p.000009:
p.000009: (67) An electronic system should be set up at Union level to ensure that every clinical
p.000009: investigation is recorded and reported in a publicly accessible database. To protect the right to the
p.000009: protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the
p.000009: European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation
...
p.000010: (2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
p.000010: medical devices and
p.000010: repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).
p.000010:
p.000010: 5.5.2017 EN
p.000010: Official Journal of the European Union
p.000011: L 117/11
p.000011:
p.000011: technical expertise in the field of medical devices including in vitro diagnostic medical devices. When
p.000011: establishing subgroups, appropriate consideration should be given to the possibility of involving existing
p.000011: groups at Union level in the field of medical devices.
p.000011:
p.000011:
p.000011: (83) Expert panels and expert laboratories should be designated by the Commission on the basis of
p.000011: their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific,
p.000011: technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in
p.000011: relation to the implementation of this Regulation. Moreover, expert panels should fulfil the
p.000011: tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of
p.000011: certain high-risk devices.
p.000011:
p.000011: (84) Closer coordination between national competent authorities through information exchange and
p.000011: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000011: consistently high level of health and safety protection within the internal market, in particular in the
p.000011: areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment
p.000011: should also apply across other authority activities described in this Regulation, such as the designation of
p.000011: notified bodies and should be encouraged in the area of market surveillance of devices. Joint working,
p.000011: coordination and communication of activities should also lead to more efficient use of resources and expertise at
p.000011: national level.
p.000011:
p.000011: (85) The Commission should provide scientific, technical and corresponding logistical support
p.000011: to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000011: implemented at Union level based on sound scientific evidence.
p.000011:
p.000011:
p.000011: (86) The Union and, where appropriate, the Member States should actively participate in international
p.000011: regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related
p.000011: information regarding medical devices and to foster the further development of international regulatory
p.000011: guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety
p.000011: protection equivalent to that set by this Regulation.
p.000011:
p.000011:
p.000011: (87) Member States should take all necessary measures to ensure that the provisions of
p.000011: this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for
p.000011: their infringement.
p.000011:
p.000011:
p.000011: (88) Whilst this Regulation should not affect the right of Member States to levy fees for
...
p.000020: a Member State, the Commission shall, after consulting the Medical Device Coordination Group established
p.000020: under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific
p.000020: product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory
p.000020: for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure
p.000020: referred to in Article 114(3) of this Regulation.
p.000020:
p.000020: 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of
p.000020: implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts
p.000020: shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000020:
p.000020: 3. The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro
p.000020: diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary,
p.000020: other products, in order to determine the appropriate regulatory status of a product, or category or group of
p.000020: products.
p.000020:
p.000020: 4. When deliberating on the possible regulatory status as a device of products involving medicinal
p.000020: products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate
p.000020: level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA)
p.000020: and the European Food Safety Authority (EFSA), as relevant.
p.000020:
p.000020: 5.5.2017 EN
p.000020: Official Journal of the European Union
p.000021: L 117/21
p.000021:
p.000021: CHAPTER II
p.000021:
p.000021: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS,
p.000021: REPROCESSING, CE MARKING, FREE MOVEMENT
p.000021:
p.000021: Article 5
p.000021:
p.000021: Placing on the market and putting into service
p.000021:
p.000021: 1. A device may be placed on the market or put into service only if it complies with this
p.000021: Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
p.000021:
p.000021: 2. A device shall meet the general safety and performance requirements set out in Annex I which
p.000021: apply to it, taking into account its intended purpose.
p.000021:
p.000021: 3. Demonstration of conformity with the general safety and performance requirements shall
p.000021: include a clinical evaluation in accordance with Article 61.
p.000021:
p.000021: 4. Devices that are manufactured and used within health institutions shall be considered as having
p.000021: been put into service.
p.000021:
p.000021: 5. With the exception of the relevant general safety and performance requirements set out
p.000021: in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used
p.000021: only within health institutions established in the Union, provided that all of the following conditions are met:
p.000021: (a) the devices are not transferred to another legal entity,
p.000021: (b) manufacture and use of the devices occur under appropriate quality management systems,
p.000021: (c) the health institution justifies in its documentation that the target patient group's specific needs
p.000021: cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the
p.000021: market,
p.000021: (d) the health institution provides information upon request on the use of such devices to its
p.000021: competent authority, which shall include a justification of their manufacturing, modification and use;
p.000021: (e) the health institution draws up a declaration which it shall make publicly available, including:
p.000021: (i) the name and address of the manufacturing health institution;
p.000021: (ii) the details necessary to identify the devices;
p.000021: (iii) a declaration that the devices meet the general safety and performance requirements set out in
p.000021: Annex I to this Regulation and, where applicable, information on which requirements are not fully met
p.000021: with a reasoned justifi cation therefor,
p.000021: (f) the health institution draws up documentation that makes it possible to have an understanding of the
p.000021: manufacturing facility, the manufacturing process, the design and performance data of the devices,
p.000021: including the intended purpose, and that is sufficiently detailed to enable the competent authority
p.000021: to ascertain that the general safety and performance requirements set out in Annex I to this Regulation
p.000021: are met;
p.000021: (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance
p.000021: with the documentation referred to in point (f), and
p.000021: (h) the health institution reviews experience gained from clinical use of the devices and takes all
p.000021: necessary corrective actions.
p.000021: Member States may require that such health institutions submit to the competent authority any
p.000021: further relevant information about such devices which have been manufactured and used on their territory.
p.000021: Member States shall retain the right to restrict the manufacture and the use of any specific type of
p.000021: such devices and shall be permitted access to inspect the activities of the health institutions.
p.000021:
p.000021: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000021:
p.000021: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000021: acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
p.000021: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000021:
p.000022: L 117/22 EN
p.000022: Official Journal of the European Union
p.000022: 5.5.2017
p.000022:
p.000022: Article 6
p.000022:
p.000022: Distance sales
p.000022:
p.000022: 1. A device offered by means of information society services, as defined in point (b)
p.000022: of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply
p.000022: with this Regulation.
p.000022:
p.000022: 2. Without prejudice to national law regarding the exercise of the medical profession, a device
p.000022: that is not placed on the market but used in the context of a commercial activity, whether in return
p.000022: for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by
p.000022: means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or
p.000022: by other means of communication, directly or through intermediaries, to a natural or legal person established in the
p.000022: Union shall comply with this Regulation.
p.000022:
p.000022: 3. Upon request by a competent authority, any natural or legal person offering a device
p.000022: in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy
p.000022: of the EU declaration of conformity of the device concerned.
p.000022:
p.000022: 4. A Member State may, on grounds of protection of public health, require a provider of information society
p.000022: services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
p.000022:
p.000022:
p.000022: Article 7
p.000022:
p.000022: Claims
p.000022:
p.000022: In the labelling, instructions for use, making available, putting into service and advertising of
p.000022: devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may
p.000022: mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
p.000022:
p.000022: (a) ascribing functions and properties to the device which the device does not have;
p.000022:
p.000022: (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not
p.000022: have;
p.000022:
p.000022: (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with
p.000022: its intended purpose;
p.000022:
p.000022: (d) suggesting uses for the device other than those stated to form part of the intended
p.000022: purpose for which the conformity assessment was carried out.
p.000022:
p.000022:
p.000022: Article 8
p.000022:
p.000022: Use of harmonised standards
p.000022:
...
p.000023: documentation shall include the elements set out in Annexes II and III.
p.000023:
p.000023: The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the
p.000023: light of technical progress, the Annexes II and III.
p.000023:
p.000023: 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent
p.000023: authorities documentation in accordance with Section 2 of Annex XIII.
p.000023:
p.000023: 6. Where compliance with the applicable requirements has been demonstrated following the applicable
p.000023: conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall
p.000023: draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of
p.000023: conformity in accordance with Article 20.
p.000023:
p.000023: 7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article
p.000023: 27 and with the registration obligations referred to in Articles 29 and 31.
p.000023:
p.000023: 8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if
p.000023: applicable, a copy of any relevant certificate, including any amendments and supplements, issued in
p.000023: accordance with Article 56, available for the competent authorities for a period of at least 10 years
p.000023: after the last device covered by the EU declaration of conformity has been placed on the market. In the
p.000023: case of implantable devices, the period shall be at least 15 years after the last device has been placed on
p.000023: the market.
p.000023:
p.000023: Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that
p.000023: technical documen tation in its entirety or a summary thereof.
p.000023:
p.000023: A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised
p.000023: representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the
p.000023: necessary documentation permanently available.
p.000023:
p.000024: L 117/24 EN
p.000024: Official Journal of the European Union
p.000024: 5.5.2017
p.000024:
p.000024: 9. Manufacturers shall ensure that procedures are in place to keep series production in
p.000024: conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in
p.000024: the harmonised standards or CS by reference to which the conformity of a device is declared shall be
p.000024: adequately taken into account in a timely manner. Manufacturers of devices, other than investigational
p.000024: devices, shall establish, document, implement, maintain, keep up to date and continually improve a
p.000024: quality management system that shall ensure compliance with this Regulation in the most effective
p.000024: manner and in a manner that is proportionate to the risk class and the type of device.
p.000024:
p.000024: The quality management system shall cover all parts and elements of a manufacturer's organisation dealing
p.000024: with the quality of processes, procedures and devices. It shall govern the structure, responsibilities,
...
p.000024: to the user or patient. The particulars on the label shall be indelible, easily legible and clearly
p.000024: comprehensible to the intended user or patient.
p.000024:
p.000024: 12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or
p.000024: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000024: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the
p.000024: distributors of the device in question and, where applicable, the authorised representative and importers
p.000024: accordingly.
p.000024:
p.000024: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000024: of the Member States in which they made the device available and, where applicable, the notified body that
p.000024: issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any
p.000024: corrective action taken.
p.000024:
p.000024: 13. Manufacturers shall have a system for recording and reporting of incidents and field safety
p.000024: corrective actions as described in Articles 87 and 88.
p.000024:
p.000024: 5.5.2017 EN
p.000024: Official Journal of the European Union
p.000025: L 117/25
p.000025:
p.000025: 14. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000025: and documen tation necessary to demonstrate the conformity of the device, in an official
p.000025: Union language determined by the Member State concerned. The competent authority of the Member State
p.000025: in which the manufacturer has its registered place of business may require that the manufacturer provide
p.000025: samples of the device free of charge or, where that is impracticable, grant access to the device.
p.000025: Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken
p.000025: to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000025: the market or put into service.
p.000025:
p.000025: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000025: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000025: safety, take all appropriate measures to prohibit or restrict the device's being made available on its
p.000025: national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or
p.000025: provides complete and correct information.
p.000025:
p.000025: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000025: upon request, facilitate the provision of the information and documentation referred to in the first
p.000025: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000025: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000025: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000025: overriding public interest in disclosure, without prejudice to the protection of intellectual property
p.000025: rights.
p.000025:
p.000025: The competent authority need not comply with the obligation laid down in the third subparagraph where
p.000025: disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt
p.000025: with in the context of legal proceedings.
p.000025:
p.000025: 15. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000025: person the information on the identity of that person shall be part of the information to be
p.000025: submitted in accordance with Article 30(1).
p.000025:
p.000025: 16. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000025: accordance with applicable Union and national law.
p.000025:
p.000025: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000025: of the enterprise, have measures in place to provide sufficient financial coverage in respect
p.000025: of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under
p.000025: national law.
p.000025:
p.000025:
p.000025: Article 11
p.000025:
p.000025: Authorised representative
p.000025:
p.000025: 1. Where the manufacturer of a device is not established in a Member State, the device may only
p.000025: be placed on the Union market if the manufacturer designates a sole authorised representative.
p.000025:
p.000025: 2. The designation shall constitute the authorised representative's mandate, it shall be valid only
p.000025: when accepted in writing by the authorised representative and shall be effective at least for all devices of the same
p.000025: generic device group.
p.000025:
p.000025: 3. The authorised representative shall perform the tasks specified in the mandate agreed
p.000025: between it and the manufacturer. The authorised representative shall provide a copy of the mandate to
p.000025: the competent authority, upon request.
p.000025:
p.000025: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000025: least the following tasks in relation to the devices that it covers:
p.000025:
p.000025: (a) verify that the EU declaration of conformity and technical documentation have been drawn
p.000025: up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the
p.000025: manufacturer;
p.000025:
p.000025: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if
p.000025: applicable, a copy of the relevant certificate, including any amendments and supplements, issued in
p.000025: accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
p.000025:
p.000025: (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied
p.000025: with the registration obligations laid down in Articles 27 and 29;
p.000025:
p.000026: L 117/26 EN
p.000026: Official Journal of the European Union
p.000026: 5.5.2017
p.000026:
p.000026: (d) in response to a request from a competent authority, provide that competent authority with all the
p.000026: information and documentation necessary to demonstrate the conformity of a device, in an official Union
p.000026: language determined by the Member State concerned;
p.000026: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000026: resentative has its registered place of business for samples, or access to a device and verify that
p.000026: the competent authority receives the samples or is given access to the device;
p.000026: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate
p.000026: or, if that is not possible, mitigate the risks posed by devices;
p.000026: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000026: patients and users about suspected incidents related to a device for which they have been designated;
p.000026: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000026: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's
p.000026: obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
p.000026:
p.000026: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000026: and has not complied with the obligations laid down in Article 10, the authorised representative shall
p.000026: be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000026:
p.000026: 6. An authorised representative who terminates its mandate on the ground referred to in point (h)
p.000026: of paragraph 3 shall immediately inform the competent authority of the Member State in which it is
p.000026: established and, where applicable, the notified body that was involved in the conformity assessment for
p.000026: the device of the termination of the mandate and the reasons therefor.
p.000026:
p.000026: 7. Any reference in this Regulation to the competent authority of the Member State in which the
p.000026: manufacturer has its registered place of business shall be understood as a reference to the competent
p.000026: authority of the Member State in which the authorised representative, designated by a manufacturer referred
p.000026: to in paragraph 1, has its registered place of business.
p.000026:
p.000026: Article 12
p.000026:
p.000026: Change of authorised representative
p.000026:
p.000026: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000026: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000026: representative. That agreement shall address at least the following aspects:
p.000026: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000026: beginning of the mandate of the incoming authorised representative;
p.000026: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000026: supplied by the manufacturer, including any promotional material;
p.000026: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000026: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000026: forward to the manufacturer or incoming authorised representative any complaints or reports
p.000026: from healthcare professionals, patients or users about suspected incidents related to a device for which
p.000026: it had been designated as authorised rep resentative.
p.000026:
p.000026: Article 13
p.000026:
p.000026: General obligations of importers
p.000026:
p.000026: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000026:
p.000026: 2. In order to place a device on the market, importers shall verify that:
p.000026: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000026: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000026: designated by the manufacturer;
p.000026: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000026: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
p.000026:
p.000026: 5.5.2017 EN
p.000026: Official Journal of the European Union
p.000027: L 117/27
p.000027:
p.000027: Where an importer considers or has reason to believe that a device is not in conformity with the
p.000027: requirements of this Regulation, it shall not place the device on the market until it has been brought
p.000027: into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where
p.000027: the importer considers or has reason to believe that the device presents a serious risk or is a
p.000027: falsified device, it shall also inform the competent authority of the Member State in which the importer is
p.000027: established.
p.000027:
p.000027: 3. Importers shall indicate on the device or on its packaging or in a document accompanying the
p.000027: device their name, registered trade name or registered trade mark, their registered place of business and
p.000027: the address at which they can be contacted, so that their location can be established. They shall
p.000027: ensure that any additional label does not obscure any information on the label provided by the manufacturer.
p.000027:
p.000027: 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29.
p.000027: Importers shall add their details to the registration in accordance with Article 31.
p.000027:
p.000027: 5. Importers shall ensure that, while a device is under their responsibility, storage or transport
p.000027: conditions do not jeopardise its compliance with the general safety and performance requirements set out
p.000027: in Annex I and shall comply with the conditions set by the manufacturer, where available.
p.000027:
p.000027: 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and
p.000027: withdrawals, and provide the manufacturer, authorised representative and distributors with any information
p.000027: requested by them, in order to allow them to investigate complaints.
p.000027:
p.000027: 7. Importers who consider or have reason to believe that a device which they have placed on the
p.000027: market is not in conformity with this Regulation shall immediately inform the manufacturer and its
p.000027: authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised
p.000027: representative and the competent authorities to ensure that the necessary corrective action to bring that
p.000027: device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall
p.000027: also immediately inform the competent authorities of the Member States in which they made the device
p.000027: available and, if applicable, the notified body that issued a certificate in accordance with Article 56
p.000027: for the device in question, giving details, in particular, of the non-compliance and of any corrective
p.000027: action taken.
p.000027:
p.000027: 8. Importers who have received complaints or reports from healthcare professionals, patients
p.000027: or users about suspected incidents related to a device which they have placed on the market shall immediately
p.000027: forward this information to the manufacturer and its authorised representative.
p.000027:
p.000027: 9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of
p.000027: conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements,
p.000027: issued in accordance with Article 56.
p.000027:
p.000027: 10. Importers shall cooperate with competent authorities, at the latters' request, on any action
p.000027: taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have
p.000027: placed on the market. Importers, upon request by a competent authority of the Member State in which the
p.000027: importer has its registered place of business, shall provide samples of the device free of charge or, where
p.000027: that is impracticable, grant access to the device.
p.000027:
p.000027:
p.000027: Article 14
p.000027:
p.000027: General obligations of distributors
p.000027:
p.000027: 1. When making a device available on the market, distributors shall, in the context of their
p.000027: activities, act with due care in relation to the requirements applicable.
p.000027:
p.000027: 2. Before making a device available on the market, distributors shall verify that all of the
p.000027: following requirements are met:
p.000027: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000027: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
p.000027: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000027: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000027: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000027: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000027:
p.000028: L 117/28 EN
p.000028: Official Journal of the European Union
p.000028: 5.5.2017
p.000028:
p.000028: Where a distributor considers or has reason to believe that a device is not in conformity with the
p.000028: requirements of this Regulation, it shall not make the device available on the market until it has been
p.000028: brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's
p.000028: authorised representative, and the importer. Where the distributor considers or has reason to believe that
p.000028: the device presents a serious risk or is a falsified device, it shall also inform the competent authority
p.000028: of the Member State in which it is established.
p.000028:
p.000028: 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport
p.000028: conditions comply with the conditions set by the manufacturer.
p.000028:
p.000028: 4. Distributors that consider or have reason to believe that a device which they have made available on the
p.000028: market is not in conformity with this Regulation shall immediately inform the manufacturer and, where
p.000028: applicable, the manufac turer's authorised representative and the importer. Distributors shall co-operate
p.000028: with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and
p.000028: with competent authorities to ensure that the necessary corrective action to bring that device into conformity,
p.000028: to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe
p.000028: that the device presents a serious risk, it shall also immediately inform the competent authorities of
p.000028: the Member States in which it made the device available, giving details, in particular, of the
p.000028: non-compliance and of any corrective action taken.
p.000028:
p.000028: 5. Distributors that have received complaints or reports from healthcare professionals, patients
p.000028: or users about suspected incidents related to a device they have made available, shall immediately
p.000028: forward this information to the manufacturer and, where applicable, the manufacturer's authorised
p.000028: representative, and the importer. They shall keep a register of complaints, of non-conforming devices and
p.000028: of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and
p.000028: the importer informed of such monitoring and provide them with any information upon their request.
p.000028:
p.000028: 6. Distributors shall, upon request by a competent authority, provide it with all the information
p.000028: and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
p.000028:
p.000028: Distributors shall be considered to have fulfilled the obligation referred to in the first
p.000028: subparagraph when the manufacturer or, where applicable, the authorised representative for the
p.000028: device in question provides the required information. Distributors shall cooperate with competent
p.000028: authorities, at their request, on any action taken to eliminate the risks posed by devices which they
p.000028: have made available on the market. Distributors, upon request by a competent authority, shall provide free
p.000028: samples of the device or, where that is impracticable, grant access to the device.
p.000028:
p.000028:
p.000028: Article 15
p.000028:
p.000028: Person responsible for regulatory compliance
p.000028:
p.000028: 1. Manufacturers shall have available within their organisation at least one person
p.000028: responsible for regulatory compliance who possesses the requisite expertise in the field of medical
p.000028: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000028:
p.000028: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a
p.000028: university degree or of a course of study recognised as equivalent by the Member State concerned, in law,
p.000028: medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of
p.000028: professional experience in regulatory affairs or in quality management systems relating to medical devices;
p.000028:
p.000028: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000028: to medical devices.
p.000028:
p.000028: Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made
p.000028: devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of
p.000028: professional experience within a relevant field of manufacturing.
p.000028:
p.000028: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000028: not be required to have the person responsible for regulatory compliance within their organisation but
...
p.000030:
p.000030: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of
p.000030: paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a
p.000030: document accompanying the device, the activity carried out together with its name, registered trade name
p.000030: or registered trade mark, registered place of business and the address at which it can be contacted, so that its
p.000030: location can be established.
p.000030:
p.000030: Distributors and importers shall ensure that they have in place a quality management system that
p.000030: includes procedures which ensure that the translation of information is accurate and up-to-date, and that
p.000030: the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that
p.000030: preserve the original condition of the device and that the packaging of the repackaged device is not
p.000030: defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures
p.000030: ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer
p.000030: in relation to the device in question in order to respond to safety issues or to bring it into conformity
p.000030: with this Regulation.
p.000030:
p.000030: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000030: distributors or importers carrying out any of the activities mentioned in points (a) and (b)
p.000030: of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in
p.000030: which they plan to make the device available of the intention to make the relabelled or repackaged
p.000030: device available and, upon request, shall provide the manufacturer and the competent authority with a sample
p.000030: or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
p.000030: Within the same period of 28 days, the distributor or importer shall submit to the competent authority
p.000030: a certificate, issued by a notified body designated for the type of devices that are subject to
p.000030: activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system
p.000030: of the distributer or importer complies with the requirements laid down in paragraph 3.
p.000030:
p.000030:
p.000030: Article 17
p.000030:
p.000030: Single-use devices and their reprocessing
p.000030:
p.000030: 1. Reprocessing and further use of single-use devices may only take place where permitted by
p.000030: national law and only in accordance with this Article.
p.000030:
p.000030: 2. Any natural or legal person who reprocesses a single-use device to make it suitable for further
p.000030: use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the
p.000030: obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to
p.000030: the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The
p.000030: reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive
p.000030: 85/374/EEC.
p.000030:
p.000030: 3. By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a
p.000030: health institution, Member States may decide not to apply all of the rules relating to manufacturers'
...
p.000032: shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE
p.000032: marking.
p.000032:
p.000032: 6. Where devices are subject to other Union legislation which also provides for the affixing of
p.000032: the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other
p.000032: legislation.
p.000032:
p.000032: 5.5.2017 EN
p.000032: Official Journal of the European Union
p.000033: L 117/33
p.000033:
p.000033: Article 21
p.000033:
p.000033: Devices for special purposes
p.000033:
p.000033: 1. Member States shall not create obstacles to:
p.000033: (a) investigational devices being supplied to an investigator for the purpose of a clinical
p.000033: investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the
p.000033: implementing acts adopted pursuant to Article 81 and in Annex XV;
p.000033: (b) custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.
p.000033: The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of
p.000033: the devices referred to in Article 74.
p.000033:
p.000033: 2. Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall
p.000033: be made available to the particular patient or user identified by name, an acronym or a numerical code.
p.000033:
p.000033: Member States may require that the manufacturer of a custom-made device submit to the competent
p.000033: authority a list of such devices which have been made available in their territory.
p.000033:
p.000033: 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create
p.000033: obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly
p.000033: indicates that such devices are intended for presentation or demonstration purposes only and cannot be made
p.000033: available until they have been brought into compliance with this Regulation.
p.000033:
p.000033:
p.000033: Article 22
p.000033:
p.000033: Systems and procedure packs
p.000033:
p.000033: 1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE
p.000033: marking with the following other devices or products, in a manner that is compatible with the intended
p.000033: purpose of the devices or other products and within the limits of use specified by their manufacturers, in order
p.000033: to place them on the market as a system or procedure pack:
p.000033: (a) other devices bearing the CE marking;
p.000033: (b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
p.000033: (c) other products which are in conformity with legislation that applies to those products only where
p.000033: they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
p.000033: 2. In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
p.000033: (a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the
p.000033: manu facturers' instructions and have carried out their activities in accordance with those instructions;
...
p.000034: order to maintain or restore the function of the device without changing its performance or safety
p.000034: characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety
p.000034: and performance of the device. Supporting evidence shall be kept available for the competent authorities of
p.000034: the Member States.
p.000034:
p.000034: 2. An item that is intended specifically to replace a part or component of a device and that
p.000034: significantly changes the performance or safety characteristics or the intended purpose of the device shall
p.000034: be considered to be a device and shall meet the requirements laid down in this Regulation.
p.000034:
p.000034:
p.000034: Article 24
p.000034:
p.000034: Free movement
p.000034:
p.000034: Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or
p.000034: restrict the making available on the market or putting into service within their territory of devices
p.000034: which comply with the requirements of this Regulation.
p.000034:
p.000034: CHAPTER III
p.000034:
p.000034: IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF
p.000034: SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
p.000034:
p.000034: Article 25
p.000034:
p.000034: Identification within the supply chain
p.000034:
p.000034: 1. Distributors and importers shall co-operate with manufacturers or authorised representatives
p.000034: to achieve an appropriate level of traceability of devices.
p.000034:
p.000034: 2. Economic operators shall be able to identify the following to the competent authority, for the period
p.000034: referred to in Article 10(8):
p.000034: (a) any economic operator to whom they have directly supplied a device;
p.000034: (b) any economic operator who has directly supplied them with a device;
p.000034: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000034:
p.000034: Article 26
p.000034:
p.000034: Medical devices nomenclature
p.000034:
p.000034: To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in
p.000034: Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is
p.000034: available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
p.000034: that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other
p.000034: stakeholders free of charge, where reasonably practicable.
p.000034:
p.000034: 5.5.2017 EN
p.000034: Official Journal of the European Union
p.000035: L 117/35
p.000035:
p.000035: Article 27
p.000035:
p.000035: Unique Device Identification system
p.000035:
p.000035: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000035: allow the identifi cation and facilitate the traceability of devices, other than custom-made and
p.000035: investigational devices, and shall consist of the following:
p.000035: (a) production of a UDI that comprises the following:
p.000035: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
p.000035: the information laid down in Part B of Annex VI;
...
p.000037:
p.000037: 2. Member States may maintain or introduce national provisions on registration of distributors of devices which
p.000037: have been made available on their territory.
p.000037:
p.000037: 3. Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify
p.000037: that the manufacturer or authorised representative has provided to the electronic system the information
p.000037: referred to in paragraph 1.
p.000037:
p.000037: Where applicable, importers shall inform the relevant authorised representative or manufacturer if the
p.000037: information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the
p.000037: relevant entry/entries.
p.000037:
p.000037:
p.000037: Article 31
p.000037:
p.000037: Registration of manufacturers, authorised representatives and importers
p.000037:
p.000037: 1. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised
p.000037: representatives and importers shall, in order to register, submit to the electronic system referred to in
p.000037: Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have
p.000037: not already registered in accordance with this Article. In cases where the conformity assessment procedure
p.000037: requires the involvement of a notified body pursuant to Article 52, the information referred to in
p.000037: Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000037: notified body.
p.000037:
p.000037: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000037: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and
p.000037: issue it to the manufacturer, the authorised representative or the importer.
p.000037:
p.000038: L 117/38 EN
p.000038: Official Journal of the European Union
p.000038: 5.5.2017
p.000038:
p.000038: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for
p.000038: accessing Eudamed in order to fulfil its obligations under Article 29.
p.000038:
p.000038: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000038: Article, the economic operator shall update the data in the electronic system referred to in Article 30.
p.000038:
p.000038: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000038: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the
p.000038: event of a failure to do so within six months of those deadlines, any Member State may take appropriate
p.000038: corrective measures within its territory until that economic operator complies with that obligation.
p.000038:
p.000038: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority
p.000038: shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000038:
p.000038: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in
p.000038: Article 30 shall be accessible to the public.
p.000038:
p.000038: 8. The competent authority may use the data to charge the manufacturer, the authorised
p.000038: representative or the importer a fee pursuant to Article 111.
p.000038:
p.000038: Article 32
p.000038:
p.000038: Summary of safety and clinical performance
p.000038:
p.000038: 1. For implantable devices and for class III devices, other than custom-made or
p.000038: investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
p.000038:
p.000038: The summary of safety and clinical performance shall be written in a way that is clear to the
p.000038: intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
p.000038:
p.000038: The draft of the summary of safety and clinical performance shall be part of the documentation to be
p.000038: submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by
p.000038: that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer
p.000038: shall mention on the label or instructions for use where the summary is available.
p.000038:
p.000038: 2. The summary of safety and clinical performance shall include at least the following aspects:
p.000038: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the
p.000038: SRN;
p.000038: (b) the intended purpose of the device and any indications, contraindications and target populations;
p.000038: (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a
p.000038: description of the differences, as well as, where relevant, a description of any accessories, other devices and
p.000038: products, which are intended to be used in combination with the device;
...
p.000040: 5.5.2017
p.000040:
p.000040: Article 34
p.000040:
p.000040: Functionality of Eudamed
p.000040:
p.000040: 1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for
p.000040: Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May
p.000040: 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the
p.000040: Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that
p.000040: all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation
p.000040: (EU) 2017/746 are met.
p.000040:
p.000040: 2. The Commission shall, on the basis of an independent audit report, inform the MDCG when it has
p.000040: verified that Eudamed has achieved full functionality and Eudamed meets the functional
p.000040: specifications drawn up pursuant to paragraph 1.
p.000040:
p.000040: 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred
p.000040: to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
p.000040:
p.000040:
p.000040: CHAPTER IV
p.000040:
p.000040: NOTIFIED BODIES
p.000040:
p.000040: Article 35
p.000040:
p.000040: Authorities responsible for notified bodies
p.000040:
p.000040: 1. Any Member State that intends to designate a conformity assessment body as a notified body, or
p.000040: has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an
p.000040: authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities
p.000040: under national law and shall be responsible for setting up and carrying out the necessary procedures for
p.000040: the assessment, designation and notification of conformity assessment bodies and for the monitoring of
p.000040: notified bodies, including subcontractors and subsidiaries of those bodies.
p.000040:
p.000040: 2. The authority responsible for notified bodies shall be established, organised and operated so as
p.000040: to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with
p.000040: conformity assessment bodies.
p.000040:
p.000040: 3. The authority responsible for notified bodies shall be organised in a manner such that each
p.000040: decision relating to designation or notification is taken by personnel different from those who carried out the
p.000040: assessment.
p.000040:
p.000040: 4. The authority responsible for notified bodies shall not perform any activities that notified
p.000040: bodies perform on a commercial or competitive basis.
p.000040:
p.000040: 5. The authority responsible for notified bodies shall safeguard the confidential aspects of the
p.000040: information it obtains. However, it shall exchange information on notified bodies with other Member States,
p.000040: the Commission and, when required, with other regulatory authorities.
p.000040:
p.000040: 6. The authority responsible for notified bodies shall have a sufficient number of competent
p.000040: personnel permanently available for the proper performance of its tasks.
p.000040:
p.000040: Where the authority responsible for notified bodies is a different authority from the national competent
p.000040: authority for medical devices, it shall ensure that the national authority responsible for medical devices
p.000040: is consulted on relevant matters.
p.000040:
p.000040: 7. Member States shall make publicly available general information on their measures governing the
p.000040: assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies,
p.000040: and on changes which have a significant impact on such tasks.
p.000040:
p.000040: 8. The authority responsible for notified bodies shall participate in the peer-review
p.000040: activities provided for in Article 48.
p.000040:
p.000040: 5.5.2017 EN
p.000040: Official Journal of the European Union
p.000041: L 117/41
p.000041:
p.000041: Article 36
p.000041:
p.000041: Requirements relating to notified bodies
p.000041:
p.000041: 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this
p.000041: Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and
p.000041: process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex
p.000041: VII.
p.000041:
p.000041: In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent
p.000041: availability of sufficient administrative, technical and scientific personnel in accordance with Section
p.000041: 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of
p.000041: Annex VII, where possible employed by the notified body itself.
p.000041:
p.000041: The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified
p.000041: body itself and shall not be external experts or subcontractors.
p.000041:
p.000041: 2. Notified bodies shall make available and submit upon request all relevant documentation, including
p.000041: the manufac turer's documentation, to the authority responsible for notified bodies to allow it to conduct its
p.000041: assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined
p.000041: in this Chapter.
p.000041:
p.000041: 3. In order to ensure the uniform application of the requirements set out in Annex VII, the
p.000041: Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent
p.000041: interpretation and of practical application. Those implementing acts shall be adopted in accordance with the
p.000041: examination procedure referred to in Article 114(3).
p.000041:
p.000041: Article 37
p.000041:
p.000041: Subsidiaries and subcontracting
p.000041:
p.000041: 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has
p.000041: recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that
p.000041: the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the
p.000041: authority responsible for notified bodies accordingly.
p.000041:
p.000041: 2. Notified bodies shall take full responsibility for the tasks performed on their behalf
p.000041: by subcontractors or subsidiaries.
p.000041:
p.000041: 3. Notified bodies shall make publicly available a list of their subsidiaries.
p.000041:
p.000041: 4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided
p.000041: that the legal or natural person that applied for conformity assessment has been informed accordingly.
p.000041:
p.000041: 5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all
p.000041: relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the
p.000041: work carried out by them under this Regulation.
p.000041:
p.000041: Article 38
p.000041:
p.000041: Application by conformity assessment bodies for designation
p.000041:
p.000041: 1. Conformity assessment bodies shall submit an application for designation to the authority
p.000041: responsible for notified bodies.
p.000041:
p.000041: 2. The application shall specify the conformity assessment activities as defined in this Regulation,
p.000041: and the types of devices for which the body is applying to be designated, and shall be supported by
p.000041: documentation demonstrating compliance with Annex VII.
p.000041:
p.000041: In respect of the organisational and general requirements and the quality management
p.000041: requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the
p.000041: corresponding evaluation report delivered by a national accreditation body in accordance with Regulation
p.000041: (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described
p.000041: in Article 39. However, the applicant shall make available all the documentation referred to in the first
p.000041: subparagraph to demonstrate compliance with those requirements upon request.
p.000041:
p.000041: 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant
p.000041: changes occur, in order to enable the authority responsible for notified bodies to monitor and verify
p.000041: continuous compliance with all the requirements set out in Annex VII.
p.000041:
p.000042: L 117/42 EN
p.000042: Official Journal of the European Union
p.000042: 5.5.2017
p.000042:
p.000042: Article 39
p.000042:
p.000042: Assessment of the application
p.000042:
p.000042: 1. The authority responsible for notified bodies shall within 30 days check that the application
p.000042: referred to in Article 38 is complete and shall request the applicant to provide any missing
p.000042: information. Once the application is complete that authority shall send it to the Commission.
p.000042:
p.000042: The authority responsible for notified bodies shall review the application and supporting documentation in
p.000042: accordance with its own procedures and shall draw up a preliminary assessment report.
p.000042:
p.000042: 2. The authority responsible for notified bodies shall submit the preliminary assessment report to
p.000042: the Commission which shall immediately transmit it to the MDCG.
p.000042:
p.000042: 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in
p.000042: conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the
p.000042: specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One
p.000042: of the experts shall be a representa tive of the Commission who shall coordinate the activities of the
p.000042: joint assessment team. The other two experts shall come from Member States other than the one in which the
p.000042: applicant conformity assessment body is established.
p.000042:
p.000042: The joint assessment team shall be comprised of experts who are competent to assess the conformity
p.000042: assessment activities and the types of devices which are the subject of the application or, in
p.000042: particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific
p.000042: concern can be appropriately assessed.
p.000042:
p.000042: 4. Within 90 days of its appointment, the joint assessment team shall review the documentation
p.000042: submitted with the application in accordance with Article 38. The joint assessment team may provide
p.000042: feedback to, or require clarification from, the authority responsible for notified bodies on the application and on
p.000042: the planned on-site assessment.
p.000042:
p.000042: The authority responsible for notified bodies together with the joint assessment team shall plan and
p.000042: conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or
p.000042: subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.
p.000042:
p.000042: The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
p.000042:
p.000042: 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements
p.000042: set out in Annex VII shall be raised during the assessment process and discussed between the authority
p.000042: responsible for notified bodies and the joint assessment team with a view to reaching consensus and
p.000042: resolving any diverging opinions, with respect to the assessment of the application.
p.000042:
p.000042: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the
p.000042: applicant conformity assessment body the non-compliances resulting from the assessment and summarise
p.000042: the assessment by the joint assessment team.
p.000042:
p.000042: Within a specified timeframe, the applicant conformity assessment body shall submit to the
p.000042: national authority a corrective and preventive action plan to address the non-compliances.
p.000042:
p.000042: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment
p.000042: within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000042:
p.000042: 7. The authority responsible for notified bodies shall following receipt of a corrective and preventive action
p.000042: plan from the applicant body assess whether non-compliances identified during the assessment have been
p.000042: appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and
p.000042: shall include a timeframe for implemen tation of the actions therein.
p.000042:
p.000042: The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward
p.000042: it and its opinion thereon to the joint assessment team. The joint assessment team may
p.000042: request of the authority responsible for notified bodies further clarification and modifications.
p.000042:
p.000042: 5.5.2017 EN
p.000042: Official Journal of the European Union
p.000043: L 117/43
p.000043:
p.000043: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000043: — the result of the assessment,
p.000043: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000043: required, implemented,
p.000043: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000043: — the recommended scope of designation.
p.000043: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000043: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000043:
p.000043: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared
p.000043: by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days
p.000043: of receipt of those documents to the Commission, which shall immediately submit that final opinion to
p.000043: the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue
p.000043: a recommendation with regard to the draft designation, which the authority responsible for notified bodies
p.000043: shall duly take into consideration for its decision on the designation of the notified body.
p.000043:
p.000043: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000043: arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the
p.000043: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000043: accordance with the examination procedure referred to in Article 114(3).
p.000043:
p.000043: Article 40
p.000043:
p.000043: Nomination of experts for joint assessment of applications for notification
p.000043:
p.000043: 1. The Member States and the Commission shall nominate experts qualified in the
p.000043: assessment of conformity assessment bodies in the field of medical devices to participate in the activities
p.000043: referred to in Articles 39 and 48.
p.000043:
p.000043: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this
p.000043: Article, together with information on their specific field of competence and expertise. That list shall
p.000043: be made available to Member States competent authorities through the electronic system referred to in Article 57.
p.000043:
p.000043: Article 41
p.000043:
p.000043: Language requirements
p.000043:
p.000043: All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages
p.000043: which shall be determined by the Member State concerned.
p.000043:
...
p.000043:
p.000043: The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts
p.000043: thereof into an official Union language, such as is necessary for that documentation to be readily understood by the
p.000043: joint assessment team appointed in accordance with Article 39(3).
p.000043:
p.000043: Article 42
p.000043:
p.000043: Designation and notification procedure
p.000043:
p.000043: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to
p.000043: Article 39 was completed and which comply with Annex VII.
p.000043:
p.000043: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000043: have designated, using the electronic notification tool within the database of notified bodies developed
p.000043: and managed by the Commission (NANDO).
p.000043:
p.000043: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this
p.000043: Article, the scope of the designation indicating the conformity assessment activities as defined in this
p.000043: Regulation and the types of devices which the notified body is authorised to assess and, without
p.000043: prejudice to Article 44, any conditions associated with the designation.
p.000043:
p.000044: L 117/44 EN
p.000044: Official Journal of the European Union
p.000044: 5.5.2017
p.000044:
p.000044: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000044: for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and
p.000044: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of
p.000044: the MDCG, it shall provide a duly substantiated justification.
p.000044:
p.000044: 5. The notifying Member State shall, without prejudice to Article 44, inform the
p.000044: Commission and the other Member States of any conditions associated with the designation and provide
p.000044: documentary evidence regarding the arrangements in place to ensure that the notified body will be
p.000044: monitored regularly and will continue to satisfy the requirements set out in Annex VII.
p.000044:
p.000044: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the
p.000044: Commission may raise written objections, setting out its arguments, with regard either to the notified
p.000044: body or to its monitoring by the authority responsible for notified bodies. Where no objection is
p.000044: raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as
p.000044: referred to in paragraph 2.
p.000044:
p.000044: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
p.000044: bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph
p.000044: 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days
p.000044: of the matter having been brought before it. Where the MDCG is of the opinion that the notification
p.000044: can be accepted, the Commission shall publish in NANDO the notification within 14 days.
p.000044:
p.000044: 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or
p.000044: raises another objection, the notifying Member State shall provide a written response to the MDCG
p.000044: opinion within 40 days of its receipt. The response shall address the objections raised in the opinion,
p.000044: and set out the reasons for the notifying Member State's decision to designate or not designate the conformity
p.000044: assessment body.
p.000044:
p.000044: 9. Where the notifying Member State decides to uphold its decision to designate the conformity
p.000044: assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in
...
p.000044:
p.000044:
p.000044: Article 43
p.000044:
p.000044: Identification number and list of notified bodies
p.000044:
p.000044: 1. The Commission shall assign an identification number to each notified body for which the
p.000044: notification becomes valid in accordance with Article 42(11). It shall assign a single identification
p.000044: number even when the body is notified under several Union acts. If they are successfully designated in
p.000044: accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain
p.000044: the identification number assigned to them pursuant to those Directives.
p.000044:
p.000044: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000044: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000044: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000044: It shall also make this list available on the electronic system referred to in Article 57. The Commission shall
p.000044: ensure that the list is kept up to date.
p.000044:
p.000044: 5.5.2017 EN
p.000044: Official Journal of the European Union
p.000045: L 117/45
p.000045:
p.000045: Article 44
p.000045:
p.000045: Monitoring and re-assessment of notified bodies
p.000045:
p.000045: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority
p.000045: responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out
p.000045: in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they
p.000045: have been designated.
p.000045:
p.000045: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on
p.000045: their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the
p.000045: requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall,
p.000045: upon request by their authority responsible for notified bodies, supply all relevant information and
p.000045: documents, required to enable the authority, the Commission and other Member States to verify compliance.
p.000045:
p.000045: 3. Where the Commission or the authority of a Member State submits a request to a notified body established on
p.000045: the territory of another Member State relating to a conformity assessment carried out by that notified
p.000045: body, it shall send a copy of that request to the authority responsible for notified bodies of that
p.000045: other Member State. The notified body concerned shall respond without delay and within 15 days at the
p.000045: latest to the request. The authority responsible for notified bodies of the Member State in which the
p.000045: body is established shall ensure that requests submitted by authorities of any other Member State or by
p.000045: the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in
p.000045: which case the matter may be referred to the MDCG.
p.000045:
p.000045: 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether
p.000045: the notified bodies established on their respective territory and, where appropriate, the subsidiaries and
p.000045: subcontractors under the responsi bility of those notified bodies still satisfy the requirements and
p.000045: fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified
p.000045: body and, where necessary, of its subsidiaries and subcontractors.
p.000045:
p.000045: The authority responsible for notified bodies shall conduct its monitoring and assessment activities
p.000045: according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the
p.000045: notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for
p.000045: the frequency of assessment of the notified body and, in particular, associated subsidiaries and
p.000045: subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body
p.000045: for which it is responsible to the MDCG and to the Commission.
p.000045:
p.000045: 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include
p.000045: observed audits of notified body personnel, including where necessary any personnel from
p.000045: subsidiaries and subcontractors, as that personnel is in the process of conducting quality management system
p.000045: assessments at a manufacturer's facility.
p.000045:
p.000045: 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies
p.000045: shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its
p.000045: activities.
p.000045:
p.000045: The authority responsible for notified bodies shall provide for a systematic follow-up of
p.000045: complaints and other information, including from other Member States, which may indicate non-fulfilment
p.000045: of the obligations by a notified body or its deviation from common or best practice.
p.000045:
p.000045: 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments
p.000045: conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify
p.000045: compliance.
p.000045:
p.000045: 8. The authority responsible for notified bodies shall review the assessments by notified bodies of
p.000045: manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in
p.000045: Article 45.
p.000045:
p.000045: 9. The authority responsible for notified bodies shall document and record any findings regarding
p.000045: non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely
p.000045: implementation of corrective and preventive actions.
p.000045:
p.000045: 10. Three years after notification of a notified body, and again every fourth year thereafter, a
p.000045: complete re-assessment to determine whether the notified body still satisfies the requirements set out in
p.000045: Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the
p.000045: body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 38
p.000045: and 39.
p.000045:
p.000046: L 117/46 EN
p.000046: Official Journal of the European Union
p.000046: 5.5.2017
p.000046:
p.000046: 11. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to
p.000046: amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be
p.000046: carried out.
p.000046:
p.000046: 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on
p.000046: their monitoring and on-site assessment activities regarding notified bodies and, where applicable,
p.000046: subsidiaries and subcontractors. The report shall provide details of the outcome of those activities,
p.000046: including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the
p.000046: Commission; however it shall contain a summary which shall be made publicly available.
p.000046:
p.000046: The summary of the report shall be uploaded to the electronic system referred to in Article 57.
p.000046:
p.000046:
p.000046: Article 45
p.000046:
p.000046: Review of notified body assessment of technical documentation and clinical evaluation documentation
p.000046:
p.000046: 1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified
p.000046: bodies, shall review an appropriate number of notified body assessments of manufacturers' technical
p.000046: documentation, in particular the clinical evaluation documentation as referred to in points (c) and (d) of
p.000046: Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information
p.000046: presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted
p.000046: both off-site and on-site.
p.000046:
p.000046: 2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and
p.000046: representative of the types and risk of devices certified by the notified body, in particular high-risk devices,
p.000046: and be appropriately justified and documented in a sampling plan, which shall be made available by the
p.000046: authority responsible for notified bodies to the MDCG upon request.
p.000046:
p.000046: 3. The authority responsible for notified bodies shall review whether the assessment by the
p.000046: notified body was conducted appropriately and shall check the procedures used, associated documentation and
p.000046: the conclusions drawn by the notified body. Such checking shall include the technical documentation and clinical
p.000046: evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall
p.000046: be conducted utilising CS.
p.000046:
p.000046: 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with
p.000046: Article 44(10) and the joint assessment activities referred to in Article 47(3). The reviews shall be conducted
p.000046: utilising appropriate expertise.
p.000046:
p.000046: 5. Based on the reports of the reviews and assessments by the authority responsible for notified
p.000046: bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market
p.000046: surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or
p.000046: on the identification of concerns and emerging issues concerning the safety and performance of devices,
p.000046: the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser
p.000046: proportion of the technical documentation and clinical evaluation documen tation assessed by a notified body.
p.000046:
p.000046: 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000046: arrangements, associated documents for, and coordination of, the review of assessments of technical
p.000046: documentation and clinical evaluation documentation, as referred to in this Article. Those implementing
p.000046: acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000046:
p.000046:
p.000046: Article 46
p.000046:
p.000046: Changes to designations and notifications
p.000046:
p.000046: 1. The authority responsible for notified bodies shall notify the Commission and the other Member
p.000046: States of any relevant changes to the designation of a notified body.
p.000046:
p.000046: The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
p.000046:
p.000046: For changes to the designation other than extensions of its scope, the procedures laid down in the following
p.000046: paragraphs shall apply.
p.000046:
p.000046: 5.5.2017 EN
p.000046: Official Journal of the European Union
p.000047: L 117/47
p.000047:
p.000047: 2. The Commission shall immediately publish the amended notification in NANDO. The
p.000047: Commission shall immediately enter information on the changes to the designation of the notified body in
p.000047: the electronic system referred to in Article 57.
p.000047:
p.000047: 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority
p.000047: responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned
p.000047: cessation one year before ceasing its activities. The certificates may remain valid for a temporary period
p.000047: of nine months after cessation of the notified body's activities on condition that another notified body
p.000047: has confirmed in writing that it will assume responsibilities for the devices covered by those
p.000047: certificates. The new notified body shall complete a full assessment of the devices affected by the end
p.000047: of that period before issuing new certificates for those devices. Where the notified body has ceased its
p.000047: activity, the authority responsible for notified bodies shall withdraw the designation.
p.000047:
p.000047: 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer
p.000047: meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has
p.000047: not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or
p.000047: partially withdraw the designation, depending on the seriousness of the failure to meet those requirements
p.000047: or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same
p.000047: period.
p.000047:
p.000047: The authority responsible for notified bodies shall immediately inform the Commission and the other Member
p.000047: States of any suspension, restriction or withdrawal of a designation.
p.000047:
p.000047: 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the
p.000047: notified body shall inform the manufacturers concerned at the latest within 10 days.
p.000047:
p.000047: 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for
p.000047: notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are
p.000047: kept and make them available to authorities in other Member States responsible for notified bodies and to
p.000047: authorities responsible for market surveillance at their request.
p.000047:
p.000047: 7. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for
p.000047: notified bodies shall:
p.000047:
p.000047: (a) assess the impact on the certificates issued by the notified body;
p.000047:
p.000047: (b) submit a report on its findings to the Commission and the other Member States within three months
p.000047: of having notified the changes to the designation;
p.000047:
p.000047: (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by
p.000047: the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
p.000047:
p.000047: (d) enter into the electronic system referred to in Article 57 information in relation to certificates
p.000047: of which it has required their suspension or withdrawal;
p.000047:
p.000047: (e) inform the competent authority for medical devices of the Member State in which the
p.000047: manufacturer has its registered place of business through the electronic system referred to in Article 57 of the
p.000047: certificates for which it has required suspension or withdrawal. That competent authority shall take the
p.000047: appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or
p.000047: others.
p.000047:
p.000047: 8. With the exception of certificates unduly issued, and where a designation has been suspended or
p.000047: restricted, the certificates shall remain valid in the following circumstances:
p.000047:
p.000047: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or
p.000047: restriction, that there is no safety issue in relation to certificates affected by the suspension or
p.000047: restriction, and the authority responsible for notified bodies has outlined a timeline and actions
p.000047: anticipated to remedy the suspension or restriction; or
p.000047:
p.000047: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000047: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000047: whether the notified body has the capability of continuing to monitor and remain responsible for existing
p.000047: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000047: responsible for notified bodies determines that the notified body does not have the capability to support
p.000047: existing certificates issued, the manufacturer shall provide, to the competent authority for medical
p.000047: devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000047: registered place of business, within three months of the suspension or restriction, a written confirmation
p.000047: that another qualified notified body is temporarily assuming the functions of the notified body to
p.000047: monitor and remain responsible for the certificates during the period of suspension or restriction.
p.000047:
p.000048: L 117/48 EN
p.000048: Official Journal of the European Union
p.000048: 5.5.2017
p.000048:
p.000048: 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates
p.000048: shall remain valid for a period of nine months in the following circumstances:
p.000048:
p.000048: (a) where the competent authority for medical devices of the Member State in which the manufacturer of
p.000048: the device covered by the certificate has its registered place of business has confirmed that there is
p.000048: no safety issue associated with the devices in question; and
p.000048:
p.000048: (b) another notified body has confirmed in writing that it will assume immediate responsibilities for
p.000048: those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.
p.000048:
p.000048: In the circumstances referred to in the first subparagraph, the competent authority for
p.000048: medical devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000048: place of business may extend the provisional validity of the certificates for further periods of
p.000048: three months, which altogether shall not exceed twelve months.
p.000048:
p.000048: The authority or the notified body assuming the functions of the notified body affected by the change
p.000048: of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
p.000048:
p.000048:
p.000048: Article 47
p.000048:
p.000048: Challenge to the competence of notified bodies
p.000048:
p.000048: 1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have
p.000048: been brought to its attention regarding the continued fulfilment by a notified body, or of one or more
p.000048: of its subsidiaries or subcon tractors, of the requirements set out in Annex VII or the obligations to
p.000048: which they are subject. It shall ensure that the relevant authority responsible for notified bodies is
p.000048: informed and is given an opportunity to investigate those concerns.
p.000048:
p.000048: 2. The notifying Member State shall provide the Commission, on request, with all
p.000048: information regarding the designation of the notified body concerned.
p.000048:
p.000048: 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment
p.000048: procedure described in Article 39(3) and (4), where there is reasonable concern about the ongoing
p.000048: compliance of a notified body or a subsidiary or subcontractor of the notified body with the
p.000048: requirements set out in Annex VII and where the investi gation by the authority responsible for
p.000048: notified bodies is not deemed to have fully addressed the concerns or upon request of the authority
p.000048: responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles
p.000048: of Article 39. Alternatively, depending on the severity of the issue, the Commission, in conjunction with
p.000048: the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two
p.000048: experts from the list established pursuant to Article 40 in an on-site assessment as part of the
p.000048: planned monitoring and assessment activities in accordance with Article 44 and as outlined in the annual assessment
p.000048: plan described in Article 44(4).
p.000048:
p.000048: 4. Where the Commission ascertains that a notified body no longer meets the requirements for its
p.000048: designation, it shall inform the notifying Member State accordingly and request it to take the necessary
p.000048: corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.
p.000048:
p.000048: Where the Member State fails to take the necessary corrective measures, the Commission may,
p.000048: by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing
p.000048: acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It
p.000048: shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in
p.000048: Article 57.
p.000048:
p.000048: 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is
p.000048: treated accordingly.
p.000048:
p.000048:
p.000048: Article 48
p.000048:
p.000048: Peer review and exchange of experience between authorities responsible for notified bodies
p.000048:
p.000048: 1. The Commission shall provide for the organisation of exchange of experience and coordination of
p.000048: administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements
p.000048: including:
p.000048: (a) development of best practice documents relating to the activities of the authorities responsible for notified
p.000048: bodies;
p.000048:
p.000048: 5.5.2017 EN
p.000048: Official Journal of the European Union
p.000049: L 117/49
p.000049:
p.000049: (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation;
p.000049: (c) training and qualification of the experts referred to in Article 40;
p.000049: (d) monitoring of trends relating to changes to notified body designations and notifications and trends
p.000049: in certificate withdrawals and transfers between notified bodies;
p.000049: (e) monitoring of the application and applicability of scope codes referred to in Article 42(13);
p.000049: (f) development of a mechanism for peer reviews between authorities and the Commission;
p.000049: (g) methods of communication to the public on the monitoring and surveillance activities of authorities
p.000049: and the Commission on notified bodies.
p.000049: 2. The authorities responsible for notified bodies shall participate in a peer review every third
p.000049: year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be
p.000049: conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority
p.000049: may make the choice of having such reviews take place as part of its monitoring activities referred to in
p.000049: Article 44.
p.000049:
p.000049: 3. The Commission shall participate in the organisation and provide support to the implementation of
p.000049: the peer review mechanism.
p.000049:
p.000049: 4. The Commission shall compile an annual summary report of the peer review activities, which shall
p.000049: be made publicly available.
p.000049:
p.000049: 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000049: arrangements and related documents for the peer review mechanism and training and qualification as
p.000049: referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in
p.000049: accordance with the examination procedure referred to in Article 114(3).
p.000049:
p.000049:
p.000049: Article 49
p.000049:
p.000049: Coordination of notified bodies
p.000049:
p.000049: The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and
p.000049: operated in the form of a coordination group of notified bodies in the field of medical devices,
p.000049: including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually.
p.000049:
p.000049: The bodies notified under this Regulation shall participate in the work of that group.
p.000049:
p.000049: The Commission may establish the specific arrangements for the functioning of the coordination group of
p.000049: notified bodies.
p.000049:
p.000049:
p.000049: Article 50
p.000049:
p.000049: List of standard fees
p.000049:
p.000049: Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they
p.000049: carry out and shall make those lists publicly available.
p.000049:
p.000049: CHAPTER V
p.000049: CLASSIFICATION AND CONFORMITY ASSESSMENT
p.000049:
p.000049: SECTION 1
p.000049: Classification
p.000049:
p.000049: Article 51
p.000049:
p.000049: Classification of devices
p.000049:
p.000049: 1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended
p.000049: purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.
p.000049:
p.000050: L 117/50 EN
p.000050: Official Journal of the European Union
p.000050: 5.5.2017
p.000050:
p.000050: 2. Any dispute between the manufacturer and the notified body concerned, arising from the
p.000050: application of Annex VIII, shall be referred for a decision to the competent authority of the Member
p.000050: State in which the manufacturer has its registered place of business. In cases where the manufacturer has no
p.000050: registered place of business in the Union and has not yet designated an authorised representative, the matter
p.000050: shall be referred to the competent authority of the Member State in which the authorised
p.000050: representative referred to in the last indent of point (b) of the second paragraph of Section
p.000050: 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established
p.000050: in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after
p.000050: consultation with the competent authority of the Member State that designated the notified body.
p.000050:
p.000050: The competent authority of the Member State in which the manufacturer has its registered place of business shall
p.000050: notify the MDCG and the Commission of its decision. The decision shall be made available upon request.
p.000050:
p.000050: 3. At the request of a Member State the Commission shall after consulting the MDCG,
p.000050: decide, by means of implementing acts, on the following:
p.000050:
p.000050: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the
p.000050: classifi cation of such devices;
p.000050:
p.000050: (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific
p.000050: evidence, or based on any information which becomes available in the course of the vigilance and market
p.000050: surveillance activities be reclassified, by way of derogation from Annex VIII.
p.000050:
p.000050: 4. The Commission may also, on its own initiative and after consulting the MDCG,
p.000050: decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3.
p.000050:
p.000050: 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific
p.000050: opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent
p.000050: necessary to resolve issues of divergent interpretation and of practical application.
p.000050:
p.000050: 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance
p.000050: with the examination procedure referred to in Article 114(3).
p.000050:
p.000050:
p.000050: SECTION 2
p.000050:
p.000050: Conformity assessment
p.000050:
p.000050: Article 52
p.000050:
...
p.000052: follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX
p.000052: or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the
p.000052: following devices:
p.000052:
p.000052: (a) class III implantable devices, and
p.000052:
p.000052: (b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to
p.000052: in Section 6.4 of Annex VIII (Rule 12).
p.000052:
p.000052: 2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
p.000052:
p.000052: (a) in the case of renewal of a certificate issued under this Regulation;
p.000052:
p.000052: 5.5.2017 EN
p.000052: Official Journal of the European Union
p.000053: L 117/53
p.000053:
p.000053: (b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same
p.000053: intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body
p.000053: that the modifications do not adversely affect the benefit-risk ratio of the device; or
p.000053:
p.000053: (c) where the principles of the clinical evaluation of the device type or category have been addressed in a CS
p.000053: referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer
p.000053: for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
p.000053:
p.000053: 3. The notified body shall notify the competent authorities, the authority responsible for notified
p.000053: bodies and the Commission through the electronic system referred to in Article 57 of whether or not the
p.000053: procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by
p.000053: the clinical evaluation assessment report.
p.000053:
p.000053: 4. The Commission shall draw up an annual overview of devices which have been subject to the
p.000053: procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall
p.000053: include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and
p.000053: a listing of the cases where the notified body did not follow the advice from the expert panel. The
p.000053: Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
p.000053:
p.000053: 5. The Commission shall by 27 May 2025 draw up a report on the operation of this Article and
p.000053: submit it to the European Parliament and to the Council. The report shall take into account the annual
p.000053: overviews and any available relevant recommendations from the MDCG. On the basis of that report the
p.000053: Commission shall, if appropriate, make proposals for amendments to this Regulation.
p.000053:
p.000053:
p.000053: Article 55
p.000053:
p.000053: Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
p.000053:
p.000053: 1. A notified body shall notify the competent authorities of certificates it has granted to devices
p.000053: for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall
p.000053: take place through the electronic system referred to in Article 57 and shall include the summary of safety and
p.000053: clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions
p.000053: for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the
p.000053: expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the
p.000053: case of divergent views between the notified body and the expert panels, a full justifi cation shall
p.000053: also be included.
p.000053:
p.000053: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns
p.000053: apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate
p.000053: measures in accordance with Articles 95 and 97.
p.000053:
p.000053: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request
p.000053: scientific advice from the expert panels in relation to the safety and performance of any device.
p.000053:
p.000053:
p.000053: Article 56
p.000053:
p.000053: Certificates of conformity
p.000053:
p.000053: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000053: Union language determined by the Member State in which the notified body is established or otherwise in
p.000053: an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set
p.000053: out in Annex XII.
p.000053:
p.000053: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On
p.000053: application by the manufacturer, the validity of the certificate may be extended for further periods, each not
p.000053: exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment
p.000053: procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is
p.000053: valid.
p.000053:
p.000053: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups
...
p.000054:
p.000054: 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with
p.000054: another notified body in respect of the conformity assessment of the same device, the detailed
p.000054: arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the
p.000054: incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the
p.000054: following aspects:
p.000054: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000054: (b) the date until which the identification number of the outgoing notified body may be indicated in
p.000054: the information supplied by the manufacturer, including any promotional material;
p.000054: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000054: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000054: the incoming notified body;
p.000054: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000054: 2. The outgoing notified body shall withdraw the certificates it has issued for the device
p.000054: concerned on the date on which they become invalid.
p.000054:
p.000054: 5.5.2017 EN
p.000054: Official Journal of the European Union
p.000055: L 117/55
p.000055:
p.000055: Article 59
p.000055:
p.000055: Derogation from the conformity assessment procedures
p.000055:
p.000055: 1. By way of derogation from Article 52, any competent authority may authorise, on a duly
p.000055: justified request, the placing on the market or putting into service within the territory of the Member State
p.000055: concerned, of a specific device for which the procedures referred to in that Article have not been carried
p.000055: out but use of which is in the interest of public health or patient safety or health.
p.000055:
p.000055: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000055: authorise the placing on the market or putting into service of a device in accordance with paragraph 1
p.000055: where such authorisation is granted for use other than for a single patient.
p.000055:
p.000055: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional
p.000055: cases relating to public health or patient safety or health, may, by means of implementing acts, extend
p.000055: for a limited period of time the validity of an authorisation granted by a Member State in accordance with
p.000055: paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may
p.000055: be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the
p.000055: examination procedure referred to in Article 114(3).
p.000055:
p.000055: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000055: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
p.000055: Article 114(4).
p.000055:
p.000055:
p.000055: Article 60
p.000055:
p.000055: Certificate of free sale
...
p.000071: accordingly.
p.000071:
p.000072: L 117/72 EN
p.000072: Official Journal of the European Union
p.000072: 5.5.2017
p.000072:
p.000072: 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is
p.000072: identified, the manufacturer shall implement the appropriate measures and inform the competent authorities
p.000072: concerned and, where applicable, the notified body. Where a serious incident is identified or a field
p.000072: safety corrective action is implemented, it shall be reported in accordance with Article 87.
p.000072:
p.000072:
p.000072: Article 84
p.000072:
p.000072: Post-market surveillance plan
p.000072:
p.000072: The post-market surveillance system referred to in Article 83 shall be based on a post-market
p.000072: surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices
p.000072: other than custom-made devices, the post- market surveillance plan shall be part of the technical documentation
p.000072: specified in Annex II.
p.000072:
p.000072:
p.000072: Article 85
p.000072:
p.000072: Post-market surveillance report
p.000072:
p.000072: Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and
p.000072: conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000072: surveillance plan referred to in Article 84 together with a rationale and description of any preventive
p.000072: and corrective actions taken. The report shall be updated when necessary and made available to the competent
p.000072: authority upon request.
p.000072:
p.000072:
p.000072: Article 86
p.000072:
p.000072: Periodic safety update report
p.000072:
p.000072: 1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety
p.000072: update report (‘PSUR’) for each device and where relevant for each category or group of devices
p.000072: summarising the results and conclusions of the analyses of the post-market surveillance data gathered as
p.000072: a result of the post-market surveillance plan referred to in Article 84 together with a rationale and
p.000072: description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned,
p.000072: that PSUR shall set out:
p.000072:
p.000072: (a) the conclusions of the benefit-risk determination;
p.000072:
p.000072: (b) the main findings of the PMCF; and
p.000072:
p.000072: (c) the volume of sales of the device and an estimate evaluation of the size and other
p.000072: characteristics of the population using the device and, where practicable, the usage frequency of the device.
p.000072:
p.000072: Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR
p.000072: shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II
p.000072: and III.
p.000072:
p.000072: Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
p.000072: That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in
p.000072: Annexes II and III.
p.000072:
...
p.000073:
p.000073: 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's
p.000073: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000073: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000073: after the date on which the manufacturer becomes aware of the serious incident.
p.000073:
p.000073: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that
p.000073: is incomplete followed up by a complete report.
p.000073:
p.000073: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain
p.000073: about whether the incident is reportable, it shall nevertheless submit a report within the
p.000073: timeframe required in accordance with paragraphs 2 to 5.
p.000073:
p.000073: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000073: immediately, the manufacturer shall, without undue delay, report the field safety corrective
p.000073: action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being
p.000073: undertaken.
p.000073:
p.000073: 9. For similar serious incidents that occur with the same device or device type and for which the root cause
p.000073: has been identified or a field safety corrective action implemented or where the incidents are common and
p.000073: well documented, the manufacturer may provide periodic summary reports instead of individual serious
p.000073: incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in
p.000073: consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with
p.000073: the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single
p.000073: competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic
p.000073: summary reports following agreement with that competent authority.
p.000073:
p.000073: 10. The Member States shall take appropriate measures such as organising targeted information
p.000073: campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent
p.000073: authorities suspected serious incidents referred to in point (a) of paragraph 1.
p.000073:
p.000073: The competent authorities shall record centrally at national level reports they receive from healthcare
p.000073: professionals, users and patients.
p.000073:
p.000074: L 117/74 EN
p.000074: Official Journal of the European Union
p.000074: 5.5.2017
p.000074:
p.000074: 11. Where a competent authority of a Member State obtains such reports on suspected serious
p.000074: incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it
p.000074: shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the
p.000074: suspected serious incident without delay.
p.000074:
p.000074: Where the manufacturer of the device concerned considers that the incident is a serious incident, it
p.000074: shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the
p.000074: competent authority of the Member State in which that serious incident occurred and shall take the appropriate
p.000074: follow-up action in accordance with Article 89.
p.000074:
p.000074: Where the manufacturer of the device concerned considers that the incident is not a serious incident or
p.000074: is an expected undesirable side-effect, which will be covered by trend reporting in accordance with
p.000074: Article 88, it shall provide an explanatory statement. If the competent authority does not agree with
p.000074: the conclusion of the explanatory statement, it may require the manufacturer to provide a report in
p.000074: accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action
p.000074: is taken in accordance with Article 89.
p.000074:
p.000074:
p.000074:
p.000074: Article 88
p.000074:
p.000074: Trend reporting
p.000074:
p.000074: 1. Manufacturers shall report, by means of the electronic system referred to in Article 92, any
p.000074: statistically significant increase in the frequency or severity of incidents that are not serious
p.000074: incidents or that are expected undesirable side- effects that could have a significant impact on the
p.000074: benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to
p.000074: risks to the health or safety of patients, users or other persons that are unacceptable when weighed
p.000074: against the intended benefits. The significant increase shall be established in comparison to
p.000074: the foreseeable frequency or severity of such incidents in respect of the device, or category or group of
p.000074: devices, in question during a specific period as specified in the technical documentation and product information.
p.000074:
p.000074: The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and
p.000074: the methodology used for determining any statistically significant increase in the frequency or severity
p.000074: of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article
p.000074: 84.
p.000074:
p.000074: 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1
p.000074: and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to
p.000074: ensure the protection of public health and patient safety. Each competent authority shall inform the
p.000074: Commission, the other competent authorities and the notified body that issued the certificate, of the
p.000074: results of such assessment and of the adoption of such measures.
p.000074:
p.000074:
p.000074:
p.000074: Article 89
p.000074:
p.000074: Analysis of serious incidents and field safety corrective actions
p.000074:
p.000074: 1. Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer shall,
p.000074: without delay, perform the necessary investigations in relation to the serious incident and the devices
p.000074: concerned. This shall include a risk assessment of the incident and field safety corrective action
p.000074: taking into account criteria as referred to in paragraph 3 of this Article as appropriate.
p.000074:
p.000074: The manufacturer shall co-operate with the competent authorities and where relevant with the notified body
p.000074: concerned during the investigations referred to in the first subparagraph and shall not perform any
p.000074: investigation which involves altering the device or a sample of the batch concerned in a way which may
p.000074: affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of
p.000074: such action.
p.000074:
p.000074: 2. Member States shall take the necessary steps to ensure that any information regarding a serious
p.000074: incident that has occurred within their territory, or a field safety corrective action that has been or
p.000074: is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87
p.000074: is evaluated centrally at national level by their competent authority, if possible together with the manufacturer,
p.000074: and, where relevant, the notified body concerned.
p.000074:
p.000074: 5.5.2017 EN
p.000074: Official Journal of the European Union
p.000075: L 117/75
p.000075:
p.000075: 3. In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks
p.000075: arising from the reported serious incident and evaluate any related field safety corrective actions,
p.000075: taking into account the protection of public health and criteria such as causality, detectability and
p.000075: probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or
p.000075: indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and
p.000075: population affected. The competent authority shall also evaluate the adequacy of the field safety
p.000075: corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other
p.000075: corrective action, in particular taking into account the principle of inherent safety contained in Annex
p.000075: I.
p.000075:
p.000075: Upon request by the national competent authority, manufacturers shall provide all documents necessary for
p.000075: the risk assessment.
p.000075:
p.000075: 4. The competent authority shall monitor the manufacturer's investigation of a serious incident.
p.000075: Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent
p.000075: investigation.
p.000075:
p.000075: 5. The manufacturer shall provide a final report to the competent authority setting out its
p.000075: findings from the investi gation by means of the electronic system referred to in Article 92. The
p.000075: report shall set out conclusions and where relevant indicate corrective actions to be taken.
p.000075:
p.000075: 6. In the case of devices referred to in the first subparagraph of Article 1(8) and where the
p.000075: serious incident or field safety corrective action may be related to a substance which, if used
p.000075: separately, would be considered to be a medicinal product, the evaluating competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national
p.000075: competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article
p.000075: 52(9), of that serious incident or field safety corrective action.
p.000075:
p.000075: In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and
p.000075: where the serious incident or field safety corrective action may be related to the derivatives of
p.000075: tissues or cells of human origin utilised for the manufacture of the device, and in the case of
p.000075: devices falling under this Regulation pursuant to Article 1(10), the competent authority or the
p.000075: coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent
p.000075: authority for human tissues and cells that was consulted by the notified body in accordance with Article
p.000075: 52(10).
p.000075:
p.000075: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the
p.000075: evaluating competent authority shall, through the electronic system referred to in Article 92, inform,
p.000075: without delay, the other competent authorities of the corrective action taken or envisaged by the
p.000075: manufacturer or required of it to minimise the risk of recurrence of the serious incident, including
p.000075: information on the underlying events and the outcome of its assessment.
p.000075:
p.000075: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000075: brought without delay to the attention of users of the device in question by means of a field safety notice. The
p.000075: field safety notice shall be edited in an official Union language or languages determined by the Member
p.000075: State in which the field safety corrective action is taken. Except in cases of urgency, the content of
p.000075: the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases
p.000075: referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly
p.000075: justified by the situation of the individual Member State, the content of the field safety notice shall be consistent
p.000075: in all Member States.
p.000075:
p.000075: The field safety notice shall allow the correct identification of the device or devices involved, in
p.000075: particular by including the relevant UDIs, and the correct identification, in particular, by
p.000075: including the SRN, if already issued, of the manufacturer that has undertaken the field safety
p.000075: corrective action. The field safety notice shall explain, in a clear manner, without understating the
p.000075: level of risk, the reasons for the field safety corrective action with reference to the device
p.000075: malfunction and associated risks for patients, users or other persons, and shall clearly indicate all
p.000075: the actions to be taken by users.
p.000075:
p.000075: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which
p.000075: that notice shall be accessible to the public.
p.000075:
p.000075: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
p.000075: referred to in paragraph 3 in the following cases:
p.000075:
p.000075: (a) where there is concern regarding a particular serious incident or cluster of serious incidents
p.000075: relating to the same device or type of device of the same manufacturer in more than one Member State;
p.000075:
p.000076: L 117/76 EN
p.000076: Official Journal of the European Union
p.000076: 5.5.2017
p.000076:
p.000076: (b) where the appropriateness of a field safety corrective action that is proposed by a manufacturer in
p.000076: more than one Member State is in question.
p.000076: That coordinated procedure shall cover the following:
p.000076: — designation of a coordinating competent authority on a case by case basis, when required;
p.000076: — defining the coordinated assessment process, including the tasks and responsibilities of the
p.000076: coordinating competent authority and the involvement of other competent authorities.
p.000076: Unless otherwise agreed between the competent authorities, the coordinating competent authority
p.000076: shall be the competent authority of the Member State in which the manufacturer has its registered place of
p.000076: business.
p.000076:
p.000076: The coordinating competent authority shall, through the electronic system referred to in
p.000076: Article 92, inform the manufacturer, the other competent authorities and the Commission that it has
p.000076: assumed the role of coordinating authority.
p.000076:
p.000076: 10. The designation of a coordinating competent authority shall not affect the rights of
p.000076: the other competent authorities to perform their own assessment and to adopt measures in accordance
p.000076: with this Regulation in order to ensure the protection of public health and patient safety. The
p.000076: coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment
p.000076: and the adoption of any such measures.
p.000076:
p.000076: 11. The Commission shall provide administrative support to the coordinating competent
p.000076: authority in the accomplishment of its tasks under this Chapter.
p.000076:
p.000076: Article 90
p.000076:
p.000076: Analysis of vigilance data
p.000076:
p.000076: The Commission shall, in collaboration with the Member States, put in place systems and processes to
p.000076: actively monitor the data available in the electronic system referred to in Article 92, in order to identify trends,
p.000076: patterns or signals in the data that may reveal new risks or safety concerns.
p.000076:
p.000076: Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely
p.000076: changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating
p.000076: competent authority shall inform the manufacturer, or where applicable the authorised representative, which
p.000076: shall then take the necessary corrective actions.
p.000076:
p.000076: Article 91
p.000076:
p.000076: Implementing acts
p.000076:
p.000076: The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt
p.000076: the detailed arrangements and procedural aspects necessary for the implementation of Articles 85 to 90
p.000076: and 92 as regards the following:
p.000076: (a) the typology of serious incidents and field safety corrective actions in relation to specific
p.000076: devices, or categories or groups of devices;
p.000076: (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and
p.000076: the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by
p.000076: manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
p.000076: (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting
p.000076: of suspected serious incidents by healthcare professionals, users and patients;
p.000076: (d) timelines for the reporting of field safety corrective actions, and for the provision by
p.000076: manufacturers of periodic summary reports and trend reports, taking into account the severity of the
p.000076: incident to be reported as referred to in Article 87;
p.000076: (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 89;
p.000076: (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process,
p.000076: including tasks and responsibilities of the coordinating competent authority and involvement of other competent
p.000076: authorities in this process.
p.000076: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000076: referred to in Article 114(3).
p.000076:
p.000076: 5.5.2017 EN
p.000076: Official Journal of the European Union
p.000077: L 117/77
p.000077:
p.000077: Article 92
p.000077:
p.000077: Electronic system on vigilance and on post-market surveillance
p.000077:
p.000077: 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to
p.000077: collate and process the following information:
p.000077:
p.000077: (a) the reports by manufacturers on serious incidents and field safety corrective actions referred to in
p.000077: Article 87(1) and Article 89(5);
p.000077:
p.000077: (b) the periodic summary reports by manufacturers referred to in Article 87(9);
p.000077:
p.000077: (c) the reports by manufacturers on trends referred to in Article 88;
p.000077:
p.000077: (d) the PSURs referred to in Article 86;
p.000077:
p.000077: (e) the field safety notices by manufacturers referred to in Article 89(8);
p.000077:
p.000077: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000077: them and the Commission in accordance with Article 89(7) and (9).
p.000077:
p.000077: That electronic system shall include relevant links to the UDI database.
p.000077:
p.000077: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000077: system to the competent authorities of the Member States and to the Commission. The notified bodies shall
p.000077: also have access to that information to the extent that it relates to devices for which they issued a certificate
p.000077: in accordance with Article 53.
p.000077:
p.000077: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels
p.000077: of access to the electronic system referred to in paragraph 1.
p.000077:
p.000077: 4. On the basis of arrangements between the Commission and competent authorities of third countries
p.000077: or internat ional organisations, the Commission may grant those competent authorities or international
p.000077: organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those
p.000077: arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent
p.000077: to those applicable in the Union.
p.000077:
p.000077: 5. The reports on serious incidents referred to in point (a) of Article 87(1) shall be
p.000077: automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of
p.000077: this Article, to the competent authority of the Member State in which the incident occurred.
p.000077:
p.000077: 6. The trend reports referred to in Article 88(1) shall be automatically transmitted upon receipt
p.000077: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000077: the Member State in which the incidents occurred.
p.000077:
p.000077: 7. The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall
p.000077: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000077: competent authorities of the following Member States:
p.000077:
p.000077: (a) the Member States in which the field safety corrective action is being or is to be undertaken;
p.000077:
p.000077: (b) the Member State in which the manufacturer has its registered place of business.
p.000077:
p.000077: 8. The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon
p.000077: receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
p.000077:
p.000077: (a) the Member State or Member States participating in the coordination procedure in accordance with
p.000077: Article 89(9) and which have agreed on the periodic summary report;
p.000077:
p.000077: (b) the Member State in which the manufacturer has its registered place of business.
p.000077:
p.000077: 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically
p.000077: transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to
p.000077: the notified body that issued the certificate for the device in question in accordance with Article 56.
p.000077:
p.000078: L 117/78 EN
p.000078: Official Journal of the European Union
p.000078: 5.5.2017
p.000078:
p.000078: SECTION 3
p.000078:
p.000078: Market surveillance
p.000078:
p.000078: Article 93
p.000078:
p.000078: Market surveillance activities
p.000078:
p.000078: 1. The competent authorities shall perform appropriate checks on the conformity characteristics and
p.000078: performance of devices including, where appropriate, a review of documentation and physical or laboratory
p.000078: checks on the basis of adequate samples. The competent authorities shall, in particular, take account of
p.000078: established principles regarding risk assessment and risk management, vigilance data and complaints.
p.000078:
p.000078: 2. The competent authorities shall draw up annual surveillance activity plans and allocate a
p.000078: sufficient number of material and competent human resources in order to carry out those activities taking into
p.000078: account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local
p.000078: circumstances.
p.000078:
p.000078: 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
p.000078:
p.000078: (a) may require economic operators to, inter alia, make available the documentation and information
p.000078: necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary
p.000078: samples of devices or access to devices free of charge; and
p.000078:
p.000078: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of
p.000078: economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of
p.000078: professional users.
p.000078:
p.000078: 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities
p.000078: and make it accessible to other competent authorities by means of the electronic system referred to in Article 100.
p.000078:
p.000078: 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices
p.000078: that present an unacceptable risk or falsified devices where they deem it necessary to do so in the
p.000078: interests of the protection of public health.
p.000078:
p.000078: 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent
p.000078: authority shall draw up a report on the findings of the inspection that concern compliance with the
p.000078: legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions
p.000078: needed.
p.000078:
p.000078: 7. The competent authority which carried out the inspection shall communicate the content of the report referred
p.000078: to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before
p.000078: adopting the final report, the competent authority shall give that economic operator the opportunity to submit
p.000078: comments. That final inspection report shall be entered in the electronic system provided for in Article 100.
p.000078:
p.000078: 8. The Member States shall review and assess the functioning of their market surveillance activities. Such
p.000078: reviews and assessments shall be carried out at least every four years and the results thereof shall be
p.000078: communicated to the other Member States and the Commission. Each Member State shall make a summary of the results
p.000078: accessible to the public by means of the electronic system referred to in Article 100.
p.000078:
p.000078: 9. The competent authorities of the Member States shall coordinate their market surveillance
p.000078: activities, cooperate with each other and share with each other and with the Commission the results
p.000078: thereof, to provide for a harmonised and high level of market surveillance in all Member States.
p.000078:
p.000078: Where appropriate, the competent authorities of the Member States shall agree on work-sharing,
p.000078: joint market surveillance activities and specialisation.
p.000078:
p.000078: 10. Where more than one authority in a Member State is responsible for market surveillance and
p.000078: external border controls, those authorities shall cooperate with each other, by sharing information relevant to their
p.000078: role and functions.
p.000078:
p.000078: 11. Where appropriate, the competent authorities of the Member States shall cooperate with
p.000078: the competent authorities of third countries with a view to exchanging information and technical support
p.000078: and promoting activities relating to market surveillance.
p.000078:
p.000078: 5.5.2017 EN
p.000078: Official Journal of the European Union
p.000079: L 117/79
p.000079:
p.000079: Article 94
p.000079:
p.000079: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
p.000079:
p.000079: Where the competent authorities of a Member State, based on data obtained by vigilance or market
p.000079: surveillance activities or on other information, have reason to believe that a device:
p.000079: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or
p.000079: to other aspects of the protection of public health; or
p.000079: (b) otherwise does not comply with the requirements laid down in this Regulation,
p.000079: they shall carry out an evaluation of the device concerned covering all requirements laid down in this
p.000079: Regulation relating to the risk presented by the device, or to any other non-compliance of the device.
...
p.000081: acts, whether the national measures are justified or not. In the absence of a Commission decision within
p.000081: six months of their notification, the national measures shall be considered to be justified. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
p.000081:
p.000081: 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making
p.000081: available on the market or putting into service of a device, specific category or group of devices should be
p.000081: prohibited, restricted or made subject to particular requirements or that such device or category or group
p.000081: of devices should be withdrawn from the market or recalled in all Member States in order to protect
p.000081: the health and safety of patients, users or other persons or other aspects of public health, the
p.000081: Commission may adopt implementing acts to take the necessary and duly justified measures. Those
p.000081: implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000081: 114(3).
p.000081:
p.000081:
p.000081: Article 99
p.000081:
p.000081: Good administrative practice
p.000081:
p.000081: 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 95 to 98
p.000081: shall state the exact grounds on which it is based. Where such a measure is addressed to a specific
p.000081: economic operator, the competent authority shall notify without delay the economic operator concerned of that
p.000081: measure, and shall at the same time inform that economic operator of the remedies available under the law
p.000081: or the administrative practice of the Member State concerned and of the time limits to which such remedies are
p.000081: subject. Where the measure is of general ap plicability, it shall be appropriately published.
p.000081:
p.000081: 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human
p.000081: health or safety, the economic operator concerned shall be given the opportunity to make submissions to
p.000081: the competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
p.000081:
p.000081: Where action has been taken without the economic operator having had the opportunity to make submissions
p.000081: as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon
p.000081: as possible and the action taken shall be reviewed promptly thereafter.
p.000081:
p.000081: 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's
p.000081: demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements
p.000081: of this Regulation.
p.000081:
p.000081: 4. Where a measure adopted pursuant to Articles 95 to 98 concerns a device for which a notified
p.000081: body has been involved in the conformity assessment, the competent authorities shall by means of the
p.000081: electronic system referred to in Article 100 inform the relevant notified body and the authority responsible for
p.000081: the notified body of the measure taken.
p.000081:
p.000081:
p.000081: Article 100
p.000081:
p.000081: Electronic system on market surveillance
p.000081:
p.000081: 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to
p.000081: collate and process the following information:
p.000081: (a) summaries of the results of the surveillance activities referred to in Article 93(4);
p.000081: (b) the final inspection report referred to in Article 93(7);
p.000081: (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article
p.000081: 95(2),
p.000081: (4) and (6);
p.000081: (d) information in relation to non-compliance of products as referred to in Article 97(2);
p.000081: (e) information in relation to the preventive health protection measures referred to in Article 98(2);
p.000081: (f) summaries of the results of the reviews and assessments of the market surveillance activities of
p.000081: the Member States referred to in 93(8).
p.000081:
p.000082: L 117/82 EN
p.000082: Official Journal of the European Union
p.000082: 5.5.2017
p.000082:
p.000082: 2. The information referred to in paragraph 1 of this Article shall be immediately transmitted
p.000082: through the electronic system to all competent authorities concerned and, where applicable, to the
p.000082: notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible
p.000082: to the Member States and to the Commission.
p.000082:
p.000082: 3. Information exchanged between Member States shall not be made public where to do so might
p.000082: impair market surveillance activities and co-operation between Member States.
p.000082:
p.000082: CHAPTER VIII
p.000082:
p.000082: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT
p.000082: PANELS AND DEVICE REGISTERS
p.000082:
p.000082: Article 101
p.000082:
p.000082: Competent authorities
p.000082:
p.000082: The Member States shall designate the competent authority or authorities responsible for the
p.000082: implementation of this Regulation. They shall entrust their authorities with the powers, resources,
p.000082: equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation.
p.000082: The Member States shall communicate the names and contact details of the competent authorities to the Commission
p.000082: which shall publish a list of competent authorities.
p.000082:
p.000082:
p.000082: Article 102
p.000082:
p.000082: Cooperation
p.000082:
p.000082: 1. The competent authorities of the Member States shall cooperate with each other and with the
p.000082: Commission. The Commission shall provide for the organisation of exchanges of information necessary to
p.000082: enable this Regulation to be applied uniformly.
p.000082:
p.000082: 2. Member States shall, with the support of the Commission, participate, where appropriate, in
p.000082: initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in
p.000082: the field of medical devices.
p.000082:
p.000082:
p.000082: Article 103
p.000082:
p.000082: Medical Device Coordination Group
p.000082:
p.000082: 1. A Medical Device Coordination Group (‘MDCG’) is hereby established.
p.000082:
p.000082: 2. Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one
p.000082: member and one alternate each with expertise in the field of medical devices, and one member and one alternate with
p.000082: expertise in the field of in vitro diagnostic medical devices. A Member State may choose to appoint only one
p.000082: member and one alternate, each with expertise in both fields.
p.000082:
...
p.000086: information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and
p.000086: performance of devices, or the traceability of implantable devices, or all of such characteristics.
p.000086:
p.000086:
p.000086: CHAPTER IX
p.000086:
p.000086: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
p.000086:
p.000086: Article 109
p.000086:
p.000086: Confidentiality
p.000086:
p.000086: 1. Unless otherwise provided for in this Regulation and without prejudice to existing
p.000086: national provisions and practices in the Member States on confidentiality, all parties involved in the
p.000086: application of this Regulation shall respect the confidentiality of information and data obtained in carrying out
p.000086: their tasks in order to protect the following:
p.000086:
p.000086: (a) personal data, in accordance with Article 110;
p.000086:
p.000086: (b) commercially confidential information and trade secrets of a natural or legal person, including
p.000086: intellectual property rights; unless disclosure is in the public interest;
p.000086:
p.000086: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000086: audits.
p.000086:
p.000086: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent
p.000086: authorities and between competent authorities and the Commission shall not be disclosed without the prior
p.000086: agreement of the originating authority.
p.000086:
p.000086: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000086: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000086: obligations of the persons concerned to provide information under criminal law.
p.000086:
p.000086: 5.5.2017 EN
p.000086: Official Journal of the European Union
p.000087: L 117/87
p.000087:
p.000087: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000087: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000087:
p.000087: Article 110
p.000087:
p.000087: Data protection
p.000087:
p.000087: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the
p.000087: Member States pursuant to this Regulation.
p.000087:
p.000087: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000087: Commission pursuant to this Regulation.
p.000087:
p.000087: Article 111
p.000087:
p.000087: Levying of fees
p.000087:
p.000087: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the
p.000087: activities set out in this Regulation, provided that the level of the fees is set in a transparent
p.000087: manner and on the basis of cost-recovery principles.
p.000087:
p.000087: 2. Member States shall inform the Commission and the other Member States at least three months
...
p.000088: and the Council have both informed the Commission that they will not object. That period shall be extended by
p.000088: three months at the initiative of the European Parliament or of the Council.
p.000088:
p.000088:
p.000088: Article 116
p.000088:
p.000088: Separate delegated acts for different delegated powers
p.000088:
p.000088: The Commission shall adopt a separate delegated act in respect of each power delegated to
p.000088: it pursuant to this Regulation.
p.000088:
p.000088:
p.000088: Article 117
p.000088:
p.000088: Amendment to Directive 2001/83/EC
p.000088:
p.000088: In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
p.000088: ‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of
p.000088: Regulation (EU) 2017/745 of the European Parliament and of the Council (*), a product is governed by this Directive,
p.000088: the marketing authorisation dossier shall include, where available, the results of the assessment of the
p.000088: conformity of the device part with the relevant general safety and performance requirements set out in
p.000088: Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant
p.000088: certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
p.000088: If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and
p.000088: where for the conformity assessment of the device, if used separately, the involvement of a notified
p.000088: body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to
p.000088: provide an opinion on the conformity of the device part with the relevant general safety and performance
p.000088: requirements set out in Annex I to that Regulation issued by a notified body designated in accordance
p.000088: with that Regulation for the type of device in question.
p.000088:
p.000088: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000088: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000088: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000088:
p.000088: 5.5.2017 EN
p.000088: Official Journal of the European Union
p.000089: L 117/89
p.000089:
p.000089: Article 118
p.000089:
p.000089: Amendment to Regulation (EC) No 178/2002
p.000089:
p.000089: In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
p.000089: ‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of
p.000089: the Council (*).
p.000089:
p.000089: (*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
p.000089: devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
p.000089: 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
p.000089:
p.000089: Article 119
p.000089:
p.000089: Amendment to Regulation (EC) No 1223/2009
p.000089:
p.000089: In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
...
p.000107: indications, undesirable side-effects and risks relating to overdose;
p.000107:
p.000107: (u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and
p.000107: substances to which patients can be exposed;
p.000107:
p.000107: (v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories
p.000107: and the consumables used with it, if any. This information shall cover, where appropriate:
p.000107:
p.000107: — infection or microbial hazards such as explants, needles or surgical equipment contaminated with
p.000107: potentially infectious substances of human origin, and
p.000107:
p.000107: — physical hazards such as from sharps.
p.000107:
p.000107: If in accordance with the point (d) of Section 23.1 no instructions for use are required, this
p.000107: information shall be made available to the user upon request;
p.000107:
p.000107: (w) for devices intended for use by lay persons, the circumstances in which the user
p.000107: should consult a healthcare professional;
p.000107:
p.000107: (x) for the devices covered by this Regulation pursuant to Article 1(2), information regarding the
p.000107: absence of a clinical benefit and the risks related to use of the device;
p.000107:
p.000107: (y) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000107: identifier of the latest revision of the instructions for use;
p.000107:
p.000107: (z) a notice to the user and/or patient that any serious incident that has occurred in relation to
p.000107: the device should be reported to the manufacturer and the competent authority of the Member State in
p.000107: which the user and/or patient is established;
p.000107:
p.000107: (aa) information to be supplied to the patient with an implanted device in accordance with Article 18;
p.000107:
p.000107: (ab) for devices that incorporate electronic programmable systems, including software, or software that
p.000107: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000107: security measures, including protection against unauthorised access, necessary to run the software as
p.000107: intended.
p.000107:
p.000108: L 117/108 EN
p.000108: Official Journal of the European Union
p.000108: 5.5.2017
p.000108:
p.000108: ANNEX II
p.000108:
p.000108: TECHNICAL DOCUMENTATION
p.000108:
p.000108: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000108: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in
p.000108: particular the elements listed in this Annex.
p.000108:
p.000108: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000108:
p.000108: 1.1. Device description and specification
p.000108:
p.000108: (a) product or trade name and a general description of the device including its intended purpose and
p.000108: intended users;
p.000108: (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device
p.000108: in question, as soon as identification of this device becomes based on a UDI system, or otherwise a
...
p.000123: status shall be fully documented. Such documentation shall include information about ownership and the legal
p.000123: or natural persons exercising control over the notified body.
p.000123:
p.000123: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of
p.000123: that organisation as well as its organisational structure and governance, and the relationship with the
p.000123: notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable
p.000123: to both the notified body and the organisation to which it belongs.
p.000123:
p.000123: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a
p.000123: third country or is owned by another legal entity, the activities and responsibilities of those entities,
p.000123: as well as their legal and operational relationships with the notified body, shall be clearly defined
p.000123: and documented. Personnel of those entities performing conformity assessment activities under this
p.000123: Regulation shall be subject to the applicable requirements of this Regulation.
p.000123:
p.000123: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000123: body shall be such that they ensure that there is confidence in the performance by the notified body
p.000123: and in the results of the conformity assessment activities it conducts.
p.000123:
p.000123: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
p.000123: responsibilities and authority of its top-level management and of other personnel who may have an influence
p.000123: upon the performance by the notified body and upon the results of its conformity assessment activities.
p.000123:
p.000123: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000123: and responsi bility for each of the following:
p.000123:
p.000123: — the provision of adequate resources for conformity assessment activities;
p.000123:
p.000123: — the development of procedures and policies for the operation of the notified body;
p.000123:
p.000123: — the supervision of implementation of the procedures, policies and quality management systems of the notified body;
p.000123:
p.000123: — the supervision of the notified body's finances;
p.000123:
p.000123: — the activities and decisions taken by the notified body, including contractual agreements;
p.000123:
p.000123: — the delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000123: defined activities;
p.000123:
p.000123: — the interaction with the authority responsible for notified bodies and the obligations regarding
p.000123: communi cations with other competent authorities, the Commission and other notified bodies.
p.000123:
p.000123: 1.2. Independence and impartiality
p.000123:
p.000123: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in
p.000123: relation to which it performs conformity assessment activities. The notified body shall also be independent
p.000123: of any other economic operator having an interest in the device as well as of any competitors of the
p.000123: manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for
p.000123: competing manufacturers.
p.000123:
p.000124: L 117/124 EN
p.000124: Official Journal of the European Union
p.000124: 5.5.2017
p.000124:
p.000124: 1.2.2. The notified body shall be organised and operated so as to safeguard the
p.000124: independence, objectivity and impartiality of its activities. The notified body shall document and
p.000124: implement a structure and procedures for safeguarding impartiality and for promoting and applying
p.000124: the principles of impartiality throughout its organisation, personnel and assessment activities. Such
p.000124: procedures shall provide for the identification, investi gation and resolution of any case in which a
p.000124: conflict of interest may arise, including involvement in consultancy services in the field of devices prior
p.000124: to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented.
p.000124:
...
p.000124:
p.000124: (e) be linked to any organisation which itself provides consultancy services as referred to in point
p.000124: (d). Such restriction does not preclude general training activities that are not client specific and that relate to
p.000124: regulation of devices or to related standards.
p.000124:
p.000124: 1.2.4. Involvement in consultancy services in the field of devices prior to taking up employment with a
p.000124: notified body shall be fully documented at the time of employment and potential conflicts of interest
p.000124: shall be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a
p.000124: specific client, or provided consultancy services in the field of devices to that specific client prior
p.000124: to taking up employment with a notified body, shall not be assigned for conformity assessment activities for
p.000124: that specific client or companies belonging to the same group for a period of three years.
p.000124:
p.000124: 1.2.5. The impartiality of notified bodies, of their top-level management and of the assessment personnel
p.000124: shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel
p.000124: of a notified body and subcontractors, involved in assessment activities shall not depend on the results
p.000124: of the assessments. Notified bodies shall make publicly available the declarations of interest of their top-level
p.000124: management.
p.000124:
p.000124: 1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conflict of
p.000124: interest shall be ensured and documented between, on the one hand, the authority responsible for notified
p.000124: bodies and/or the competent authority and, on the other hand, the notified body.
p.000124:
p.000124: 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or
p.000124: subcontractors, or of any associated body, including the activities of its owners do not affect
p.000124: its independence, impartiality or the objectivity of its conformity assessment activities.
p.000124:
p.000124: 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable
p.000124: terms and conditions, taking into account the interests of small and medium-sized
p.000124: enterprises as defined in Recommen dation 2003/361/EC in relation to fees.
p.000124:
p.000124: 1.2.9. The requirements laid down in this Section in no way preclude exchanges of technical information and
p.000124: regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
p.000124:
p.000124: 1.3. Confidentiality
p.000124:
p.000124: 1.3.1. The notified body shall have documented procedures in place ensuring that its
p.000124: personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect
p.000124: the confidentiality of the information which comes into its possession during the performance of conformity
p.000124: assessment activities, except when disclosure is required by law.
p.000124:
p.000124: 5.5.2017 EN
p.000124: Official Journal of the European Union
p.000125: L 117/125
p.000125:
p.000125: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
...
p.000128: personnel shall, as a group, have proven knowledge and comprehensive experience of all of the following:
p.000128:
p.000128: — devices legislation and relevant guidance documents;
p.000128:
p.000128: — the device conformity assessments relevant to this Regulation;
p.000128:
p.000128: — the types of qualifications, experience and expertise relevant to device conformity assessment;
p.000128:
p.000128: — a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of
p.000128: devices being reviewed for certification, the device industry and the design and manufacture of devices;
p.000128:
p.000128: 5.5.2017 EN
p.000128: Official Journal of the European Union
p.000129: L 117/129
p.000129:
p.000129: — the notified body's quality management system, related procedures and the required
p.000129: qualifications for personnel involved;
p.000129: — the ability to draw up records and reports demonstrating that the conformity assessment activities have
p.000129: been appropriately carried out.
p.000129:
p.000129: 3.3. Documentation of qualification, training and authorisation of personnel
p.000129:
p.000129: 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each
p.000129: member of personnel involved in conformity assessment activities and the satisfaction of the qualification
p.000129: criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the
p.000129: qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall
p.000129: justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry
p.000129: out specific conformity assessment activities.
p.000129:
p.000129: 3.3.2. For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and
p.000129: maintain up to date:
p.000129: — a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment
p.000129: activities; and
p.000129: — records attesting to the required knowledge and experience for the conformity assessment activity for
p.000129: which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for
p.000129: each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
p.000129:
p.000129: 3.4. Subcontractors and external experts
p.000129:
p.000129: 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined
p.000129: component parts of a conformity assessment activity.
p.000129: The subcontracting of the auditing of quality management systems or of product related reviews as a whole shall not
p.000129: be permitted; nevertheless parts of those activities may be conducted by subcontractors and external auditors and
p.000129: experts working on behalf of the notified body. The notified body in question shall retain full
p.000129: responsibility for being able to produce appropriate evidence of the competence of subcontractors and
p.000129: experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and
p.000129: for the work conducted by subcontractors and experts on its behalf.
p.000129: The following activities may not be subcontracted by notified bodies:
...
p.000135:
p.000135: — the clinical evaluation report, and
p.000135:
p.000135: — justifications in relation to non-performance of clinical investigations or PMCF.
p.000135:
p.000135: In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in
p.000135: question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the
p.000135: approved clinical investigation plan.
p.000135:
p.000135: The notified body shall ensure that the clinical evaluation adequately addresses the relevant
p.000135: safety and performance requirements provided for in Annex I, that it is appropriately aligned with the
p.000135: risk management requirements, that it is conducted in accordance with Annex XIV and that it is
p.000135: appropriately reflected in the information provided relating to the device.
p.000135:
p.000135:
p.000135: 4.5.6. Specific Procedures
p.000135:
p.000135: The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred
p.000135: to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, for which
p.000135: they are designated.
p.000135:
p.000135: In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives,
p.000135: such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have
p.000135: documented procedures in place that fulfil the requirements laid down in that Regulation, including for
p.000135: the preparation of a summary evaluation report for the relevant competent authority.
p.000135:
p.000135:
p.000135: 4.6. Reporting
p.000135:
p.000135: The notified body shall:
p.000135:
p.000135: — ensure that all steps of the conformity assessment are documented so that the conclusions of the
p.000135: assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent
p.000135: objective evidence of such compliance to persons that are not themselves involved in the assessment, for
p.000135: example personnel in designating authorities,
p.000135:
p.000135: — ensure that records that are sufficient to provide a discernible audit trail are available for quality
p.000135: management system audits,
p.000135:
p.000135: — clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation
p.000135: assessment report, and
p.000135:
p.000135: — for each specific project, provide a detailed report which shall be based on a standard format
p.000135: containing a minimum set of elements determined by the MDCG.
p.000135:
p.000136: L 117/136 EN
p.000136: Official Journal of the European Union
p.000136: 5.5.2017
p.000136:
p.000136: The report of the notified body shall:
p.000136:
p.000136: — clearly document the outcome of its assessment and draw clear conclusions from the verification of
p.000136: the manufacturer's conformity with the requirements of this Regulation,
p.000136:
p.000136: — make a recommendation for a final review and for a final decision to be taken by the notified
p.000136: body; this recommendation shall be signed off by the member of personnel responsible in the notified body, and
p.000136:
p.000136: — be provided to the manufacturer in question.
p.000136:
p.000136:
p.000136: 4.7. Final review
...
p.000137: which shall contain the justified conclusions of its assessment.
p.000137: 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures:
p.000137:
p.000137: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures
p.000137: shall include arrangements for unannounced on-site audits of manufacturers and, where applicable,
p.000137: subcontractors and suppliers carrying out product tests and the monitoring of compliance with any
p.000137: conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at
p.000137: defined intervals,
p.000137:
p.000137: — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of
p.000137: their designation. Such information shall be taken into account in the planning and conduct of surveillance
p.000137: activities, and
p.000137:
p.000137: — to review vigilance data to which they have access under Article 92(2) in order to estimate its
p.000137: impact, if any, on the validity of existing certificates. The results of the evaluation and
p.000137: any decisions taken shall be thoroughly documented.
p.000137:
p.000137: The notified body in question shall, upon receipt of information about vigilance cases from a
p.000137: manufacturer or competent authorities, decide which of the following options to apply:
p.000137:
p.000137: — not to take action on the basis that the vigilance case is clearly not related to the certification granted,
p.000137:
p.000137: — observe the manufacturer's and competent authority's activities and the results of the manufacturer's
p.000137: investi gation so as to determine whether the certification granted is at risk or whether adequate
p.000137: corrective action has been taken,
p.000137:
p.000137: — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits
p.000137: and product testing, where it is likely that the certification granted is at risk,
p.000137:
p.000137: — increase the frequency of surveillance audits,
p.000137:
p.000137: — review specific products or processes on the occasion of the next audit of the manufacturer, or
p.000137:
p.000137: — take any other relevant measure.
p.000137:
p.000138: L 117/138 EN
p.000138: Official Journal of the European Union
p.000138: 5.5.2017
p.000138:
p.000138: In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
p.000138:
p.000138: — conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned
p.000138: and conducted in line with the relevant requirements in Section 4.5,
p.000138:
p.000138: — ensure adequate assessment of the manufacturer's documentation on, and application of the provisions
p.000138: on, vigilance, the post-market surveillance, and PMCF,
p.000138:
p.000138: — sample and test devices and technical documentation, during audits, according to pre-defined
p.000138: sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved
p.000138: quality management system,
p.000138:
...
p.000146: — a description of the procedures in place to keep up to date the post-market surveillance system,
p.000146: and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations
p.000146: resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the
p.000146: manufacturer to apply those procedures,
p.000146:
p.000146: — documentation on the clinical evaluation plan, and
p.000146:
p.000146: — a description of the procedures in place to keep up to date the clinical evaluation plan, taking
p.000146: into account the state of the art.
p.000146:
p.000146: 2.2. Implementation of the quality management system shall ensure compliance with this
p.000146: Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality
p.000146: management system shall be documented in a systematic and orderly manner in the form of a quality
p.000146: manual and written policies and procedures such as quality programmes, quality plans and quality records.
p.000146:
p.000146: 5.5.2017 EN
p.000146: Official Journal of the European Union
p.000147: L 117/147
p.000147:
p.000147: Moreover, the documentation to be submitted for the assessment of the quality management system shall include an
p.000147: adequate description of, in particular:
p.000147: (a) the manufacturer's quality objectives;
p.000147: (b) the organisation of the business and in particular:
p.000147:
p.000147: — the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the
p.000147: responsibilities of the managerial staff and their organisational authority,
p.000147:
p.000147: — the methods of monitoring whether the operation of the quality management system is efficient and in
p.000147: particular the ability of that system to achieve the desired design and device quality, including control
p.000147: of devices which fail to conform,
p.000147:
p.000147: — where the design, manufacture and/or final verification and testing of the devices, or parts of any
p.000147: of those processes, is carried out by another party, the methods of monitoring the efficient operation of the
p.000147: quality management system and in particular the type and extent of control applied to the other party,
p.000147: and
p.000147:
p.000147: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000147: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000147: representative to accept the mandate;
p.000147:
p.000147: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
p.000147: devices and the corresponding documentation as well as the data and records arising from those
p.000147: procedures and techniques. Those procedures and techniques shall specifically cover:
p.000147:
p.000147: — the strategy for regulatory compliance, including processes for identification of
p.000147: relevant legal requirements, qualification, classification, handling of equivalence, choice of and
p.000147: compliance with conformity assessment procedures,
p.000147:
...
p.000151: provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
p.000151:
p.000151:
p.000151: 5.2. Procedure in the case of devices incorporating a medicinal substance
p.000151:
p.000151:
p.000151: (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.000151: considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive
p.000151: 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action
p.000151: ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by
p.000151: analogy with the methods specified in Annex I to Directive 2001/83/EC.
p.000151:
p.000152: L 117/152 EN
p.000152: Official Journal of the European Union
p.000152: 5.5.2017
p.000152:
p.000152: (b) Before issuing an EU technical documentation assessment certificate, the notified body shall, having
p.000152: verified the usefulness of the substance as part of the device and taking account of the intended
p.000152: purpose of the device, seek a scientific opinion from one of the competent authorities designated by the
p.000152: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred
p.000152: to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under
p.000152: this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the
p.000152: substance into the device. Where the device incorporates a human blood or plasma derivative or a substance
p.000152: that, if used separately, may be considered to be a medicinal product falling exclusively within the
p.000152: scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
p.000152:
p.000152: (c) When issuing its opinion, the medicinal products authority consulted shall take into account the manufactur ing
p.000152: process and the data relating to the usefulness of incorporation of the substance into the device as
p.000152: determined by the notified body.
p.000152:
p.000152: (d) The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of
p.000152: receipt of all the necessary documentation.
p.000152:
p.000152: (e) The scientific opinion of the medicinal products authority consulted, and any possible
p.000152: update of that opinion, shall be included in the documentation of the notified body concerning the
p.000152: device. The notified body shall give due consideration to the views expressed in the scientific opinion
p.000152: when making its decision. The notified body shall not deliver the certificate if the scientific opinion is
p.000152: unfavourable and shall convey its final decision to the medicinal products authority consulted.
p.000152:
p.000152: (f) Before any change is made with respect to an ancillary substance incorporated in a device, in
p.000152: particular related to its manufacturing process, the manufacturer shall inform the notified body of the
p.000152: changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order
p.000152: to confirm that the quality and safety of the ancillary substance remain unchanged. The
p.000152: medicinal products authority consulted shall take into account the data relating to the usefulness of
p.000152: incorporation of the substance into the device as determined by the notified body, in order to ensure
p.000152: that the changes have no negative impact on the risk or benefit previously established concerning the
p.000152: incorporation of the substance into the device. The medicinal products authority consulted shall provide
p.000152: its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The
p.000152: notified body shall not deliver the supplement to the EU technical documentation assessment certificate
p.000152: if the scientific opinion provided by the medicinal products authority consulted is
p.000152: unfavourable. The notified body shall convey its final decision to the medicinal products authority
p.000152: consulted.
p.000152:
p.000152: (g) Where the medicinal products authority consulted obtains information on the ancillary substance,
p.000152: which could have an impact on the risk or benefit previously established concerning the incorporation of
p.000152: the substance into the device, it shall advise the notified body as to whether this information has an
p.000152: impact on the risk or benefit previously established concerning the incorporation of the substance into
p.000152: the device. The notified body shall take that advice into account in reconsidering its assessment of the conformity
p.000152: assessment procedure.
p.000152:
p.000152:
p.000152: 5.3. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of
p.000152: human or animal origin, or their derivatives, that are non-viable or rendered non-viable
p.000152:
p.000152:
p.000152:
p.000152: 5.3.1. Tissues or cells of human origin or their derivatives
p.000152:
p.000152:
p.000152: (a) For devices manufactured utilising derivatives of tissues or cells of human origin that are covered
p.000152: by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as
p.000152: an integral part, tissues or cells of human origin, or their derivatives, covered by Directive
p.000152: 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to
p.000152: issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the
p.000152: competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human
p.000152: tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing
p.000152: of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of
p.000152: the preliminary conformity assessment which provides, among other things, information about the
p.000152: non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk
p.000152: or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
p.000152:
p.000152: 5.5.2017 EN
p.000152: Official Journal of the European Union
p.000153: L 117/153
p.000153:
p.000153: (b) Within 120 days of receipt of all the necessary documentation, the human tissues and cells
p.000153: competent authority shall provide to the notified body its opinion.
p.000153:
p.000153: (c) The scientific opinion of the human tissues and cells competent authority, and any possible update,
p.000153: shall be included in the documentation of the notified body concerning the device. The notified body
p.000153: shall give due consideration to the views expressed in the scientific opinion of the human tissues and
p.000153: cells competent authority when making its decision. The notified body shall not deliver the certificate
p.000153: if that scientific opinion is unfavourable. It shall convey its final decision to the human tissues and
p.000153: cells competent authority concerned.
p.000153:
p.000153: (d) Before any change is made with respect to non-viable tissues or cells of human origin or their
p.000153: derivatives incorporated in a device, in particular relating to their donation, testing or procurement,
p.000153: the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority
p.000153: that was involved in the initial consultation, in order to confirm that the quality and safety of the
p.000153: tissues or cells of human origin or their derivatives incorporated in the device are maintained. The
p.000153: human tissues and cells competent authority concerned shall take into account the data relating to the usefulness
p.000153: of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the
p.000153: notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of
p.000153: the addition of the tissues or cells of human origin or their derivatives in the device. It shall
p.000153: provide its opinion within 60 days of receipt of all the necessary documentation regarding the intended changes. The
p.000153: notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the
p.000153: scientific opinion is unfavourable and shall convey its final decision to the human tissues and
p.000153: cells competent authority concerned.
p.000153:
p.000153: 5.3.2. Tissues or cells of animal origin or their derivatives
p.000153:
p.000153: In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising
p.000153: non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the
p.000153: notified body shall apply the relevant requirements laid down in that Regulation.
p.000153:
p.000153:
p.000153: 5.4. Procedure in the case of devices that are composed of substances or of combinations of
p.000153: substances that are absorbed by or locally dispersed in the human body
p.000153:
p.000153: (a) The quality and safety of devices that are composed of substances or of combinations of substances
p.000153: that are intended to be introduced into the human body via a body orifice or applied to the skin and
p.000153: that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and
p.000153: only in respect of the requirements not covered by this Regulation, in accordance with the relevant
p.000153: requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution,
p.000153: metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or
p.000153: other substances and potential for adverse reactions.
p.000153:
p.000153: (b) In addition, for devices, or their products of metabolism, that are systemically absorbed by the
p.000153: human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion
p.000153: from one of the competent authorities designated by the Member States in accordance with Directive
p.000153: 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal
p.000153: products authority consulted’ depending on which has been consulted under this point, on the compliance
p.000153: of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
p.000153:
p.000153: (c) The opinion of the medicinal products authority consulted shall be drawn up within 150 days of
p.000153: receipt of all the necessary documentation.
p.000153:
p.000153: (d) The scientific opinion of the medicinal products authority consulted, and any possible update, shall
p.000153: be included in the documentation of the notified body concerning the device. The notified body shall
p.000153: give due consideration to the views expressed in the scientific opinion when making its decision and
p.000153: shall convey its final decision to the medicinal products authority consulted.
p.000153:
p.000153: 6. Batch verification in the case of devices incorporating, as an integral part, a medicinal
p.000153: substance which, if used separately, would be considered to be a medicinal product derived from human
p.000153: blood or human plasma as referred to in Article 1(8)
p.000153:
p.000153: Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a
p.000153: medicinal substance which, if used separately, would be considered to be a medicinal product derived from
p.000153: human blood
p.000153:
p.000154: L 117/154 EN
p.000154: Official Journal of the European Union
p.000154: 5.5.2017
p.000154:
p.000154: or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform
p.000154: the notified body of the release of the batch of devices and send it the official certificate
p.000154: concerning the release of the batch of human blood or plasma derivative used in the device, issued by
p.000154: a Member State laboratory or a laboratory designated for that purpose by a Member State in
p.000154: accordance with Article 114(2) of Directive 2001/83/EC.
p.000154:
p.000154: CHAPTER III
p.000154:
p.000154: ADMINISTRATIVE PROVISIONS
p.000154:
p.000154: 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000154: its authorised representative shall, for a period ending no sooner than 10 years, and in the case of
...
p.000167:
p.000167: 1. Application form
p.000167:
p.000167: The application form shall be duly filled in, containing information regarding:
p.000167: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and
p.000167: contact details of its contact person or legal representative in accordance with Article 62(2) established in the
p.000167: Union;
p.000167:
p.000168: L 117/168 EN
p.000168: Official Journal of the European Union
p.000168: 5.5.2017
p.000168:
p.000168: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
p.000168: of the device intended for clinical investigation and, if applicable, of its authorised representative;
p.000168:
p.000168: 1.3. title of the clinical investigation;
p.000168:
p.000168: 1.4. status of the clinical investigation application (i.e. first submission, resubmission, significant
p.000168: amendment);
p.000168:
p.000168: 1.5. details and/or reference to the clinical evaluation plan;
p.000168:
p.000168: 1.6. If the application is a resubmission with regard to a device for which an application has been already
p.000168: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000168: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000168: changes from the previous application together with a rationale for those changes, in particular, whether
p.000168: any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000168:
p.000168: 1.7. if the application is submitted in parallel with an application for a clinical
p.000168: trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the
p.000168: clinical trial;
p.000168:
p.000168: 1.8. identification of the Member States and third countries in which the clinical investigation is
p.000168: to be conducted as part of a multicentre or multinational study at the time of application;
p.000168:
p.000168: 1.9. a brief description of the investigational device, its classification and other information necessary for
p.000168: the identifi cation of the device and device type;
p.000168:
p.000168: 1.10. information as to whether the device incorporates a medicinal substance, including a human
p.000168: blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal
p.000168: origin, or their derivatives;
p.000168:
p.000168: 1.11. summary of the clinical investigation plan including the objective or objectives of the clinical
p.000168: investigation, the number and gender of subjects, criteria for subject selection, whether there are
p.000168: subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies,
p.000168: planned dates of commencement and of completion of the clinical investigation;
p.000168:
p.000168: 1.12. if applicable, information regarding a comparator device, its classification and other
p.000168: information necessary for the identification of the comparator device;
p.000168:
p.000168: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are
p.000168: capable of conducting the clinical investigation in accordance with the clinical investigation plan;
p.000168:
p.000168: 1.14. details of the anticipated start date and duration of the investigation;
p.000168:
p.000168: 1.15. details to identify the notified body, if already involved at the stage of application for a clinical
p.000168: investigation;
p.000168:
p.000168: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics
p.000168: committee that is assessing or has assessed the application; and
p.000168:
p.000168: 1.17. the statement referred to in Section 4.1.
p.000168:
p.000168:
p.000168: 2. Investigator's Brochure
p.000168:
p.000168:
p.000168: The investigator's brochure (IB) shall contain the clinical and non-clinical information on the
p.000168: investigational device that is relevant for the investigation and available at the time of application.
p.000168: Any updates to the IB or other relevant information that is newly available shall be brought to the
p.000168: attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular
p.000168: the following information:
p.000168:
p.000168: 2.1. Identification and description of the device, including information on the intended purpose,
p.000168: the risk classifi cation and applicable classification rule pursuant to Annex VIII, design and
p.000168: manufacturing of the device and reference to previous and similar generations of the device.
p.000168:
p.000168: 5.5.2017 EN
p.000168: Official Journal of the European Union
p.000169: L 117/169
p.000169:
p.000169: 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for
p.000169: use, including storage and handling requirements, as well as, to the extent that such information is available,
p.000169: information to be placed on the label, and instructions for use to be provided with the device when
...
p.000171: opinion or opinions shall be submitted as soon as available.
p.000171:
p.000171: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to
p.000171: Article 69 and the corresponding national law.
p.000171:
p.000171: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and
p.000171: the informed consent document.
p.000171:
p.000171: 4.5. Description of the arrangements to comply with the applicable rules on the protection and
p.000171: confidentiality of personal data, in particular:
p.000171:
p.000171: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000171: dissemination, alteration or loss of information and personal data processed;
p.000171:
p.000171: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000171: subjects; and
p.000171:
p.000171: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000171: possible adverse effects.
p.000171:
p.000171: 4.6. Full details of the available technical documentation, for example detailed risk
p.000171: analysis/management documen tation or specific test reports, shall, upon request, be submitted to the
p.000171: competent authority reviewing an application.
p.000171:
p.000171:
p.000171: CHAPTER III
p.000171:
p.000171: OTHER OBLIGATIONS OF THE SPONSOR
p.000171:
p.000171: 1. The sponsor shall undertake to keep available for the competent national authorities
p.000171: any documentation necessary to provide evidence for the documentation referred to in Chapter II of
p.000171: this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the
p.000171: investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000171:
p.000172: L 117/172 EN
p.000172: Official Journal of the European Union
p.000172: 5.5.2017
p.000172:
p.000172: 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or
p.000172: any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in
p.000172: a timely manner.
p.000172:
p.000172: 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years
p.000172: after the clinical investigation with the device in question has ended, or, in the event that the
p.000172: device is subsequently placed on the market, at least 10 years after the last device has been placed
p.000172: on the market. In the case of implantable devices, the period shall be at least 15 years.
p.000172:
p.000172: Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the
p.000172: period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000063: opinion which is valid for the entire Member State, under national law, has not been issued by an ethics
p.000063: committee in the Member State concerned in respect of the clinical investigation. The Member State shall
p.000063: notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph
p.000063: 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
p.000063:
p.000063: 8. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in
p.000063: the light of technical progress and global regulatory developments, the requirements laid down in Chapter II of Annex
p.000063: XV.
p.000063:
p.000063: 9. In order to ensure the uniform application of the requirements laid down in Chapter II of
p.000063: Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of
p.000063: divergent interpretation and of practical application. Those implementing acts shall be adopted in
p.000063: accordance with the examination procedure referred to in Article 114(3).
p.000063:
p.000063:
p.000063: Article 71
p.000063:
p.000063: Assessment by Member States
p.000063:
p.000063: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do
p.000063: not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural
p.000063: or legal persons financing the clinical investigation, as well as free of any other undue influence.
p.000063:
p.000064: L 117/64 EN
p.000064: Official Journal of the European Union
p.000064: 5.5.2017
p.000064:
p.000064: 2. Member States shall ensure that the assessment is done jointly by an appropriate number of
p.000064: persons who collectively have the necessary qualifications and experience.
p.000064:
p.000064: 3. Member States shall assess whether the clinical investigation is designed in such a way that
p.000064: potential remaining risks to subjects or third persons, after risk minimization, are justified, when
p.000064: weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or
p.000064: harmonised standards, examine in particular:
p.000064:
p.000064: (a) the demonstration of compliance of the investigational device(s) with the applicable general safety
p.000064: and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard
p.000064: to those aspects, every precaution has been taken to protect the health and safety of the subjects. This
p.000064: includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;
p.000064:
p.000064: (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards
p.000064: and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000008: safety and performance requirements laid down in this Regulation should be based on clinical data that,
p.000008: for class III devices and implantable devices should, as a general rule, be sourced from clinical
p.000008: investigations that have been carried out under the responsibility of a sponsor. It should be possible both for
p.000008: the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical
p.000008: investigation.
p.000008:
p.000008: 5.5.2017 EN
p.000008: Official Journal of the European Union
p.000009: L 117/9
p.000009:
p.000009: (64) The rules on clinical investigations should be in line with well-established international
p.000009: guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical
p.000009: investigations of medical devices for human subjects, so as to make it easier for the results of clinical
p.000009: investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for
p.000009: the results of clinical investi gations conducted outside the Union in accordance with international guidelines to be
p.000009: accepted within the Union. In addition, the rules should be in line with the most recent
p.000009: version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research
p.000009: Involving Human Subjects.
p.000009:
p.000009:
p.000009: (65) It should be left to the Member State where a clinical investigation is to be conducted
p.000009: to determine the appropriate authority to be involved in the assessment of the application to conduct
p.000009: a clinical investigation and to organise the involvement of ethics committees within the timelines for the
p.000009: authorisation of that clinical investi gation as set out in this Regulation. Such decisions are a matter
p.000009: of internal organisation for each Member State. In that context, Member States should ensure the
p.000009: involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the
p.000009: necessary expertise is available.
p.000009:
p.000009:
p.000009: (66) Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
p.000009: or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in
p.000009: such cases, including issues of causality and the level of damages and sanctions, should remain governed by
p.000009: national law.
p.000009:
p.000009:
p.000009: (67) An electronic system should be set up at Union level to ensure that every clinical
p.000009: investigation is recorded and reported in a publicly accessible database. To protect the right to the
...
Orphaned Trigger Words
p.000023: need to address public health concerns, the Commission, after having consulted the MDCG, may, by means
p.000023: of implementing acts, adopt common specifications (CS) in respect of the general safety and performance
p.000023: requirements set out in Annex I, the technical documentation set out in Annexes II and III, the
p.000023: clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding
p.000023: clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination
p.000023: procedure referred to in Article 114(3).
p.000023:
p.000023: 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in
p.000023: conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
p.000023:
p.000023: 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify
p.000023: that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
p.000023:
p.000023: 4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the
p.000023: relevant CS for those products.
p.000023:
p.000023:
p.000023: Article 10
p.000023:
p.000023: General obligations of manufacturers
p.000023:
p.000023: 1. When placing their devices on the market or putting them into service, manufacturers shall ensure
p.000023: that they have been designed and manufactured in accordance with the requirements of this Regulation.
p.000023:
p.000023: 2. Manufacturers shall establish, document, implement and maintain a system for risk management as
p.000023: described in Section 3 of Annex I.
p.000023:
p.000023: 3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in
p.000023: Article 61 and Annex XIV, including a PMCF.
p.000023:
p.000023: 4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date
p.000023: technical documen tation for those devices. The technical documentation shall be such as to allow the
p.000023: conformity of the device with the requirements of this Regulation to be assessed. The technical
p.000023: documentation shall include the elements set out in Annexes II and III.
p.000023:
p.000023: The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the
p.000023: light of technical progress, the Annexes II and III.
p.000023:
p.000023: 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent
p.000023: authorities documentation in accordance with Section 2 of Annex XIII.
p.000023:
p.000023: 6. Where compliance with the applicable requirements has been demonstrated following the applicable
p.000023: conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall
p.000023: draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of
p.000023: conformity in accordance with Article 20.
p.000023:
p.000023: 7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article
p.000023: 27 and with the registration obligations referred to in Articles 29 and 31.
p.000023:
p.000023: 8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if
...
p.000057: devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in
p.000057: order to protect the health and safety of patients, users or other persons or other aspects of public
p.000057: health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to
p.000057: amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and
p.000057: in point (b) of paragraph 6 of this Article, by adding other types of implantable or class III devices
p.000057: to that list or removing devices therefrom.
p.000057:
p.000057: 9. In the case of the products without an intended medical purpose listed in Annex XVI, the
p.000057: requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV
p.000057: shall be understood as a requirement to demonstrate the performance of the device. Clinical evaluations
p.000057: of those products shall be based on relevant data concerning safety, including data from post-market
p.000057: surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be
p.000057: performed for those products unless reliance on existing clinical data from an analogous medical device is duly
p.000057: justified.
p.000057:
p.000057: 10. Without prejudice to paragraph 4, where the demonstration of conformity with general safety and
p.000057: performance requirements based on clinical data is not deemed appropriate, adequate justification for any
p.000057: such exception shall be given based on the results of the manufacturer's risk management and
p.000057: on consideration of the specifics of the interaction between the device and the human body,
p.000057: the clinical performance intended and the claims of the manufacturer. In such a case, the
p.000057: manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it
p.000057: considers a demonstration of conformity with general safety and performance requirements that is based on
p.000057: the results of non-clinical testing methods alone, including performance evaluation, bench testing and
p.000057: pre- clinical evaluation, to be adequate.
p.000057:
p.000057: 11. The clinical evaluation and its documentation shall be updated throughout the life cycle of the
p.000057: device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in
p.000057: accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.
p.000057:
p.000057: For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary
p.000057: of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.
p.000057:
p.000057: 12. The clinical evaluation, its results and the clinical evidence derived from it shall be
p.000057: documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for
p.000057: custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device
p.000057: concerned.
p.000057:
p.000057: 13. Where necessary to ensure the uniform application of Annex XIV, the Commission may, having due
...
p.000080: Article, the second subparagraph of Article 95(7) shall apply. If the Commission considers the
p.000080: national measure to be unjustified, the Member State concerned shall withdraw the measure.
p.000080:
p.000080: Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt
p.000080: of the notification referred to in Article 95(4), the national measure shall be considered to be justified.
p.000080:
p.000080: 3. Where a Member State or the Commission considers that the risk to health and safety emanating
p.000080: from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or
p.000080: Member States concerned, the Commission, at the request of a Member State or on its own initiative, may
p.000080: take, by means of implementing acts, the necessary and duly justified measures to ensure the protection
p.000080: of health and safety, including measures restricting or prohibiting the placing on the market and putting
p.000080: into service of the device concerned. Those implementing acts shall be adopted in accordance with the
p.000080: examination procedure referred to in Article 114(3).
p.000080:
p.000080:
p.000080: Article 97
p.000080:
p.000080: Other non-compliance
p.000080:
p.000080: 1. Where, having performed an evaluation pursuant to Article 94, the competent authorities of a
p.000080: Member State find that a device does not comply with the requirements laid down in this Regulation but does not
p.000080: present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the
p.000080: protection of public health, they shall require the relevant economic operator to bring the non-compliance
p.000080: concerned to an end within a reasonable period that is clearly defined and communicated to the economic
p.000080: operator and that is proportionate to the non- compliance.
p.000080:
p.000080: 2. Where the economic operator does not bring the non-compliance to an end within the period
p.000080: referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate
p.000080: measures to restrict or prohibit the product being made available on the market or to ensure that it is
p.000080: recalled or withdrawn from the market. That Member State shall inform the Commission and the other
p.000080: Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
p.000080:
p.000080: 3. In order to ensure the uniform application of this Article, the Commission may, by means of
p.000080: implementing acts, specify appropriate measures to be taken by competent authorities to address given
p.000080: types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure
p.000080: referred to in Article 114(3).
p.000080:
p.000080:
p.000080: Article 98
p.000080:
p.000080: Preventive health protection measures
p.000080:
p.000080: 1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a
p.000080: device or a specific category or group of devices, considers that, in order to protect the health and
...
p.000095: L 117/95
p.000095:
p.000095: 6. The characteristics and performance of a device shall not be adversely affected to such a
p.000095: degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised
p.000095: during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the
p.000095: stresses which can occur during normal conditions of use and has been properly maintained in accordance
p.000095: with the manufacturer's instructions.
p.000095:
p.000095: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000095: performance during their intended use are not adversely affected during transport and storage,
p.000095: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000095: information provided by the manufacturer.
p.000095:
p.000095: 8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and
p.000095: be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the
p.000095: achieved performance of the device during normal conditions of use.
p.000095:
p.000095: 9. For the devices referred to in Annex XVI, the general safety requirements set out in
p.000095: Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for
p.000095: the purposes intended, does not present a risk at all or presents a risk that is no more than the
p.000095: maximum acceptable risk related to the product's use which is consistent with a high level of protection for the
p.000095: safety and health of persons.
p.000095:
p.000095:
p.000095: CHAPTER II
p.000095:
p.000095: REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
p.000095:
p.000095:
p.000095: 10. Chemical, physical and biological properties
p.000095:
p.000095: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the
p.000095: characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be
p.000095: paid to:
p.000095:
p.000095: (a) the choice of materials and substances used, particularly as regards toxicity and, where
p.000095: relevant, flammability;
p.000095:
p.000095: (b) the compatibility between the materials and substances used and biological tissues, cells and body
p.000095: fluids, taking account of the intended purpose of the device and, where relevant, absorption,
p.000095: distribution, metabolism and excretion;
p.000095:
p.000095: (c) the compatibility between the different parts of a device which consists of more than one implantable part;
p.000095:
p.000095: (d) the impact of processes on material properties;
p.000095:
p.000095: (e) where appropriate, the results of biophysical or modelling research the validity of which
p.000095: has been demonstrated beforehand;
p.000095:
p.000095: (f) the mechanical properties of the materials used, reflecting, where appropriate, matters such as
p.000095: strength, ductility, fracture resistance, wear resistance and fatigue resistance;
p.000095:
p.000095: (g) surface properties; and
p.000095:
p.000095: (h) the confirmation that the device meets any defined chemical and/or physical specifications.
p.000095:
...
p.000098: shall comply, where applicable and in a manner limited to the aspects not covered by this
p.000098: Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the
p.000098: evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with
p.000098: other devices, medicinal products or other substances and potential for adverse reactions, as required by
p.000098: the applicable conformity assessment procedure under this Regulation.
p.000098:
p.000098: 13. Devices incorporating materials of biological origin
p.000098:
p.000098: 13.1. For devices manufactured utilising derivatives of tissues or cells of human origin which are
p.000098: non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article
p.000098: 1(6), the following shall apply:
p.000098:
p.000098: (a) donation, procurement and testing of the tissues and cells shall be done in
p.000098: accordance with Directive 2004/23/EC;
p.000098:
p.000098: (b) processing, preservation and any other handling of those tissues and cells or their derivatives
p.000098: shall be carried out so as to provide safety for patients, users and, where applicable, other persons.
p.000098: In particular, safety with regard to viruses and other transmissible agents shall be addressed by
p.000098: appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation
p.000098: in the course of the manufacturing process;
p.000098:
p.000098: (c) the traceability system for those devices shall be complementary and compatible with the
p.000098: traceability and data protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC.
p.000098:
p.000098: 13.2. For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are
p.000098: non-viable or rendered non-viable the following shall apply:
p.000098:
p.000098: (a) where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives,
p.000098: shall originate from animals that have been subjected to veterinary controls that are adapted to
p.000098: the intended use of the tissues. Information on the geographical origin of the animals shall be retained
p.000098: by manufacturers;
p.000098:
p.000098: (b) sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal
p.000098: origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where
p.000098: applicable, other persons. In particular safety with regard to viruses and other transmissible agents
p.000098: shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the
p.000098: manufacturing process, except when the use of such methods would lead to unacceptable degradation
p.000098: compromising the clinical benefit of the device;
p.000098:
p.000098: (c) in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as
p.000098: referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.
p.000098:
p.000098: 13.3. For devices manufactured utilising non-viable biological substances other than those
p.000098: referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those
...
p.000109: their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the
p.000109: technical documentation;
p.000109:
p.000109: (c) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities
p.000109: are performed.
p.000109:
p.000109: 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000109:
p.000109: The documentation shall contain information for the demonstration of conformity with the general safety
p.000109: and performance requirements set out in Annex I that are applicable to the device taking into account
p.000109: its intended purpose, and shall include a justification, validation and verification of the solutions
p.000109: adopted to meet those requirements. The demonstration of conformity shall include:
p.000109:
p.000109: (a) the general safety and performance requirements that apply to the device and an explanation as to
p.000109: why others do not apply;
p.000109:
p.000109: (b) the method or methods used to demonstrate conformity with each applicable general safety and
p.000109: performance requirement;
p.000109: (c) the harmonised standards, CS or other solutions applied; and
p.000109: (d) the precise identity of the controlled documents offering evidence of conformity with each
p.000109: harmonised standard, CS or other method applied to demonstrate conformity with the general safety and
p.000109: performance requirements. The information referred to under this point shall incorporate a cross-reference to the
p.000109: location of such evidence within the full technical documentation and, if applicable, the summary technical
p.000109: documentation.
p.000109:
p.000109: 5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
p.000109:
p.000109: The documentation shall contain information on:
p.000109: (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
p.000109: (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
p.000109:
p.000109: 6. PRODUCT VERIFICATION AND VALIDATION
p.000109:
p.000109: The documentation shall contain the results and critical analyses of all verifications and validation
p.000109: tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this
p.000109: Regulation and in particular the applicable general safety and performance requirements.
p.000109:
p.000109: 6.1. Pre-clinical and clinical data
p.000109:
p.000109: (a) results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation
p.000109: of published literature applicable to the device, taking into account its intended purpose, or to similar
p.000109: devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
p.000109:
p.000109: (b) detailed information regarding test design, complete test or study protocols, methods of data
p.000109: analysis, in addition to data summaries and test conclusions regarding in particular:
p.000109:
p.000109: — the biocompatibility of the device including the identification of all materials in direct or indirect
p.000109: contact with the patient or user;
p.000109: — physical, chemical and microbiological characterisation;
p.000109: — electrical safety and electromagnetic compatibility;
p.000109:
p.000110: L 117/110 EN
...
p.000125: L 117/125
p.000125:
p.000125: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
p.000125: under this Regulation or any provision of national law giving effect to it, except in relation to the authorities
p.000125: responsible for notified bodies, competent authorities for medical devices in the Member States or the
p.000125: Commission. Proprietary rights shall be protected. The notified body shall have documented
p.000125: procedures in place in respect of the requirements of this Section.
p.000125:
p.000125: 1.4. Liability
p.000125:
p.000125: 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment
p.000125: activities, unless liability is assumed by the Member State in question in accordance with national law
p.000125: or that Member State is directly responsible for the conformity assessment.
p.000125:
p.000125: 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic
p.000125: scope of activities of the notified body and be commensurate with the risk profile of the devices
p.000125: certified by the notified body. The liability insurance shall cover cases where the notified body may be
p.000125: obliged to withdraw, restrict or suspend certificates.
p.000125:
p.000125: 1.5. Financial requirements
p.000125:
p.000125: The notified body shall have at its disposal the financial resources required to conduct its conformity
p.000125: assessment activities within its scope of designation and related business operations. It shall document
p.000125: and provide evidence of its financial capacity and its long-term economic viability, taking into account,
p.000125: where relevant, any specific circumstances during an initial start-up phase.
p.000125:
p.000125: 1.6. Participation in coordination activities
p.000125:
p.000125: 1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of,
p.000125: any relevant stan dardisation activities and in the activities of the notified body coordination group
p.000125: referred to in Article 49 and that its assessment and decision-making personnel are informed of all
p.000125: relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
p.000125:
p.000125: 1.6.2. The notified body shall take into consideration guidance and best practice documents.
p.000125:
p.000125: 2. QUALITY MANAGEMENT REQUIREMENTS
p.000125:
p.000125: 2.1. The notified body shall establish, document, implement, maintain and operate a quality management
p.000125: system that is appropriate to the nature, area and scale of its conformity assessment activities and is
p.000125: capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.
p.000125:
p.000125: 2.2. The quality management system of the notified body shall address at least the following:
p.000125: — management system structure and documentation, including policies and objectives for its activities;
p.000125: — policies for assignment of activities and responsibilities to personnel;
p.000125: — assessment and decision-making processes in accordance with the tasks, responsibilities and role of
p.000125: the notified body's personnel and top-level management;
p.000125: — the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
...
p.000133: L 117/133
p.000133:
p.000133: The documentation shall be sampled in such a manner as to reflect the risks associated with the intended use of the
p.000133: device, the complexity of the manufacturing technologies, the range and classes of devices produced and any
p.000133: available post-market surveillance information,
p.000133:
p.000133: — if not already covered by the audit programme, audit the control of processes on the premises of
p.000133: the manufacturer's suppliers, when the conformity of finished devices is significantly influenced
p.000133: by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient
p.000133: control over its suppliers,
p.000133:
p.000133: — conduct assessments of the technical documentation based on its sampling plan and taking account of
p.000133: Sections 4.5.4. and 4.5.5. for pre-clinical and clinical evaluations, and
p.000133:
p.000133: — the notified body shall ensure that audit findings are appropriately and consistently
p.000133: classified in accordance with the requirements of this Regulation and with relevant standards, or with
p.000133: best practice documents developed or adopted by the MDCG.
p.000133:
p.000133: 4.5.3. Product verification
p.000133:
p.000133: Assessment of the technical documentation
p.000133:
p.000133: For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX,
p.000133: notified bodies shall have sufficient expertise, facilities and documented procedures for:
p.000133:
p.000133: — the allocation of appropriately qualified and authorised personnel for the examination of individual
p.000133: aspects such as use of the device, biocompatibility, clinical evaluation, risk management, and sterilisation, and
p.000133:
p.000133: — the assessment of conformity of the design with this Regulation, and for taking account of Sections
p.000133: 4.5.4. to 4.5.6. That assessment shall include examination of the implementation by manufacturers of incoming, in-
p.000133: process and final checks and the results thereof. If further tests or other evidence is
p.000133: required for the assessment of conformity with the requirements of this Regulation, the notified body
p.000133: in question shall carry out adequate physical or laboratory tests in relation to the device or request
p.000133: the manufacturer to carry out such tests.
p.000133:
p.000133: Type-examinations
p.000133:
p.000133: The notified body shall have documented procedures, sufficient expertise and facilities for the
p.000133: type-examination of devices in accordance with Annex X including the capacity to:
p.000133:
p.000133: — examine and assess the technical documentation taking account of Sections 4.5.4. to 4.5.6., and verify
p.000133: that the type has been manufactured in conformity with that documentation;
p.000133:
p.000133: — establish a test plan identifying all relevant and critical parameters which need to be tested by
p.000133: the notified body or under its responsibility;
p.000133:
p.000133: — document its rationale for the selection of those parameters;
p.000133:
p.000133: — carry out the appropriate examinations and tests in order to verify that the solutions
p.000133: adopted by the manufacturer meet the general safety and performance requirements set out in Annex I.
...
p.000134: (d) have documented procedures to carry out the appropriate assessments and tests in order to verify
p.000134: the conformity of the device with the requirements of this Regulation by examining and testing every product
p.000134: as specified in Section 15 of Annex XI;
p.000134: (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and
p.000134: where necessary tests that are not to be carried out by the notified body itself are to be performed; and
p.000134: (f) assume full responsibility for test results in accordance with documented procedures; test reports
p.000134: submitted by the manufacturer shall only be taken into account if they have been issued by conformity
p.000134: assessment bodies which are competent and independent of the manufacturer.
p.000134:
p.000134: 4.5.4. Pre-clinical evaluation assessment
p.000134:
p.000134: The notified body shall have documented procedures in place for the review of the manufacturer's
p.000134: procedures and documentation relating to the evaluation of pre-clinical aspects. The notified body shall examine,
p.000134: validate and verify that the manufacturer's procedures and documentation adequately address:
p.000134: (a) the planning, conduct, assessment, reporting and, where appropriate, updating of the pre-clinical
p.000134: evaluation, in particular of
p.000134: — the scientific pre-clinical literature search, and
p.000134: — the pre-clinical testing, for example laboratory testing, simulated use testing, computer modelling, the
p.000134: use of animal models,
p.000134: (b) the nature and duration of body contact and the specific associated biological risks,
p.000134: (c) the interface with the risk management process, and
p.000134: (d) the appraisal and analysis of the available pre-clinical data and its relevance with regard to
p.000134: demonstrating conformity with the relevant requirements in Annex I.
p.000134: The notified body's assessment of pre-clinical evaluation procedures and documentation shall address the
p.000134: results of literature searches and all validation, verification and testing performed and conclusions
p.000134: drawn, and shall typically include considering the use of alternative materials and substances and take
p.000134: account of the packaging, stability, including shelf life, of the finished device. Where no new testing has been
p.000134: undertaken by a manufacturer or where there are deviations from procedures, the notified body in question
p.000134: shall critically examine the justifi cation presented by the manufacturer.
p.000134:
p.000134: 4.5.5. Clinical evaluation assessment
p.000134:
p.000134: The notified body shall have documented procedures in place relating to the assessment of a
p.000134: manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity
p.000134: assessment and on an ongoing basis. The notified body shall examine, validate and verify that manufacturers'
p.000134: procedures and documen tation adequately address:
p.000134: — the planning, conduct, assessment, reporting and updating of the clinical evaluation as
p.000134: referred to in Annex XIV,
p.000134: — post-market surveillance and PMCF,
p.000134: — the interface with the risk management process,
p.000134: — the appraisal and analysis of the available data and its relevance with regard to demonstrating
...
p.000136: body; this recommendation shall be signed off by the member of personnel responsible in the notified body, and
p.000136:
p.000136: — be provided to the manufacturer in question.
p.000136:
p.000136:
p.000136: 4.7. Final review
p.000136:
p.000136: The notified body shall prior to making a final decision:
p.000136:
p.000136: — ensure that the personnel assigned for the final review and decision-making on specific
p.000136: projects are appropriately authorised and are different from the personnel who have conducted the assessments,
p.000136:
p.000136: — verify that the report or reports and supporting documentation needed for decision making,
p.000136: including concerning resolution of non-conformities noted during assessment, are complete and sufficient
p.000136: with respect to the scope of the application, and
p.000136:
p.000136: — verify whether there are any unresolved non-conformities preventing issuance of a certificate.
p.000136:
p.000136:
p.000136: 4.8. Decisions and Certifications
p.000136:
p.000136: The notified body shall have documented procedures for decision-making including as regards the allocation
p.000136: of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those
p.000136: procedures shall include the notification requirements laid down in Chapter V of this Regulation. The
p.000136: procedures shall allow the notified body in question to:
p.000136:
p.000136: — decide, based on the assessment documentation and additional information available, whether
p.000136: the requirements of this Regulation are fulfilled,
p.000136:
p.000136: — decide, based on the results of its assessment of the clinical evaluation and risk management,
p.000136: whether the post-market surveillance plan, including the PMCF plan, is adequate,
p.000136:
p.000136: — decide on specific milestones for further review by the notified body of the up to date clinical evaluation,
p.000136:
p.000136: — decide whether specific conditions or provisions need to be defined for the certification,
p.000136:
p.000136: — decide, based on the novelty, risk classification, clinical evaluation and conclusions from the risk
p.000136: analysis of the device, on a period of certification not exceeding five years,
p.000136:
p.000136: — clearly document decision making and approval steps including approval by signature of the members of
p.000136: personnel responsible,
p.000136:
p.000136: — clearly document responsibilities and mechanisms for communication of decisions, in particular, where
p.000136: the final signatory of a certificate differs from the decision maker or decision makers or does not
p.000136: fulfil the requirements laid down in Section 3.2.7,
p.000136:
p.000136: — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex
p.000136: XII for a period of validity not exceeding five years and shall indicate whether there are specific
p.000136: conditions or limitations associated with the certification,
p.000136:
p.000136: — issue a certificate or certificates for the applicant alone and shall not issue certificates covering
p.000136: multiple entities, and
p.000136:
p.000136: — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that
p.000136: they are entered into the electronic system referred to in Article 57.
p.000136:
...
p.000150: 5.5.2017
p.000150:
p.000150: 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or
p.000150: totally on data from devices which are claimed to be equivalent to the device under assessment, assess
p.000150: the suitability of using such data, taking into account factors such as new indications and
p.000150: innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and
p.000150: on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the
p.000150: device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what
p.000150: extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
p.000150:
p.000150: 4.6. The notified body shall verify that the clinical evidence and the clinical evaluation are
p.000150: adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant
p.000150: general safety and performance requirements. That verification shall include consideration of the adequacy
p.000150: of the benefit-risk determination, the risk management, the instructions for use, the user training and
p.000150: the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the
p.000150: PMCF plan proposed, where applicable.
p.000150:
p.000150: 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the
p.000150: clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined
p.000150: to allow the notified body to review updates to the clinical evidence that result from post-market surveillance
p.000150: and PMCF data.
p.000150:
p.000150: 4.8. The notified body shall clearly document the outcome of its assessment in the clinical
p.000150: evaluation assessment report.
p.000150:
p.000150: 4.9. The notified body shall provide the manufacturer with a report on the technical documentation
p.000150: assessment, including a clinical evaluation assessment report. If the device conforms to the relevant
p.000150: provisions of this Regulation, the notified body shall issue an EU technical documentation assessment
p.000150: certificate. The certificate shall contain the conclusions of the technical documentation assessment, the
p.000150: conditions of the certificate's validity, the data needed for identification of the approved design, and,
p.000150: where appropriate, a description of the intended purpose of the device.
p.000150:
p.000150: 4.10. Changes to the approved device shall require approval from the notified body which issued the
p.000150: EU technical documentation assessment certificate where such changes could affect the safety and
p.000150: performance of the device or the conditions prescribed for use of the device. Where the manufacturer
p.000150: plans to introduce any of the above- mentioned changes it shall inform the notified body which issued the
p.000150: EU technical documentation assessment certificate thereof. The notified body shall assess the planned
p.000150: changes and decide whether the planned changes require a new conformity assessment in accordance with
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| education | education |
| elderly | Elderly |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| foetus | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| illness | Physically Disabled |
| immuno-compromised | immuno-compromised |
| impairment | Cognitive Impairment |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| military | Soldier |
| minor | Youth/Minors |
| nation | stateless persons |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| sexually transmitted | sexually transmitted disases |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| usage | Drug Usage |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| home | ['property'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| influence | ['substance', 'usage'] |
| liberty | ['restricted'] |
| property | ['home'] |
| restricted | ['liberty'] |
| substance | ['influence', 'usage'] |
| usage | ['influence', 'substance'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
developing
ethics
harm
justice
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input