79C3C34C52B45572883A05D425EB0F82

Medical Devices Regulation 2017/745

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

http://leaux.net/URLS/ConvertAPI Text Files/85C32D53376910B434C7561283672186.en.txt

Examining the file media/Synopses/85C32D53376910B434C7561283672186.html:

This file was generated: 2020-12-01 05:04:23

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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIllegal Activityunlawful1
Politicalcriminalcriminal2
Politicalpolitical affiliationparty5
Politicalstateless personsnation1
Politicalvulnerablevulnerable4
Politicalvulnerablevulnerability2
HealthCognitive Impairmentimpairment4
HealthDrug Usageinfluence7
HealthDrug Usagesubstance49
HealthDrug Usageusage1
HealthMentally Disableddisabled1
HealthMentally Disableddisability2
HealthPhysically Disabledillness4
HealthPregnantpregnant7
Healthbreastfeedingbreastfeeding7
Healthimmuno-compromisedimmuno-compromised1
Healthinjuredinjured6
Healthsexually transmitted disasessexually transmitted1
SocialAccess to Social Goodsaccess36
SocialAccess to informationaccess to information1
SocialAgeage5
SocialChildchild2
SocialChildchildren4
SocialElderlyelderly1
SocialFetus/Neonatefoetus1
SocialIncarceratedliberty1
SocialIncarceratedrestricted4
SocialLinguistic Proficiencylanguage15
SocialMarital Statussingle63
SocialProperty Ownershiphome2
SocialProperty Ownershipproperty7
SocialSoldiermilitary1
SocialThreat of Stigmathreat4
SocialTrade Union Membershipunion298
SocialWomenwomen8
SocialYouth/Minorsminor9
Socialeducationeducation6
Socialembryoembryo1
Socialemployeesemployees1
Socialgendergender1
Socialphilosophical differences/differences of opinionopinion69
EconomicEconomic/Povertypoor1
General/OtherDependentdependent1
General/OtherIncapacitatedincapacitated10
General/OtherIncapacitatedincapacity1
General/OtherNatural Hazardshazard2
General/OtherPublic Emergencyemergency4
General/OtherRelationship to Authorityauthority215
General/OtherUndue Influenceundue influence1
General/Otherdeclaration of helsinkihelsinki1

Political / Illegal Activity

Searching for indicator unlawful:

(return to top)
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:
...

Political / criminal

Searching for indicator criminal:

(return to top)
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.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
...

Political / political affiliation

Searching for indicator party:

(return to top)
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
...

Political / stateless persons

Searching for indicator nation:

(return to top)
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
...

Political / vulnerable

Searching for indicator vulnerable:

(return to top)
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
...

Searching for indicator usage:

(return to top)
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:
...

Health / Mentally Disabled

Searching for indicator disabled:

(return to top)
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
...

Searching for indicator disability:

(return to top)
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:

(return to top)
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:
...

Social / Access to information

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
...

Social / Marital Status

Searching for indicator single:

(return to top)
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:

(return to top)
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 p