79C3C34C52B45572883A05D425EB0F82
In Vitro Diagnostic Medical Devices Regulation 2017/746
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.000233:
p.000233:
p.000233: Article 68
p.000233:
p.000233: Conduct of a performance study
p.000233:
p.000233: 1. The sponsor and the investigator shall ensure that the performance study is conducted in
p.000233: accordance with the approved performance study plan.
p.000233:
p.000233: 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are
p.000233: reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this
p.000233: Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The
p.000233: extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes
p.000233: into consideration all character istics of the performance study including the following:
p.000233: (a) the objective and methodology of the performance study; and
p.000233: (b) the degree of deviation of the intervention from normal clinical practice.
p.000233: 3. All performance study information shall be recorded, processed, handled, and stored by
p.000233: the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and
p.000233: verified while the confiden tiality of records and the personal data of the subjects remain protected in
p.000233: accordance with the applicable law on personal data protection.
p.000233:
p.000233: 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data
p.000233: processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental
p.000233: loss, in particular where the processing involves transmission over a network.
p.000233:
p.000233: 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance
p.000233: studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
p.000233:
p.000234: L 117/234 EN
p.000234: Official Journal of the European Union
p.000234: 5.5.2017
p.000234:
p.000234: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification
p.000234: and, where necessary, an immediate recall of the devices used in the study.
p.000234:
p.000234:
p.000234: Article 69
p.000234:
p.000234: Electronic system on performance studies
p.000234:
p.000234: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000234: electronic system:
p.000234: (a) to create the single identification numbers for performance studies referred to in Article 66(1);
p.000234: (b) to be used as an entry point for the submission of all applications or notifications for performance studies
p.000234: referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
p.000234: (c) for the exchange of information relating to performance studies in accordance with this Regulation
p.000234: between the Member States and between them and the Commission including the exchange of information
p.000234: referred to in to Articles 72 and 74;
...
Political / criminal
Searching for indicator criminal:
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p.000253:
p.000253: Article 102
p.000253:
p.000253: Confidentiality
p.000253:
p.000253: 1. Unless otherwise provided for in this Regulation and without prejudice to existing national
p.000253: provisions and practices in the Member States on confidentiality, all parties involved in the application of this
p.000253: Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to
p.000253: protect the following:
p.000253: (a) personal data in accordance with Article 103;
p.000253: (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual
p.000253: property rights unless disclosure is in the public interest;
p.000253: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000253: audits.
p.000253:
p.000254: L 117/254 EN
p.000254: Official Journal of the European Union
p.000254: 5.5.2017
p.000254:
p.000254: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities
p.000254: and between competent authorities and the Commission shall not be disclosed without the prior agreement
p.000254: of the originating authority.
p.000254:
p.000254: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000254: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000254: obligations of the persons concerned to provide information under criminal law.
p.000254:
p.000254: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000254: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000254:
p.000254: Article 103
p.000254:
p.000254: Data protection
p.000254:
p.000254: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member
p.000254: States pursuant to this Regulation.
p.000254:
p.000254: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000254: Commission pursuant to this Regulation.
p.000254:
p.000254: Article 104
p.000254:
p.000254: Levying of fees
p.000254:
p.000254: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities
p.000254: set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of
p.000254: cost-recovery principles.
p.000254:
p.000254: 2. Member States shall inform the Commission and the other Member States at least three months
p.000254: before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly
p.000254: available on request.
p.000254:
p.000254: Article 105
p.000254:
p.000254: Funding of activities related to designation and monitoring of notified bodies
p.000254:
p.000254: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
p.000254: shall, by means of implementing acts, lay down the scale and structure of recoverable costs
...
Political / political affiliation
Searching for indicator party:
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p.000190: received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's
p.000190: behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
p.000190:
p.000190: (26) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000190: country on the Union market;
p.000190:
p.000190: (27) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the
p.000190: importer, that makes a device available on the market, up until the point of putting into service;
p.000190:
p.000190: (28) ‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
p.000190:
p.000190: (29) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or
p.000190: the promotion of public health;
p.000190:
p.000190: (30) ‘user’ means any healthcare professional or lay person who uses a device;
p.000190:
p.000190: (31) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical
p.000190: discipline;
p.000190:
p.000190: (32) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to
p.000190: a device have been fulfilled;
p.000190:
p.000190: (33) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000190: including calibration, testing, certification and inspection;
p.000190:
p.000190: (34) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000190:
p.000190: (35) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000190: conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation
p.000190: legislation providing for its affixing;
p.000190:
p.000190: (36) ‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device
p.000190: of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the
p.000190: intended clinical benefit(s), when used as intended by the manufacturer;
p.000190:
p.000190: (37) ‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening,
p.000190: monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
p.000190:
p.000190: (38) ‘scientific validity of an analyte’ means the association of an analyte with a clinical condition
p.000190: or a physiological state;
p.000190:
p.000190: (39) ‘performance of a device’ means the ability of a device to achieve its intended purpose as
p.000190: claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting
p.000190: that intended purpose;
p.000190:
p.000190: (40) ‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
p.000190:
...
p.000278: Official Journal of the European Union
p.000279: L 117/279
p.000279:
p.000279: ANNEX V
p.000279:
p.000279: CE MARKING OF CONFORMITY
p.000279:
p.000279: 1. The CE marking shall consist of the initials ‘CE’ taking the following form:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279: 2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected.
p.000279:
p.000279: 3. The various components of the CE marking shall have substantially the same vertical dimension, which
p.000279: may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
p.000279:
p.000280: L 117/280 EN
p.000280: Official Journal of the European Union
p.000280: 5.5.2017
p.000280:
p.000280: ANNEX VI
p.000280:
p.000280: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000280: WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN
p.000280: ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
p.000280:
p.000280: PART A
p.000280:
p.000280: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000280: WITH ARTICLES 26(3) AND 28
p.000280:
p.000280: Manufacturers or, when applicable, authorised representatives, and, when applicable, importers
p.000280: shall submit the information referred to in Section 1 and shall ensure that the information on their
p.000280: devices referred to in Section 2 is complete, correct and updated by the relevant party.
p.000280:
p.000280: 1. Information relating to the economic operator
p.000280:
p.000280: 1.1. type of economic operator (manufacturer, authorised representative, or importer),
p.000280: 1.2. name, address and contact details of the economic operator,
p.000280:
p.000280: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000280: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000280:
p.000280: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000280: referred to in Article 15,
p.000280:
p.000280: 2. Information relating to the device
p.000280:
p.000280: 2.1. Basic UDI-DI,
p.000280:
p.000280: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000280: identification number of that notified body and the link to the information that appears on the
p.000280: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000280: 2.3. Member State in which the device shall or has been placed on the market in the Union,
p.000280: 2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made
p.000280: available,
p.000280: 2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n),
p.000280: 2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No
p.000280: 722/2012(y/n),
p.000280: 2.7. presence of cells or substances of microbial origin (y/n),
p.000280: 2.8. risk class of the device,
...
p.000287: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
p.000287: responsibilities and authority of its top-level management and of other personnel who may have an influence upon the
p.000287: performance by the notified body upon the results of its conformity assessment activities.
p.000287:
p.000287: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000287: and responsi bility for each of the following:
p.000287:
p.000287: (a) provision of adequate resources for conformity assessment activities;
p.000287:
p.000287: (b) development of procedures and policies for the operation of the notified body;
p.000287:
p.000287: (c) supervision of implementation of the procedures, policies and quality management systems of the
p.000287: notified body;
p.000287:
p.000287: (d) supervision of the notified body's finances;
p.000287:
p.000287: (e) activities and decisions taken by the notified body, including contractual agreements;
p.000287:
p.000287: (f) delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000287: defined activities;
p.000287:
p.000287: (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with
p.000287: other competent authorities, the Commission and other notified bodies.
p.000287:
p.000287: 1.2. Independence and impartiality
p.000287:
p.000287: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation
p.000287: to which it performs conformity assessment activities. The notified body shall also be independent of any
p.000287: other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does
p.000287: not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
p.000287:
p.000288: L 117/288 EN
p.000288: Official Journal of the European Union
p.000288: 5.5.2017
p.000288:
p.000288: 1.2.2. The notified body shall be organised and operated so as to safeguard the independence,
p.000288: objectivity and impartiality of its activities. The notified body shall document and implement a structure
p.000288: and procedures for safeguarding impartiality and for promoting and applying the principles of
p.000288: impartiality throughout its organisation, personnel and assessment activities. Such procedures shall
p.000288: provide for the identification, investi gation and resolution of any case in which a conflict of interest may
p.000288: arise including involvement in consultancy services in the field of devices prior to taking up employment with the
p.000288: notified body. The investigation, outcome and its resolution shall be documented.
p.000288:
p.000288: 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the
p.000288: conformity assessment tasks shall not:
p.000288:
p.000288: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess,
p.000288: nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of
...
p.000306: into account the state of the art.
p.000306:
p.000306: 2.2. Implementation of the quality management system shall ensure compliance with this Regulation.
p.000306: All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be
p.000306: documented in a systematic and orderly manner in the form of a quality manual and written policies and
p.000306: procedures, such as quality programmes, quality plans and quality records.
p.000306:
p.000306: 5.5.2017 EN
p.000306: Official Journal of the European Union
p.000307: L 117/307
p.000307:
p.000307: Moreover, the documentation to be submitted for the assessment of the quality management system shall
p.000307: include an adequate description of, in particular:
p.000307:
p.000307: (a) the manufacturer's quality objectives;
p.000307:
p.000307: (b) the organisation of the business and in particular:
p.000307:
p.000307: — the organisational structures with the assignment of staff responsibilities in relation to
p.000307: critical procedures, the responsibilities of the managerial staff and their organisational authority,
p.000307:
p.000307: — the methods of monitoring whether the operation of the quality management system is efficient and in particular the
p.000307: ability of that system to achieve the desired design and device quality, including control of devices which fail to
p.000307: conform,
p.000307:
p.000307: — where the design, manufacture, and/or final verification and testing of the devices, or parts of any
p.000307: of those processes, is carried out by another party, the methods of monitoring the efficient operation of
p.000307: the quality management system and in particular the type and extent of control applied to the other
p.000307: party,
p.000307:
p.000307: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000307: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000307: representative to accept the mandate;
p.000307:
p.000307: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
p.000307: devices, and the corresponding documentation as well as the data and records arising from those
p.000307: procedures and techniques. Those procedures and techniques shall specifically cover:
p.000307:
p.000307: — the strategy for regulatory compliance, including processes for identification of relevant
p.000307: legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with,
p.000307: conformity assessment procedures,
p.000307:
p.000307: — identification of applicable general safety and performance requirements and solutions to fulfil those
p.000307: requirements, taking applicable CS into account and, where opted for, harmonised standards,
p.000307:
p.000307: — risk management as referred to in Section 3 of Annex I,
p.000307:
p.000307: — the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding design and construction, including
p.000307: appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the
p.000307: device, in particular the requirements of Chapter III of Annex I,
p.000307:
...
p.000325: performance study subjects;
p.000325:
p.000325: (z) policy as regards the establishment of the clinical performance study report and publication of
p.000325: results in accordance with the legal requirements and the ethical principles referred to in Section 2.2;
p.000325:
p.000325: (aa) list of the technical and functional features of the device indicating those that are covered by
p.000325: the performance study;
p.000325:
p.000325: (ab) bibliography.
p.000325:
p.000325: If part of the information referred to in the second paragraph is submitted in a separate document, it shall
p.000325: be referenced in the CPSP. For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
p.000325:
p.000325: Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due
p.000325: to the specific study design chosen, such as use of left-over samples versus interventional clinical
p.000325: performance studies, a justification shall be provided.
p.000325:
p.000326: L 117/326 EN
p.000326: Official Journal of the European Union
p.000326: 5.5.2017
p.000326:
p.000326: 2.3.3. Clinical performance study report
p.000326:
p.000326: A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall
p.000326: contain documented information on the clinical performance study protocol plan, results and conclusions of the
p.000326: clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias
p.000326: and clinically relevant. The report shall contain sufficient information to enable it to be understood by an
p.000326: independent party without reference to other documents. The report shall also include as appropriate any protocol
p.000326: amendments or deviations, and data exclusions with the appropriate rationale.
p.000326:
p.000326:
p.000326: 3. OTHER PERFORMANCE STUDIES
p.000326:
p.000326: By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in
p.000326: Section 2.3.3, shall be documented for other performance studies than clinical performance studies.
p.000326:
p.000326:
p.000326: PART B
p.000326:
p.000326: POST-MARKET PERFORMANCE FOLLOW-UP
p.000326:
p.000326: 4. PMPF shall be understood to be a continuous process that updates the performance evaluation
p.000326: referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the
p.000326: manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect
p.000326: and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is
p.000326: placed on the market or put into service within its intended purpose as referred to in the relevant conformity
p.000326: assessment procedure, with the aim of confirming the safety, performance and scientific validity throughout
p.000326: the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and
p.000326: of detecting emerging risks on the basis of factual evidence.
p.000326:
p.000326: 5. PMPF shall be performed pursuant to a documented method laid down in a PMPF plan.
p.000326:
p.000326: 5.1. The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating
p.000326: safety, performance and scientific data with the aim of:
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000226: responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation. Any
p.000226: communication with that legal representative shall be deemed to be a communication with the sponsor.
p.000226:
p.000226: Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their
p.000226: territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor
p.000226: establishes at least a contact person on their territory in respect of that performance study who shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation.
p.000226:
p.000226: 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions
p.000226: are met:
p.000226:
p.000226: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is
p.000226: to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000226:
p.000226: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in
p.000226: relation to the performance study, which is valid for that entire Member State under its national law;
p.000226:
p.000226: (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;
p.000226:
p.000226: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
p.000226:
p.000226: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000226: inconveniences and compliance with this condition is constantly monitored;
p.000226:
p.000226: (f) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative has given informed consent, in accordance with Article 59;
p.000226:
p.000226: (g) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative, has been provided with the contact details of an entity where further information can be received in
p.000226: case of need;
p.000226:
p.000226: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data
p.000226: concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000226:
p.000226: (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable
p.000226: risk as possible for the subjects, and both the risk threshold and the degree of distress are
p.000226: specifically defined in the performance study plan and constantly monitored;
p.000226:
p.000226: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or,
...
p.000324:
p.000324: (i) the instructions for use of the device or test protocol, the necessary training and experience of the user, the
p.000324: appropriate calibration procedures and means of control, the indication of any other devices, medical
p.000324: devices, medicinal product or other articles to be included or excluded and the specifications on any
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
...
Health / Cognitive Impairment
Searching for indicator impairment:
(return to top)
p.000191: performance study that are relevant to the subject's decision to participate or, in the case of minors and of
p.000191: incapacitated subjects, an authoris ation or agreement from their legally designated representative to include them in
p.000191: the performance study;
p.000191:
p.000191: (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that
p.000191: Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of
p.000191: laypersons, in particular patients or patients' organisations;
p.000191:
p.000191: (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision,
p.000191: unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in
p.000191: subjects, users or other persons, in the context of a performance study, whether or not related to the device for
p.000191: performance study;
p.000191:
p.000191: (61) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000191:
p.000191: (a) a patient management decision resulting in death or an imminent life-threatening situation for the
p.000191: individual being tested, or in the death of the individual's offspring,
p.000191:
p.000191: (b) death,
p.000191:
p.000191: (c) serious deterioration in the health of the individual being tested or the recipient of tested
p.000191: donations or materials, that resulted in any of the following:
p.000191:
p.000191: (i) life-threatening illness or injury,
p.000191:
p.000191: (ii) permanent impairment of a body structure or a body function,
p.000191:
p.000192: L 117/192 EN
p.000192: Official Journal of the European Union
p.000192: 5.5.2017
p.000192:
p.000192: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000192:
p.000192: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
p.000192: to a body structure or a body function,
p.000192:
p.000192: (v) chronic disease,
p.000192:
p.000192: (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000192:
p.000192: (62) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000192: performance of a device for performance study, including malfunction, use errors or inadequacy in
p.000192: information supplied by the manufacturer;
p.000192:
p.000192: (63) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000192: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000192: and review experience gained from devices they place on the market, make available on the market or put into service
p.000192: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000192:
p.000192: (64) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and
p.000192: ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation
p.000192: and do not endanger health, safety or any other aspect of public interest protection;
p.000192:
p.000192: (65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the
p.000192: end user;
p.000192:
p.000192: (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000192: made available on the market;
p.000192:
p.000192: (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made
p.000192: available on the market, including use-error due to ergonomic features, as well as any inadequacy in the
...
p.000261:
p.000261: 9.2. The performance characteristics of the device shall be maintained during the lifetime of the device as
p.000261: indicated by the manufacturer.
p.000261:
p.000261: 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the
p.000261: metrological traceability of values assigned to calibrators and/or control materials shall be assured through
p.000261: suitable reference measurement procedures and/or suitable reference materials of a higher metrological
p.000261: order. Where available, metrological traceability of values assigned to calibrators and control materials
p.000261: shall be assured to certified reference materials or reference measurement procedures.
p.000261:
p.000261: 9.4. The characteristics and performances of the device shall be specifically checked in the event
p.000261: that they may be affected when the device is used for the intended use under normal conditions:
p.000261:
p.000261: (a) for devices for self-testing, performances obtained by laypersons;
p.000261:
p.000261: (b) for devices for near-patient testing, performances obtained in relevant environments (for example,
p.000261: patient home, emergency units, ambulances).
p.000261:
p.000261: 10. Chemical, physical and biological properties
p.000261:
p.000261: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance
p.000261: requirements referred to in Chapter I are fulfilled.
p.000261:
p.000261: Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or
p.000261: chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as
p.000261: biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
p.000261:
p.000262: L 117/262 EN
p.000262: Official Journal of the European Union
p.000262: 5.5.2017
p.000262:
p.000262: 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed
p.000262: by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons
p.000262: involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to
p.000262: those contaminants and residues and to the duration and frequency of exposure.
p.000262:
p.000262: 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably
p.000262: practicable the risks posed by substances or particles, including wear debris, degradation products and
p.000262: processing residues, that may be released from the device. Special attention shall be given to substances
p.000262: which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex
p.000262: VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having
p.000262: endocrine disrupting properties for which there is scientific evidence of probable serious effects to human
p.000262: health and which are identified in accordance with the procedure set out in Article 59 of Regulation
...
p.000264: with the intended purpose, whilst not restricting the application of appropriate specified levels for
p.000264: diagnostic purposes.
p.000264:
p.000264: 15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing
p.000264: radiation, they shall as far as possible be:
p.000264:
p.000264: (a) designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation
p.000264: emitted can be controlled and/or adjusted; and
p.000264: (b) fitted with visual displays and/or audible warnings of such emissions.
p.000264: 15.3. The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain
p.000264: detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of
p.000264: avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information
p.000264: regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure
p.000264: shall also be specified.
p.000264:
p.000264: 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that
p.000264: are devices in themselves
p.000264:
p.000264: 16.1. Devices that incorporate electronic programmable systems, including software, or software that are
p.000264: devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000264: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as
p.000264: far as possible consequent risks or impairment of performance.
p.000264:
p.000264: 16.2. For devices that incorporate software or for software that are devices in themselves, the software
p.000264: shall be developed and manufactured in accordance with the state of the art taking into account the
p.000264: principles of development life cycle, risk management, including information security, verification and validation.
p.000264:
p.000264: 16.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms
p.000264: shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and
p.000264: contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of
p.000264: light or noise).
p.000264:
p.000264: 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and
p.000264: IT security measures, including protection against unauthorised access, necessary to run the software as intended.
p.000264:
p.000264: 17. Devices connected to or equipped with an energy source
p.000264:
p.000264: 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition,
p.000264: appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
p.000264:
p.000264: 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of
...
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.000190: that intended purpose;
p.000190:
p.000190: (40) ‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
p.000190:
p.000190: (41) ‘clinical performance’ means the ability of a device to yield results that are correlated with a
p.000190: particular clinical condition or a physiological or pathological process or state in accordance with the target
p.000190: population and intended user;
p.000190:
p.000190: (42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical
p.000190: performance of a device;
p.000190:
p.000190: (43) ‘performance study plan’ means a document that describes the rationale, objectives, design
p.000190: methodology, monitoring, statistical considerations, organisation and conduct of a performance study;
p.000190:
p.000190: (44) ‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity,
p.000190: the analytical and, where applicable, the clinical performance of a device;
p.000190:
p.000190: (45) ‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.
p.000190:
p.000190: A device intended to be used for research purposes, without any medical objective, shall not be deemed
p.000190: to be a device for performance study;
p.000190:
p.000190: 5.5.2017 EN
p.000190: Official Journal of the European Union
p.000191: L 117/191
p.000191:
p.000191: (46) ‘interventional clinical performance study’ means a clinical performance study where the test results may
p.000191: influence patient management decisions and/or may be used to guide treatment;
p.000191:
p.000191: (47) ‘subject’ means an individual who participates in a performance study and whose specimen(s) undergo
p.000191: in vitro
p.000191: examination by a device for performance study and/or by a device used for control purposes;
p.000191:
p.000191: (48) ‘investigator’ means an individual responsible for the conduct of a performance study at a performance study
p.000191: site;
p.000191:
p.000191: (49) ‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (50) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (51) ‘predictive value’ means the probability that a person with a positive device test result has a given condition
p.000191: under investigation, or that a person with a negative device test result does not have a given condition;
p.000191:
p.000191: (52) ‘positive predictive value’ means the ability of a device to separate true positive results from false positive
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (53) ‘negative predictive value’ means the ability of a device to separate true negative results from false negative
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (54) ‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical
p.000191: condition or physiological state compared to the likelihood of the same result arising in an individual
p.000191: without that clinical condition or physiological state;
p.000191:
...
p.000221: manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for
p.000221: conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge
p.000221: an application in parallel with another notified body for the same conformity assessment procedure.
p.000221:
p.000222: L 117/222 EN
p.000222: Official Journal of the European Union
p.000222: 5.5.2017
p.000222:
p.000222: 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the
p.000222: other notified bodies of any manufacturer that withdraws its application prior to the notified body's
p.000222: decision regarding the conformity assessment.
p.000222:
p.000222: 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn
p.000222: an application with another notified body prior to the decision of that notified body and provide information about any
p.000222: previous application for the same conformity assessment that has been refused by another notified body.
p.000222:
p.000222: 4. The notified body may require any information or data from the manufacturer, which is necessary
p.000222: in order to properly conduct the chosen conformity assessment procedure.
p.000222:
p.000222: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities
p.000222: with the highest degree of professional integrity and the requisite technical and scientific competence in
p.000222: the specific field and shall be free from all pressures and inducements, particularly financial, which
p.000222: might influence their judgement or the results of their conformity assessment activities, especially as regards
p.000222: persons or groups with an interest in the results of those activities.
p.000222:
p.000222:
p.000222: Article 50
p.000222:
p.000222: Mechanism for scrutiny of conformity assessments of class D devices
p.000222:
p.000222: 1. A notified body shall notify the competent authority of certificates it has granted for class D
p.000222: devices, with the exception of applications to supplement or renew existing certificates. Such notification
p.000222: shall take place through the electronic system referred to in Article 52 and shall include the
p.000222: instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to
p.000222: in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the
p.000222: scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and
p.000222: where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106
p.000222: of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a
p.000222: full justification shall also be included.
p.000222:
p.000222: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further
p.000222: procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in
p.000222: accordance with to Articles 90 and 92.
p.000222:
...
p.000265: reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
p.000265:
p.000265: 18.6. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which
p.000265: the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible
p.000265: risks.
p.000265:
p.000265: 18.7. Errors likely to be made when fitting or refitting certain parts which could be a source of
p.000265: risk shall be made impossible by the design and construction of such parts or, failing this, by
p.000265: information given on the parts themselves and/or their housings.
p.000265:
p.000265: The same information shall be given on moving parts and/or their housings where the direction of
p.000265: movement needs to be known in order to avoid a risk.
p.000265:
p.000265: 18.8. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures)
p.000265: and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.
p.000265:
p.000265: 19. Protection against the risks posed by devices intended for self-testing or near-patient testing
p.000265:
p.000265: 19.1. Devices intended for self-testing or near-patient testing shall be designed and manufactured in
p.000265: such a way that they perform appropriately for their intended purpose taking into account the skills and the
p.000265: means available to the intended user and the influence resulting from variation that can be reasonably
p.000265: anticipated in the intended user's technique and environment. The information and instructions provided by the
p.000265: manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result
p.000265: provided by the device and to avoid misleading information. In the case of near-patient testing, the information and
p.000265: the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience
p.000265: required by the user.
p.000265:
p.000265: 19.2. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as
p.000265: to:
p.000265:
p.000265: (a) ensure that the device can be used safely and accurately by the intended user at all stages of the procedure if
p.000265: necessary after appropriate training and/or information; and
p.000265:
p.000265: (b) reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable,
p.000265: the specimen, and also in the interpretation of the results.
p.000265:
p.000266: L 117/266 EN
p.000266: Official Journal of the European Union
p.000266: 5.5.2017
p.000266:
p.000266: 19.3. Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by
p.000266: which the intended user:
p.000266:
p.000266: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and
p.000266: (b) be warned if the device has failed to provide a valid result.
p.000266:
p.000266: CHAPTER III
p.000266:
p.000266: REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
p.000266:
p.000266:
...
p.000268: — the determination of the safety and compatibility with potential recipients;
p.000268: — the prediction of treatment response or reactions;
p.000268: — the definition or monitoring of therapeutic measures;
p.000268: (iv) whether it is automated or not;
p.000268: (v) whether it is qualitative, semi-quantitative or quantitative;
p.000268: (vi) the type of specimen(s) required;
p.000268: (vii) where applicable, the testing population; and
p.000268: (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for
p.000268: which it is a companion test.
p.000268:
p.000268: 5.5.2017 EN
p.000268: Official Journal of the European Union
p.000269: L 117/269
p.000269:
p.000269: (d) an indication that the device is an in vitro diagnostic medical device, or, if the device is a
p.000269: ‘device for performance study’, an indication of that fact;
p.000269:
p.000269: (e) the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare
p.000269: professionals);
p.000269:
p.000269: (f) the test principle;
p.000269:
p.000269: (g) a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated
p.000269: instrument only);
p.000269:
p.000269: (h) a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated
p.000269: instrument only) and the composition of the reagent product by nature and amount or concentration of the
p.000269: active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the
p.000269: device contains other ingredients which might influence the measurement;
p.000269:
p.000269: (i) a list of materials provided and a list of special materials required but not provided;
p.000269:
p.000269: (j) for devices intended for use in combination with or installed with or connected to other devices
p.000269: and/or general purpose equipment:
p.000269:
p.000269: — information to identify such devices or equipment, in order to obtain a validated and safe combination, including
p.000269: key performance characteristics, and/or
p.000269:
p.000269: — information on any known restrictions to combinations of devices and equipment.
p.000269:
p.000269: (k) an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling
p.000269: conditions which apply;
p.000269:
p.000269: (l) in-use stability which may include the storage conditions, and shelf life following the first opening of the
p.000269: primary container, together with the storage conditions and stability of working solutions, where this is
p.000269: relevant;
p.000269:
p.000269: (m) if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and
p.000269: instructions in the event of the sterile packaging being damaged before use;
p.000269:
p.000269: (n) information that allows the user to be informed of any warnings, precautions, measures to be taken and
p.000269: limitations of use regarding the device. That information shall cover, where appropriate:
p.000269:
p.000269: (i) warnings, precautions and/or measures to be taken in the event of malfunction of the device or
p.000269: its degradation as suggested by changes in its appearance that may affect performance,
p.000269:
p.000269: (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external
...
p.000287: status shall be fully documented. Such documentation shall include information about ownership and the legal
p.000287: or natural persons exercising control over the notified body.
p.000287:
p.000287: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that
p.000287: organisation as well as its organisational structure and governance, and the relationship with the notified
p.000287: body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both
p.000287: the notified body and the organisation to which it belongs.
p.000287:
p.000287: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country
p.000287: or is owned by another legal entity, the activities and responsibilities of those entities, as well as
p.000287: their legal and operational relationships with the notified body, shall be clearly defined and documented.
p.000287: Personnel of those entities performing conformity assessment activities under this Regulation shall be
p.000287: subject to the applicable requirements of this Regulation.
p.000287:
p.000287: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000287: body shall be such that they ensure that there is confidence in the performance by the notified body and in the
p.000287: results of the conformity assessment activities it conducts.
p.000287:
p.000287: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
p.000287: responsibilities and authority of its top-level management and of other personnel who may have an influence upon the
p.000287: performance by the notified body upon the results of its conformity assessment activities.
p.000287:
p.000287: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000287: and responsi bility for each of the following:
p.000287:
p.000287: (a) provision of adequate resources for conformity assessment activities;
p.000287:
p.000287: (b) development of procedures and policies for the operation of the notified body;
p.000287:
p.000287: (c) supervision of implementation of the procedures, policies and quality management systems of the
p.000287: notified body;
p.000287:
p.000287: (d) supervision of the notified body's finances;
p.000287:
p.000287: (e) activities and decisions taken by the notified body, including contractual agreements;
p.000287:
p.000287: (f) delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000287: defined activities;
p.000287:
p.000287: (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with
p.000287: other competent authorities, the Commission and other notified bodies.
p.000287:
p.000287: 1.2. Independence and impartiality
p.000287:
p.000287: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation
p.000287: to which it performs conformity assessment activities. The notified body shall also be independent of any
p.000287: other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does
...
Searching for indicator substance:
(return to top)
p.000191: in vitro
p.000191: examination by a device for performance study and/or by a device used for control purposes;
p.000191:
p.000191: (48) ‘investigator’ means an individual responsible for the conduct of a performance study at a performance study
p.000191: site;
p.000191:
p.000191: (49) ‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (50) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (51) ‘predictive value’ means the probability that a person with a positive device test result has a given condition
p.000191: under investigation, or that a person with a negative device test result does not have a given condition;
p.000191:
p.000191: (52) ‘positive predictive value’ means the ability of a device to separate true positive results from false positive
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (53) ‘negative predictive value’ means the ability of a device to separate true negative results from false negative
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (54) ‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical
p.000191: condition or physiological state compared to the likelihood of the same result arising in an individual
p.000191: without that clinical condition or physiological state;
p.000191:
p.000191: (55) ‘calibrator’ means a measurement reference material used in the calibration of a device;
p.000191:
p.000191: (56) ‘control material’ means a substance, material or article intended by its manufacturer to be used
p.000191: to verify the performance characteristics of a device;
p.000191:
p.000191: (57) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the
p.000191: initiation, for the management and setting up of the financing of the performance study;
p.000191:
p.000191: (58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000191: participate in a particular performance study, after having been informed of all aspects of the
p.000191: performance study that are relevant to the subject's decision to participate or, in the case of minors and of
p.000191: incapacitated subjects, an authoris ation or agreement from their legally designated representative to include them in
p.000191: the performance study;
p.000191:
p.000191: (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that
p.000191: Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of
p.000191: laypersons, in particular patients or patients' organisations;
p.000191:
p.000191: (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision,
p.000191: unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in
p.000191: subjects, users or other persons, in the context of a performance study, whether or not related to the device for
p.000191: performance study;
p.000191:
...
p.000266:
p.000266: (d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases
p.000266: instructions for use shall not be required or may be abbreviated if the device can be used safely and
p.000266: as intended by the manufacturer without any such instructions for use.
p.000266:
p.000266: (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient
p.000266: testing, are supplied to a single user and/or location, a single copy of the instructions for use may
p.000266: be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
p.000266:
p.000266: (f) When the device is intended for professional use only, instructions for use may be provided to the user in
p.000266: non-paper format (e.g. electronic), except when the device is intended for near-patient testing.
p.000266:
p.000266: (g) Residual risks which are required to be communicated to the user and/or other person shall be included as
p.000266: limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000266:
p.000266: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000266: internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used
p.000266: shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols
p.000266: and colours shall be described in the documentation supplied with the device.
p.000266:
p.000266: (i) In the case of devices containing a substance or a mixture which may be considered as being
p.000266: dangerous, taking account of the nature and quantity of its constituents and the form under which they
p.000266: are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where
p.000266: there is insufficient space to put all the information on the device itself or on its label, the relevant hazard
p.000266: pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given
p.000266: in the instructions for use.
p.000266:
p.000266: (j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all
p.000266: relevant information, as appropriate, is already made available in the instructions for use.
p.000266:
p.000266: 5.5.2017 EN
p.000266: Official Journal of the European Union
p.000267: L 117/267
p.000267:
p.000267: 20.2. Information on the label
p.000267:
p.000267: The label shall bear all of the following particulars:
p.000267: (a) the name or trade name of the device;
p.000267:
p.000267: (b) the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the
p.000267: intended purpose of the device;
p.000267:
p.000267: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000267: its registered place of business;
p.000267:
p.000267: (d) if the manufacturer has its registered place of business outside the Union, the name of its authorised rep
...
p.000274: methods, information on the timeframe between taking the specimen and its analysis and storage conditions
p.000274: such as duration, temperature limits and freeze/thaw cycles.
p.000274:
p.000274: 6.1.2. Analytical performance characteristics
p.000274: 6.1.2.1. Accuracy of measurement
p.000274: (a) Trueness of measurement
p.000274: This Section shall provide information on the trueness of the measurement procedure and summarise the data in
p.000274: sufficient detail to allow an assessment of the adequacy of the means selected to establish the
p.000274: trueness. Trueness measures apply to both quantitative and qualitative assays only when a certified
p.000274: reference material or certified reference method is available.
p.000274: (b) Precision of measurement
p.000274: This Section shall describe repeatability and reproducibility studies.
p.000274: 6.1.2.2. Analytical sensitivity
p.000274:
p.000274: This Section shall include information about the study design and results. It shall provide a
p.000274: description of specimen type and preparation including matrix, analyte levels, and how levels were established. The
p.000274: number of replicates tested at each concentration shall also be provided as well as a description of the calculation
p.000274: used to determine assay sensitivity.
p.000274:
p.000274: 6.1.2.3. Analytical specificity
p.000274:
p.000274: This Section shall describe interference and cross reactivity studies performed to determine the
p.000274: analytical specificity in the presence of other substances/agents in the specimen.
p.000274: Information shall be provided on the evaluation of potentially interfering and cross-reacting substances
p.000274: or agents on the assay, on the tested substance or agent type and its concentration, specimen type,
p.000274: analyte test concentration, and results.
p.000274: Interferents and cross-reacting substances or agents, which vary greatly depending on the assay type and design, could
p.000274: derive from exogenous or endogenous sources such as:
p.000274: (a) substances used for patient treatment such as medicinal products;
p.000274: (b) substances ingested by the patient such as alcohol, foods;
p.000274: (c) substances added during specimen preparation such as preservatives, stabilisers;
p.000274: (d) substances encountered in specific specimen types such as haemoglobin, lipids, bilirubin, proteins;
p.000274: (e) analytes of similar structure such as precursors, metabolites or medical conditions unrelated to the
p.000274: test condition including specimens negative for the assay but positive for a condition that can mimic the
p.000274: test condition.
p.000274:
p.000274: 5.5.2017 EN
p.000274: Official Journal of the European Union
p.000275: L 117/275
p.000275:
p.000275: 6.1.2.4. Metrological traceability of calibrator and control material values
p.000275:
p.000275: 6.1.2.5. Measuring range of the assay
p.000275:
p.000275: This Section shall include information on the measuring range regardless of whether the measuring systems are linear or
p.000275: non-linear, including the limit of detection and describe information on how the range and detection limit were
p.000275: established.
p.000275:
p.000275: This information shall include a description of specimen type, number of specimens, number of replicates, and specimen
p.000275: preparation including information on the matrix, analyte levels and how levels were established. If
...
p.000300:
p.000300: — clearly document decision making and approval steps including approval by signature of the members of
p.000300: personnel responsible,
p.000300:
p.000300: 5.5.2017 EN
p.000300: Official Journal of the European Union
p.000301: L 117/301
p.000301:
p.000301: — clearly document responsibilities and mechanisms for communication of decisions, in particular, where
p.000301: the final signatory of a certificate differs from the decision maker or decision makers or does not
p.000301: fulfil the requirements laid down in Section 3.2.7.,
p.000301:
p.000301: — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII
p.000301: for a period of validity not exceeding five years and shall indicate whether there are specific
p.000301: conditions or limitations associated with the certification,
p.000301:
p.000301: — issue a certificate or certificates for the applicant alone and shall not issue certificates covering
p.000301: multiple entities,
p.000301:
p.000301: — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they
p.000301: are entered into the electronic system referred to in Article 52.
p.000301:
p.000301: 4.9. Changes and modifications
p.000301:
p.000301: The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to
p.000301: the manufacturers' information obligations and the assessment of changes to:
p.000301: — the approved quality management system or systems or to the product-range covered,
p.000301: — the approved design of a device,
p.000301: — the approved type of a device,
p.000301: — any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific
p.000301: procedures in accordance with Section 4.5.5.
p.000301:
p.000301: The procedures and contractual arrangements referred to in the first paragraph shall include measures for
p.000301: checking the significance of the changes referred to in the first paragraph.
p.000301: In accordance with its documented procedures, the notified body in question shall:
p.000301: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first
p.000301: paragraph and relevant information relating to such changes,
p.000301:
p.000301: — assess the changes proposed and verify whether, after these changes, the quality management system, or the design
p.000301: of a device or type of a device, still meets the requirements of this Regulation,
p.000301:
p.000301: — notify the manufacturer of its decision and provide a report or, as applicable, a supplementary report, which shall
p.000301: contain the justified conclusions of its assessment.
p.000301: 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures:
p.000301: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include
p.000301: arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers
p.000301: carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and
p.000301: associated with certification decisions, such as updates to clinical data at defined intervals,
p.000301:
p.000301: — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of
...
Searching for indicator usage:
(return to top)
p.000240:
p.000240: Post-market surveillance report
p.000240:
p.000240: Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the
p.000240: results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000240: surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective
p.000240: actions taken. The report shall be updated when necessary and made available to the notified body and
p.000240: the competent authority upon request.
p.000240:
p.000240: 5.5.2017 EN
p.000240: Official Journal of the European Union
p.000241: L 117/241
p.000241:
p.000241: Article 81
p.000241:
p.000241: Periodic safety update report
p.000241:
p.000241: 1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each
p.000241: device and where relevant for each category or group of devices summarising the results and conclusions of the analyses
p.000241: of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article
p.000241: 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime
p.000241: of the device concerned, that PSUR shall set out:
p.000241: (a) the conclusions of the benefit-risk determination;
p.000241: (b) the main findings of the PMPF; and
p.000241: (c) the volume of sales of the device and an estimate of the size and other characteristics of the population using
p.000241: the device and, where practicable, the usage frequency of the device.
p.000241: Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the
p.000241: technical documentation as specified in Annexes II and III.
p.000241:
p.000241: 2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87
p.000241: to the notified body involved in the conformity assessment of such devices in accordance with Article
p.000241: 48. The notified body shall review the report and add its evaluation to that electronic system with details of any
p.000241: action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities
p.000241: through that electronic system.
p.000241:
p.000241: 3. For class C devices, manufacturers shall make PSURs available to the notified body involved in
p.000241: the conformity assessment and, upon request, to competent authorities.
p.000241:
p.000241: Section 2
p.000241: Vigilance
p.000241:
p.000241: Article 82
p.000241:
p.000241: Reporting of serious incidents and field safety corrective actions
p.000241:
p.000241: 1. Manufacturers of devices, made available on the Union market, other than devices for performance
p.000241: study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
p.000241: (a) any serious incident involving devices made available on the Union market, except expected erroneous results which
p.000241: are clearly documented and quantified in the product information and in the technical documentation and
p.000241: are subject to trend reporting pursuant to Article 83;
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000260: safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturers
p.000260: shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged
p.000260: acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
p.000260: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000260:
p.000260: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000260: risks that cannot be eliminated; and
p.000260:
p.000260: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training
p.000260: to users.
p.000260: Manufacturers shall inform users of any residual risks.
p.000260:
p.000260: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000260:
p.000260: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000260: environment in which the device is intended to be used (design for patient safety), and
p.000260:
p.000260: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000260: where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or
p.000260: other users).
p.000260:
p.000260: 5.5.2017 EN
p.000260: Official Journal of the European Union
p.000261: L 117/261
p.000261:
p.000261: 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the
p.000261: health or safety of the patient or the user and, where applicable, of other persons are compromised during the
p.000261: lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur
p.000261: during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
p.000261:
p.000261: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000261: performance during their intended use are not adversely affected during transport and storage,
p.000261: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000261: information provided by the manufacturer.
p.000261:
p.000261: 8. All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed
p.000261: against the evaluated potential benefits to the patients and/or the user arising from the intended performance of
p.000261: the device during normal conditions of use.
p.000261:
p.000261: CHAPTER II
p.000261:
p.000261: REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
p.000261:
p.000261:
p.000261: 9. Performance characteristics
p.000261:
p.000261: 9.1. Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to
p.000261: in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the
...
Searching for indicator disability:
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p.000304: — determining the infectious load of a life-threatening disease where monitoring is critical in the
p.000304: process of patient management.
p.000304:
p.000304: 2.2. Rule 2
p.000304:
p.000304: Devices intended to be used for blood grouping, or tissue typing to ensure the immunological
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
p.000305: (h) to be used in screening, diagnosis, or staging of cancer;
p.000305: (i) for human genetic testing;
p.000305: (j) for monitoring of levels of medicinal products, substances or biological components, when there is
p.000305: a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation
p.000305: for the patient or for the patient's offspring;
p.000305: (k) for management of patients suffering from a life-threatening disease or condition;
p.000305: (l) for screening for congenital disorders in the embryo or foetus;
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000191: participate in a particular performance study, after having been informed of all aspects of the
p.000191: performance study that are relevant to the subject's decision to participate or, in the case of minors and of
p.000191: incapacitated subjects, an authoris ation or agreement from their legally designated representative to include them in
p.000191: the performance study;
p.000191:
p.000191: (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that
p.000191: Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of
p.000191: laypersons, in particular patients or patients' organisations;
p.000191:
p.000191: (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision,
p.000191: unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in
p.000191: subjects, users or other persons, in the context of a performance study, whether or not related to the device for
p.000191: performance study;
p.000191:
p.000191: (61) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000191:
p.000191: (a) a patient management decision resulting in death or an imminent life-threatening situation for the
p.000191: individual being tested, or in the death of the individual's offspring,
p.000191:
p.000191: (b) death,
p.000191:
p.000191: (c) serious deterioration in the health of the individual being tested or the recipient of tested
p.000191: donations or materials, that resulted in any of the following:
p.000191:
p.000191: (i) life-threatening illness or injury,
p.000191:
p.000191: (ii) permanent impairment of a body structure or a body function,
p.000191:
p.000192: L 117/192 EN
p.000192: Official Journal of the European Union
p.000192: 5.5.2017
p.000192:
p.000192: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000192:
p.000192: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
p.000192: to a body structure or a body function,
p.000192:
p.000192: (v) chronic disease,
p.000192:
p.000192: (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000192:
p.000192: (62) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000192: performance of a device for performance study, including malfunction, use errors or inadequacy in
p.000192: information supplied by the manufacturer;
p.000192:
p.000192: (63) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000192: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000192: and review experience gained from devices they place on the market, make available on the market or put into service
p.000192: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000192:
p.000192: (64) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and
p.000192: ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation
p.000192: and do not endanger health, safety or any other aspect of public interest protection;
p.000192:
p.000192: (65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the
p.000192: end user;
p.000192:
p.000192: (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000192: made available on the market;
p.000192:
p.000192: (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made
p.000192: available on the market, including use-error due to ergonomic features, as well as any inadequacy in the
p.000192: information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not
p.000192: taken on the basis of information or result(s) provided by the device;
p.000192:
p.000192: (68) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000192: lead to any of the following:
p.000192:
p.000192: (a) the death of a patient, user or other person,
p.000192:
p.000192: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000192:
p.000192: (c) a serious public health threat;
p.000192:
p.000192: (69) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration
p.000192: in a person's state of health, or serious illness, that may require prompt remedial action, and that
p.000192: may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
p.000192:
p.000192: (70) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000192: non-conformity or other undesirable situation;
p.000192:
p.000192: (71) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons
p.000192: to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
p.000192:
p.000192: (72) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000192: relation to a field safety corrective action;
p.000192:
p.000192: (73) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of
p.000192: Regulation (EU) No 1025/2012;
p.000192:
p.000192: (74) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000192: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000192:
p.000192: 5.5.2017 EN
p.000192: Official Journal of the European Union
p.000193: L 117/193
p.000193:
p.000193: Section 2
p.000193: Regulatory status of products and counselling
p.000193:
p.000193: Article 3
p.000193:
p.000193: Regulatory status of products
p.000193:
p.000193: 1. Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device
p.000193: Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000229: minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
...
p.000324: devices, medicinal product or other articles to be included or excluded and the specifications on any
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
...
Health / immuno-compromised
Searching for indicator immuno-compromised:
(return to top)
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
p.000325: (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and
p.000325: procedures and timelines for reporting;
p.000325:
...
Health / injured
Searching for indicator injured:
(return to top)
p.000179: context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used
p.000179: only within health institutions, including hospitals as well as institutions, such as laboratories and public health
p.000179: institutes that support the health care system and/or address patient needs, but which do not treat or care for
p.000179: patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
p.000179: It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue
p.000179: health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result,
p.000179: the exemption applicable to health institutions does not apply to such establishments.
p.000179:
p.000179:
p.000179: (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective
p.000179: device in accordance with applicable Union and national law, it is appropriate to require manufacturers
p.000179: to have measures in place to provide sufficient financial coverage in respect of their potential
p.000179: liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to the risk class, type of
p.000179: device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the
p.000179: facilitation, by a competent authority, of the provision of information to persons who may have been injured by a
p.000179: defective device.
p.000179:
p.000179:
p.000179: (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of
p.000179: this Regulation and that experience from the use of the devices they manufacture is taken into account for the
p.000179: production process, all manufacturers should have a quality management system and a post-market surveillance system in
p.000179: place which should be proportionate to the risk class and the type of the device in question. In
p.000179: addition, in order to minimize risks or prevent incidents related to devices, manufacturers should
p.000179: establish a system for risk management and a system for reporting incidents and field safety corrective actions.
p.000179:
p.000179:
p.000179: (32) The risk management system should be carefully aligned with and reflected in the performance
p.000179: evaluation process for the device, including the clinical risks to be addressed as part of performance
p.000179: studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation
p.000179: processes should be inter-dependent and should be regularly updated.
p.000179:
p.000179:
p.000179: (33) It should be ensured that supervision and control of the manufacture of devices, as well as
p.000179: post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's
...
p.000198: the Member State concerned. The competent authority of the Member State in which the manufacturer has its
p.000198: registered place of business may require that the manufacturer provide samples of the device free of charge or,
p.000198: where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent
p.000198: authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000198: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000198: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000198: overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
p.000198:
p.000198: The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the
p.000198: information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal
p.000198: proceedings.
p.000198:
p.000198: 14. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000198: person the information on the identity of that person shall be part of the information to be submitted in accordance
p.000198: with Article 27(1).
p.000198:
p.000198: 15. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000198: accordance with applicable Union and national law.
p.000198:
p.000198: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000198: of the enterprise, have measures in place to provide sufficient financial coverage in respect of their
...
Health / sexually transmitted disases
Searching for indicator sexually transmitted:
(return to top)
p.000304: — detection of the presence of, or exposure to, a transmissible agent in blood, blood components,
p.000304: cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for
p.000304: transfusion, transplantation or cell administration;
p.000304: — detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening
p.000304: disease with a high or suspected high risk of propagation;
p.000304: — determining the infectious load of a life-threatening disease where monitoring is critical in the
p.000304: process of patient management.
p.000304:
p.000304: 2.2. Rule 2
p.000304:
p.000304: Devices intended to be used for blood grouping, or tissue typing to ensure the immunological
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
p.000305: (h) to be used in screening, diagnosis, or staging of cancer;
p.000305: (i) for human genetic testing;
p.000305: (j) for monitoring of levels of medicinal products, substances or biological components, when there is
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000184: the national competent authorities, to ensure effective coordination of their market surveillance activities
p.000184: and to clarify the applicable procedures.
p.000184:
p.000184: (82) Any statistically significant increase in the number or severity of incidents that are not
p.000184: serious or in expected erroneous results that could have a significant impact on the benefit-risk
p.000184: analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to
p.000184: permit their assessment and the adoption of appropriate measures.
p.000184:
p.000184: (83) An expert committee, the MDCG, composed of persons designated by the Member States based on their role and
p.000184: expertise in the field of medical devices including in vitro diagnostic medical devices, should be
p.000184: established in
p.000184:
p.000184: (1) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals
p.000184: used for scientific purposes (OJ L 276, 20.10.2010. p. 33).
p.000184:
p.000184: 5.5.2017 EN
p.000184: Official Journal of the European Union
p.000185: L 117/185
p.000185:
p.000185: accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it
p.000185: by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission
p.000185: and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able
p.000185: to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical
p.000185: devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate con sideration
p.000185: should be given to the possibility of involving existing groups at Union level in the field of medical
p.000185: devices.
p.000185:
p.000185:
p.000185: (84) Closer coordination between national competent authorities through information exchange and
p.000185: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000185: uniform high level of health and safety protection within the internal market, in particular in the
p.000185: areas of performance studies and vigilance. The principle of coordinated exchange and assessment should
p.000185: also apply across other authority activities described in this Regulation, such as the designation of notified
p.000185: bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and
p.000185: communication of activities should also lead to more efficient use of resources and expertise at national level.
p.000185:
p.000185:
p.000185: (85) The Commission should provide scientific, technical and corresponding logistical support to
p.000185: coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000185: implemented at Union level based on sound scientific evidence.
p.000185:
p.000185:
...
p.000185: at national level, Member States should, in order to ensure transparency, inform the Commission and the
p.000185: other Member States before they decide on the level and structure of such fees. In order to further ensure
p.000185: transparency, the structure and level of the fees should be publicly available on request.
p.000185:
p.000185:
p.000185: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000185: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000185: data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should
p.000185: be applied by the Member States in accordance with those rights and principles.
p.000185:
p.000185:
p.000185: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in
p.000185: order to amend certain non-essential provisions of this Regulation. It is of particular importance that
p.000185: the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that
p.000185: those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13
p.000185: April 2016 on Better Law Making (1). In particular, to ensure equal participation in the preparation of
p.000185: delegated acts, the European Parliament and the Council receive all documents at the same time as
p.000185: Member States' experts, and their experts systematically have access to meetings of Commission expert
p.000185: groups dealing with preparation of delegated acts.
p.000185:
p.000185:
p.000185: (91) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers
p.000185: should be conferred on the Commission. Those powers should be exercised in accordance with Regulation
p.000185: (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000185:
p.000185: (1) OJ L 123, 12.5.2016, p. 1.
p.000185: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000185: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of
p.000185: implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000185:
p.000186: L 117/186 EN
p.000186: Official Journal of the European Union
p.000186: 5.5.2017
p.000186:
p.000186: (92) The advisory procedure should be used for implementing acts that set out the form and presentation of the data
p.000186: elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free
p.000186: sale, given that such implementing acts are of a procedural nature and do not directly have an impact on
p.000186: health and safety at Union level.
p.000186:
p.000186: (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating
p.000186: to the extension to the territory of the Union of a national derogation from the applicable conformity assessment
p.000186: procedures, imperative grounds of urgency so require.
p.000186:
...
p.000193:
p.000193: 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical
p.000193: devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary,
p.000193: other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
p.000193:
p.000193: 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human
p.000193: tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of
p.000193: consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food
p.000193: Safety Authority, as relevant.
p.000193:
p.000193: Article 4
p.000193:
p.000193: Genetic information, counselling and informed consent
p.000193:
p.000193: 1. Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as
p.000193: defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council (1) and for the
p.000193: medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested
p.000193: or, where applicable, his or her legally designated representative is provided with relevant information on
p.000193: the nature, the significance and the implications of the genetic test, as appropriate.
p.000193:
p.000193: 2. In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that
p.000193: there is appropriate access to counselling in the case of the use of genetic tests that provide information on the
p.000193: genetic predispo sition for medical conditions and/or diseases which are generally considered to be untreatable
p.000193: according to the state of science and technology.
p.000193:
p.000193: 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease
p.000193: which the individual being tested is already known to have is confirmed by a genetic test or in cases where a
p.000193: companion diagnostic is used.
p.000193:
p.000193: 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at
p.000193: national level which are more protective of patients, more specific or which deal with informed consent.
p.000193:
p.000193: CHAPTER II
p.000193: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE
p.000193: MARKING, FREE MOVEMENT
p.000193:
p.000193: Article 5
p.000193:
p.000193: Placing on the market and putting into service
p.000193:
p.000193: 1. A device may be placed on the market or put into service only if it complies with this
p.000193: Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
p.000193:
p.000193: (1) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients'
p.000193: rights in cross- border healthcare (OJ L 88, 4.4.2011, p. 45).
p.000193:
p.000194: L 117/194 EN
p.000194: Official Journal of the European Union
p.000194: 5.5.2017
p.000194:
...
p.000194: Regulation and, where applicable, information on which requirements are not fully met with a reasoned justifi cation
p.000194: therefor;
p.000194:
p.000194: (g) as regards class D devices in accordance with the rules set out in Annex VIII, the health
p.000194: institution draws up documentation that makes it possible to have an understanding of the manufacturing
p.000194: facility, the manufacturing process, the design and performance data of the devices, including the
p.000194: intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the
p.000194: general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply
p.000194: this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
p.000194:
p.000194: (h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with
p.000194: the documentation referred to in point (g); and
p.000194:
p.000194: (i) the health institution reviews experience gained from clinical use of the devices and takes all
p.000194: necessary corrective actions.
p.000194:
p.000194: Member States may require that such health institutions submit to the competent authority any further
p.000194: relevant information about such devices which have been manufactured and used on their territory. Member States shall
p.000194: retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access
p.000194: to inspect the activities of the health institutions.
p.000194:
p.000194: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000194:
p.000194: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000194: acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those
p.000194: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000194:
p.000194: 5.5.2017 EN
p.000194: Official Journal of the European Union
p.000195: L 117/195
p.000195:
p.000195: Article 6
p.000195:
p.000195: Distance sales
p.000195:
p.000195: 1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive
p.000195: (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
p.000195: 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed
p.000195: on the market but used in the context of a commercial activity, whether in return for payment or free of charge,
p.000195: for the provision of a diagnostic or therapeutic service offered by means of information society services, as defined
p.000195: in point (b) of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication, directly or through
p.000195: intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
...
p.000197: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors
p.000197: of the device in question and, where applicable, the authorised representative and importers accordingly.
p.000197:
p.000197: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000197: of the Member States in which they made the device available and, where applicable, the notified body that issued a
p.000197: certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective
p.000197: action taken.
p.000197:
p.000198: L 117/198 EN
p.000198: Official Journal of the European Union
p.000198: 5.5.2017
p.000198:
p.000198: 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions
p.000198: as described in Articles 82 and 83.
p.000198:
p.000198: 13. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000198: and documen tation necessary to demonstrate the conformity of the device, in an official Union language determined by
p.000198: the Member State concerned. The competent authority of the Member State in which the manufacturer has its
p.000198: registered place of business may require that the manufacturer provide samples of the device free of charge or,
p.000198: where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent
p.000198: authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000198: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000198: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
...
p.000198: least the following tasks in relation to the devices that it covers:
p.000198: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and,
p.000198: where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
p.000198: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy
p.000198: of the relevant certificate, including any amendments and supplements, issued in accordance with Article
p.000198: 51, at the disposal of competent authorities for the period referred to in Article 10(7);
p.000198: (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied
p.000198: with the registration obligations laid down in Article 26;
p.000198:
p.000198: 5.5.2017 EN
p.000198: Official Journal of the European Union
p.000199: L 117/199
p.000199:
p.000199: (d) in response to a request from a competent authority, provide that competent authority with all the information and
p.000199: documentation necessary to demonstrate the conformity of a device, in an official Union language determined
p.000199: by the Member State concerned;
p.000199: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000199: resentative has its registered place of business for samples, or access to a device and verify that
p.000199: the competent authority receives the samples or is given access to the device;
p.000199: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is
p.000199: not possible, mitigate the risks posed by devices;
p.000199: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000199: patients and users about suspected incidents related to a device for which they have been designated;
p.000199: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000199: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid
p.000199: down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
p.000199:
p.000199: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000199: and has not complied with the obligations laid down in Article 10, the authorised representative shall be
p.000199: legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000199:
p.000199: 6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3
p.000199: shall immediately inform the competent authority of the Member State in which it is established and, where applicable,
p.000199: the notified body that was involved in the conformity assessment for the device of the termination of the mandate and
p.000199: the reasons therefor.
p.000199:
p.000199: 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has
...
p.000200: competent authorities to ensure that the necessary corrective action to bring that device into conformity, to
p.000200: withdraw or recall it, is taken. Where the device presents a serious risk, they shall also immediately inform the
p.000200: competent authorities of the Member States in which they made the device available and, if applicable, the
p.000200: notified body that issued a certificate in accordance with Article 51 for the device in question, giving
p.000200: details, in particular, of the non-compliance and of any corrective action taken.
p.000200:
p.000200: 8. Importers who have received complaints or reports from healthcare professionals, patients or users
p.000200: about suspected incidents related to a device which they have placed on the market shall immediately forward this
p.000200: information to the manufacturer and its authorised representative.
p.000200:
p.000200: 9. Importers shall, for the period referred to in Article 10(7), keep a copy of the EU declaration of conformity
p.000200: and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued
p.000200: in accordance with Article 51.
p.000200:
p.000200: 10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to
p.000200: eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000200: the market. Importers, upon request by a competent authority of the Member State in which the importer has its
p.000200: registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant
p.000200: access to the device.
p.000200:
p.000200:
p.000200: Article 14
p.000200:
p.000200: General obligations of distributors
p.000200:
p.000200: 1. When making a device available on the market, distributors shall, in the context of their
p.000200: activities, act with due care in relation to the requirements applicable.
p.000200:
p.000200: 2. Before making a device available on the market, distributors shall verify that all of the following
p.000200: requirements are met:
p.000200: (a) the device has been CE marked and the EU declaration of conformity of the device has been drawn up;
p.000200: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10);
p.000200: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000200: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000200: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000200: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000200:
p.000200: 5.5.2017 EN
p.000200: Official Journal of the European Union
p.000201: L 117/201
p.000201:
p.000201: Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this
p.000201: Regulation, it shall not make the device available on the market until it has been brought into
p.000201: conformity and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and
p.000201: the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a
...
p.000201: device available, giving details, in particular, of the non-compliance and of any corrective action taken.
p.000201:
p.000201: 5. Distributors that have received complaints or reports from healthcare professionals, patients or
p.000201: users about suspected incidents related to a device they have made available, shall immediately forward
p.000201: this information to the manufacturer and, where applicable, the manufacturer's authorised representative,
p.000201: and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and
p.000201: withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer
p.000201: informed of such monitoring and provide them with any information upon their request.
p.000201:
p.000201: 6. Distributors shall, upon request by a competent authority, provide it with all the information and
p.000201: documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
p.000201:
p.000201: Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph
p.000201: when the manufacturer or, where applicable, the authorised representative for the device in question
p.000201: provides the required information. Distributors shall cooperate with competent authorities, at their request, on any
p.000201: action taken to eliminate the risks posed by devices which they have made available on the market.
p.000201: Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is
p.000201: impracticable, grant access to the device.
p.000201:
p.000201:
p.000201: Article 15
p.000201:
p.000201: Person responsible for regulatory compliance
p.000201:
p.000201: 1. Manufacturers shall have available within their organisation at least one person responsible for
p.000201: regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical
p.000201: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000201:
p.000201: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or
p.000201: of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or
p.000201: another relevant scientific discipline, and at least one year of professional experience in regulatory
p.000201: affairs or in quality management systems relating to in vitro diagnostic medical devices;
p.000201: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000201: to in vitro
p.000201: diagnostic medical devices.
p.000201:
p.000201: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000201: not be required to have the person responsible for regulatory compliance within their organisation but shall have such
p.000201: person permanently and continuously at their disposal.
p.000201:
p.000201: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000201:
p.000201: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
p.000201: system under which the devices are manufactured, before a device is released;
p.000201:
...
p.000205: L 117/205
p.000205:
p.000205: 2. Economic operators shall be able to identify the following to the competent authority, for the period referred
p.000205: to in Article 10(7):
p.000205: (a) any economic operator to whom they have directly supplied a device;
p.000205: (b) any economic operator who has directly supplied them with a device;
p.000205: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000205:
p.000205: Article 23
p.000205:
p.000205: Medical devices nomenclature
p.000205:
p.000205: To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in
p.000205: Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally
p.000205: recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal
p.000205: persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that
p.000205: nomenclature is available to other stakeholders free of charge, where reasonably practicable.
p.000205:
p.000205: Article 24
p.000205:
p.000205: Unique Device Identification system
p.000205:
p.000205: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000205: allow the identifi cation and facilitate the traceability of devices, other than devices for performance
p.000205: studies, and shall consist of the following:
p.000205: (a) production of a UDI that comprises the following:
p.000205: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
p.000205: the information laid down in Part B of Annex VI;
p.000205: (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the
p.000205: packaged devices, as specified in Part C of Annex VI;
p.000205: (b) placing of the UDI on the label of the device or on its packaging;
p.000205: (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with
p.000205: the conditions laid down in paragraphs 8 and 9 respectively;
p.000205: (d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article
p.000205: 28 of Regulation (EU) 2017/745.
p.000205: 2. The Commission shall, by means of implementing acts, designate one or several entities to operate a
p.000205: system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those
p.000205: entities shall satisfy all of the following criteria:
p.000205: (a) the entity is an organisation with legal personality;
p.000205: (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution
p.000205: and use in accordance with the requirements of this Regulation;
p.000205: (c) its system for the assignment of UDIs conforms to the relevant international standards;
p.000205: (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance
p.000205: with a set of predetermined and transparent terms and conditions;
p.000205: (e) the entity undertakes to do the following:
p.000205: (i) operate its system for the assignment of UDIs for at least 10 years after its designation;
p.000205: (ii) make available to the Commission and to the Member States, upon request, information concerning its system for
p.000205: the assignment of UDIs;
p.000205: (iii) remain in compliance with the criteria for designation and the terms of designation.
p.000205: When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of
p.000205: Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to
p.000205: minimising financial and administrative burdens for economic operators, health institutions and healthcare
p.000205: professionals.
p.000205:
p.000206: L 117/206 EN
p.000206: Official Journal of the European Union
p.000206: 5.5.2017
p.000206:
p.000206: 3. Before placing a device, other than a device for performance study, on the market, the manufacturer shall
p.000206: assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules
p.000206: of the issuing entity designated by the Commission in accordance with paragraph 2.
p.000206:
p.000206: Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that
p.000206: the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to
p.000206: the UDI database referred to in Article 25.
p.000206:
...
p.000233:
p.000233: Article 68
p.000233:
p.000233: Conduct of a performance study
p.000233:
p.000233: 1. The sponsor and the investigator shall ensure that the performance study is conducted in
p.000233: accordance with the approved performance study plan.
p.000233:
p.000233: 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are
p.000233: reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this
p.000233: Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The
p.000233: extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes
p.000233: into consideration all character istics of the performance study including the following:
p.000233: (a) the objective and methodology of the performance study; and
p.000233: (b) the degree of deviation of the intervention from normal clinical practice.
p.000233: 3. All performance study information shall be recorded, processed, handled, and stored by
p.000233: the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and
p.000233: verified while the confiden tiality of records and the personal data of the subjects remain protected in
p.000233: accordance with the applicable law on personal data protection.
p.000233:
p.000233: 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data
p.000233: processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental
p.000233: loss, in particular where the processing involves transmission over a network.
p.000233:
p.000233: 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance
p.000233: studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
p.000233:
p.000234: L 117/234 EN
p.000234: Official Journal of the European Union
p.000234: 5.5.2017
p.000234:
p.000234: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification
p.000234: and, where necessary, an immediate recall of the devices used in the study.
p.000234:
p.000234:
p.000234: Article 69
p.000234:
p.000234: Electronic system on performance studies
p.000234:
p.000234: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000234: electronic system:
p.000234: (a) to create the single identification numbers for performance studies referred to in Article 66(1);
p.000234: (b) to be used as an entry point for the submission of all applications or notifications for performance studies
p.000234: referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
p.000234: (c) for the exchange of information relating to performance studies in accordance with this Regulation
p.000234: between the Member States and between them and the Commission including the exchange of information
p.000234: referred to in to Articles 72 and 74;
...
p.000245: including tasks and responsibilities of the coordinating competent authority and involvement of other competent
p.000245: authorities in this process.
p.000245:
p.000245: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000245: referred to in Article 107(3).
p.000245:
p.000245:
p.000245: Article 87
p.000245:
p.000245: Electronic system on vigilance and post-market surveillance
p.000245:
p.000245: 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to
p.000245: collate and process the following information:
p.000245: (a) reports by manufacturers on serious incidents and field safety corrective actions referred to in
p.000245: Article 82(1) and Article 84(5);
p.000245: (b) the periodic summary reports by manufacturers referred to in Article 82(9);
p.000245: (c) the reports by manufacturers on trends referred to in Article 83;
p.000245: (d) the PSURs referred to in Article 81;
p.000245: (e) the field safety notices by manufacturers referred to in Article 84(8);
p.000245: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000245: them and the Commission in accordance with Article 84(7) and (9).
p.000245: That electronic system shall include relevant links to the UDI database.
p.000245:
p.000245: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000245: system to the competent authorities of the Member States and to the Commission. The notified bodies shall also
p.000245: have access to that information to the extent that it relates to devices for which they issued a certificate in
p.000245: accordance with Article 49.
p.000245:
p.000245: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to
p.000245: the electronic system referred to in paragraph 1.
p.000245:
p.000245: 4. On the basis of arrangements between the Commission and competent authorities of third countries or internat
p.000245: ional organisations, the Commission may grant those competent authorities or international organisations access to the
p.000245: electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity
p.000245: and make provision for confidentiality and data protection equivalent to those applicable in the Union.
p.000245:
p.000246: L 117/246 EN
p.000246: Official Journal of the European Union
p.000246: 5.5.2017
p.000246:
p.000246: 5. The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted,
p.000246: upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the
p.000246: Member State in which the incident occurred.
p.000246:
p.000246: 6. The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt
p.000246: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000246: the Member States in which the incidents occurred.
p.000246:
p.000246: 7. The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall
p.000246: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000246: competent authorities of the following Member States:
p.000246: (a) the Member State in which the field safety corrective action is being or is to be undertaken;
p.000246: (b) the Member State in which the manufacturer has its registered place of business.
p.000246: 8. The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via
...
p.000246: 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon
p.000246: receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued
p.000246: the certificate for the device in question in accordance with Article 51.
p.000246:
p.000246: Section 3
p.000246: Market sur veillance
p.000246:
p.000246: Article 88
p.000246:
p.000246: Market surveillance activities
p.000246:
p.000246: 1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of
p.000246: devices including, where appropriate, a review of documentation and physical or laboratory checks on the
p.000246: basis of adequate samples. The competent authorities shall, in particular, take account of established
p.000246: principles regarding risk assessment and risk management, vigilance data and complaints.
p.000246:
p.000246: 2. The competent authorities shall draw up annual surveillance activity plans and allocate a
p.000246: sufficient number of material and competent human resources in order to carry out those activities taking into
p.000246: account the European market surveillance programme developed by the MDCG pursuant to Article 99 and local
p.000246: circumstances.
p.000246:
p.000246: 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
p.000246: (a) may require economic operators to, inter alia, make available the documentation and information necessary for
p.000246: the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of
p.000246: devices or access to devices free of charge; and
p.000246: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators,
p.000246: as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
p.000246:
p.000246: 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and
p.000246: make it accessible to other competent authorities by means of the electronic system referred to in Article 95.
p.000246:
p.000246: 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that
p.000246: present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the
p.000246: protection of public health.
p.000246:
p.000246: 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority
p.000246: shall draw up a report on the findings of the inspection that concern compliance with the legal and technical
p.000246: requirements applicable under this Regulation. The report shall set out any corrective actions needed.
p.000246:
p.000246: 5.5.2017 EN
p.000246: Official Journal of the European Union
p.000247: L 117/247
p.000247:
p.000247: 7. The competent authority which carried out the inspection shall communicate the content of the report referred
p.000247: to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting
...
p.000264:
p.000264: 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that
p.000264: are devices in themselves
p.000264:
p.000264: 16.1. Devices that incorporate electronic programmable systems, including software, or software that are
p.000264: devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000264: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as
p.000264: far as possible consequent risks or impairment of performance.
p.000264:
p.000264: 16.2. For devices that incorporate software or for software that are devices in themselves, the software
p.000264: shall be developed and manufactured in accordance with the state of the art taking into account the
p.000264: principles of development life cycle, risk management, including information security, verification and validation.
p.000264:
p.000264: 16.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms
p.000264: shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and
p.000264: contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of
p.000264: light or noise).
p.000264:
p.000264: 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and
p.000264: IT security measures, including protection against unauthorised access, necessary to run the software as intended.
p.000264:
p.000264: 17. Devices connected to or equipped with an energy source
p.000264:
p.000264: 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition,
p.000264: appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
p.000264:
p.000264: 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of
p.000264: determining the state of the power supply and an appropriate warning or indication for when the capacity of the power
p.000264: supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming
p.000264: critical.
p.000264:
p.000264: 17.3. Devices shall be designed and manufactured in such a way as to reduce as far as possible the
p.000264: risks of creating electromagnetic interference which could impair the operation of the device in question
p.000264: or other devices or equipment in the intended environment.
p.000264:
p.000264: 17.4. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electro
p.000264: magnetic interference such that is adequate to enable them to operate as intended.
p.000264:
p.000264: (1) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating
p.000264: to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).
p.000264:
p.000264: 5.5.2017 EN
p.000264: Official Journal of the European Union
p.000265: L 117/265
p.000265:
p.000265: 17.5. Devices shall be designed and manufactured in such a way as to avoid as far as possible the
p.000265: risk of accidental electric shocks to the user, or other person both during normal use of the device and in the event
p.000265: of a single fault condition in the device, provided the device is installed and maintained as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18. Protection against mechanical and thermal risks
p.000265:
p.000265: 18.1. Devices shall be designed and manufactured in such a way as to protect users and other persons
p.000265: against mechanical risks.
p.000265:
p.000265: 18.2. Devices shall be sufficiently stable under the foreseen operating conditions. They shall be
p.000265: suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the
p.000265: expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or
p.000265: leakage of substances, then appropriate protection means shall be incorporated.
p.000265:
p.000265: Any guards or other means included with the device to provide protection, in particular against moving
p.000265: parts, shall be secure and shall not interfere with access for the normal operation of the device, or
p.000265: restrict routine maintenance of the device as intended by the manufacturer.
p.000265:
p.000265: 18.4. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible
p.000265: level the risks arising from vibration generated by the devices, taking account of technical progress and of the
p.000265: means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified
p.000265: performance.
p.000265:
p.000265: 18.5. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible
p.000265: level the risks arising from the noise emitted, taking account of technical progress and of the means available to
p.000265: reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
p.000265:
p.000265: 18.6. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which
p.000265: the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible
p.000265: risks.
p.000265:
p.000265: 18.7. Errors likely to be made when fitting or refitting certain parts which could be a source of
p.000265: risk shall be made impossible by the design and construction of such parts or, failing this, by
p.000265: information given on the parts themselves and/or their housings.
p.000265:
p.000265: The same information shall be given on moving parts and/or their housings where the direction of
p.000265: movement needs to be known in order to avoid a risk.
p.000265:
...
p.000270:
p.000270: (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000270: its registered place of business at which he can be contacted and its location be established, together
p.000270: with a telephone number and/or fax number and/or website address to obtain technical assistance;
p.000270:
p.000270: 5.5.2017 EN
p.000270: Official Journal of the European Union
p.000271: L 117/271
p.000271:
p.000271: (ae) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000271: identifier of the latest revision of the instructions for use, with a clear indication of the introduced
p.000271: modifications;
p.000271:
p.000271: (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to
p.000271: the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
p.000271:
p.000271: (ag) where device kits include individual reagents and articles that may be made available as separate devices,
p.000271: each of these devices shall comply with the instructions for use requirements contained in this Section and with the
p.000271: requirements of this Regulation;
p.000271:
p.000271: (ah) for devices that incorporate electronic programmable systems, including software, or software that
p.000271: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000271: security measures, including protection against unauthorised access, necessary to run the software as
p.000271: intended.
p.000271:
p.000271: 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the
p.000271: following principles:
p.000271:
p.000271: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection
p.000271: and/or preparation and information on how to run the test and interpret the results;
p.000271:
p.000271: (b) specific particulars may be omitted provided that the other information supplied by the manufacturer
p.000271: is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
p.000271:
p.000271: (c) the device's intended purpose shall provide sufficient information to enable the user to understand
p.000271: the medical context and to allow the intended user to make a correct interpretation of the results;
p.000271: (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
p.000271: (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or
p.000271: indeterminate result), on the test limitations and on the possibility of false positive or false negative result.
p.000271: Information shall also be provided as to any factors that can affect the test result such as age,
p.000271: gender, menstruation, infection, exercise, fasting, diet or medication;
p.000271:
p.000271: (f) the information provided shall include a statement clearly directing that the user should not take
p.000271: any decision of medical relevance without first consulting the appropriate healthcare professional,
...
p.000282:
p.000282: THE UDI SYSTEM
p.000282:
p.000282: 1. Definitions
p.000282: Automatic identification and data capture (‘AIDC’)
p.000282:
p.000282: AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart
p.000282: cards, biometrics and RFID.
p.000282:
p.000282: Basic UDI-DI
p.000282:
p.000282: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of
p.000282: the device unit of use. It is the main key for records in the UDI database and is referenced in
p.000282: relevant certificates and EU declarations of conformity.
p.000282:
p.000282: Unit of Use DI
p.000282:
p.000282: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000282: UDI is not labelled on the individual device at the level of its unit of use, for example in the
p.000282: event of several units of the same device being packaged together.
p.000282:
p.000282: Configurable device
p.000282:
p.000282: A configurable device is a device that consists of several components which can be
p.000282: assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
p.000282:
p.000282: Configuration
p.000282:
p.000282: Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a
p.000282: device to achieve an intended purpose. The combination of items may be modified, adjusted or customised
p.000282: to meet specific needs.
p.000282:
p.000282: UDI-DI
p.000282:
p.000282: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the
p.000282: ‘access key’ to information stored in a UDI database.
p.000282:
p.000282: Human Readable Interpretation (HRI)
p.000282: HRI is a legible interpretation of the data characters encoded in the UDI carrier.
p.000282:
p.000282: Packaging levels
p.000282:
p.000282: Packaging levels means the various levels of device packaging that contain a fixed quantity of devices,
p.000282: such as a carton or case.
p.000282:
p.000282: Production Identifier (UDI-PI)
p.000282: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
p.000282:
p.000282: The different types of UDI-PI(s) include serial number, lot number, software identification and
p.000282: manufacturing or expiry date or both types of date.
p.000282:
p.000282: Radio Frequency Identification (‘RFID’)
p.000282:
p.000282: RFID is a technology that uses communication through the use of radio waves to exchange data between a
p.000282: reader and an electronic tag attached to an object, for the purpose of identification.
p.000282:
p.000282: Shipping containers
p.000282:
p.000282: A shipping container is a container in relation to which traceability is controlled by a process specific to logistics
p.000282: systems.
p.000282:
p.000282: 5.5.2017 EN
p.000282: Official Journal of the European Union
p.000283: L 117/283
p.000283:
p.000283: Unique Device Identifier (‘UDI’)
p.000283:
p.000283: The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted
p.000283: device identification and coding standard. It allows the unambiguous identification of a specific device
p.000283: on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
p.000283:
p.000283: The word ‘Unique’ does not imply serialisation of individual production units.
...
p.000283: following UDI database data elements shall require a new UDI-DI:
p.000283: (a) Name or trade name,
p.000283: (b) device version or model,
p.000283: (c) labelled as single use,
p.000283: (d) packaged sterile,
p.000283: (e) need for sterilization before use,
p.000283:
p.000284: L 117/284 EN
p.000284: Official Journal of the European Union
p.000284: 5.5.2017
p.000284:
p.000284: (f) quantity of devices provided in a package,
p.000284: (g) critical warnings or contra-indications.
p.000284: 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of
p.000284: the original device manufacturer's UDI.
p.000284:
p.000284: 4. UDI carrier
p.000284:
p.000284: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and
p.000284: on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000284:
p.000284: 4.2. In the event of there being significant space constraints on the unit of use packaging the
p.000284: UDI carrier may be placed on the next higher packaging level.
p.000284:
p.000284: 4.3. For single use class A and class B devices packaged and labelled individually, the UDI
p.000284: carrier shall not be required to appear on the packaging but it shall appear on a higher level of
p.000284: packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected
p.000284: to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI
p.000284: shall be placed on the packaging.
p.000284:
p.000284: 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be
p.000284: required to appear on the point of sale packaging.
p.000284:
p.000284: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000284: readily identifiable.
p.000284:
p.000284: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000284: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000284:
p.000284: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000284: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000284: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000284: results in there being no space for the AIDC.
p.000284:
p.000284: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000284:
p.000284: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000284: standard provided by the issuing entities shall also be provided on the label.
p.000284:
p.000284: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
...
p.000290:
p.000290: (i) corrective and preventive actions;
p.000290: (j) complaints and appeals;
p.000290: (k) continuous training.
p.000290:
p.000290: Where documents are used in various languages, the notified body shall ensure and control that they have
p.000290: the same content.
p.000290:
p.000290: 2.3. The top-level management of the notified body shall ensure that the quality management system is
p.000290: fully understood, implemented and maintained throughout the notified body organisation including subsidiaries
p.000290: and subcontractors involved in conformity assessment activities pursuant to this Regulation.
p.000290:
p.000290: 2.4. The notified body shall require all personnel to formally commit themselves by a signature or
p.000290: equivalent to comply with the procedures defined by the notified body. That commitment shall cover
p.000290: aspects relating to confidentiality and to independence from commercial and other interests, and any
p.000290: existing or prior association with clients. The personnel shall be required to complete written statements
p.000290: indicating their compliance with confidentiality, independence and impartiality principles.
p.000290:
p.000290: 3. RESOURCE REQUIREMENTS
p.000290:
p.000290: 3.1. General
p.000290:
p.000290: 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this
p.000290: Regulation with the highest degree of professional integrity and the requisite competence in the specific field,
p.000290: whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility.
p.000290:
p.000290: In particular, notified bodies shall have the necessary personnel and possess or have access to all
p.000290: equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks
p.000290: entailed in the conformity assessment activities in relation to which they have been designated.
p.000290: Such requirement presupposes at all times and for each conformity assessment procedure and each type of
p.000290: devices in relation to which they have been designated, that the notified body has permanent availability
p.000290: of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the
p.000290: relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure
p.000290: that the notified body in question can perform the conformity assessment tasks, including the assessment
p.000290: of the medical functionality, performance evaluations and the performance and safety of devices, for which
p.000290: it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex
p.000290: I.
p.000290:
p.000290: A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is
p.000290: designated. The notified body shall have sufficient internal competence to critically evaluate assessments
p.000290: conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set
p.000290: out in Section 4.1.
p.000290:
p.000290: Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices
p.000290: shall have appropriate knowledge to set up and operate a system for the selection of assessment and
...
p.000294: The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of
p.000294: each conformity assessment activity for which it is designated, comprising the individual steps from pre-
p.000294: application activities up to decision making and surveillance and taking into account, when necessary,
p.000294: the respective specificities of the devices.
p.000294:
p.000294: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of
p.000294: notified bodies and shall not be subcontracted.
p.000294: 4.2. Notified body quotations and pre-application activities The notified body shall
p.000294:
p.000294: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000294: obtain certification from it. That description shall include which languages are acceptable for submission
p.000294: of documentation and for any related correspondence;
p.000294:
p.000294: (b) have documented procedures relating to, and documented details about, fees charged for specific conformity
p.000294: assessment activities and any other financial conditions relating to notified bodies' assessment activities
p.000294: for devices;,
p.000294:
p.000294: 5.5.2017 EN
p.000294: Official Journal of the European Union
p.000295: L 117/295
p.000295:
p.000295: (c) have documented procedures in relation to advertising of its conformity assessment services.
p.000295: Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading
p.000295: to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier
p.000295: or less stringent than that of other notified bodies;
p.000295:
p.000295: (d) have documented procedures requiring the review of pre-application information including the
p.000295: preliminary verification that the product is covered by this Regulation and its classification prior to issuing any
p.000295: quotation to the manufacturer relating to a specific conformity assessment;
p.000295:
p.000295: (e) ensure that all contracts relating to the conformity assessment activities covered by this Regulation
p.000295: are concluded directly between the manufacturer and the notified body and not with any other organisation.
p.000295:
p.000295: 4.3. Application review and contract
p.000295:
p.000295: The notified body shall require a formal application signed by a manufacturer or an authorised
p.000295: representative containing all of the information and the manufacturer's declarations required by the
p.000295: relevant conformity assessment as referred to in Annexes IX to XI.
p.000295:
p.000295: The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both
p.000295: parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain
p.000295: obligations that enable the notified body to act as required under this Regulation, including an obligation on the
p.000295: manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or
p.000295: withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
p.000295:
p.000295: The notified body shall have documented procedures to review applications, addressing:
p.000295:
p.000295: (a) the completeness of those applications with respect to the requirements of the relevant
...
p.000301: checking the significance of the changes referred to in the first paragraph.
p.000301: In accordance with its documented procedures, the notified body in question shall:
p.000301: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first
p.000301: paragraph and relevant information relating to such changes,
p.000301:
p.000301: — assess the changes proposed and verify whether, after these changes, the quality management system, or the design
p.000301: of a device or type of a device, still meets the requirements of this Regulation,
p.000301:
p.000301: — notify the manufacturer of its decision and provide a report or, as applicable, a supplementary report, which shall
p.000301: contain the justified conclusions of its assessment.
p.000301: 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures:
p.000301: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include
p.000301: arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers
p.000301: carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and
p.000301: associated with certification decisions, such as updates to clinical data at defined intervals,
p.000301:
p.000301: — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of
p.000301: their designation. Such information shall be taken into account in the planning and conduct of surveillance activities,
p.000301:
p.000301: — to review vigilance data to which they have access under to Article 87 in order to estimate its impact, if any, on
p.000301: the validity of existing certificates. The results of the evaluation and any decisions taken shall be
p.000301: thoroughly documented.
p.000301:
p.000301: The notified body in question shall, upon receipt of information about vigilance cases from a
p.000301: manufacturer or competent authorities, decide on which of the following options to apply:
p.000301: — not to take action on the basis that the vigilance case is clearly not related to the certification granted,
p.000301: — observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investi
p.000301: gation so as to determine whether the certification granted is at risk or whether adequate corrective
p.000301: action has been taken,
p.000301:
p.000302: L 117/302 EN
p.000302: Official Journal of the European Union
p.000302: 5.5.2017
p.000302:
p.000302: — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and
p.000302: product testing, where it is likely that the certification granted is at risk,
p.000302: — increase the frequency of surveillance audits,
p.000302: — review specific products or processes on the occasion of the next audit of the manufacturer, or
p.000302: — take any other relevant measure.
p.000302: In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
p.000302:
p.000302: — conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned
p.000302: and conducted in line with the relevant requirements in Section 4.5.,
p.000302:
...
p.000307:
p.000307: — identification of applicable general safety and performance requirements and solutions to fulfil those
p.000307: requirements, taking applicable CS into account and, where opted for, harmonised standards,
p.000307:
p.000307: — risk management as referred to in Section 3 of Annex I,
p.000307:
p.000307: — the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding design and construction, including
p.000307: appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the
p.000307: device, in particular the requirements of Chapter III of Annex I,
p.000307:
p.000307: — the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant
p.000307: documents at every stage of manufacture, and
p.000307:
p.000307: — management of design or quality management system changes;
p.000307:
p.000307: (d) the verification and quality assurance techniques at the manufacturing stage and in particular the processes and
p.000307: procedures which are to be used, particularly as regards sterilisation, and the relevant documents, and
p.000307:
p.000307: (e) the appropriate tests and trials which are to be carried out before, during and after manufacture,
p.000307: the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back
p.000307: adequately the calibration of that test equipment.
p.000307:
p.000307: In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in
p.000307: Annexes II and III.
p.000307:
p.000308: L 117/308 EN
p.000308: Official Journal of the European Union
p.000308: 5.5.2017
p.000308:
p.000308: 2.3. Audit
p.000308:
p.000308: The notified body shall audit the quality management system to determine whether it meets the requirements referred
p.000308: to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related to a quality
p.000308: management system, the notified body shall assess conformity with those standards or CS. The notified
p.000308: body shall assume that a quality management system which satisfies the relevant harmonised standards or
p.000308: CS conforms to the requirements covered by those standards or CS, unless it duly substantiate not doing so.
p.000308:
p.000308: The audit team of the notified body shall include at least one member with past experience of assessments of the
p.000308: technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is
p.000308: not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of
p.000308: that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the
p.000308: premises of the manufacturer's suppliers and/or subcontractors to verify the manufac turing and other relevant
p.000308: processes.
p.000308:
p.000308: Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the
p.000308: assessment of the technical documentation for devices selected on a representative basis in accordance with provisions
...
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
p.000325: (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and
p.000325: procedures and timelines for reporting;
p.000325:
p.000325: (w) criteria and procedures for suspension or early termination of the clinical performance study;
p.000325:
p.000325: (x) criteria and procedures for follow up of subjects following completion of a performance study, procedures for
p.000325: follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have
p.000325: withdrawn their consent and procedures for subjects lost to follow up;
p.000325:
p.000325: (y) procedures for communication of test results outside the study, including communication of test results to the
p.000325: performance study subjects;
p.000325:
p.000325: (z) policy as regards the establishment of the clinical performance study report and publication of
p.000325: results in accordance with the legal requirements and the ethical principles referred to in Section 2.2;
p.000325:
...
p.000329:
p.000329: 4.2. Where applicable according to national law, a copy of the opinion or opinions of the ethics
p.000329: committee or committees concerned. Where under national law the opinion or opinions of the ethics
p.000329: committee or committees is not required at the time of the submission of the application, a copy of the opinion or
p.000329: opinions shall be submitted as soon as available.
p.000329:
p.000329: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article
p.000329: 65 and the corresponding national law.
p.000329:
p.000330: L 117/330 EN
p.000330: Official Journal of the European Union
p.000330: 5.5.2017
p.000330:
p.000330: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the
p.000330: informed consent document.
p.000330:
p.000330: 4.5 Description of the arrangements to comply with the applicable rules on the protection and
p.000330: confidentiality of personal data, in particular:
p.000330:
p.000330: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000330: dissemination, alteration or loss of information and personal data processed;
p.000330:
p.000330: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000330: subjects;
p.000330:
p.000330: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000330: possible adverse effects.
p.000330:
p.000330: 4.6. Full details of the available technical documentation, for example detailed risk analysis/management
p.000330: documen tation or specific test reports shall be submitted to the competent authority reviewing an
p.000330: application upon request.
p.000330:
p.000330: CHAPTER II
p.000330: OTHER OBLIGATIONS OF THE SPONSOR
p.000330:
p.000330: 1. The sponsor shall undertake to keep available for the competent national authorities any
p.000330: documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the
p.000330: sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance
p.000330: study, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000330:
p.000330: 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event
p.000330: as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
p.000330:
p.000330: 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10
p.000330: years after the clinical performance study with the device in question has ended, or, in the event that the device is
...
Searching for indicator access to information:
(return to top)
p.000180: devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to
p.000180: decide whether to restrict the use of any specific type of device in relation to aspects that are not
p.000180: covered by this Regulation.
p.000180:
p.000180:
p.000180: (38) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000180: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000180: activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and
p.000180: better monitoring by competent authorities. It should also help to reduce medical errors and to fight against
p.000180: falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and
p.000180: stock-management by health institutions and other economic operators and, where possible, be compatible with other
p.000180: authentication systems already in place in those settings.
p.000180:
p.000180:
p.000180: (39) The UDI system should apply to all devices placed on the market except devices for performance studies, and be
p.000180: based on internationally recognised principles including definitions that are compatible with those used by major trade
p.000180: partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed
p.000180: rules should be laid down in this Regulation and in Regulation (EU) 2017/745 of the European Parliament
p.000180: and of the Council (2).
p.000180:
p.000180:
p.000180: (40) Transparency and adequate access to information, appropriately presented for the intended user, are essential
p.000180: in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
p.000180: to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the
p.000180: regulatory system.
p.000180:
p.000180:
p.000180: (41) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on
p.000180: medical devices (Eudamed) that should integrate different electronic systems to collate and process information
p.000180: regarding devices on the market and the relevant economic operators, certain aspects of conformity
p.000180: assessment, notified bodies, certificates, performance studies, vigilance and market surveillance. The objectives of
p.000180: the database are to enhance overall transparency, including through better access to information for the public and
p.000180: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000180: States and to streamline and facilitate the flow of information between economic operators, notified
p.000180: bodies or sponsors and Member States as well as between Member States among themselves and with the
p.000180: Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should
p.000180: therefore further develop and manage the European databank on medical devices set up by
p.000180: Commission Decision 2010/227/EU (3).
p.000180:
p.000180:
p.000180: (42) To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature
p.000180: should be available free of charge to manufacturers and other natural or legal persons required by this
p.000180: Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably
p.000180: practicable, free of charge also to other stakeholders.
p.000180:
p.000180: (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.000180: (2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
p.000180: amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
p.000180: Directives 90/385/EEC and 93/42/EEC (see page 1 of this Official Journal).
p.000180: (3) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102,
p.000180: 23.4.2010, p. 45).
p.000180:
p.000180: 5.5.2017 EN
...
Social / Age
Searching for indicator age:
(return to top)
p.000229:
p.000229: (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study
p.000229: will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
p.000229: (a) the informed consent of their legally designated representative has been obtained;
p.000229:
p.000229: (b) the minors have received the information referred to in Article 59(2) in a way adapted to their
p.000229: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000229: experienced in working with children;
p.000229:
p.000229: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000229: referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is
p.000229: respected by the investigator;
p.000229:
p.000229: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000229: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000229: the performance study;
p.000229:
p.000229: (e) the performance study is intended to investigate treatments for a medical condition that only occurs in
p.000229: minors or the performance study is essential with respect to minors to validate data obtained in
p.000229: performance studies on persons able to give informed consent or by other research methods;
p.000229:
p.000229: (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is
p.000229: of such a nature that it can only be carried out on minors;
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the minor concerned when the performance study will pose only
p.000229: minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
...
p.000270: of applied reference materials and/or reference measurement procedures of higher order and information
p.000270: regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of
p.000270: measure;
p.000270:
p.000270: (v) assay procedure including calculations and interpretation of results and where relevant if any confirmatory
p.000270: testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding
p.000270: batch to batch variation provided with relevant figures and units of measure;
p.000270:
p.000270: (w) analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness
p.000270: (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision),
p.000270: limits of detection and measurement range, (information needed for the control of known relevant
p.000270: interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use
p.000270: of available reference measurement procedures and materials by the user;
p.000270: (x) clinical performance characteristics as defined in Section 9.1 of this Annex;
p.000270: (y) the mathematical approach upon which the calculation of the analytical result is made;
p.000270:
p.000270: (z) where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity
p.000270: and diagnostic specificity, positive and negative predictive value;
p.000270: (aa) where relevant, reference intervals in normal and affected populations;
p.000270:
p.000270: (ab) information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age
p.000270: of specimen) that may affect the performance of the device;
p.000270:
p.000270: (ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and
p.000270: the consumables used with it, if any. This information shall cover, where appropriate:
p.000270:
p.000270: (i) infection or microbial hazards, such as consumables contaminated with potentially infectious
p.000270: substances of human origin;
p.000270:
p.000270: (ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of
p.000270: radiation);
p.000270: (iii) physical hazards such as explosion.
p.000270:
p.000270: (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000270: its registered place of business at which he can be contacted and its location be established, together
p.000270: with a telephone number and/or fax number and/or website address to obtain technical assistance;
p.000270:
p.000270: 5.5.2017 EN
p.000270: Official Journal of the European Union
p.000271: L 117/271
p.000271:
p.000271: (ae) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000271: identifier of the latest revision of the instructions for use, with a clear indication of the introduced
p.000271: modifications;
p.000271:
p.000271: (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to
p.000271: the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
p.000271:
...
p.000271: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000271: security measures, including protection against unauthorised access, necessary to run the software as
p.000271: intended.
p.000271:
p.000271: 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the
p.000271: following principles:
p.000271:
p.000271: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection
p.000271: and/or preparation and information on how to run the test and interpret the results;
p.000271:
p.000271: (b) specific particulars may be omitted provided that the other information supplied by the manufacturer
p.000271: is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
p.000271:
p.000271: (c) the device's intended purpose shall provide sufficient information to enable the user to understand
p.000271: the medical context and to allow the intended user to make a correct interpretation of the results;
p.000271: (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
p.000271: (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or
p.000271: indeterminate result), on the test limitations and on the possibility of false positive or false negative result.
p.000271: Information shall also be provided as to any factors that can affect the test result such as age,
p.000271: gender, menstruation, infection, exercise, fasting, diet or medication;
p.000271:
p.000271: (f) the information provided shall include a statement clearly directing that the user should not take
p.000271: any decision of medical relevance without first consulting the appropriate healthcare professional,
p.000271: information on disease effects and prevalence, and, where available, information specific to the Member
p.000271: State(s) where the device is placed on the market on where a user can obtain further advice such as
p.000271: national helplines, websites;
p.000271:
p.000271: (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing
p.000271: disease or condition, the information shall specify that the patient should only adapt the treatment if he has
p.000271: received the appropriate training to do so.
p.000271:
p.000272: L 117/272 EN
p.000272: Official Journal of the European Union
p.000272: 5.5.2017
p.000272:
p.000272: ANNEX II
p.000272:
p.000272: TECHNICAL DOCUMENTATION
p.000272:
p.000272: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000272: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular
p.000272: the elements listed in this Annex.
p.000272:
p.000272: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000272: 1.1. Device description and specification
p.000272:
p.000272: (a) product or trade name and a general description of the device including its intended purpose and intended users;
...
Social / Child
Searching for indicator child:
(return to top)
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
...
Searching for indicator children:
(return to top)
p.000229: will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
p.000229: (a) the informed consent of their legally designated representative has been obtained;
p.000229:
p.000229: (b) the minors have received the information referred to in Article 59(2) in a way adapted to their
p.000229: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000229: experienced in working with children;
p.000229:
p.000229: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000229: referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is
p.000229: respected by the investigator;
p.000229:
p.000229: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000229: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000229: the performance study;
p.000229:
p.000229: (e) the performance study is intended to investigate treatments for a medical condition that only occurs in
p.000229: minors or the performance study is essential with respect to minors to validate data obtained in
p.000229: performance studies on persons able to give informed consent or by other research methods;
p.000229:
p.000229: (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is
p.000229: of such a nature that it can only be carried out on minors;
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the minor concerned when the performance study will pose only
...
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
...
p.000324: appropriate calibration procedures and means of control, the indication of any other devices, medical
p.000324: devices, medicinal product or other articles to be included or excluded and the specifications on any
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
p.000325: (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and
p.000325: procedures and timelines for reporting;
p.000325:
p.000325: (w) criteria and procedures for suspension or early termination of the clinical performance study;
p.000325:
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
...
p.000304: process of patient management.
p.000304:
p.000304: 2.2. Rule 2
p.000304:
p.000304: Devices intended to be used for blood grouping, or tissue typing to ensure the immunological
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
p.000305: (h) to be used in screening, diagnosis, or staging of cancer;
p.000305: (i) for human genetic testing;
p.000305: (j) for monitoring of levels of medicinal products, substances or biological components, when there is
p.000305: a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation
p.000305: for the patient or for the patient's offspring;
p.000305: (k) for management of patients suffering from a life-threatening disease or condition;
p.000305: (l) for screening for congenital disorders in the embryo or foetus;
p.000305: (m) for screening for congenital disorders in new-born babies where failure to detect and treat such
p.000305: disorders could lead to life-threatening situations or severe disabilities.
p.000305:
p.000305: 2.4. Rule 4
p.000305: (a) Devices intended for self-testing are classified as class C, except for devices for the detection of
p.000305: pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of
p.000305: glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B.
p.000305: (b) Devices intended for near-patient testing are classified in their own right.
p.000305:
p.000305: 2.5. Rule 5
p.000305: The following devices are classified as class A:
p.000305: (a) products for general laboratory use, accessories which possess no critical characteristics, buffer
p.000305: solutions, washing solutions, and general culture media and histological stains, intended by the
p.000305: manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;
p.000305: (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
p.000305: (c) specimen receptacles.
p.000305:
p.000305: 2.6. Rule 6
p.000305: Devices not covered by the above-mentioned classification rules are classified as class B.
p.000305:
p.000305: 2.7. Rule 7
p.000305: Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
p.000305:
p.000306: L 117/306 EN
p.000306: Official Journal of the European Union
p.000306: 5.5.2017
p.000306:
p.000306: ANNEX IX
p.000306:
...
Searching for indicator foetuses:
(return to top)
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
p.000230: condition, the subject is unable to provide prior informed consent and to receive prior information on the performance
p.000230: study;
p.000230:
p.000230: (b) there are scientific grounds to expect that participation of the subject in the performance study
p.000230: will have the potential to produce a direct clinically relevant benefit for the subject resulting in a
p.000230: measurable health-related improvement alleviating the suffering and/or improving the health of the subject,
p.000230: or in the diagnosis of its condition;
p.000230:
p.000230: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
...
Searching for indicator restricted:
(return to top)
p.000216: cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine
p.000216: months after cessation of the notified body's activities on condition that another notified body has
p.000216: confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new
p.000216: notified body shall complete a full assessment of the devices affected by the end of that period before issuing new
p.000216: certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified
p.000216: bodies shall withdraw the designation.
p.000216:
p.000216: 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer
p.000216: meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has
p.000216: not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or
p.000216: partially withdraw the designation, depending on the seriousness of the failure to meet those requirements
p.000216: or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same
p.000216: period.
p.000216:
p.000216: The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of
p.000216: any suspension, restriction or withdrawal of a designation.
p.000216:
p.000216: 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the
p.000216: notified body shall inform the manufacturers concerned at the latest within 10 days.
p.000216:
p.000216: 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified
p.000216: bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them
p.000216: available to authorities in other Member States responsible for notified bodies and to authorities responsible for
p.000216: market surveillance at their request.
p.000216:
p.000216: 7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified
p.000216: bodies shall:
p.000216:
p.000216: (a) assess the impact on the certificates issued by the notified body;
p.000216:
p.000216: (b) submit a report on its findings to the Commission and the other Member States within three months
p.000216: of having notified the changes to the designation;
p.000216:
p.000216: (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority,
p.000216: any certificates which were unduly issued to ensure the safety of devices on the market;
p.000216:
p.000216: (d) enter in the electronic system referred to in Article 52 information in relation to certificates of which it has
p.000216: required their suspension or withdrawal;
p.000216:
p.000216: (e) inform the competent authority for in vitro diagnostic medical devices of the Member State in
p.000216: which the manufacturer has its registered place of business through the electronic system referred to in
p.000216: Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall
p.000216: take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or
p.000216: others.
p.000216:
p.000216: 5.5.2017 EN
p.000216: Official Journal of the European Union
p.000217: L 117/217
p.000217:
p.000217: 8. With the exception of certificates unduly issued, and where a designation has been suspended or
p.000217: restricted, the certificates shall remain valid in the following circumstances:
p.000217:
p.000217: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction,
p.000217: that there is no safety issue in relation to certificates affected by the suspension or restriction and
p.000217: the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy
p.000217: the suspension or restriction; or
p.000217:
p.000217: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000217: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000217: whether the notified body has the capability of continuing to monitor, and remain responsible for, existing
p.000217: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000217: responsible for notified bodies determines that the notified body does not have the capability to support
p.000217: existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic
p.000217: medical devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000217: registered place of business, within three months of the suspension or restriction, a written confirmation that
p.000217: another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain
...
p.000249: proportionate to the non- compliance.
p.000249:
p.000249: 2. Where the economic operator does not bring the non-compliance to an end within the period
p.000249: referred to in paragraph 1 of this Article, the Member State concerned shall without delay take all appropriate
p.000249: measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or
p.000249: withdrawn from the market. That Member State shall inform the Commission and the other Member States
p.000249: without delay of those measures, by means of the electronic system referred to in Article 95.
p.000249:
p.000249: 3. In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts,
p.000249: specify appropriate measures to be taken by competent authorities to address given types of
p.000249: non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in
p.000249: Article 107(3).
p.000249:
p.000249:
p.000249: Article 93
p.000249:
p.000249: Preventive health protection measures
p.000249:
p.000249: 1. Where a Member State, after having performed an evaluation, which indicates a potential risk related to a
p.000249: device or a specific category or group of devices considers that, in order to protect the health and safety of
p.000249: patients, users or other persons or other aspects of public health, the making available on the market or
p.000249: putting into service of a device or a specific category or group of devices should be prohibited,
p.000249: restricted or made subject to particular requirements or that such device or category or group of
p.000249: devices should be withdrawn from the market or recalled, it may take any necessary and justified measures.
p.000249:
p.000249: 2. The Member State referred to in paragraph 1 shall immediately notify the Commission and all
p.000249: other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 95.
p.000249:
p.000249: 3. The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall
p.000249: assess the national measures taken. The Commission may decide, by means of implementing acts, whether the national
p.000249: measures are justified or not. In the absence of a Commission decision within six months of their
p.000249: notification, the national measures shall be considered to be justified. Those implementing acts shall be adopted in
p.000249: accordance with the examination procedure referred to in Article 107(3).
p.000249:
p.000249: 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making
p.000249: available on the market or putting into service of a device, specific category or group of devices should be
p.000249: prohibited, restricted or made subject to particular requirements or that such device or category or group of
p.000249: devices should be withdrawn from the market or recalled in all Member States in order to protect the health and
p.000249: safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing
p.000249: acts) to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance
p.000249: with the examination procedure referred to in Article 107(3).
p.000249:
p.000249:
p.000249: Article 94
p.000249:
p.000249: Good administrative practice
p.000249:
p.000249: 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state
p.000249: the exact grounds on which it is based. Where such a measure is addressed to a specific economic
p.000249: operator, the competent authority shall notify without delay the economic operator concerned of that measure, and
p.000249: shall at the same time inform that economic operator of the remedies available under the law or the
p.000249: administrative practice of the Member State concerned and of the time limits to which such remedies are subject.
p.000249: Where the measure is of general ap plicability, it shall be appropriately published.
p.000249:
p.000250: L 117/250 EN
p.000250: Official Journal of the European Union
p.000250: 5.5.2017
p.000250:
p.000250: 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human health
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000197: those requirements;
p.000197: (c) responsibility of the management;
p.000197: (d) resource management, including selection and control of suppliers and sub-contractors;
p.000197: (e) risk management as set out in Section 3 of Annex I;
p.000197: (f) performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF;
p.000197: (g) product realisation, including planning, design, development, production and service provision;
p.000197:
p.000197: (h) verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices
p.000197: and ensuring consistency and validity of information provided in accordance with Article 26;
p.000197: (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78;
p.000197:
p.000197: (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or
p.000197: other stakeholders;
p.000197: (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
p.000197: (l) management of corrective and preventive actions and verification of their effectiveness;
p.000197: (m) processes for monitoring and measurement of output, data analysis and product improvement.
p.000197:
p.000197: 9. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance
p.000197: with Article 78.
p.000197:
p.000197: 10. Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I
p.000197: in an official Union language(s) determined by the Member State in which the device is made available
p.000197: to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible
p.000197: to the intended user or patient.
p.000197:
p.000197: The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing
p.000197: shall be easily understandable and provided in the official Union language(s) determined by the Member State in which
p.000197: the device is made available to the user or patient.
p.000197:
p.000197: 11. Manufacturers that consider or have reason to believe that a device which they have placed on the market or
p.000197: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000197: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors
p.000197: of the device in question and, where applicable, the authorised representative and importers accordingly.
p.000197:
p.000197: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000197: of the Member States in which they made the device available and, where applicable, the notified body that issued a
p.000197: certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective
p.000197: action taken.
p.000197:
p.000198: L 117/198 EN
p.000198: Official Journal of the European Union
p.000198: 5.5.2017
p.000198:
p.000198: 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions
p.000198: as described in Articles 82 and 83.
p.000198:
p.000198: 13. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000198: and documen tation necessary to demonstrate the conformity of the device, in an official Union language determined by
p.000198: the Member State concerned. The competent authority of the Member State in which the manufacturer has its
p.000198: registered place of business may require that the manufacturer provide samples of the device free of charge or,
p.000198: where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent
p.000198: authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
...
p.000198: and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent
p.000198: authority, upon request.
p.000198:
p.000198: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000198: least the following tasks in relation to the devices that it covers:
p.000198: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and,
p.000198: where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
p.000198: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy
p.000198: of the relevant certificate, including any amendments and supplements, issued in accordance with Article
p.000198: 51, at the disposal of competent authorities for the period referred to in Article 10(7);
p.000198: (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied
p.000198: with the registration obligations laid down in Article 26;
p.000198:
p.000198: 5.5.2017 EN
p.000198: Official Journal of the European Union
p.000199: L 117/199
p.000199:
p.000199: (d) in response to a request from a competent authority, provide that competent authority with all the information and
p.000199: documentation necessary to demonstrate the conformity of a device, in an official Union language determined
p.000199: by the Member State concerned;
p.000199: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000199: resentative has its registered place of business for samples, or access to a device and verify that
p.000199: the competent authority receives the samples or is given access to the device;
p.000199: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is
p.000199: not possible, mitigate the risks posed by devices;
p.000199: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000199: patients and users about suspected incidents related to a device for which they have been designated;
p.000199: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000199: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid
p.000199: down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
p.000199:
p.000199: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000199: and has not complied with the obligations laid down in Article 10, the authorised representative shall be
p.000199: legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000199:
p.000199: 6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3
...
p.000203: distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall
p.000203: inform the manufacturer and the competent authority of the Member State in which they plan to make the device
p.000203: available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the
p.000203: manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device,
p.000203: including any translated label and instructions for use. Within the same period of 28 days, the
p.000203: distributor or importer shall submit to the competent authority a certificate, issued by a notified body
p.000203: designated for the type of devices that are subject to activities mentioned in points (a) and (b) of
p.000203: paragraph 2, attesting that the quality management system of the distributer or importer complies with the
p.000203: requirements laid down in paragraph 3.
p.000203:
p.000203:
p.000203: Article 17
p.000203:
p.000203: EU declaration of conformity
p.000203:
p.000203: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been
p.000203: fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of
p.000203: conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official
p.000203: Union language or languages required by the Member State(s) in which the device is made available.
p.000203:
p.000203: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000203: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000203: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in
p.000203: respect of all Union acts applicable to the device. The declaration shall contain all the information
p.000203: required for identification of the Union legislation to which the declaration relates.
p.000203:
p.000203: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000203: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000203:
p.000203: 4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the
p.000203: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000203:
p.000203:
p.000203: Article 18
p.000203:
p.000203: CE marking of conformity
p.000203:
p.000203: 1. Devices, other than devices for performance studies, considered to be in conformity with the requirements of
p.000203: this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000203:
p.000203: 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
p.000203:
...
p.000212: of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with
p.000212: regard to the draft designation, which the authority responsible for notified bodies shall duly take into
p.000212: consideration for its decision on the designation of the notified body.
p.000212:
p.000212: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000212: arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the
p.000212: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000212: accordance with the examination procedure referred to in Article 107(3).
p.000212:
p.000212:
p.000212: Article 36
p.000212:
p.000212: Nomination of experts for joint assessment of applications for notification
p.000212:
p.000212: 1. The Member States and the Commission shall nominate experts qualified in the assessment of
p.000212: conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the
p.000212: activities referred to in Articles 35 and 44.
p.000212:
p.000212: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article,
p.000212: together with information on their specific field of competence and expertise. That list shall be made available to
p.000212: Member States competent authorities through the electronic system referred to in Article 52.
p.000212:
p.000212:
p.000212: Article 37
p.000212:
p.000212: Language requirements
p.000212:
p.000212: All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which
p.000212: shall be determined by the Member State concerned.
p.000212:
p.000212: Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in
p.000212: the medical field, for all or part of the documentation concerned.
p.000212:
p.000212: The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an
p.000212: official Union language, such as is necessary for that documentation to be readily understood by the joint assessment
p.000212: team appointed in accordance with Article 35(3).
p.000212:
p.000212:
p.000212: Article 38
p.000212:
p.000212: Designation and notification procedure
p.000212:
p.000212: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35
p.000212: was completed and which comply with Annex VII.
p.000212:
p.000212: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000212: have designated, using the electronic notification tool within the database of notified bodies developed and managed by
p.000212: the Commission (NANDO).
p.000212:
p.000212: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope
p.000212: of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of
p.000212: devices which the notified body is authorised to assess and, without prejudice to Article 40, any
p.000212: conditions associated with the designation.
p.000212:
p.000212: 5.5.2017 EN
p.000212: Official Journal of the European Union
p.000213: L 117/213
p.000213:
p.000213: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000213: for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and
p.000213: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it
...
p.000221: a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical
p.000221: documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of
p.000221: devices.
p.000221:
p.000221: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000221: testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out
p.000221: in Section 5.1 of Annex IX.
p.000221:
p.000221: 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of
p.000221: their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical
p.000221: documen tation set out in Annexes II and III.
p.000221:
p.000221: However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures
p.000221: set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to
p.000221: establishing, securing and maintaining sterile conditions.
p.000221:
p.000221: 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.
p.000221:
p.000221: 12. The Member State in which the notified body is established may require that all or certain documents,
p.000221: including the technical documentation, audit, assessment and inspection reports, relating to the procedures
p.000221: referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State.
p.000221: In the absence of such requirement, those documents shall be available in any official Union language acceptable to the
p.000221: notified body.
p.000221:
p.000221: 13. The Commission may, by means of implementing acts, specify the detailed arrangements and procedural aspects
p.000221: with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies, for
p.000221: any of the following aspects:
p.000221:
p.000221: (a) the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as
p.000221: set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices;
p.000221:
p.000221: (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified
p.000221: bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
p.000221:
p.000221: (c) the frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU
p.000221: reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex
p.000221: XI; or
p.000221:
p.000221: (d) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests,
p.000221: assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and
p.000221: points
p.000221: (f) and (g) of Section 3. of Annex X.
p.000221:
p.000221: The implementing acts referred to in the first subparagraph shall be adopted in accordance with the
p.000221: examination procedure referred to in Article 107(3).
p.000221:
p.000221:
p.000221: Article 49
p.000221:
p.000221: Involvement of notified bodies in conformity assessment procedures
p.000221:
...
p.000222: shall take place through the electronic system referred to in Article 52 and shall include the
p.000222: instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to
p.000222: in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the
p.000222: scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and
p.000222: where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106
p.000222: of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a
p.000222: full justification shall also be included.
p.000222:
p.000222: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further
p.000222: procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in
p.000222: accordance with to Articles 90 and 92.
p.000222:
p.000222: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice
p.000222: from the expert panels in relation to the safety and performance of any device.
p.000222:
p.000222:
p.000222: Article 51
p.000222:
p.000222: Certificates of conformity
p.000222:
p.000222: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000222: Union language determined by the Member State in which the notified body is established or otherwise in an
p.000222: official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out
p.000222: in Annex XII.
p.000222:
p.000222: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application
p.000222: by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five
p.000222: years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any
p.000222: supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
p.000222:
p.000222: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or
p.000222: users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII.
p.000222:
p.000222: 4. Where a notified body finds that the requirements of this Regulation are no longer met by the
p.000222: manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the
p.000222: certificate issued or impose any restrictions on it unless compliance with such requirements is ensured
p.000222: by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the
p.000222: notified body. The notified body shall give the reasons for its decision.
p.000222:
p.000222: 5.5.2017 EN
p.000222: Official Journal of the European Union
p.000223: L 117/223
p.000223:
p.000223: 5. The notified body shall enter in the electronic system referred to in Article 52 any information
p.000223: regarding certificates issued, including amendments and supplements thereto, and regarding suspended,
...
p.000243: referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member
p.000243: State that authorised the medicinal products or the EMA was consulted by the notified body in accordance
p.000243: with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent
p.000243: authority or the EMA, as appropriate.
p.000243:
p.000243: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating
p.000243: competent authority shall, through the electronic system referred to in Article 87, inform without delay
p.000243: the other competent authorities of the corrective action taken or envisaged by the manufacturer or
p.000243: required of it to minimise the risk of recurrence of the serious incident, including information on the
p.000243: underlying serious incidents and the outcome of its assessment.
p.000243:
p.000244: L 117/244 EN
p.000244: Official Journal of the European Union
p.000244: 5.5.2017
p.000244:
p.000244: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000244: brought without delay to the attention of users of the device in question by means of a field safety notice. The field
p.000244: safety notice shall be edited in an official Union language or languages determined by the Member State in which the
p.000244: field safety corrective action is taken. Except in cases of urgency, the content of the draft field
p.000244: safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph
p.000244: 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of
p.000244: the individual Member State, the content of the field safety notice shall be consistent in all Member States.
p.000244:
p.000244: The field safety notice shall allow the correct identification of the device or devices involved, in particular by
p.000244: including the relevant UDIs, and the correct identification, in particular by including the SRN, if
p.000244: already issued, of the manufacturer that has undertaken the field safety corrective action. The field
p.000244: safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for
p.000244: the field safety corrective action with reference to the device malfunction and associated risks for patients,
p.000244: users or other persons and shall clearly indicate all the actions to be taken by users.
p.000244:
p.000244: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which
p.000244: that notice shall be accessible to the public.
p.000244:
p.000244: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
p.000244: referred to in paragraph 3 in the following cases:
p.000244:
...
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p.000178: standardisation,
p.000178: amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
p.000178: 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council
p.000178: and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council
p.000178: (OJ L 316, 14.11.2012, p. 12).
p.000178: (3) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the
p.000178: requirements for accredita
p.000178: tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218,
p.000178: 13.8.2008, p. 30).
p.000178: (4) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
p.000178: marketing of
p.000178: products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
p.000178:
p.000178: 5.5.2017 EN
p.000178: Official Journal of the European Union
p.000179: L 117/179
p.000179:
p.000179: (27) Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were
p.000179: set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions
p.000179: of this Regulation to facilitate its application.
p.000179:
p.000179:
p.000179: (28) To ensure the highest level of health protection, the rules governing in vitro diagnostic
p.000179: medical devices, manufactured and used within a single health institution only, should be clarified and
p.000179: strengthened. That use should be understood to include measurement and delivery of results.
p.000179:
p.000179:
p.000179: (29) Health institutions should have the possibility of manufacturing, modifying and using devices
p.000179: in-house and thereby addressing, on a non-industrial scale, the specific needs of target patient groups which cannot
p.000179: be met at the appropriate level of performance by an equivalent device available on the market. In that
p.000179: context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used
p.000179: only within health institutions, including hospitals as well as institutions, such as laboratories and public health
p.000179: institutes that support the health care system and/or address patient needs, but which do not treat or care for
p.000179: patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
p.000179: It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue
p.000179: health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result,
p.000179: the exemption applicable to health institutions does not apply to such establishments.
p.000179:
p.000179:
p.000179: (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective
p.000179: device in accordance with applicable Union and national law, it is appropriate to require manufacturers
p.000179: to have measures in place to provide sufficient financial coverage in respect of their potential
...
p.000180: Commission Decision 2010/227/EU (3).
p.000180:
p.000180:
p.000180: (42) To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature
p.000180: should be available free of charge to manufacturers and other natural or legal persons required by this
p.000180: Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably
p.000180: practicable, free of charge also to other stakeholders.
p.000180:
p.000180: (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.000180: (2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
p.000180: amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
p.000180: Directives 90/385/EEC and 93/42/EEC (see page 1 of this Official Journal).
p.000180: (3) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102,
p.000180: 23.4.2010, p. 45).
p.000180:
p.000180: 5.5.2017 EN
p.000180: Official Journal of the European Union
p.000181: L 117/181
p.000181:
p.000181: (43) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and
p.000181: certificates should enable the public to be adequately informed about devices on the Union market. The electronic
p.000181: system on performance studies should serve as a tool for the cooperation between Member States and for enabling
p.000181: sponsors to submit, on a voluntary basis, a single application for several Member States and to report
p.000181: serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable
p.000181: manufacturers to report serious incidents and other reportable events and to support the coordination of the
p.000181: evaluation of such incidents and events by competent authorities. The electronic system regarding market
p.000181: surveillance should be a tool for the exchange of information between competent authorities.
p.000181:
p.000181: (44) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
p.000181: European Parliament and of the Council (1) applies to the processing of personal data carried out in the Member States,
p.000181: under the supervision of the Member States' competent authorities, in particular the public independent authorities
p.000181: designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (2) applies
p.000181: to the processing of personal data carried out by the Commission within the framework of this
p.000181: Regulation, under the supervision of the European Data Protection Supervisor. In accordance with
p.000181: Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its
p.000181: electronic systems.
p.000181:
p.000181: (45) For class C and D devices, manufacturers should summarise the main safety and performance
p.000181: aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.
p.000181:
...
p.000183: set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that
p.000183: context, Member States should ensure the involvement of laypersons, in particular patients or patients'
p.000183: organisations. They should also ensure that the necessary expertise is available.
p.000183:
p.000183:
p.000183: (68) An electronic system should be set up at Union level to ensure that every interventional
p.000183: clinical performance study and other performance study involving risks for the subjects of the studies is
p.000183: recorded and reported in a publicly accessible database. To protect the right to protection of personal data,
p.000183: recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data
p.000183: of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with
p.000183: the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable
p.000183: with the EU database to be set up for clinical trials on medicinal products for human use.
p.000183:
p.000183:
p.000183: (69) Where an interventional clinical performance study or another performance study involving risks for the
p.000183: subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a
p.000183: single application in order to reduce administrative burden. In order to allow for resource-sharing and
p.000183: to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance
p.000183: study and of the scientific design of that performance study, the procedure for the assessment of such single
p.000183: application should be coordinated between the Member States under the direction of a coordinating Member
p.000183: State. Such coordinated assessment should not include the assessment of intrinsically national, local and
p.000183: ethical aspects of a performance study, including informed consent. For an initial period of seven years from the
p.000183: date of application of this Regulation, Member States should be able to participate on a voluntary basis
p.000183: in the coordinated assessment. After that period, all Member States should be obliged to participate in the
p.000183: coordinated assessment. The Commission, based on the experience gained from the voluntary coordination
p.000183: between Member States, should draw up a report on the application of the relevant provisions regarding
p.000183: the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission
p.000183: should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment
p.000183: procedure.
p.000183:
p.000183:
p.000183: (70) Sponsors should report certain adverse events and device deficiencies that occur during
p.000183: interventional clinical performance studies and other performance studies involving risks for the subjects
p.000183: to the Member States in which those studies are being conducted. Member States should have the possibility of
p.000183: terminating or suspending the studies or revoking the authorisation for those studies, if considered
p.000183: necessary to ensure a high level of protection of the subjects participating in such studies. Such information
...
p.000188: the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s);
p.000188:
p.000188: (5) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including
p.000188: devices used for testing services offered to lay persons by means of information society services;
p.000188:
p.000188: (6) ‘device for near-patient testing’ means any device that is not intended for self-testing but is
p.000188: intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a
p.000188: health professional;
p.000188:
p.000188: (7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a
p.000188: corresponding medicinal product to:
p.000188:
p.000188: (a) identify, before and/or during treatment, patients who are most likely to benefit from the
p.000188: corresponding medicinal product; or
p.000188:
p.000188: (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse
p.000188: reactions as a result of treatment with the corresponding medicinal product;
p.000188:
p.000188: (8) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of
p.000188: technology allowing them to be classified in a generic manner not reflecting specific characteristics;
p.000188:
p.000188: 5.5.2017 EN
p.000188: Official Journal of the European Union
p.000189: L 117/189
p.000189:
p.000189: (9) ‘single-use device’ means a device that is intended to be used during a single procedure;
p.000189:
p.000189: (10) ‘falsified device’ means any device with a false presentation of its identity and/or of its source
p.000189: and/or its CE marking certificates or documents relating to CE marking procedures. This definition does
p.000189: not include uninten tional non-compliance and is without prejudice to infringements of intellectual property rights;
p.000189:
p.000189: (11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in
p.000189: vitro
p.000189: diagnostic examination, or a part thereof;
p.000189:
p.000189: (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied
p.000189: by the manufacturer on the label, in the instructions for use or in promotional or sales materials or
p.000189: statements or as specified by the manufacturer in the performance evaluation;
p.000189:
p.000189: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the
p.000189: packaging of each unit or on the packaging of multiple devices;
p.000189:
p.000189: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000189: intended purpose and proper use and of any precautions to be taken;
p.000189:
p.000189: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through
p.000189: in ternationally accepted device identification and coding standards and that allows unambiguous
p.000189: identification of specific devices on the market;
p.000189:
...
p.000203: manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device,
p.000203: including any translated label and instructions for use. Within the same period of 28 days, the
p.000203: distributor or importer shall submit to the competent authority a certificate, issued by a notified body
p.000203: designated for the type of devices that are subject to activities mentioned in points (a) and (b) of
p.000203: paragraph 2, attesting that the quality management system of the distributer or importer complies with the
p.000203: requirements laid down in paragraph 3.
p.000203:
p.000203:
p.000203: Article 17
p.000203:
p.000203: EU declaration of conformity
p.000203:
p.000203: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been
p.000203: fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of
p.000203: conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official
p.000203: Union language or languages required by the Member State(s) in which the device is made available.
p.000203:
p.000203: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000203: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000203: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in
p.000203: respect of all Union acts applicable to the device. The declaration shall contain all the information
p.000203: required for identification of the Union legislation to which the declaration relates.
p.000203:
p.000203: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000203: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000203:
p.000203: 4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the
p.000203: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000203:
p.000203:
p.000203: Article 18
p.000203:
p.000203: CE marking of conformity
p.000203:
p.000203: 1. Devices, other than devices for performance studies, considered to be in conformity with the requirements of
p.000203: this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000203:
p.000203: 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
p.000203:
p.000203: 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile
p.000203: packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE
p.000203: marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any
p.000203: sales packaging.
p.000203:
p.000204: L 117/204 EN
...
p.000207: provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to
p.000207: that device.
p.000207:
p.000207: 2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and
p.000207: (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article
p.000207: 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the
p.000207: manufacturer applies to a notified body for that assessment.
p.000207:
p.000207: For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI
p.000207: on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in
p.000207: Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the
p.000207: relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to
p.000207: the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
p.000207:
p.000207: 3. Before placing a device on the market, the manufacturer shall enter or, if already provided, verify in Eudamed
p.000207: the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2
p.000207: thereof, and thereafter shall keep the information updated.
p.000207:
p.000207:
p.000207: Article 27
p.000207:
p.000207: Electronic system for registration of economic operators
p.000207:
p.000207: 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to
p.000207: create the single registration number referred to in Article 28(2) and to collate and process information
p.000207: that is necessary and propor tionate to identify the manufacturer and, where applicable, the authorised
p.000207: representative and the importer. The details regarding the information to be provided to that electronic system by
p.000207: the economic operators are laid down in Section 1 of Part A of Annex VI.
p.000207:
p.000207: 2. Member States may maintain or introduce national provisions on registration of distributors of devices which
p.000207: have been made available on their territory.
p.000207:
p.000207: 3. Within two weeks of placing a device on the market, importers shall verify that the manufacturer or
p.000207: authorised representative has provided to the electronic system the information referred to in paragraph 1.
p.000207:
p.000207: Where applicable, importers shall inform the relevant authorised representative or manufacturer if the
p.000207: information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the
p.000207: relevant entry/entries.
p.000207:
p.000207:
p.000207: Article 28
p.000207:
p.000207: Registration of manufacturers, authorised representatives and importers
p.000207:
p.000207: 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order
p.000207: to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part
p.000207: A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the
p.000207: conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information
p.000207: referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000207: notified body.
p.000207:
p.000207: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000207: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and
p.000207: issue it to the manufacturer, the authorised representative or the importer.
p.000207:
p.000207: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing
p.000207: Eudamed in order to fulfil its obligations under Article 26.
p.000207:
p.000207: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000207: Article, the economic operator shall update the data in the electronic system referred to in Article 27.
p.000207:
p.000208: L 117/208 EN
p.000208: Official Journal of the European Union
p.000208: 5.5.2017
p.000208:
p.000208: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000208: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure
p.000208: to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its
p.000208: territory until that economic operator complies with that obligation.
p.000208:
p.000208: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify
p.000208: the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000208:
p.000208: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27
p.000208: shall be accessible to the public.
p.000208:
...
p.000213: 10. When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in
p.000213: Article 52 the information relating to the notification of the notified body along with the documents
p.000213: mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this
p.000213: Article.
p.000213:
p.000213: 11. The designation shall become valid the day after the notification is published in NANDO. The
p.000213: published notification shall state the scope of lawful conformity assessment activity of the notified body.
p.000213:
p.000213: 12. The conformity assessment body concerned may perform the activities of a notified body only
p.000213: after the designation has become valid in accordance with paragraph 11.
p.000213:
p.000213: 13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000213: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000213: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000213: referred to in Article 107(3). The Commission, after consulting the MDCG, may update this list based,
p.000213: inter alia, on information arising from the coordination activities described in Article 44.
p.000213:
p.000213:
p.000213: Article 39
p.000213:
p.000213: Identification number and list of notified bodies
p.000213:
p.000213: 1. The Commission shall assign an identification number to each notified body for which the notification
p.000213: becomes valid in accordance with Article 38(11). It shall assign a single identification number even when
p.000213: the body is notified under several Union acts. If they are successfully designated in accordance with this
p.000213: Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them
p.000213: pursuant to that Directive.
p.000213:
p.000213: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000213: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000213: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000213: It shall also make this list available on the electronic system referred to in Article 52. The Commission shall
p.000213: ensure that the list is kept up to date.
p.000213:
p.000214: L 117/214 EN
p.000214: Official Journal of the European Union
p.000214: 5.5.2017
p.000214:
p.000214: Article 40
p.000214:
p.000214:
p.000214: Monitoring and re-assessment of notified bodies
p.000214:
p.000214:
p.000214: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for
p.000214: notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or
p.000214: their ability to conduct the conformity assessment activities relating to the devices for which they have been
p.000214: designated.
p.000214:
p.000214: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their
...
p.000223: information supplied by the manufacturer, including any promotional material;
p.000223: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000223: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000223: the incoming notified body;
p.000223: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000223: 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date
p.000223: on which they become invalid.
p.000223:
p.000223: Article 54
p.000223:
p.000223: Derogation from the conformity assessment procedures
p.000223:
p.000223: 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified
p.000223: request, the placing on the market or putting into service, within the territory of the Member State concerned, of a
p.000223: specific device for which the procedures referred to in that Article have not been carried out but use
p.000223: of which is in the interest of public health or patient safety or health.
p.000223:
p.000224: L 117/224 EN
p.000224: Official Journal of the European Union
p.000224: 5.5.2017
p.000224:
p.000224: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000224: authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such
p.000224: authorisation is granted for use other than for a single patient.
p.000224:
p.000224: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating
p.000224: to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of
p.000224: time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the
p.000224: territory of the Union and set the conditions under which the device may be placed on the market or
p.000224: put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to
p.000224: in Article 107(3).
p.000224:
p.000224: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000224: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
p.000224: Article 107(4).
p.000224:
p.000224:
p.000224: Article 55
p.000224:
p.000224: Certificate of free sale
p.000224:
p.000224: 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State
p.000224: in which the manufacturer or the authorised representative has its registered place of business shall issue a
p.000224: certificate of free sale declaring that the manufacturer or the authorised representative, as applicable,
p.000224: has its registered place of business on its territory and that the device in question bearing the CE-marking in
p.000224: accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic
p.000224: UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate
...
p.000227:
p.000227: (a) enable the subject or his or her legally designated representative to understand:
p.000227:
p.000227: (i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study;
p.000227:
p.000227: (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her
p.000227: right to refuse to participate in and the right to withdraw from the performance study at any time
p.000227: without any resulting detriment and without having to provide any justification;
p.000227:
p.000228: L 117/228 EN
p.000228: Official Journal of the European Union
p.000228: 5.5.2017
p.000228:
p.000228: (iii) the conditions under which the performance study is to be conducted, including the expected duration of the
p.000228: subject's participation in the performance study; and
p.000228:
p.000228: (iv) the possible treatment alternatives, including the follow-up measures if the participation of the
p.000228: subject in the performance study is discontinued;
p.000228:
p.000228: (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her
p.000228: legally designated representative;
p.000228:
p.000228: (c) be provided in a prior interview with a member of the investigating team who is appropriately
p.000228: qualified under national law; and
p.000228:
p.000228: (d) include information about the applicable damage compensation system referred to in Article 65;
p.000228:
p.000228: (e) include the Union-wide unique single identification number for the performance study referred to in Article
p.000228: 66(1) and information about the availability of the performance study results in accordance with paragraph
p.000228: 6 of this Article.
p.000228:
p.000228: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or,
p.000228: where the subject is not able to give informed consent, his or her legally designated representative.
p.000228:
p.000228: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information
p.000228: needs of specific patient populations and of individual subjects, as well as to the methods used to give the
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
p.000228: by the legally designated representative, a minor who is capable of forming an opinion and assessing the information
...
p.000231: consent, he or she shall be informed of the right to object to the use of data obtained from the performance study.
p.000231:
p.000231:
p.000231: Article 65
p.000231:
p.000231: Damage compensation
p.000231:
p.000231: 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from
p.000231: par ticipation in a performance study conducted on their territory are in place in the form of
p.000231: insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate
p.000231: to the nature and the extent of the risk.
p.000231:
p.000231: 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form
p.000231: appropriate for the Member State in which the performance study is conducted.
p.000231:
p.000231:
p.000231: Article 66
p.000231:
p.000231: Application for performance studies
p.000231:
p.000231: 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application
p.000231: to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article
p.000231: as ‘Member State concerned’) accompanied by the documentation referred to in Sections 2 and 3 of Annex
p.000231: XIII and in Annex XIV.
p.000231:
p.000231: The application shall be submitted by means of the electronic system referred to in Article 69, which
p.000231: shall generate a Union-wide unique single identification number for the performance study which shall be
p.000231: used for all relevant communication in relation to that performance study. Within 10 days of receiving
p.000231: the application, the Member State concerned shall notify the sponsor as to whether the performance study falls
p.000231: within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I
p.000231: of Annex XIV.
p.000231:
p.000231: 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV,
p.000231: the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to
p.000231: the documentation clearly identifiable. The Member State concerned shall be notified of the update by
p.000231: means of that electronic system.
p.000231:
p.000232: L 117/232 EN
p.000232: Official Journal of the European Union
p.000232: 5.5.2017
p.000232:
p.000232: 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of
p.000232: this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit
p.000232: of maximum 10 days for the sponsor to comment or to complete the application by means of the
p.000232: electronic system referred to in Article 69. The Member State concerned may extend this period by a
p.000232: maximum of 20 days where appropriate.
p.000232:
p.000232: Where the sponsor has not provided comments nor completed the application within the time limit referred to in the
p.000232: first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the
...
p.000233: verified while the confiden tiality of records and the personal data of the subjects remain protected in
p.000233: accordance with the applicable law on personal data protection.
p.000233:
p.000233: 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data
p.000233: processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental
p.000233: loss, in particular where the processing involves transmission over a network.
p.000233:
p.000233: 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance
p.000233: studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
p.000233:
p.000234: L 117/234 EN
p.000234: Official Journal of the European Union
p.000234: 5.5.2017
p.000234:
p.000234: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification
p.000234: and, where necessary, an immediate recall of the devices used in the study.
p.000234:
p.000234:
p.000234: Article 69
p.000234:
p.000234: Electronic system on performance studies
p.000234:
p.000234: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000234: electronic system:
p.000234: (a) to create the single identification numbers for performance studies referred to in Article 66(1);
p.000234: (b) to be used as an entry point for the submission of all applications or notifications for performance studies
p.000234: referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
p.000234: (c) for the exchange of information relating to performance studies in accordance with this Regulation
p.000234: between the Member States and between them and the Commission including the exchange of information
p.000234: referred to in to Articles 72 and 74;
p.000234: (d) for information to be provided by the sponsor in accordance with Article 73, including the
p.000234: performance study report and its summary as required in paragraph 5 of that Article;
p.000234: (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76.
p.000234: 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure
p.000234: that it is interoperable with the EU database for clinical trials on medicinal products for human use
p.000234: set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of
p.000234: the Council (1) as concerns performance studies of companion diagnostics.
p.000234:
p.000234: 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member
p.000234: States and the Commission. The information referred to in the other points of that paragraph shall be accessible to
p.000234: the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the
p.000234: following grounds:
...
p.000236: study are going to be available, together with a justification.
p.000236:
p.000236: 6. The Commission shall issue guidelines regarding the content and structure of the summary of the
p.000236: performance study report.
p.000236:
p.000236: In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases
p.000236: where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt,
p.000236: where possible, existing guidelines for sharing of raw data in the field of performance studies.
p.000236:
p.000236: 7. The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly
p.000236: accessible through the electronic system referred to in Article 69, at the latest when the device is
p.000236: registered in accordance with Article 26 and before it is placed on the market. In cases of early termination or
p.000236: temporary halt, the summary and the report shall become publicly accessible immediately after submission.
p.000236:
p.000236: If the device is not registered in accordance with Article 26 within one year of the summary and the performance study
p.000236: report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become
p.000236: publicly accessible at that point in time.
p.000236:
p.000236:
p.000236: Article 74
p.000236:
p.000236: Coordinated assessment procedure for performance studies
p.000236:
p.000236: 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted
p.000236: in more than one Member State may submit, for the purpose of Article 66, a single application that, upon
p.000236: receipt, is transmitted electronically to all Member States in which the performance study is to be conducted.
p.000236:
p.000236: 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States
p.000236: in which the performance study is to be conducted acts as coordinating Member State. The Member States in
p.000236: which the performance study is to be conducted shall, within six days of submission of the application,
p.000236: agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating
p.000236: Member State, the coordinating Member State proposed by the sponsor shall assume that role.
p.000236:
p.000236: 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States
p.000236: concerned shall coordinate their assessment of the application, in particular of the documentation referred
p.000236: to in Chapter I of Annex XIV.
p.000236:
p.000236: However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of
p.000236: Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed
p.000236: separately by each Member State concerned in accordance with Article 66(1) to (5).
p.000236:
p.000236: 5.5.2017 EN
p.000236: Official Journal of the European Union
p.000237: L 117/237
p.000237:
p.000237: 4. With regard to documentation other than that referred to in the second subparagraph of paragraph
p.000237: 3, the coordinating Member State shall:
p.000237:
p.000237: (a) within six days of receipt of the single application, notify the sponsor that it is the
p.000237: coordinating Member State (‘notification date’);
p.000237:
p.000237: (b) for the purpose of the validation of the application, take into account any considerations submitted
p.000237: within seven days of the notification date by any Member State concerned;
p.000237:
p.000237: (c) within 10 days of the notification date, assess whether the performance study falls within the
p.000237: scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article
p.000237: 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
p.000237:
p.000237: (d) establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the
p.000237: validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned
p.000237: shall transmit their comments and proposals on the draft assessment report and the underlying application
p.000237: to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of
p.000237: the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and
p.000237: the other Member States concerned.
p.000237:
p.000237: The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's
p.000237: application in accordance with Article 66(7).
p.000237:
p.000237: 5. As regards the assessment of the documentation referred to in the second subparagraph of
p.000237: paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor.
p.000237: The sponsor shall submit the requested additional information within the period set by the Member State
p.000237: concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last deadline pursuant
p.000237: to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional
p.000237: information has been received.
p.000237:
p.000237: 6. For class C and D devices, the coordinating Member State may also extend the periods referred to in paragraph 4
p.000237: by a further 50 days, for the purpose of consulting with experts.
p.000237:
p.000237: 7. The Commission may, by means of implementing acts, further specify the procedures and timescales
p.000237: for coordinated assessments to be taken into account by Member States concerned when deciding on the
p.000237: sponsor's application. Such implementing acts may also set out the procedures and timescales for coordinated assessment
p.000237: in the case of substantial modifications pursuant to paragraph 12 of this Article and in the case of reporting of
p.000237: adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where
p.000237: the medicinal products are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No
p.000237: 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000237: 107(3).
p.000237:
p.000237: 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the
p.000237: conduct of the performance study is acceptable or acceptable subject to compliance with specific
...
p.000237: electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the
p.000237: sponsor.
p.000237:
p.000237: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the
p.000237: performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member
p.000237: States concerned.
p.000237:
p.000238: L 117/238 EN
p.000238: Official Journal of the European Union
p.000238: 5.5.2017
p.000238:
p.000238: 10. A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of
p.000238: the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or
p.000238: if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of
p.000238: Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation
p.000238: to that performance study which is valid in accordance with national law for that entire Member State. That Member
p.000238: State shall provide for an appeal procedure in respect of such refusal.
p.000238:
p.000238: 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69
p.000238: as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether
p.000238: authorisation has been refused. Notification shall be done by way of one single decision within five days of the
p.000238: transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final
p.000238: assessment report. Where an authorisation of a performance study is subject to conditions, those conditions may only be
p.000238: such that, by their nature, they cannot be fulfilled at the time of that authorisation.
p.000238:
p.000238: 12. Any substantial modifications as referred to in Article 71 shall be notified to the Member States
p.000238: concerned by means of the electronic system referred to in Article 69. Any assessment as to whether
p.000238: there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this
p.000238: Article shall be carried out under the direction of the coordinating Member State, except for substantial
p.000238: modifications concerning sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of
p.000238: Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned.
p.000238:
p.000238: 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of
p.000238: its tasks under this Chapter.
p.000238:
p.000238: 14. The procedure set out in this Article shall, until 27 May 2029, be applied only by those of the Member States
p.000238: in which the performance studies are to be conducted which have agreed to apply it. After 27 May 2029,
p.000238: all Member States shall be required to apply that procedure.
p.000238:
p.000238:
p.000238: Article 75
p.000238:
p.000238: Review of the coordinated assessment procedure
p.000238:
p.000238: By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on
...
p.000238: of the following by means of the electronic system referred to in Article 69:
p.000238: (a) any serious adverse event that has a causal relationship with the device, the comparator or the study procedure
p.000238: or where such causal relationship is reasonably possible;
p.000238: (b) any device deficiency that might have led to a serious adverse event if appropriate action had not
p.000238: been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000238: (c) any new findings in relation to any event referred to in points (a) and (b).
p.000238:
p.000238: 5.5.2017 EN
p.000238: Official Journal of the European Union
p.000239: L 117/239
p.000239:
p.000239: The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting,
p.000239: the sponsor may submit an initial report that is incomplete followed up by a complete report.
p.000239:
p.000239: Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide
p.000239: all information referred to in paragraph 1.
p.000239:
p.000239: 3. The sponsor shall also report to the Member States in which the performance study is being conducted any event
p.000239: referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is
p.000239: performed under the same clinical performance study plan as the one applying to a performance study covered by this
p.000239: Regulation by means of the electronic system referred to in Article 69.
p.000239:
p.000239: 4. In the case of a performance study for which the sponsor has used the single application referred to in Article
p.000239: 74, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the
p.000239: electronic system referred to in Article 69. Upon receipt, this report shall be transmitted electronically to all
p.000239: Member States in which the performance study is being conducted.
p.000239:
p.000239: Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate
p.000239: their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate
p.000239: the performance study or whether to revoke the authorisation for that performance study.
p.000239:
p.000239: This paragraph shall not affect the rights of the other Member States to perform their own evaluation
p.000239: and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and
p.000239: patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such
p.000239: evaluation and the adoption of any such measures.
p.000239:
p.000239: 5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82
p.000239: to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article.
p.000239:
p.000239: 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the
p.000239: serious adverse event and the preceding performance study has been established.
p.000239:
p.000239:
p.000239: Article 77
p.000239:
p.000239: Implementing acts
p.000239:
p.000239: The Commission may, by means of implementing acts, establish the detailed arrangements and procedural
...
p.000241:
p.000242: L 117/242 EN
p.000242: Official Journal of the European Union
p.000242: 5.5.2017
p.000242:
p.000242: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is
p.000242: incomplete followed up by a complete report.
p.000242:
p.000242: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about
p.000242: whether the incident is reportable, it shall nevertheless submit a report within the timeframe required
p.000242: in accordance with paragraphs 2 to 5.
p.000242:
p.000242: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000242: immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in
p.000242: point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
p.000242:
p.000242: 9. For similar serious incidents that occur with the same device or device type and for which the root cause has
p.000242: been identified or a field safety corrective action implemented or where the incidents are common and well documented,
p.000242: the manufacturer may provide periodic summary reports instead of individual serious incident reports, on
p.000242: condition that the coordinating competent authority referred to in Article 84(9), in consultation with the
p.000242: competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the
p.000242: manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent
p.000242: authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary
p.000242: reports following agreement with that competent authority.
p.000242:
p.000242: 10. The Member States shall take appropriate measures such as organising targeted information
p.000242: campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent
p.000242: authorities suspected serious incidents referred to in point (a) of paragraph 1.
p.000242:
p.000242: The competent authorities shall record centrally at national level reports they receive from healthcare
p.000242: professionals, users and patients.
p.000242:
p.000242: 11. Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to
p.000242: in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to
p.000242: ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
p.000242:
p.000242: Where the manufacturer of the device concerned considers that the incident is a serious incident, it
p.000242: shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent
p.000242: authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action
p.000242: in accordance with Article 84.
p.000242:
p.000242: Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be
...
p.000263: and where appropriate ergonomic features;
p.000263:
p.000263: (b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic
p.000263: fields, external electrical and electromagnetic effects, electrostatic discharge, radiation
p.000263: associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and
p.000263: acceleration or radio signal interferences;
p.000263:
p.000263: (c) the risks associated with the use of the device when it comes into contact with materials,
p.000263: liquids, and substances, including gases, to which it is exposed during normal conditions of use;
p.000263:
p.000263: (d) the risks associated with the possible negative interaction between software and the IT environment
p.000263: within which it operates and interacts;
p.000263: (e) the risks of accidental ingress of substances into the device;
p.000263:
p.000263: (f) the risk of incorrect identification of specimens and the risk of erroneous results due to, for
p.000263: example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts
p.000263: and/or accessories used with devices in order to perform the test or assay as intended;
p.000263: (g) the risks of any foreseeable interference with other devices.
p.000263:
p.000263: 13.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or
p.000263: explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended
p.000263: use of which includes exposure to or use in association with flammable or explosive substances or
p.000263: substances which could cause combustion.
p.000263:
p.000263: 13.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be
p.000263: done safely and effectively.
p.000263:
p.000263: 13.5. Devices that are intended to be operated together with other devices or products shall be
p.000263: designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
p.000263:
p.000263: 13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe
p.000263: disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test
p.000263: procedures and measures as a result of which their devices can be safely disposed after use. Such
p.000263: procedures shall be described in the instructions for use.
p.000263:
p.000263: 13.7 The measuring, monitoring or display scale (including colour change and other visual indicators) shall be
p.000263: designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the
p.000263: en vironmental conditions in which the devices are intended to be used.
p.000263:
p.000263: 14. Devices with a measuring function
p.000263:
p.000263: 14.1. Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to
p.000263: provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I,
p.000263: taking into account the intended purpose of the device.
p.000263:
p.000264: L 117/264 EN
...
p.000264: radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible
p.000264: with the intended purpose, whilst not restricting the application of appropriate specified levels for
p.000264: diagnostic purposes.
p.000264:
p.000264: 15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing
p.000264: radiation, they shall as far as possible be:
p.000264:
p.000264: (a) designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation
p.000264: emitted can be controlled and/or adjusted; and
p.000264: (b) fitted with visual displays and/or audible warnings of such emissions.
p.000264: 15.3. The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain
p.000264: detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of
p.000264: avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information
p.000264: regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure
p.000264: shall also be specified.
p.000264:
p.000264: 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that
p.000264: are devices in themselves
p.000264:
p.000264: 16.1. Devices that incorporate electronic programmable systems, including software, or software that are
p.000264: devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their
p.000264: intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as
p.000264: far as possible consequent risks or impairment of performance.
p.000264:
p.000264: 16.2. For devices that incorporate software or for software that are devices in themselves, the software
p.000264: shall be developed and manufactured in accordance with the state of the art taking into account the
p.000264: principles of development life cycle, risk management, including information security, verification and validation.
p.000264:
p.000264: 16.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms
p.000264: shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and
p.000264: contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of
p.000264: light or noise).
p.000264:
p.000264: 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and
p.000264: IT security measures, including protection against unauthorised access, necessary to run the software as intended.
p.000264:
p.000264: 17. Devices connected to or equipped with an energy source
p.000264:
p.000264: 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition,
p.000264: appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
p.000264:
p.000264: 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of
p.000264: determining the state of the power supply and an appropriate warning or indication for when the capacity of the power
p.000264: supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming
p.000264: critical.
p.000264:
p.000264: 17.3. Devices shall be designed and manufactured in such a way as to reduce as far as possible the
p.000264: risks of creating electromagnetic interference which could impair the operation of the device in question
p.000264: or other devices or equipment in the intended environment.
p.000264:
p.000264: 17.4. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electro
p.000264: magnetic interference such that is adequate to enable them to operate as intended.
p.000264:
p.000264: (1) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating
p.000264: to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).
p.000264:
p.000264: 5.5.2017 EN
p.000264: Official Journal of the European Union
p.000265: L 117/265
p.000265:
p.000265: 17.5. Devices shall be designed and manufactured in such a way as to avoid as far as possible the
p.000265: risk of accidental electric shocks to the user, or other person both during normal use of the device and in the event
p.000265: of a single fault condition in the device, provided the device is installed and maintained as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18. Protection against mechanical and thermal risks
p.000265:
p.000265: 18.1. Devices shall be designed and manufactured in such a way as to protect users and other persons
p.000265: against mechanical risks.
p.000265:
p.000265: 18.2. Devices shall be sufficiently stable under the foreseen operating conditions. They shall be
p.000265: suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the
p.000265: expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or
p.000265: leakage of substances, then appropriate protection means shall be incorporated.
p.000265:
p.000265: Any guards or other means included with the device to provide protection, in particular against moving
p.000265: parts, shall be secure and shall not interfere with access for the normal operation of the device, or
p.000265: restrict routine maintenance of the device as intended by the manufacturer.
p.000265:
p.000265: 18.4. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible
p.000265: level the risks arising from vibration generated by the devices, taking account of technical progress and of the
...
p.000266: into account the following:
p.000266:
p.000266: (a) The medium, format, content, legibility, and location of the label and instructions for use shall
p.000266: be appropriate to the particular device, its intended purpose and the technical knowledge, experience,
p.000266: education or training of the intended user(s). In particular, instructions for use shall be written in
p.000266: terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
p.000266:
p.000266: (b) The information required on the label shall be provided on the device itself. If this is not
p.000266: practicable or appropriate, some or all of the information may appear on the packaging for each unit.
p.000266: If individual full labelling of each unit is not practicable, the information shall be set out on the
p.000266: packaging of multiple devices.
p.000266:
p.000266: (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable
p.000266: information, such as radio-frequency identification or bar codes.
p.000266:
p.000266: (d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases
p.000266: instructions for use shall not be required or may be abbreviated if the device can be used safely and
p.000266: as intended by the manufacturer without any such instructions for use.
p.000266:
p.000266: (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient
p.000266: testing, are supplied to a single user and/or location, a single copy of the instructions for use may
p.000266: be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
p.000266:
p.000266: (f) When the device is intended for professional use only, instructions for use may be provided to the user in
p.000266: non-paper format (e.g. electronic), except when the device is intended for near-patient testing.
p.000266:
p.000266: (g) Residual risks which are required to be communicated to the user and/or other person shall be included as
p.000266: limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000266:
p.000266: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000266: internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used
p.000266: shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols
p.000266: and colours shall be described in the documentation supplied with the device.
p.000266:
p.000266: (i) In the case of devices containing a substance or a mixture which may be considered as being
p.000266: dangerous, taking account of the nature and quantity of its constituents and the form under which they
p.000266: are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where
p.000266: there is insufficient space to put all the information on the device itself or on its label, the relevant hazard
p.000266: pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given
...
p.000267: degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that
p.000267: order;
p.000267:
p.000267: (i) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of
p.000267: manufacture may be included as part of the lot number or serial number, provided the date is clearly
p.000267: identifiable;
p.000267:
p.000267: (j) where relevant, an indication of the net quantity of contents, expressed in terms of weight or
p.000267: volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the
p.000267: package;
p.000267:
p.000267: (k) an indication of any special storage and/or handling condition that applies;
p.000267:
p.000267: (l) where appropriate, an indication of the sterile state of the device and the sterilisation method,
p.000267: or a statement indicating any special microbial state or state of cleanliness;
p.000267:
p.000267: (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device
p.000267: or to any other person. This information may be kept to a minimum in which case more detailed information shall
p.000267: appear in the instructions for use, taking into account the intended users;
p.000267:
p.000267: (n) if the instructions for use are not provided in paper form in accordance with point (f) of
p.000267: Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where
p.000267: they can be consulted;
p.000267:
p.000267: (o) where applicable, any particular operating instructions;
p.000267:
p.000267: (p) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use
p.000267: shall be consistent across the Union;
p.000267:
p.000267: (q) if the device is intended for self-testing or near-patient testing, an indication of that fact;
p.000267: (r) where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof;
p.000267:
p.000267: (s) where device kits include individual reagents and articles that are made available as separate devices, each of
p.000267: those devices shall comply with the labelling requirements contained in this Section and with the
p.000267: requirements of this Regulation;
p.000267:
p.000267: (t) the devices and separate components shall be identified, where applicable in terms of batches, to allow all
p.000267: appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable
p.000267: and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales
p.000267: packaging;
p.000267:
p.000268: L 117/268 EN
p.000268: Official Journal of the European Union
p.000268: 5.5.2017
p.000268:
p.000268: (u) the label for devices for self-testing shall bear the following particulars:
p.000268: (i) the type of specimen(s) required to perform the test (e.g. blood, urine or saliva);
p.000268: (ii) the need for additional materials for the test to function properly;
p.000268: (iii) contact details for further advice and assistance.
p.000268: The name of devices for self-testing shall not reflect an intended purpose other than that specified by the
p.000268: manufacturer.
p.000268: 20.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’):
p.000268:
...
p.000269:
p.000269: (m) if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and
p.000269: instructions in the event of the sterile packaging being damaged before use;
p.000269:
p.000269: (n) information that allows the user to be informed of any warnings, precautions, measures to be taken and
p.000269: limitations of use regarding the device. That information shall cover, where appropriate:
p.000269:
p.000269: (i) warnings, precautions and/or measures to be taken in the event of malfunction of the device or
p.000269: its degradation as suggested by changes in its appearance that may affect performance,
p.000269:
p.000269: (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external
p.000269: influences or environmental conditions, such as magnetic fields, external electrical and electro magnetic effects,
p.000269: electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or
p.000269: temperature,
p.000269:
p.000269: (iii) warnings, precautions and/or measures to be taken as regards the risks of interference posed by
p.000269: the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations,
p.000269: therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other
p.000269: equipment,
p.000269:
p.000269: (iv) precautions related to materials incorporated into the device that contain or consist of CMR
p.000269: substances, or endocrine disrupting substances or that could result in sensitisation or an allergic
p.000269: reaction by the patient or user,
p.000269:
p.000269: (v) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use
p.000269: shall be consistent across the Union,
p.000269:
p.000269: (vi) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning,
p.000269: disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterili sation.
p.000269: Information shall be provided to identify when the device should no longer be reused, such as signs of material
p.000269: degradation or the maximum number of allowable reuses;
p.000269:
p.000270: L 117/270 EN
p.000270: Official Journal of the European Union
p.000270: 5.5.2017
p.000270:
p.000270: (o) any warnings and/or precautions related to potentially infectious material that is included in the device;
p.000270:
p.000270: (p) where relevant, requirements for special facilities, such as a clean room environment, or special
p.000270: training, such as on radiation safety, or particular qualifications of the intended user;
p.000270: (q) conditions for collection, handling, and preparation of the specimen;
p.000270:
p.000270: (r) details of any preparatory treatment or handling of the device before it is ready for use, such as
p.000270: sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer;
p.000270:
p.000270: (s) the information needed to verify whether the device is properly installed and is ready to perform safely and as
p.000270: intended by the manufacturer, together with, where relevant:
p.000270:
p.000270: — details of the nature, and frequency, of preventive and regular maintenance, including cleaning and
p.000270: disinfection;
p.000270: — identification of any consumable components and how to replace them;
p.000270:
...
p.000272: of relevant components such as antibodies, antigens, nucleic acid primers;
p.000272: and where applicable:
p.000272: (h) the description of the specimen collection and transport materials provided with the device or descriptions of
p.000272: specifications recommended for use;
p.000272: (i) for instruments of automated assays: the description of the appropriate assay characteristics or
p.000272: dedicated assays;
p.000272: (j) for automated assays: a description of the appropriate instrumentation characteristics or dedicated instru
p.000272: mentation;
p.000272: (k) a description of any software to be used with the device;
p.000272: (l) a description or complete list of the various configurations/variants of the device that are intended to be
p.000272: made available on the market;
p.000272: (m) a description of the accessories for a device, other devices and other products that are not devices, which are
p.000272: intended to be used in combination with the device.
p.000272:
p.000272: 5.5.2017 EN
p.000272: Official Journal of the European Union
p.000273: L 117/273
p.000273:
p.000273: 1.2. Reference to previous and similar generations of the device
p.000273:
p.000273: (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such
p.000273: devices exist;
p.000273: (b) an overview of identified similar devices available on the Union or international markets, where
p.000273: such devices exist.
p.000273:
p.000273: 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
p.000273:
p.000273: A complete set of
p.000273: (a) the label or labels on the device and on its packaging, such as single unit packaging, sales
p.000273: packaging, transport packaging in the case of specific management conditions, in the languages accepted in
p.000273: the Member States where the device is envisaged to be sold;
p.000273: (b) the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
p.000273:
p.000273: 3. DESIGN AND MANUFACTURING INFORMATION
p.000273:
p.000273: 3.1. Design information
p.000273:
p.000273: Information to allow the design stages applied to the device to be understood shall include:
p.000273: (a) a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid
p.000273: primers provided or recommended for use with the device;
p.000273: (b) for instruments, a description of major subsystems, analytical technology such as operating principles and
p.000273: control mechanisms, dedicated computer hardware and software;
p.000273: (c) for instruments and software, an overview of the entire system;
p.000273: (d) for software, a description of the data interpretation methodology, namely the algorithm;
p.000273: (e) for devices intended for self-testing or near-patient testing, a description of the design aspects
p.000273: that make them suitable for self-testing or near-patient testing.
p.000273:
p.000273: 3.2. Manufacturing information
p.000273:
p.000273: (a) information to allow the manufacturing processes such as production, assembly, final product testing, and
p.000273: packaging of the finished device to be understood. More detailed information shall be provided for the
p.000273: audit of the quality management system or other applicable conformity assessment procedures;
p.000273: (b) identification of all sites, including suppliers and sub-contractors, where manufacturing activities
p.000273: are performed.
...
p.000280: 1.2. name, address and contact details of the economic operator,
p.000280:
p.000280: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000280: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000280:
p.000280: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000280: referred to in Article 15,
p.000280:
p.000280: 2. Information relating to the device
p.000280:
p.000280: 2.1. Basic UDI-DI,
p.000280:
p.000280: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000280: identification number of that notified body and the link to the information that appears on the
p.000280: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000280: 2.3. Member State in which the device shall or has been placed on the market in the Union,
p.000280: 2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made
p.000280: available,
p.000280: 2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n),
p.000280: 2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No
p.000280: 722/2012(y/n),
p.000280: 2.7. presence of cells or substances of microbial origin (y/n),
p.000280: 2.8. risk class of the device,
p.000280: 2.9. where applicable, the single identification number of the performance study,
p.000280:
p.000280: 2.10. in the case of devices designed and manufactured by another legal or natural person
p.000280: as referred in Article 10(14), the name, address and contact details of that legal or natural person,
p.000280: 2.11. in the case of class C or D devices, the summary of safety and performance,
p.000280:
p.000280: 2.12. status of the device (on the market, no longer placed on the market, recalled, field safety
p.000280: corrective Action initiated),
p.000280: 2.13. indication as to whether the device is a ‘new’ device. A device shall be considered to be ‘new’ if:
p.000280: (a) there has been no such device continuously available on the Union market during the previous three
p.000280: years for the relevant analyte or other parameter;
p.000280:
p.000280: 5.5.2017 EN
p.000280: Official Journal of the European Union
p.000281: L 117/281
p.000281:
p.000281: (b) the procedure involves analytical technology not continuously used in connection with a given analyte
p.000281: or other parameter on the Union market during the previous three years.
p.000281:
p.000281: 2.14. indication as to whether the device is intended for self-testing or near-patient testing.
p.000281:
p.000281:
p.000281: PART B
p.000281:
p.000281:
p.000281: CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH
p.000281: ARTICLES 25 AND 26
p.000281:
p.000281:
p.000281: The manufacturer shall provide to the UDI database the UDI-DI and the following information
p.000281: relating to the manufacturer and the device:
p.000281:
p.000281: 1. quantity per package configuration,
p.000281:
p.000281: 2. the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs,
p.000281:
p.000281: 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot
p.000281: number, serial number),
p.000281:
p.000281: 4. if applicable, the ‘unit of use’ UDI-DI (where a UDI is not labelled on the device at the level
p.000281: of its ‘unit of use’, a ‘unit of use’ UDI-DI shall be assigned so as to associate the use of a device with a
p.000281: patient),
p.000281:
p.000281: 5. name and address of the manufacturer, as indicated on the label,
p.000281:
p.000281: 6. the SRN issued in accordance with Article 28(2),
p.000281:
p.000281: 7. if applicable, name and address of the authorised representative (as indicated on the label),
p.000281:
p.000281: 8. the medical device nomenclature code as provided for in Article 23,
p.000281:
p.000281: 9. risk class of the device,
p.000281:
p.000281: 10. if applicable, name or trade name,
p.000281:
p.000281: 11. if applicable, device model, reference, or catalogue number,
p.000281:
p.000281: 12. additional product description (optional),
p.000281:
p.000281: 13. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
p.000281:
p.000281: 14. if applicable, additional trade names of the device,
p.000281:
p.000281: 15. labelled as a single use device (y/n),
p.000281:
p.000281: 16. if applicable, the maximum number of reuses,
p.000281:
p.000281: 17. device labelled sterile (y/n),
p.000281:
p.000281: 18. need for sterilisation before use (y/n),
p.000281:
p.000281: 19. URL for additional information, such as electronic instructions for use (optional),
p.000281:
p.000281: 20. if applicable, critical warnings or contra-indications,
p.000281:
p.000281: 21. status of the device (on the market, no longer placed on the market, recalled, field safety action initiated).
p.000281:
p.000282: L 117/282 EN
p.000282: Official Journal of the European Union
p.000282: 5.5.2017
p.000282:
p.000282: PART C
p.000282:
p.000282: THE UDI SYSTEM
p.000282:
p.000282: 1. Definitions
p.000282: Automatic identification and data capture (‘AIDC’)
p.000282:
p.000282: AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart
p.000282: cards, biometrics and RFID.
p.000282:
p.000282: Basic UDI-DI
p.000282:
p.000282: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of
p.000282: the device unit of use. It is the main key for records in the UDI database and is referenced in
p.000282: relevant certificates and EU declarations of conformity.
p.000282:
p.000282: Unit of Use DI
p.000282:
p.000282: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000282: UDI is not labelled on the individual device at the level of its unit of use, for example in the
p.000282: event of several units of the same device being packaged together.
p.000282:
p.000282: Configurable device
p.000282:
...
p.000283: UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or
p.000283: to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
p.000283:
p.000283: 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.
p.000283:
p.000283: 3.4. The UDI-DI shall be unique at each level of device packaging.
p.000283:
p.000283: 3.5. If a lot number, serial number, software identification or expiry date appears on the label,
p.000283: it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need
p.000283: to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the
p.000283: UDI-PI.
p.000283:
p.000283: 3.6. Each component that is considered to be a device and is commercially available on its own
p.000283: shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own
p.000283: UDI.
p.000283:
p.000283: 3.7. Kits shall be assigned and bear their own UDI.
p.000283:
p.000283: 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.
p.000283:
p.000283: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to
p.000283: misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the
p.000283: following UDI database data elements shall require a new UDI-DI:
p.000283: (a) Name or trade name,
p.000283: (b) device version or model,
p.000283: (c) labelled as single use,
p.000283: (d) packaged sterile,
p.000283: (e) need for sterilization before use,
p.000283:
p.000284: L 117/284 EN
p.000284: Official Journal of the European Union
p.000284: 5.5.2017
p.000284:
p.000284: (f) quantity of devices provided in a package,
p.000284: (g) critical warnings or contra-indications.
p.000284: 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of
p.000284: the original device manufacturer's UDI.
p.000284:
p.000284: 4. UDI carrier
p.000284:
p.000284: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and
p.000284: on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000284:
p.000284: 4.2. In the event of there being significant space constraints on the unit of use packaging the
p.000284: UDI carrier may be placed on the next higher packaging level.
p.000284:
p.000284: 4.3. For single use class A and class B devices packaged and labelled individually, the UDI
p.000284: carrier shall not be required to appear on the packaging but it shall appear on a higher level of
p.000284: packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected
p.000284: to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI
p.000284: shall be placed on the packaging.
p.000284:
p.000284: 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be
p.000284: required to appear on the point of sale packaging.
p.000284:
p.000284: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000284: readily identifiable.
p.000284:
p.000284: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000284: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000284:
p.000284: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000284: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000284: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000284: results in there being no space for the AIDC.
p.000284:
p.000284: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000284:
p.000284: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000284: standard provided by the issuing entities shall also be provided on the label.
p.000284:
p.000284: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000284: reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent
p.000284: and readable after each process performed to make the device ready for the subsequent use throughout the
p.000284: intended lifetime of the device.
p.000284:
p.000284: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000284:
p.000284: 4.12. If the UDI carrier is readily readable or scannable through the device's packaging, the placing
p.000284: of the UDI carrier on the packaging shall not be required.
p.000284:
p.000284: 4.13. In the case of single finished devices made up of multiple parts that must be assembled
p.000284: before first use, it shall be sufficient to place the UDI carrier on only one part of each device.
p.000284:
p.000284: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal
p.000284: operation or storage.
p.000284:
p.000284: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for
p.000284: the device to operate or other data.
p.000284:
p.000284: 5. General principles of the UDI database
p.000284:
p.000284: 5.1. The UDI database shall support the use of all core UDI database data elements referred to in
p.000284: Part B of this Annex.
p.000284:
p.000284: 5.5.2017 EN
p.000284: Official Journal of the European Union
p.000285: L 117/285
p.000285:
p.000285: 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying
p.000285: information and other device data elements in the UDI database.
p.000285:
p.000285: 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.
p.000285:
p.000285: 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices
p.000285: they have placed on the market, except for devices that are no longer available on the market.
p.000285:
p.000285: 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the
p.000285: device is in conformity with this Regulation.
p.000285:
p.000285: 5.6. The database shall allow for the linking of all the packaging levels of the device.
p.000285:
...
p.000323:
p.000324: L 117/324 EN
p.000324: Official Journal of the European Union
p.000324: 5.5.2017
p.000324:
p.000324: diagnostic testing. This information is used to demonstrate compliance with the relevant general safety
p.000324: and performance requirements with respect to clinical performance. When clinical performance
p.000324: studies are conducted, the data obtained shall be used in the performance evaluation process and be
p.000324: part of the clinical evidence for the device.
p.000324:
p.000324:
p.000324: 2.2. Ethical considerations for clinical performance studies
p.000324:
p.000324: Each step in the clinical performance study, from the initial consideration of the need for and justification of the
p.000324: study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
p.000324:
p.000324:
p.000324: 2.3. Methods for clinical performance studies
p.000324:
p.000324: 2.3.1. Clinical performance study design type
p.000324:
p.000324: Clinical performance studies shall be designed in such a way as to maximize the relevance of the data
p.000324: while minimising potential bias.
p.000324:
p.000324:
p.000324: 2.3.2. Clinical performance study plan
p.000324:
p.000324: Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP).
p.000324:
p.000324: The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and
p.000324: record-keeping of the clinical performance study. It shall contain in particular the following information:
p.000324:
p.000324: (a) the single identification number of the clinical performance study, as referred to in Article 66(1);
p.000324:
p.000324: (b) identification of the sponsor, including the name, address of the registered place of business and
p.000324: contact details of the sponsor and, if applicable, the name, address of the registered place of business and contact
p.000324: details of its contact person or legal representative pursuant to Article 58(4) established in the Union;
p.000324:
p.000324: (c) information on the investigator or investigators, namely principal, coordinating or other investigator; qualifi
p.000324: cations; contact details, and investigation site or sites, such as number, qualification, contact details and, in the
p.000324: case of devices for self-testing, the location and number of lay persons involved;
p.000324:
p.000324: (d) the starting date and scheduled duration for the clinical performance study;
p.000324:
p.000324: (e) identification and description of the device, its intended purpose, the analyte or analytes or
p.000324: marker or markers, the metrological traceability, and the manufacturer;
p.000324:
p.000324: (f) information about the type of specimens under investigation;
p.000324:
p.000324: (g) overall synopsis of the clinical performance study, its design type, such as observational,
p.000324: interventional, together with the objectives and hypotheses of the study, reference to the current state
p.000324: of the art in diagnosis and/or medicine;
p.000324:
p.000324: (h) a description of the expected risks and benefits of the device and of the clinical performance study in the
p.000324: context of the state of the art in clinical practice, and with the exception of studies using left-over samples, the
...
p.000327: and documented within the performance evaluation report.
p.000327:
p.000328: L 117/328 EN
p.000328: Official Journal of the European Union
p.000328: 5.5.2017
p.000328:
p.000328: ANNEX XIV
p.000328:
p.000328: INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
p.000328:
p.000328: CHAPTER I
p.000328:
p.000328: DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE
p.000328: STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
p.000328:
p.000328: For devices intended to be used in the context of interventional clinical performance studies or other
p.000328: performance studies involving risks for the subjects of the studies, the sponsor shall draw up and
p.000328: submit the application in accordance with Article 58 accompanied by the following documents:
p.000328:
p.000328: 1. Application form
p.000328:
p.000328: The application form shall be duly filled in, containing the following information:
p.000328:
p.000328: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact
p.000328: details of its contact person or legal representative in accordance with Article 58(4) established in the Union;
p.000328:
p.000328: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
p.000328: of the device intended for performance evaluation and, if applicable, of its authorised representative;
p.000328:
p.000328: 1.3. title of the performance study;
p.000328:
p.000328: 1.4. single identification number in accordance with Article 66(1);
p.000328:
p.000328: 1.5. status of the performance study, such as. the first submission, resubmission, significant amendment;
p.000328:
p.000328: 1.6. details and/ or reference to the performance study plan, such as including details of the
p.000328: design phase of the performance study;
p.000328:
p.000328: 1.7. if the application is a resubmission with regard to a device for which an application has been already
p.000328: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000328: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000328: changes from the previous application together with a rationale for those changes, in particular, whether any
p.000328: changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000328:
p.000328: 1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with
p.000328: Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
p.000328:
p.000328: 1.9. identification of the Member States and third countries in which the clinical performance study
p.000328: is to be conducted as part of a multicentre or multinational study at the time of application;
p.000328:
p.000328: 1.10. brief description of the device for performance study, its classification and other information necessary for
p.000328: the identification of the device and device type;
p.000328:
p.000328: 1.11. summary of the performance study plan;
p.000328:
...
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p.000261: detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for
p.000261: specimen collection and handling and control of known relevant endogenous and exogenous interference,
p.000261: cross- reactions; and
p.000261:
p.000261: (b) the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value,
p.000261: negative predictive value, likelihood ratio, expected values in normal and affected populations.
p.000261:
p.000261: 9.2. The performance characteristics of the device shall be maintained during the lifetime of the device as
p.000261: indicated by the manufacturer.
p.000261:
p.000261: 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the
p.000261: metrological traceability of values assigned to calibrators and/or control materials shall be assured through
p.000261: suitable reference measurement procedures and/or suitable reference materials of a higher metrological
p.000261: order. Where available, metrological traceability of values assigned to calibrators and control materials
p.000261: shall be assured to certified reference materials or reference measurement procedures.
p.000261:
p.000261: 9.4. The characteristics and performances of the device shall be specifically checked in the event
p.000261: that they may be affected when the device is used for the intended use under normal conditions:
p.000261:
p.000261: (a) for devices for self-testing, performances obtained by laypersons;
p.000261:
p.000261: (b) for devices for near-patient testing, performances obtained in relevant environments (for example,
p.000261: patient home, emergency units, ambulances).
p.000261:
p.000261: 10. Chemical, physical and biological properties
p.000261:
p.000261: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance
p.000261: requirements referred to in Chapter I are fulfilled.
p.000261:
p.000261: Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or
p.000261: chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as
p.000261: biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
p.000261:
p.000262: L 117/262 EN
p.000262: Official Journal of the European Union
p.000262: 5.5.2017
p.000262:
p.000262: 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed
p.000262: by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons
p.000262: involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to
p.000262: those contaminants and residues and to the duration and frequency of exposure.
p.000262:
p.000262: 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably
p.000262: practicable the risks posed by substances or particles, including wear debris, degradation products and
p.000262: processing residues, that may be released from the device. Special attention shall be given to substances
...
p.000283: following UDI database data elements shall require a new UDI-DI:
p.000283: (a) Name or trade name,
p.000283: (b) device version or model,
p.000283: (c) labelled as single use,
p.000283: (d) packaged sterile,
p.000283: (e) need for sterilization before use,
p.000283:
p.000284: L 117/284 EN
p.000284: Official Journal of the European Union
p.000284: 5.5.2017
p.000284:
p.000284: (f) quantity of devices provided in a package,
p.000284: (g) critical warnings or contra-indications.
p.000284: 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of
p.000284: the original device manufacturer's UDI.
p.000284:
p.000284: 4. UDI carrier
p.000284:
p.000284: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and
p.000284: on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000284:
p.000284: 4.2. In the event of there being significant space constraints on the unit of use packaging the
p.000284: UDI carrier may be placed on the next higher packaging level.
p.000284:
p.000284: 4.3. For single use class A and class B devices packaged and labelled individually, the UDI
p.000284: carrier shall not be required to appear on the packaging but it shall appear on a higher level of
p.000284: packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected
p.000284: to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI
p.000284: shall be placed on the packaging.
p.000284:
p.000284: 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be
p.000284: required to appear on the point of sale packaging.
p.000284:
p.000284: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000284: readily identifiable.
p.000284:
p.000284: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated
p.000284: in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
p.000284:
p.000284: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label,
p.000284: only the AIDC format shall be required to appear on the label. For devices intended to be used outside
p.000284: healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this
p.000284: results in there being no space for the AIDC.
p.000284:
p.000284: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
p.000284:
p.000284: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
p.000284: standard provided by the issuing entities shall also be provided on the label.
p.000284:
p.000284: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000284: reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent
p.000284: and readable after each process performed to make the device ready for the subsequent use throughout the
p.000284: intended lifetime of the device.
p.000284:
p.000284: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000284:
p.000284: 4.12. If the UDI carrier is readily readable or scannable through the device's packaging, the placing
p.000284: of the UDI carrier on the packaging shall not be required.
p.000284:
p.000284: 4.13. In the case of single finished devices made up of multiple parts that must be assembled
p.000284: before first use, it shall be sufficient to place the UDI carrier on only one part of each device.
p.000284:
p.000284: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal
p.000284: operation or storage.
p.000284:
p.000284: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for
p.000284: the device to operate or other data.
p.000284:
...
Searching for indicator property:
(return to top)
p.000179: representative provided for in this Regulation is without prejudice to the provisions of Directive
p.000179: 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer
p.000179: and the manufacturer. The tasks of an authorised representative should be defined in a written mandate.
p.000179: Considering the role of authorised representatives, the minimum requirements they should meet should
p.000179: be clearly defined, including the requirement of having available a person who fulfils minimum
p.000179: conditions of qualification which should be similar to those for a manufacturer's person responsible for
p.000179: regulatory compliance.
p.000179:
p.000179: (1) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative
p.000179: provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
p.000179:
p.000180: L 117/180 EN
p.000180: Official Journal of the European Union
p.000180: 5.5.2017
p.000180:
p.000180: (35) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to
p.000180: clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
p.000180:
p.000180: (36) Parallel trade in products already placed on the market is a lawful form of trade within the internal market
p.000180: on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety
p.000180: and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of
p.000180: the principle of parallel trade is, however, subject to different interpretations in the Member States.
p.000180: The conditions, in particular the requirements for relabelling and repackaging, should therefore be
p.000180: specified in this Regulation, taking into account the case-law of the Court of Justice (1) in other relevant sectors
p.000180: and existing good practice in the field of in vitro diagnostic medical devices.
p.000180:
p.000180:
p.000180: (37) Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so
p.000180: that they can move freely within the Union and be put into service in accordance with their intended
p.000180: purpose. Member States should not create obstacles to the placing on the market or putting into service of
p.000180: devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to
p.000180: decide whether to restrict the use of any specific type of device in relation to aspects that are not
p.000180: covered by this Regulation.
p.000180:
p.000180:
p.000180: (38) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000180: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000180: activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and
p.000180: better monitoring by competent authorities. It should also help to reduce medical errors and to fight against
...
p.000185: (86) The Union and, where appropriate, the Member States should actively participate in international
p.000185: regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding
p.000185: devices and foster the further development of international regulatory guidelines that promote the adoption
p.000185: in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to
p.000185: that set by this Regulation.
p.000185:
p.000185:
p.000185: (87) Member States should take all necessary measures to ensure that the provisions of this
p.000185: Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their
p.000185: infringement.
p.000185:
p.000185:
p.000185: (88) Whilst this Regulation should not affect the right of Member States to levy fees for activities
p.000185: at national level, Member States should, in order to ensure transparency, inform the Commission and the
p.000185: other Member States before they decide on the level and structure of such fees. In order to further ensure
p.000185: transparency, the structure and level of the fees should be publicly available on request.
p.000185:
p.000185:
p.000185: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000185: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000185: data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should
p.000185: be applied by the Member States in accordance with those rights and principles.
p.000185:
p.000185:
p.000185: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in
p.000185: order to amend certain non-essential provisions of this Regulation. It is of particular importance that
p.000185: the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that
p.000185: those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13
p.000185: April 2016 on Better Law Making (1). In particular, to ensure equal participation in the preparation of
p.000185: delegated acts, the European Parliament and the Council receive all documents at the same time as
p.000185: Member States' experts, and their experts systematically have access to meetings of Commission expert
p.000185: groups dealing with preparation of delegated acts.
p.000185:
p.000185:
p.000185: (91) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers
p.000185: should be conferred on the Commission. Those powers should be exercised in accordance with Regulation
p.000185: (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000185:
p.000185: (1) OJ L 123, 12.5.2016, p. 1.
p.000185: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000185: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of
p.000185: implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000185:
p.000186: L 117/186 EN
...
p.000188: intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a
p.000188: health professional;
p.000188:
p.000188: (7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a
p.000188: corresponding medicinal product to:
p.000188:
p.000188: (a) identify, before and/or during treatment, patients who are most likely to benefit from the
p.000188: corresponding medicinal product; or
p.000188:
p.000188: (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse
p.000188: reactions as a result of treatment with the corresponding medicinal product;
p.000188:
p.000188: (8) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of
p.000188: technology allowing them to be classified in a generic manner not reflecting specific characteristics;
p.000188:
p.000188: 5.5.2017 EN
p.000188: Official Journal of the European Union
p.000189: L 117/189
p.000189:
p.000189: (9) ‘single-use device’ means a device that is intended to be used during a single procedure;
p.000189:
p.000189: (10) ‘falsified device’ means any device with a false presentation of its identity and/or of its source
p.000189: and/or its CE marking certificates or documents relating to CE marking procedures. This definition does
p.000189: not include uninten tional non-compliance and is without prejudice to infringements of intellectual property rights;
p.000189:
p.000189: (11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in
p.000189: vitro
p.000189: diagnostic examination, or a part thereof;
p.000189:
p.000189: (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied
p.000189: by the manufacturer on the label, in the instructions for use or in promotional or sales materials or
p.000189: statements or as specified by the manufacturer in the performance evaluation;
p.000189:
p.000189: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the
p.000189: packaging of each unit or on the packaging of multiple devices;
p.000189:
p.000189: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000189: intended purpose and proper use and of any precautions to be taken;
p.000189:
p.000189: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through
p.000189: in ternationally accepted device identification and coding standards and that allows unambiguous
p.000189: identification of specific devices on the market;
p.000189:
p.000189: (16) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
p.000189:
p.000189: (17) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance
...
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000198: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000198: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000198: overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
p.000198:
p.000198: The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the
p.000198: information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal
p.000198: proceedings.
p.000198:
p.000198: 14. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000198: person the information on the identity of that person shall be part of the information to be submitted in accordance
p.000198: with Article 27(1).
p.000198:
p.000198: 15. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000198: accordance with applicable Union and national law.
p.000198:
p.000198: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000198: of the enterprise, have measures in place to provide sufficient financial coverage in respect of their
p.000198: potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
p.000198:
p.000198: Article 11
p.000198:
p.000198: Authorised representative
p.000198:
p.000198: 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the
p.000198: Union market if the manufacturer designates a sole authorised representative.
p.000198:
p.000198: 2. The designation shall constitute the authorised representative's mandate, it shall be valid only
...
p.000199: shall immediately inform the competent authority of the Member State in which it is established and, where applicable,
p.000199: the notified body that was involved in the conformity assessment for the device of the termination of the mandate and
p.000199: the reasons therefor.
p.000199:
p.000199: 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has
p.000199: its registered place of business shall be understood as a reference to the competent authority of the
p.000199: Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its
p.000199: registered place of business.
p.000199:
p.000199: Article 12
p.000199:
p.000199: Change of authorised representative
p.000199:
p.000199: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000199: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000199: representative. That agreement shall address at least the following aspects:
p.000199: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000199: beginning of the mandate of the incoming authorised representative;
p.000199: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000199: supplied by the manufacturer, including any promotional material;
p.000199: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000199: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000199: forward to the manufacturer or incoming authorised representative any complaints or reports from
p.000199: healthcare professionals, patients or users about suspected incidents related to a device for which it had been
p.000199: designated as authorised rep resentative.
p.000199:
p.000199: Article 13
p.000199:
p.000199: General obligations of importers
p.000199: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000199: 2. In order to place a device on the market, importers shall verify that:
p.000199: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000199: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000199: designated by the manufacturer;
p.000199: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000199: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.
p.000199:
p.000200: L 117/200 EN
p.000200: Official Journal of the European Union
p.000200: 5.5.2017
p.000200:
p.000200: Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this
p.000200: Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the
p.000200: manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe
...
p.000223: (a) the list of subsidiaries referred to in Article 33(2);
p.000223: (b) the list of experts referred to in Article 36(2);
p.000223: (c) the information relating to the notification referred to in Article 38(10) and the amended notifications referred
p.000223: to in Article 42(2);
p.000223: (d) the list of notified bodies referred to in Article 39(2);
p.000223: (e) the summary of the report referred to in Article 40(12);
p.000223: (f) the notifications for conformity assessments and certificates referred to in Article 50(1);
p.000223: (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and
p.000223: Section 4.3 of Annex VII;
p.000223: (h) the information regarding certificates referred to in Article 51(5);
p.000223: (i) the summary of safety and performance referred to in Article 29.
p.000223:
p.000223: Article 53
p.000223:
p.000223: Voluntary change of notified body
p.000223:
p.000223: 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with
p.000223: another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the
p.000223: change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body
p.000223: and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
p.000223: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000223: (b) the date until which the identification number of the outgoing notified body may be indicated in the
p.000223: information supplied by the manufacturer, including any promotional material;
p.000223: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000223: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000223: the incoming notified body;
p.000223: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000223: 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date
p.000223: on which they become invalid.
p.000223:
p.000223: Article 54
p.000223:
p.000223: Derogation from the conformity assessment procedures
p.000223:
p.000223: 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified
p.000223: request, the placing on the market or putting into service, within the territory of the Member State concerned, of a
p.000223: specific device for which the procedures referred to in that Article have not been carried out but use
p.000223: of which is in the interest of public health or patient safety or health.
p.000223:
p.000224: L 117/224 EN
p.000224: Official Journal of the European Union
p.000224: 5.5.2017
p.000224:
p.000224: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000224: authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such
p.000224: authorisation is granted for use other than for a single patient.
p.000224:
p.000224: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating
p.000224: to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of
...
p.000253: laboratory is not complying with the requirements for which it has been designated, the Commission, by means
p.000253: of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the
p.000253: designation.
p.000253:
p.000253: 10. The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the
p.000253: EU reference laboratories.
p.000253:
p.000253:
p.000253: Article 101
p.000253:
p.000253: Device registers and databanks
p.000253:
p.000253: The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers
p.000253: and databanks for specific types of devices setting common principles to collect comparable information. Such registers
p.000253: and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices.
p.000253:
p.000253: CHAPTER IX
p.000253: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
p.000253:
p.000253: Article 102
p.000253:
p.000253: Confidentiality
p.000253:
p.000253: 1. Unless otherwise provided for in this Regulation and without prejudice to existing national
p.000253: provisions and practices in the Member States on confidentiality, all parties involved in the application of this
p.000253: Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to
p.000253: protect the following:
p.000253: (a) personal data in accordance with Article 103;
p.000253: (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual
p.000253: property rights unless disclosure is in the public interest;
p.000253: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000253: audits.
p.000253:
p.000254: L 117/254 EN
p.000254: Official Journal of the European Union
p.000254: 5.5.2017
p.000254:
p.000254: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities
p.000254: and between competent authorities and the Commission shall not be disclosed without the prior agreement
p.000254: of the originating authority.
p.000254:
p.000254: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000254: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000254: obligations of the persons concerned to provide information under criminal law.
p.000254:
p.000254: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000254: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000254:
p.000254: Article 103
p.000254:
p.000254: Data protection
p.000254:
p.000254: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member
p.000254: States pursuant to this Regulation.
p.000254:
p.000254: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000254: Commission pursuant to this Regulation.
p.000254:
p.000254: Article 104
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
p.000230: condition, the subject is unable to provide prior informed consent and to receive prior information on the performance
p.000230: study;
p.000230:
p.000230: (b) there are scientific grounds to expect that participation of the subject in the performance study
p.000230: will have the potential to produce a direct clinically relevant benefit for the subject resulting in a
p.000230: measurable health-related improvement alleviating the suffering and/or improving the health of the subject,
p.000230: or in the diagnosis of its condition;
p.000230:
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000192:
p.000192: (64) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and
p.000192: ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation
p.000192: and do not endanger health, safety or any other aspect of public interest protection;
p.000192:
p.000192: (65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the
p.000192: end user;
p.000192:
p.000192: (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000192: made available on the market;
p.000192:
p.000192: (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made
p.000192: available on the market, including use-error due to ergonomic features, as well as any inadequacy in the
p.000192: information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not
p.000192: taken on the basis of information or result(s) provided by the device;
p.000192:
p.000192: (68) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000192: lead to any of the following:
p.000192:
p.000192: (a) the death of a patient, user or other person,
p.000192:
p.000192: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000192:
p.000192: (c) a serious public health threat;
p.000192:
p.000192: (69) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration
p.000192: in a person's state of health, or serious illness, that may require prompt remedial action, and that
p.000192: may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
p.000192:
p.000192: (70) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000192: non-conformity or other undesirable situation;
p.000192:
p.000192: (71) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons
p.000192: to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
p.000192:
p.000192: (72) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000192: relation to a field safety corrective action;
p.000192:
p.000192: (73) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of
p.000192: Regulation (EU) No 1025/2012;
p.000192:
p.000192: (74) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000192: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000192:
p.000192: 5.5.2017 EN
p.000192: Official Journal of the European Union
p.000193: L 117/193
p.000193:
p.000193: Section 2
p.000193: Regulatory status of products and counselling
p.000193:
p.000193: Article 3
p.000193:
p.000193: Regulatory status of products
...
p.000241: study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
p.000241: (a) any serious incident involving devices made available on the Union market, except expected erroneous results which
p.000241: are clearly documented and quantified in the product information and in the technical documentation and
p.000241: are subject to trend reporting pursuant to Article 83;
p.000241: (b) any field safety corrective action in respect of devices made available on the Union market, including any field
p.000241: safety corrective action undertaken in a third country in relation to a device which is also legally made
p.000241: available on the Union market, if the reason for the field safety corrective action is not limited to the device
p.000241: made available in the third country.
p.000241: The reports referred to in the first subparagraph shall be submitted through the electronic system
p.000241: referred to in Article 87.
p.000241:
p.000241: 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity
p.000241: of the serious incident.
p.000241:
p.000241: 3. Manufacturers shall report any serious incident as referred to in point (a) immediately after they have
p.000241: established a causal relationship between that incident and their device or that such causal relationship is
p.000241: reasonably possible, and not later than 15 days after they become aware of the incident.
p.000241:
p.000241: 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph
p.000241: 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
p.000241:
p.000241: 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's
p.000241: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000241: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000241: after the date on which the manufacturer becomes aware of the serious incident.
p.000241:
p.000242: L 117/242 EN
p.000242: Official Journal of the European Union
p.000242: 5.5.2017
p.000242:
p.000242: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is
p.000242: incomplete followed up by a complete report.
p.000242:
p.000242: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about
p.000242: whether the incident is reportable, it shall nevertheless submit a report within the timeframe required
p.000242: in accordance with paragraphs 2 to 5.
p.000242:
p.000242: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000242: immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in
p.000242: point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
p.000242:
p.000242: 9. For similar serious incidents that occur with the same device or device type and for which the root cause has
p.000242: been identified or a field safety corrective action implemented or where the incidents are common and well documented,
p.000242: the manufacturer may provide periodic summary reports instead of individual serious incident reports, on
...
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p.000176: L 117/176 EN
p.000176: Official Journal of the European Union
p.000176: 5.5.2017
p.000176:
p.000176: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.000176: of 5 April 2017
p.000176: on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
p.000176:
p.000176: (Text with EEA relevance)
p.000176:
p.000176: THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
p.000176:
p.000176: Having regard to the Treaty on the Functioning of the European Union, and in particular
p.000176: Article 114 and Article 168(4)(c) thereof,
p.000176:
p.000176: Having regard to the proposal from the European Commission,
p.000176:
p.000176: After transmission of the draft legislative act to the national parliaments,
p.000176:
p.000176: Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the
p.000176: Regions,
p.000176: Acting in accordance with the ordinary legislative procedure (2), Whereas:
p.000176: (1) Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the
p.000176: Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that
p.000176: Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for
p.000176: in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation.
p.000176:
p.000176: (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in
p.000176: vitro diagnostic medical devices, taking as a base a high level of protection of health for patients
p.000176: and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the
p.000176: same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order
p.000176: to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are
p.000176: inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on
p.000176: the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on
p.000176: the market and putting into service of in vitro diagnostic medical devices and their accessories on the
p.000176: Union market thus allowing them to benefit from the principle of free movement of goods. As regards
p.000176: Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic
p.000176: medical devices by ensuring, among other things, that data generated in performance studies are reliable and
p.000176: robust and that the safety of subjects participating in performance studies is protected.
p.000176:
p.000176: (3) This Regulation does not seek to harmonise rules relating to the further making available on the
p.000176: market of in vitro diagnostic medical devices after they have already been put into service, such as in the
p.000176: context of second- hand sales.
p.000176:
p.000176: (4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk
p.000176: classification, conformity assessment procedures, performance evaluation and performance studies, vigilance
p.000176: and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability
p.000176: regarding in vitro diagnostic medical devices should be introduced, to improve health and safety.
p.000176:
p.000176: (5) To the extent possible, guidance developed for in vitro diagnostic medical devices at
p.000176: international level, in particular in the context of the Global Harmonization Task Force and its follow-up
p.000176: initiative, the International Medical Devices Regulators Forum, should be taken into account to promote
p.000176: the global convergence of
p.000176:
p.000176: (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
p.000176: (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of
p.000176: the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
p.000176: (3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical
p.000176: devices (OJ L 331,
p.000176: 7.12.1998, p. 1).
p.000176:
p.000176: 5.5.2017 EN
p.000176: Official Journal of the European Union
p.000177: L 117/177
p.000177:
p.000177: regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in
p.000177: the provisions on Unique Device Identification, general safety and performance requirements, technical
p.000177: documentation, classification rules, conformity assessment procedures and clinical evidence.
p.000177:
p.000177: (6) There are specific features of in vitro diagnostic medical devices, in particular in terms of
p.000177: risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic
p.000177: medical device sector which require the adoption of specific legislation, distinct from the legislation on other
p.000177: medical devices, whereas the horizontal aspects common to both sectors should be aligned.
p.000177:
p.000177: (7) The scope of application of this Regulation should be clearly delimited from other legislation
p.000177: concerning products, such as medical devices, general laboratory products and products for research use only.
p.000177:
p.000177: (8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a
p.000177: product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard
p.000177: across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
p.000177: initiative or at the duly substantiated request of a Member State, having consulted the Medical Device
p.000177: Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category
...
p.000177: generally acknowledged state of the art in the field of medicine.
p.000177:
p.000177: (14) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council
p.000177: (1) are an integral part of the general safety and performance requirements laid down in this Regulation
p.000177: for devices. Consequently, this Regulation should be considered a lex specialis in relation to that Directive.
p.000177:
p.000177: (15) This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing
p.000177: radiation without affecting the application of Council Directive 2013/59/Euratom (2) which pursues other
p.000177: objectives.
p.000177:
p.000177: (16) This Regulation should include requirements for devices' safety and performance characteristics
p.000177: which are developed in such a way as to prevent occupational injuries, including protection from radiation.
p.000177:
p.000177: (1) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the
p.000177: laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
p.000177: (2) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the
p.000177: dangers arising
p.000177: from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,
p.000177: 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
p.000177:
p.000178: L 117/178 EN
p.000178: Official Journal of the European Union
p.000178: 5.5.2017
p.000178:
p.000178: (17) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to
p.000178: be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic
p.000178: medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes,
p.000178: even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic
p.000178: medical device. The qualification of software, either as a device or an accessory, is independent of the software's
p.000178: location or the type of interconnection between the software and a device.
p.000178:
p.000178: (18) The definitions in this Regulation regarding the devices themselves, the making available of
p.000178: devices, economic operators, users and specific processes, the conformity assessment, clinical evidence,
p.000178: post-market surveillance, vigilance and market surveillance, standards and other technical specifications,
p.000178: should be aligned with well- established practice in the field at Union and international level in order to enhance
p.000178: legal certainty.
p.000178:
p.000178: (19) It should be made clear that it is essential that devices offered to persons in the Union by means of
p.000178: information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and
p.000178: of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic
p.000178: service to persons within the Union comply with the requirements of this Regulation, where the product in question is
p.000178: placed on the market or the service is provided in the Union.
p.000178:
p.000178: (20) To recognise the important role of standardisation in the field of in vitro diagnostic medical devices,
p.000178: compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the
p.000178: Council (2) should be a means for manufacturers to demonstrate conformity with the general safety and
p.000178: performance requirements and other legal requirements, such as those relating to quality and risk management, laid down
p.000178: in this Regulation.
p.000178:
p.000178: (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of
p.000178: in vitro diagnostic medical devices. In areas where no harmonised standards exist or where they are insufficient, the
p.000178: Commission should be empowered to lay down common specifications which provide a means of complying with
p.000178: the general safety and performance requirements and the requirements for performance studies and
p.000178: performance evaluation and/or post-market follow-up, laid down in this Regulation.
p.000178:
p.000178: (22) Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account
p.000178: of the European and international standards.
p.000178:
p.000178: (23) The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for
p.000178: the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
p.000178: Council (3) and Decision No 768/2008/EC of the European Parliament and of the Council (4).
p.000178:
p.000178: (24) The rules on Union market surveillance and control of products entering the Union market laid
p.000178: down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
p.000178: from choosing the competent authorities to carry out those tasks.
p.000178:
p.000178: (25) It is appropriate to set out clearly the general obligations of the different economic operators, including
p.000178: importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice
p.000178: to the specific obligations laid down in the various parts of this Regulation, to enhance understanding
p.000178: of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators.
p.000178:
p.000178: (26) For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition,
p.000178: holding and supplying of devices.
p.000178:
p.000178: (1) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a
p.000178: procedure for the provision of information in the field of technical regulations and of rules on Information Society
p.000178: services (OJ L 241, 17.9.2015, p. 1).
p.000178: (2) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European
p.000178: standardisation,
p.000178: amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
p.000178: 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council
p.000178: and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council
p.000178: (OJ L 316, 14.11.2012, p. 12).
p.000178: (3) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the
p.000178: requirements for accredita
p.000178: tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218,
p.000178: 13.8.2008, p. 30).
p.000178: (4) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
p.000178: marketing of
p.000178: products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
p.000178:
p.000178: 5.5.2017 EN
p.000178: Official Journal of the European Union
p.000179: L 117/179
p.000179:
p.000179: (27) Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were
p.000179: set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions
p.000179: of this Regulation to facilitate its application.
p.000179:
p.000179:
p.000179: (28) To ensure the highest level of health protection, the rules governing in vitro diagnostic
p.000179: medical devices, manufactured and used within a single health institution only, should be clarified and
p.000179: strengthened. That use should be understood to include measurement and delivery of results.
p.000179:
p.000179:
p.000179: (29) Health institutions should have the possibility of manufacturing, modifying and using devices
p.000179: in-house and thereby addressing, on a non-industrial scale, the specific needs of target patient groups which cannot
p.000179: be met at the appropriate level of performance by an equivalent device available on the market. In that
p.000179: context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used
p.000179: only within health institutions, including hospitals as well as institutions, such as laboratories and public health
p.000179: institutes that support the health care system and/or address patient needs, but which do not treat or care for
p.000179: patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
p.000179: It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue
p.000179: health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result,
p.000179: the exemption applicable to health institutions does not apply to such establishments.
p.000179:
p.000179:
p.000179: (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective
p.000179: device in accordance with applicable Union and national law, it is appropriate to require manufacturers
p.000179: to have measures in place to provide sufficient financial coverage in respect of their potential
p.000179: liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to the risk class, type of
p.000179: device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the
p.000179: facilitation, by a competent authority, of the provision of information to persons who may have been injured by a
p.000179: defective device.
p.000179:
p.000179:
p.000179: (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of
p.000179: this Regulation and that experience from the use of the devices they manufacture is taken into account for the
p.000179: production process, all manufacturers should have a quality management system and a post-market surveillance system in
p.000179: place which should be proportionate to the risk class and the type of the device in question. In
p.000179: addition, in order to minimize risks or prevent incidents related to devices, manufacturers should
p.000179: establish a system for risk management and a system for reporting incidents and field safety corrective actions.
p.000179:
p.000179:
p.000179: (32) The risk management system should be carefully aligned with and reflected in the performance
p.000179: evaluation process for the device, including the clinical risks to be addressed as part of performance
p.000179: studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation
p.000179: processes should be inter-dependent and should be regularly updated.
p.000179:
p.000179:
p.000179: (33) It should be ensured that supervision and control of the manufacture of devices, as well as
p.000179: post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's
p.000179: organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
p.000179:
p.000179:
p.000179: (34) For manufacturers who are not established in the Union, the authorised representative plays a
p.000179: pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their
p.000179: contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to
p.000179: make the authorised representative legally liable for defective devices in the event that a manufacturer established
p.000179: outside the Union has not complied with its general obligations. The liability of the authorised
p.000179: representative provided for in this Regulation is without prejudice to the provisions of Directive
p.000179: 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer
p.000179: and the manufacturer. The tasks of an authorised representative should be defined in a written mandate.
p.000179: Considering the role of authorised representatives, the minimum requirements they should meet should
p.000179: be clearly defined, including the requirement of having available a person who fulfils minimum
p.000179: conditions of qualification which should be similar to those for a manufacturer's person responsible for
p.000179: regulatory compliance.
p.000179:
p.000179: (1) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative
p.000179: provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
p.000179:
p.000180: L 117/180 EN
p.000180: Official Journal of the European Union
p.000180: 5.5.2017
p.000180:
p.000180: (35) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to
p.000180: clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
p.000180:
p.000180: (36) Parallel trade in products already placed on the market is a lawful form of trade within the internal market
p.000180: on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety
p.000180: and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of
p.000180: the principle of parallel trade is, however, subject to different interpretations in the Member States.
p.000180: The conditions, in particular the requirements for relabelling and repackaging, should therefore be
p.000180: specified in this Regulation, taking into account the case-law of the Court of Justice (1) in other relevant sectors
p.000180: and existing good practice in the field of in vitro diagnostic medical devices.
p.000180:
p.000180:
p.000180: (37) Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so
p.000180: that they can move freely within the Union and be put into service in accordance with their intended
p.000180: purpose. Member States should not create obstacles to the placing on the market or putting into service of
p.000180: devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to
p.000180: decide whether to restrict the use of any specific type of device in relation to aspects that are not
p.000180: covered by this Regulation.
p.000180:
p.000180:
p.000180: (38) The traceability of devices by means of a Unique Device Identification system (UDI system) based on
p.000180: international guidance should significantly enhance the effectiveness of the post-market safety-related
p.000180: activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and
p.000180: better monitoring by competent authorities. It should also help to reduce medical errors and to fight against
p.000180: falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and
p.000180: stock-management by health institutions and other economic operators and, where possible, be compatible with other
p.000180: authentication systems already in place in those settings.
p.000180:
p.000180:
p.000180: (39) The UDI system should apply to all devices placed on the market except devices for performance studies, and be
p.000180: based on internationally recognised principles including definitions that are compatible with those used by major trade
p.000180: partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed
p.000180: rules should be laid down in this Regulation and in Regulation (EU) 2017/745 of the European Parliament
p.000180: and of the Council (2).
p.000180:
p.000180:
p.000180: (40) Transparency and adequate access to information, appropriately presented for the intended user, are essential
p.000180: in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
p.000180: to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the
p.000180: regulatory system.
p.000180:
p.000180:
p.000180: (41) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on
p.000180: medical devices (Eudamed) that should integrate different electronic systems to collate and process information
p.000180: regarding devices on the market and the relevant economic operators, certain aspects of conformity
p.000180: assessment, notified bodies, certificates, performance studies, vigilance and market surveillance. The objectives of
p.000180: the database are to enhance overall transparency, including through better access to information for the public and
p.000180: healthcare profes sionals, to avoid multiple reporting requirements, to enhance coordination between Member
p.000180: States and to streamline and facilitate the flow of information between economic operators, notified
p.000180: bodies or sponsors and Member States as well as between Member States among themselves and with the
p.000180: Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should
p.000180: therefore further develop and manage the European databank on medical devices set up by
p.000180: Commission Decision 2010/227/EU (3).
p.000180:
p.000180:
p.000180: (42) To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature
p.000180: should be available free of charge to manufacturers and other natural or legal persons required by this
p.000180: Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably
p.000180: practicable, free of charge also to other stakeholders.
p.000180:
p.000180: (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.000180: (2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
p.000180: amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
p.000180: Directives 90/385/EEC and 93/42/EEC (see page 1 of this Official Journal).
p.000180: (3) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102,
p.000180: 23.4.2010, p. 45).
p.000180:
p.000180: 5.5.2017 EN
p.000180: Official Journal of the European Union
p.000181: L 117/181
p.000181:
p.000181: (43) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and
p.000181: certificates should enable the public to be adequately informed about devices on the Union market. The electronic
p.000181: system on performance studies should serve as a tool for the cooperation between Member States and for enabling
p.000181: sponsors to submit, on a voluntary basis, a single application for several Member States and to report
p.000181: serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable
p.000181: manufacturers to report serious incidents and other reportable events and to support the coordination of the
p.000181: evaluation of such incidents and events by competent authorities. The electronic system regarding market
p.000181: surveillance should be a tool for the exchange of information between competent authorities.
p.000181:
p.000181: (44) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
p.000181: European Parliament and of the Council (1) applies to the processing of personal data carried out in the Member States,
p.000181: under the supervision of the Member States' competent authorities, in particular the public independent authorities
p.000181: designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (2) applies
p.000181: to the processing of personal data carried out by the Commission within the framework of this
p.000181: Regulation, under the supervision of the European Data Protection Supervisor. In accordance with
p.000181: Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its
p.000181: electronic systems.
p.000181:
p.000181: (45) For class C and D devices, manufacturers should summarise the main safety and performance
p.000181: aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.
p.000181:
p.000181: (46) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection
p.000181: and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member
p.000181: States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
p.000181:
p.000181: (47) Notified bodies' assessments of manufacturers' technical documentation, in particular
p.000181: documentation on performance evaluation, should be critically evaluated by the authority responsible for
p.000181: notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities
p.000181: of notified bodies and should be based on sampling of the relevant documentation.
p.000181:
p.000181: (48) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with
p.000181: regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on
p.000181: devices to ensure continuous compliance by manufacturers after receipt of the original certification.
p.000181:
p.000181: (49) To increase transparency with regard to the oversight of notified bodies by national authorities,
p.000181: the authorities responsible for notified bodies should publish information on the national measures
p.000181: governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative
p.000181: practice, this information should be kept up to date by those authorities in particular to reflect relevant,
p.000181: significant or substantive changes to the procedures in question.
p.000181:
p.000181: (50) The Member State in which a notified body is established should be responsible for enforcing the requirements
p.000181: of this Regulation with regard to that notified body.
p.000181:
p.000181: (51) In view, in particular, of the responsibility of Member States for the organisation and delivery of health
p.000181: services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for
p.000181: the conformity assessment of devices and established on their territory as far as issues that are not regulated in
p.000181: this Regulation are concerned. Any such additional requirements laid down should not affect more specific
p.000181: horizontal Union legislation on notified bodies and equal treatment of notified bodies.
p.000181:
p.000181: (52) For class D devices, competent authorities should be informed about certificates granted by notified bodies
p.000181: and be given the right to scrutinise the assessment conducted by notified bodies.
p.000181:
p.000181: (1) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of
p.000181: individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995,
p.000181: p. 31).
p.000181: (2) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of
p.000181: individuals with
p.000181: regard to the processing of personal data by the Community institutions and bodies and on the free movement of such
p.000181: data (OJ L 8, 12.1.2001, p. 1).
p.000181:
p.000182: L 117/182 EN
p.000182: Official Journal of the European Union
p.000182: 5.5.2017
p.000182:
p.000182: (53) For class D devices for which no CS exist it is appropriate to provide that where it is the first
p.000182: certification for that specific type of device and there is no similar device on the market having the same intended
p.000182: purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of
p.000182: the performance claimed by the manufacturer and the compliance of the device by the EU reference
p.000182: laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment
p.000182: reports. The consultation of expert panels in relation to the performance evaluation should lead to a
p.000182: harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance
p.000182: aspects and developing CS on categories of devices that have undergone that consultation process.
p.000182:
p.000182: (54) To enhance patient safety and to take due account of technological progress, the current classification system
p.000182: for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the
p.000182: corresponding conformity assessment procedures should be accordingly adapted.
p.000182:
p.000182: (55) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in
p.000182: four risk classes and to establish a set of robust risk-based classification rules, in line with international
p.000182: practice.
p.000182:
...
p.000182: information and data generated in performance studies should be based on a performance evaluation plan.
p.000182:
p.000182: (62) As a general rule, clinical evidence should be sourced from performance studies that have been carried out
p.000182: under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or
p.000182: legal person to be the sponsor taking responsibility for the performance study.
p.000182:
p.000182: (63) It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such
p.000182: updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer.
p.000182: Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety
p.000182: and performance through a continuous process of performance evaluation.
p.000182:
p.000182: (64) It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is
p.000182: fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical
p.000182: devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical
p.000182: information on patients, where appropriate, assessed against medical information obtained through the use
p.000182: of other diagnostic options and technologies, whereas the final clinical outcome for the patient is
p.000182: dependent on further diagnostic and/or therapeutic options which could be available.
p.000182:
p.000182: 5.5.2017 EN
p.000182: Official Journal of the European Union
p.000183: L 117/183
p.000183:
p.000183: (65) Where specific devices have no analytical or clinical performance or specific performance requirements are
p.000183: not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions
p.000183: relating to such requirements.
p.000183:
p.000183:
p.000183: (66) The rules on performance studies should be in line with well-established international guidance in this field,
p.000183: such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of
p.000183: medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the
p.000183: Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies
p.000183: conducted outside the Union in accordance with international guidelines to be accepted within the Union.
p.000183: In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of
p.000183: Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
p.000183:
p.000183:
p.000183: (67) It should be left to the Member State where a performance study is to be conducted to determine the
p.000183: appropriate authority to be involved in the assessment of the application to conduct a performance study and to
p.000183: organise the involvement of ethics committees within the timelines for the authorisation of that performance study as
p.000183: set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that
p.000183: context, Member States should ensure the involvement of laypersons, in particular patients or patients'
p.000183: organisations. They should also ensure that the necessary expertise is available.
p.000183:
p.000183:
p.000183: (68) An electronic system should be set up at Union level to ensure that every interventional
p.000183: clinical performance study and other performance study involving risks for the subjects of the studies is
p.000183: recorded and reported in a publicly accessible database. To protect the right to protection of personal data,
p.000183: recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data
p.000183: of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with
p.000183: the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable
p.000183: with the EU database to be set up for clinical trials on medicinal products for human use.
p.000183:
p.000183:
p.000183: (69) Where an interventional clinical performance study or another performance study involving risks for the
p.000183: subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a
p.000183: single application in order to reduce administrative burden. In order to allow for resource-sharing and
p.000183: to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance
p.000183: study and of the scientific design of that performance study, the procedure for the assessment of such single
p.000183: application should be coordinated between the Member States under the direction of a coordinating Member
p.000183: State. Such coordinated assessment should not include the assessment of intrinsically national, local and
p.000183: ethical aspects of a performance study, including informed consent. For an initial period of seven years from the
p.000183: date of application of this Regulation, Member States should be able to participate on a voluntary basis
p.000183: in the coordinated assessment. After that period, all Member States should be obliged to participate in the
...
p.000183: should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment
p.000183: procedure.
p.000183:
p.000183:
p.000183: (70) Sponsors should report certain adverse events and device deficiencies that occur during
p.000183: interventional clinical performance studies and other performance studies involving risks for the subjects
p.000183: to the Member States in which those studies are being conducted. Member States should have the possibility of
p.000183: terminating or suspending the studies or revoking the authorisation for those studies, if considered
p.000183: necessary to ensure a high level of protection of the subjects participating in such studies. Such information
p.000183: should be communicated to the other Member States.
p.000183:
p.000183:
p.000183: (71) The sponsor of a performance study should submit a summary of results of the performance study that is easily
p.000183: understandable for the intended user together with the performance study report, where applicable, within
p.000183: the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the
p.000183: defined timelines for scientific reasons, the sponsor should justify this and specify when the results
p.000183: will be submitted.
p.000183:
p.000183:
p.000183: (72) With exemption of some general requirements, this Regulation should only cover performance studies intended
p.000183: to gather scientific data for the purpose of demonstrating conformity of devices.
p.000183:
p.000184: L 117/184 EN
p.000184: Official Journal of the European Union
p.000184: 5.5.2017
p.000184:
p.000184: (73) It is necessary to clarify that performance studies using left-over specimens need not be authorised.
p.000184: Nevertheless, the general requirements and other additional requirements with regard to data protection and the
p.000184: requirements applicable to procedures that are performed in accordance with national law such as ethical
p.000184: review should continue to apply to all performance studies, including when using left-over specimens.
p.000184:
p.000184: (74) The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the
p.000184: Directive 2010/63/EU of the European Parliament and the Council (1) should be observed. In particular,
p.000184: the unnecessary duplication of tests and studies should be avoided.
p.000184:
p.000184: (75) Manufacturers should play an active role during the post-market phase by systematically and actively
p.000184: gathering information from post-market experience with their devices in order to update their technical documentation
p.000184: and cooperate with the national competent authorities in charge of vigilance and market surveillance
p.000184: activities. To that end, manufacturers should establish a comprehensive post-market surveillance system, set
p.000184: up under their quality management system and based on a post-market surveillance plan. Relevant data and
p.000184: information gathered through post-market surveillance, as well as lessons learned from any implemented
p.000184: preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as
p.000184: those relating to risk assessment and performance evaluation, and should also serve the purposes of transparency.
p.000184:
p.000184: (76) In order to better protect health and safety regarding devices on the market, the electronic system on
p.000184: vigilance for devices should be made more effective by creating a central portal at Union level for
p.000184: reporting serious incidents and field safety corrective actions.
p.000184:
p.000184: (77) Member States should take appropriate measures to raise awareness among healthcare professionals,
p.000184: users and patients about the importance of reporting incidents. Healthcare professionals, users and
p.000184: patients should be encouraged and enabled to report suspected serious incidents at national level using
p.000184: harmonised formats. The national competent authorities should inform manufacturers of any suspected serious
p.000184: incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned
p.000184: should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
p.000184:
p.000184: (78) The evaluation of reported serious incidents and field safety corrective actions should be conducted at
p.000184: national level but coordination should be ensured where similar incidents have occurred or field safety corrective
p.000184: actions have to be carried out in more than one Member State, with the objective of sharing resources
p.000184: and ensuring consistency regarding the corrective action.
p.000184:
p.000184: (79) In the context of the investigation of incidents, the competent authorities should take into
p.000184: account, where appropriate, the information provided by and views of relevant stakeholders, including
p.000184: patient and healthcare professionals' organisations and manufacturers' associations.
p.000184:
p.000184: (80) The reporting of serious adverse events or device deficiencies during interventional clinical performance
p.000184: studies and other performance studies involving risks for the subjects, and the reporting of serious incidents
p.000184: occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
p.000184:
p.000184: (81) Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of
p.000184: the national competent authorities, to ensure effective coordination of their market surveillance activities
p.000184: and to clarify the applicable procedures.
p.000184:
p.000184: (82) Any statistically significant increase in the number or severity of incidents that are not
p.000184: serious or in expected erroneous results that could have a significant impact on the benefit-risk
p.000184: analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to
p.000184: permit their assessment and the adoption of appropriate measures.
p.000184:
p.000184: (83) An expert committee, the MDCG, composed of persons designated by the Member States based on their role and
p.000184: expertise in the field of medical devices including in vitro diagnostic medical devices, should be
p.000184: established in
p.000184:
p.000184: (1) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals
p.000184: used for scientific purposes (OJ L 276, 20.10.2010. p. 33).
p.000184:
p.000184: 5.5.2017 EN
p.000184: Official Journal of the European Union
p.000185: L 117/185
p.000185:
p.000185: accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it
p.000185: by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission
p.000185: and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able
p.000185: to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical
p.000185: devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate con sideration
p.000185: should be given to the possibility of involving existing groups at Union level in the field of medical
p.000185: devices.
p.000185:
p.000185:
p.000185: (84) Closer coordination between national competent authorities through information exchange and
p.000185: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000185: uniform high level of health and safety protection within the internal market, in particular in the
p.000185: areas of performance studies and vigilance. The principle of coordinated exchange and assessment should
p.000185: also apply across other authority activities described in this Regulation, such as the designation of notified
p.000185: bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and
p.000185: communication of activities should also lead to more efficient use of resources and expertise at national level.
p.000185:
p.000185:
p.000185: (85) The Commission should provide scientific, technical and corresponding logistical support to
p.000185: coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000185: implemented at Union level based on sound scientific evidence.
p.000185:
p.000185:
p.000185: (86) The Union and, where appropriate, the Member States should actively participate in international
p.000185: regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding
p.000185: devices and foster the further development of international regulatory guidelines that promote the adoption
p.000185: in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to
p.000185: that set by this Regulation.
p.000185:
p.000185:
p.000185: (87) Member States should take all necessary measures to ensure that the provisions of this
p.000185: Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their
p.000185: infringement.
p.000185:
p.000185:
p.000185: (88) Whilst this Regulation should not affect the right of Member States to levy fees for activities
p.000185: at national level, Member States should, in order to ensure transparency, inform the Commission and the
p.000185: other Member States before they decide on the level and structure of such fees. In order to further ensure
p.000185: transparency, the structure and level of the fees should be publicly available on request.
p.000185:
p.000185:
p.000185: (89) This Regulation respects the fundamental rights and observes the principles recognised in
p.000185: particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal
p.000185: data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should
p.000185: be applied by the Member States in accordance with those rights and principles.
p.000185:
p.000185:
p.000185: (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in
p.000185: order to amend certain non-essential provisions of this Regulation. It is of particular importance that
p.000185: the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that
p.000185: those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13
p.000185: April 2016 on Better Law Making (1). In particular, to ensure equal participation in the preparation of
p.000185: delegated acts, the European Parliament and the Council receive all documents at the same time as
p.000185: Member States' experts, and their experts systematically have access to meetings of Commission expert
p.000185: groups dealing with preparation of delegated acts.
p.000185:
p.000185:
p.000185: (91) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers
p.000185: should be conferred on the Commission. Those powers should be exercised in accordance with Regulation
p.000185: (EU) No 182/2011 of the European Parliament and of the Council (2).
p.000185:
p.000185: (1) OJ L 123, 12.5.2016, p. 1.
p.000185: (2) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
p.000185: rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of
p.000185: implementing powers (OJ L 55, 28.2.2011, p. 13).
p.000185:
p.000186: L 117/186 EN
p.000186: Official Journal of the European Union
p.000186: 5.5.2017
p.000186:
p.000186: (92) The advisory procedure should be used for implementing acts that set out the form and presentation of the data
p.000186: elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free
p.000186: sale, given that such implementing acts are of a procedural nature and do not directly have an impact on
p.000186: health and safety at Union level.
p.000186:
p.000186: (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating
p.000186: to the extension to the territory of the Union of a national derogation from the applicable conformity assessment
p.000186: procedures, imperative grounds of urgency so require.
p.000186:
p.000186: (94) In order to enable it to designate issuing entities and EU reference laboratories, implementing powers should
p.000186: be conferred on the Commission.
p.000186:
p.000186: (95) To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to
p.000186: the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a
p.000186: sufficient transitional period for that adaptation and for the organisational arrangements that are to be made.
p.000186: However, certain parts of the Regulation that directly affect Member States and the Commission should be
p.000186: implemented as soon as possible. It is also particularly important that, by the date of application of
p.000186: this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to
p.000186: avoid any shortage of devices on the market. Nonetheless, it is necessary that any designation of a
p.000186: notified body in accordance with the requirements of this Regulation prior to the date of its
p.000186: application be without prejudice to the validity of the designation of those notified bodies under
p.000186: Directive 98/79/EC and to their capacity to continue issuing valid certificates under that Directive until the date
p.000186: of application of this Regulation.
p.000186:
p.000186: (96) In order to ensure a smooth transition to the new rules for registration of devices and of
p.000186: certificates, the obligation to submit the relevant information to the electronic systems set up at Union
p.000186: level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to
p.000186: plan, only become fully effective from 18 months after the date of application of this Regulation. During
p.000186: this transitional period, certain provisions of Directive 98/79/EC should remain in force. However,
p.000186: in order to avoid multiple registrations, economic operators and notified bodies who register in the
p.000186: relevant electronic systems set up at Union level pursuant to this Regulation should be considered to
p.000186: be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.
p.000186:
p.000186: (97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation
p.000186: to place the UDI carrier on the label of the device should vary from one to five years after the date of application of
p.000186: this Regulation depending upon the class of the device concerned.
p.000186:
p.000186: (98) Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the
p.000186: placing of in vitro diagnostic medical devices on the market and the related aspects covered by this
p.000186: Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they
p.000186: placed on the market and manufacturers' and Member States' obligations as regards vigilance activities
p.000186: for devices placed on the market pursuant to that Directive should however continue to apply. While it should be
p.000186: left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility
p.000186: of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools
p.000186: as those for reporting on devices placed on the market pursuant to this Regulation. However, Decision 2010/227/EU
p.000186: adopted in implemen tation of that Directive and Council Directives 90/385/EEC (1) and 93/42/EEC (2) should also be
p.000186: repealed as from the date when Eudamed becomes fully functional.
p.000186:
p.000186: (99) The requirements of this Regulation should be applicable to all devices placed on the market or put into
p.000186: service from the date of application of this Regulation. However, in order to provide for a smooth transition it should
p.000186: be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by
p.000186: virtue of a valid certificate issued pursuant to Directive 98/79/EC.
p.000186:
p.000186: (100) The European Data Protection Supervisor has given an opinion (3) pursuant to Article 28(2) of Regulation (EC)
p.000186: No 45/2001.
p.000186:
p.000186: (1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
p.000186: active implantable medical devices (OJ L 189, 20.7.1990, p. 17)
p.000186: (2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) (3) OJ C 358,
p.000186: 7.12.2013, p. 10.
p.000186:
p.000186: 5.5.2017 EN
p.000186: Official Journal of the European Union
p.000187: L 117/187
p.000187:
p.000187: (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal
p.000187: market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical
p.000187: devices, thus ensuring a high level of protection of health and safety of patients, users and other
p.000187: persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be
p.000187: better achieved at Union level, the Union may adopt measures, in accordance with the principle of
p.000187: subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of
p.000187: proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve
p.000187: those objectives,
p.000187:
p.000187:
p.000187: HAVE ADOPTED THIS REGULATION:
p.000187: CHAPTER I
p.000187:
p.000187: INTRODUCTORY PROVISIONS
p.000187:
p.000187: Section 1
p.000187: Scope and def initions
p.000187:
p.000187: Article 1
p.000187:
p.000187: Subject matter and scope
p.000187:
p.000187: 1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting
p.000187: into service of in vitro diagnostic medical devices for human use and accessories for such devices in
p.000187: the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical
p.000187: devices and accessories conducted in the Union.
p.000187:
p.000187: 2. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in
p.000187: vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.
p.000187:
p.000187: 3. This Regulation does not apply to:
p.000187:
p.000187: (a) products for general laboratory use or research-use only products, unless such products, in view of their
p.000187: character istics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
p.000187:
p.000187: (b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a
p.000187: specimen;
p.000187: (c) internationally certified reference materials;
p.000187: (d) materials used for external quality assessment schemes.
p.000187:
p.000187: 4. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000187: part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be
p.000187: governed by that Regulation. The requirements of this Regulation shall apply to the in vitro diagnostic medical
p.000187: device part.
p.000187:
p.000187: 5. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
p.000187:
p.000187: 6. Devices which are also machinery within the meaning of point (a) of the second paragraph of
p.000187: Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a
p.000187: hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex
p.000187: I to that Directive to the extent to which those requirements are more specific than the general safety and performance
p.000187: requirements set out in Chapter II of Annex I to this Regulation.
p.000187:
p.000187: 7. This Regulation shall not affect the application of Directive 2013/59/Euratom.
p.000187:
p.000187: 8. This Regulation shall not affect the right of a Member State to restrict the use of any
p.000187: specific type of device in relation to aspects not covered by this Regulation.
p.000187:
p.000187: (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157,
p.000187: 9.6.2006, p. 24).
p.000187:
p.000188: L 117/188 EN
p.000188: Official Journal of the European Union
p.000188: 5.5.2017
p.000188:
p.000188: 9. This Regulation shall not affect national law concerning the organisation, delivery or financing of health
p.000188: services and medical care, such as the requirement that certain devices may only be supplied on a
p.000188: medical prescription, the requirement that only certain health professionals or health care institutions may dispense
p.000188: or use certain devices or that their use be accompanied by specific professional counselling.
p.000188:
p.000188: 10. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media
p.000188: in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under
p.000188: Article 11 of the Charter of Fundamental Rights of the European Union.
p.000188:
p.000188:
p.000188: Article 2
p.000188:
p.000188: Definitions
p.000188:
p.000188: For the purposes of this Regulation, the following definitions apply:
p.000188: (1) ‘medical device’ means ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745;
p.000188:
p.000188: (2) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator,
p.000188: control material, kit, instrument, apparatus, piece of equipment, software or system, whether
p.000188: used alone or in combination, intended by the manufacturer to be used in vitro for the examination of
p.000188: specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of
p.000188: providing information on one or more of the following:
p.000188: (a) concerning a physiological or pathological process or state;
p.000188: (b) concerning congenital physical or mental impairments;
p.000188: (c) concerning the predisposition to a medical condition or a disease;
p.000188: (d) to determine the safety and compatibility with potential recipients;
p.000188: (e) to predict treatment response or reactions;
p.000188: (f) to define or monitoring therapeutic measures.
p.000188: Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;
p.000188:
p.000188: (3) ‘specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer
p.000188: for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro
p.000188: diagnostic examination;
p.000188:
p.000188: (4) ‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being
...
p.000188: device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist
p.000188: the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s);
p.000188:
p.000188: (5) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including
p.000188: devices used for testing services offered to lay persons by means of information society services;
p.000188:
p.000188: (6) ‘device for near-patient testing’ means any device that is not intended for self-testing but is
p.000188: intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a
p.000188: health professional;
p.000188:
p.000188: (7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a
p.000188: corresponding medicinal product to:
p.000188:
p.000188: (a) identify, before and/or during treatment, patients who are most likely to benefit from the
p.000188: corresponding medicinal product; or
p.000188:
p.000188: (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse
p.000188: reactions as a result of treatment with the corresponding medicinal product;
p.000188:
p.000188: (8) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of
p.000188: technology allowing them to be classified in a generic manner not reflecting specific characteristics;
p.000188:
p.000188: 5.5.2017 EN
p.000188: Official Journal of the European Union
p.000189: L 117/189
p.000189:
p.000189: (9) ‘single-use device’ means a device that is intended to be used during a single procedure;
p.000189:
p.000189: (10) ‘falsified device’ means any device with a false presentation of its identity and/or of its source
p.000189: and/or its CE marking certificates or documents relating to CE marking procedures. This definition does
p.000189: not include uninten tional non-compliance and is without prejudice to infringements of intellectual property rights;
p.000189:
p.000189: (11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in
p.000189: vitro
p.000189: diagnostic examination, or a part thereof;
p.000189:
p.000189: (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied
p.000189: by the manufacturer on the label, in the instructions for use or in promotional or sales materials or
p.000189: statements or as specified by the manufacturer in the performance evaluation;
p.000189:
p.000189: (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the
p.000189: packaging of each unit or on the packaging of multiple devices;
p.000189:
p.000189: (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's
p.000189: intended purpose and proper use and of any precautions to be taken;
p.000189:
p.000189: (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through
p.000189: in ternationally accepted device identification and coding standards and that allows unambiguous
...
p.000189:
p.000189: (17) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance
p.000189: for the use of the device for the intended purpose, when used in accordance with the intended purpose
p.000189: given by the manufacturer;
p.000189:
p.000189: (18) ‘compatibility’ is the ability of a device, including software, when used together with one or more other devices
p.000189: in accordance with its intended purpose, to:
p.000189:
p.000189: (a) perform without losing or compromising the ability to perform as intended, and/or
p.000189:
p.000189: (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices,
p.000189: and/or
p.000189:
p.000189: (c) be used together without conflict/interference or adverse reaction;
p.000189:
p.000189: (19) ‘interoperability’ is the ability of two or more devices, including software, from the same
p.000189: manufacturer or from different manufacturers, to:
p.000189:
p.000189: (a) exchange information and use the information that has been exchanged for the correct execution of a specified
p.000189: function without changing the content of the data, and/or
p.000189:
p.000189: (b) communicate with each other, and/or
p.000189: (c) work together as intended;
p.000189:
p.000189: (20) ‘making available on the market’ means any supply of a device, other than a device for
p.000189: performance study, for distribution, consumption or use on the Union market in the course of a commercial activity,
p.000189: whether in return for payment or free of charge;
p.000189:
p.000189: (21) ‘placing on the market’ means the first making available of a device, other than a device for performance study,
p.000189: on the Union market;
p.000189:
p.000189: (22) ‘putting into service’ means the stage at which a device, other than a device for performance study, has been
p.000189: made available to the final user as being ready for use on the Union market for the first time for its intended
p.000189: purpose;
p.000189:
p.000189: (23) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or
p.000189: has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
p.000189:
p.000189: (24) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a
p.000189: device already placed on the market or put into service, or the making of a new device from used devices, to bring it
p.000189: into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;
p.000189:
p.000190: L 117/190 EN
p.000190: Official Journal of the European Union
p.000190: 5.5.2017
p.000190:
p.000190: (25) ‘authorised representative’ means any natural or legal person established within the Union who has
p.000190: received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's
p.000190: behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
p.000190:
p.000190: (26) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000190: country on the Union market;
p.000190:
p.000190: (27) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the
p.000190: importer, that makes a device available on the market, up until the point of putting into service;
p.000190:
p.000190: (28) ‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
p.000190:
p.000190: (29) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or
p.000190: the promotion of public health;
p.000190:
p.000190: (30) ‘user’ means any healthcare professional or lay person who uses a device;
p.000190:
p.000190: (31) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical
p.000190: discipline;
p.000190:
p.000190: (32) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to
p.000190: a device have been fulfilled;
p.000190:
p.000190: (33) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000190: including calibration, testing, certification and inspection;
p.000190:
p.000190: (34) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000190:
p.000190: (35) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000190: conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation
p.000190: legislation providing for its affixing;
p.000190:
p.000190: (36) ‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device
p.000190: of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the
p.000190: intended clinical benefit(s), when used as intended by the manufacturer;
p.000190:
p.000190: (37) ‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening,
p.000190: monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
p.000190:
p.000190: (38) ‘scientific validity of an analyte’ means the association of an analyte with a clinical condition
p.000190: or a physiological state;
p.000190:
p.000190: (39) ‘performance of a device’ means the ability of a device to achieve its intended purpose as
p.000190: claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting
p.000190: that intended purpose;
p.000190:
p.000190: (40) ‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
p.000190:
p.000190: (41) ‘clinical performance’ means the ability of a device to yield results that are correlated with a
p.000190: particular clinical condition or a physiological or pathological process or state in accordance with the target
p.000190: population and intended user;
p.000190:
p.000190: (42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical
p.000190: performance of a device;
p.000190:
p.000190: (43) ‘performance study plan’ means a document that describes the rationale, objectives, design
p.000190: methodology, monitoring, statistical considerations, organisation and conduct of a performance study;
p.000190:
p.000190: (44) ‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity,
p.000190: the analytical and, where applicable, the clinical performance of a device;
p.000190:
p.000190: (45) ‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.
p.000190:
p.000190: A device intended to be used for research purposes, without any medical objective, shall not be deemed
p.000190: to be a device for performance study;
p.000190:
p.000190: 5.5.2017 EN
p.000190: Official Journal of the European Union
p.000191: L 117/191
p.000191:
p.000191: (46) ‘interventional clinical performance study’ means a clinical performance study where the test results may
p.000191: influence patient management decisions and/or may be used to guide treatment;
p.000191:
p.000191: (47) ‘subject’ means an individual who participates in a performance study and whose specimen(s) undergo
p.000191: in vitro
p.000191: examination by a device for performance study and/or by a device used for control purposes;
p.000191:
p.000191: (48) ‘investigator’ means an individual responsible for the conduct of a performance study at a performance study
p.000191: site;
p.000191:
p.000191: (49) ‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (50) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker
p.000191: associated with a particular disease or condition;
p.000191:
p.000191: (51) ‘predictive value’ means the probability that a person with a positive device test result has a given condition
p.000191: under investigation, or that a person with a negative device test result does not have a given condition;
p.000191:
p.000191: (52) ‘positive predictive value’ means the ability of a device to separate true positive results from false positive
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (53) ‘negative predictive value’ means the ability of a device to separate true negative results from false negative
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (54) ‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical
...
p.000191: the performance study;
p.000191:
p.000191: (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that
p.000191: Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of
p.000191: laypersons, in particular patients or patients' organisations;
p.000191:
p.000191: (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision,
p.000191: unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in
p.000191: subjects, users or other persons, in the context of a performance study, whether or not related to the device for
p.000191: performance study;
p.000191:
p.000191: (61) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000191:
p.000191: (a) a patient management decision resulting in death or an imminent life-threatening situation for the
p.000191: individual being tested, or in the death of the individual's offspring,
p.000191:
p.000191: (b) death,
p.000191:
p.000191: (c) serious deterioration in the health of the individual being tested or the recipient of tested
p.000191: donations or materials, that resulted in any of the following:
p.000191:
p.000191: (i) life-threatening illness or injury,
p.000191:
p.000191: (ii) permanent impairment of a body structure or a body function,
p.000191:
p.000192: L 117/192 EN
p.000192: Official Journal of the European Union
p.000192: 5.5.2017
p.000192:
p.000192: (iii) hospitalisation or prolongation of patient hospitalisation,
p.000192:
p.000192: (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
p.000192: to a body structure or a body function,
p.000192:
p.000192: (v) chronic disease,
p.000192:
p.000192: (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
p.000192:
p.000192: (62) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or
p.000192: performance of a device for performance study, including malfunction, use errors or inadequacy in
p.000192: information supplied by the manufacturer;
p.000192:
p.000192: (63) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with
p.000192: other economic operators to institute and keep up to date a systematic procedure to proactively collect
p.000192: and review experience gained from devices they place on the market, make available on the market or put into service
p.000192: for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
p.000192:
p.000192: (64) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and
p.000192: ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation
p.000192: and do not endanger health, safety or any other aspect of public interest protection;
p.000192:
p.000192: (65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the
p.000192: end user;
p.000192:
p.000192: (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further
p.000192: made available on the market;
p.000192:
p.000192: (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made
p.000192: available on the market, including use-error due to ergonomic features, as well as any inadequacy in the
p.000192: information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not
p.000192: taken on the basis of information or result(s) provided by the device;
p.000192:
p.000192: (68) ‘serious incident’ means any incident that directly or indirectly led, might have led or might
p.000192: lead to any of the following:
p.000192:
p.000192: (a) the death of a patient, user or other person,
p.000192:
p.000192: (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
p.000192:
p.000192: (c) a serious public health threat;
p.000192:
p.000192: (69) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration
p.000192: in a person's state of health, or serious illness, that may require prompt remedial action, and that
p.000192: may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
p.000192:
p.000192: (70) ‘corrective action’ means action taken to eliminate the cause of a potential or actual
p.000192: non-conformity or other undesirable situation;
p.000192:
p.000192: (71) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons
p.000192: to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
p.000192:
p.000192: (72) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in
p.000192: relation to a field safety corrective action;
p.000192:
p.000192: (73) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of
p.000192: Regulation (EU) No 1025/2012;
p.000192:
p.000192: (74) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a
p.000192: standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
p.000192:
p.000192: 5.5.2017 EN
p.000192: Official Journal of the European Union
p.000193: L 117/193
p.000193:
p.000193: Section 2
p.000193: Regulatory status of products and counselling
p.000193:
p.000193: Article 3
p.000193:
p.000193: Regulatory status of products
p.000193:
p.000193: 1. Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device
p.000193: Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of
p.000193: implementing acts, determine whether or not a specific product, or category or group of products, falls
p.000193: within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical
p.000193: device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000193: 107(3) of this Regulation.
p.000193:
p.000193: 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of
p.000193: implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be
p.000193: adopted in accordance with the examination procedure referred to in Article 107(3).
p.000193:
p.000193: 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical
p.000193: devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary,
p.000193: other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
p.000193:
p.000193: 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human
p.000193: tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of
...
p.000193: there is appropriate access to counselling in the case of the use of genetic tests that provide information on the
p.000193: genetic predispo sition for medical conditions and/or diseases which are generally considered to be untreatable
p.000193: according to the state of science and technology.
p.000193:
p.000193: 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease
p.000193: which the individual being tested is already known to have is confirmed by a genetic test or in cases where a
p.000193: companion diagnostic is used.
p.000193:
p.000193: 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at
p.000193: national level which are more protective of patients, more specific or which deal with informed consent.
p.000193:
p.000193: CHAPTER II
p.000193: MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE
p.000193: MARKING, FREE MOVEMENT
p.000193:
p.000193: Article 5
p.000193:
p.000193: Placing on the market and putting into service
p.000193:
p.000193: 1. A device may be placed on the market or put into service only if it complies with this
p.000193: Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
p.000193:
p.000193: (1) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients'
p.000193: rights in cross- border healthcare (OJ L 88, 4.4.2011, p. 45).
p.000193:
p.000194: L 117/194 EN
p.000194: Official Journal of the European Union
p.000194: 5.5.2017
p.000194:
p.000194: 2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it,
p.000194: taking into account its intended purpose.
p.000194:
p.000194: 3. Demonstration of conformity with the general safety and performance requirements shall include a
p.000194: performance evaluation in accordance with Article 56.
p.000194:
p.000194: 4. Devices that are manufactured and used within health institutions, with the exception of devices for
p.000194: performance studies, shall be considered as having been put into service.
p.000194:
p.000194: 5. With the exception of the relevant general safety and performance requirements set out in Annex
p.000194: I, the requirements of this Regulation shall not apply to devices manufactured and used only within
p.000194: health institutions established in the Union, provided that all of the following conditions are met:
p.000194:
p.000194: (a) the devices are not transferred to another legal entity;
p.000194:
p.000194: (b) manufacture and use of the devices occur under appropriate quality management systems;
p.000194:
p.000194: (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where
p.000194: applicable national provisions, including national provisions regarding accreditation;
p.000194:
p.000194: (d) the health institution justifies in its documentation that the target patient group's specific needs cannot be
p.000194: met, or cannot be met at the appropriate level of performance by an equivalent device available on the market;
p.000194:
p.000194: (e) the health institution provides information upon request on the use of such devices to its
p.000194: competent authority, which shall include a justification of their manufacturing, modification and use;
p.000194:
p.000194: (f) the health institution draws up a declaration which it shall make publicly available, including:
p.000194:
p.000194: (i) the name and address of the manufacturing health institution,
p.000194:
p.000194: (ii) the details necessary to identify the devices,
p.000194:
p.000194: (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this
p.000194: Regulation and, where applicable, information on which requirements are not fully met with a reasoned justifi cation
p.000194: therefor;
p.000194:
p.000194: (g) as regards class D devices in accordance with the rules set out in Annex VIII, the health
p.000194: institution draws up documentation that makes it possible to have an understanding of the manufacturing
...
p.000194: general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply
p.000194: this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
p.000194:
p.000194: (h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with
p.000194: the documentation referred to in point (g); and
p.000194:
p.000194: (i) the health institution reviews experience gained from clinical use of the devices and takes all
p.000194: necessary corrective actions.
p.000194:
p.000194: Member States may require that such health institutions submit to the competent authority any further
p.000194: relevant information about such devices which have been manufactured and used on their territory. Member States shall
p.000194: retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access
p.000194: to inspect the activities of the health institutions.
p.000194:
p.000194: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000194:
p.000194: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000194: acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those
p.000194: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000194:
p.000194: 5.5.2017 EN
p.000194: Official Journal of the European Union
p.000195: L 117/195
p.000195:
p.000195: Article 6
p.000195:
p.000195: Distance sales
p.000195:
p.000195: 1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive
p.000195: (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
p.000195: 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed
p.000195: on the market but used in the context of a commercial activity, whether in return for payment or free of charge,
p.000195: for the provision of a diagnostic or therapeutic service offered by means of information society services, as defined
p.000195: in point (b) of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication, directly or through
p.000195: intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
p.000195: 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with
p.000195: paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of
p.000195: conformity of the device concerned.
p.000195:
p.000195: 4. A Member State may, on grounds of protection of public health, require a provider of information society
p.000195: services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
p.000195:
p.000195:
p.000195: Article 7
p.000195:
p.000195: Claims
p.000195:
p.000195: In the labelling, instructions for use, making available, putting into service and advertising of
p.000195: devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may
p.000195: mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
p.000195: (a) ascribing functions and properties to the device which the device does not have;
p.000195: (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not
p.000195: have;
p.000195:
p.000195: (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its
p.000195: intended purpose;
p.000195:
p.000195: (d) suggesting uses for the device other than those stated to form part of the intended purpose for
p.000195: which the conformity assessment was carried out.
p.000195:
p.000195:
p.000195: Article 8
p.000195:
p.000195: Use of harmonised standards
p.000195:
p.000195: 1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of
p.000195: those standards, the references of which have been published in the Official Journal of the European
p.000195: Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards
p.000195: or parts thereof.
p.000195:
p.000195: The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance
p.000195: with this Regulation by economic operators or sponsors, including those relating to quality
p.000195: management systems, risk management, post-market surveillance systems, performance studies, clinical
p.000195: evidence or post-market performance follow-up (‘PMPF’).
p.000195:
p.000195: References in this Regulation to harmonised standards shall be understood as meaning harmonised standards
p.000195: the references of which have been published in the Official Journal of the European Union.
p.000195:
p.000195: 2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharma
p.000195: copoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia,
p.000195: provided that references to those monographs have been published in the Official Journal of the European Union.
p.000195:
p.000196: L 117/196 EN
p.000196: Official Journal of the European Union
p.000196: 5.5.2017
p.000196:
p.000196: Article 9
p.000196:
p.000196: Common specifications
p.000196:
p.000196: 1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there
p.000196: is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by
p.000196: means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance
p.000196: requirements set out in Annex I, the technical documentation set out in Annexes II and III, the performance evaluation
p.000196: and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII. Those
p.000196: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000196:
p.000196: 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity
p.000196: with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
p.000196:
p.000196: 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify
p.000196: that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
p.000196:
p.000196:
p.000196: Article 10
p.000196:
p.000196: General obligations of manufacturers
p.000196:
p.000196: 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they
p.000196: have been designed and manufactured in accordance with the requirements of this Regulation.
p.000196:
p.000196: 2. Manufacturers shall establish, document, implement and maintain a system for risk management as
p.000196: described in Section 3 of Annex I.
...
p.000196: of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and
p.000196: III.
p.000196:
p.000196: The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the
p.000196: light of technical progress, the Annexes II and III.
p.000196:
p.000196: 5. Where compliance with the applicable requirements has been demonstrated following the applicable
p.000196: conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall
p.000196: draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of
p.000196: conformity in accordance with Article 18.
p.000196:
p.000196: 6. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with
p.000196: the registration obligations referred to in Article 26 and 28.
p.000196:
p.000196: 7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a
p.000196: copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51,
p.000196: available for the competent authorities for a period of at least 10 years after the last device covered
p.000196: by the EU declaration of conformity has been placed on the market.
p.000196:
p.000196: Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that
p.000196: technical documen tation in its entirety or a summary thereof.
p.000196:
p.000196: A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised
p.000196: representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the
p.000196: necessary documentation permanently available.
p.000196:
p.000196: 5.5.2017 EN
p.000196: Official Journal of the European Union
p.000197: L 117/197
p.000197:
p.000197: 8. Manufacturers shall ensure that procedures are in place to keep series production in conformity
p.000197: with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised
p.000197: standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in
p.000197: a timely manner. Manufacturers of devices, other than devices for performance study, shall establish,
p.000197: document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure
p.000197: compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class
p.000197: and the type of device.
p.000197:
p.000197: The quality management system shall cover all parts and elements of a manufacturer's organisation dealing
p.000197: with the quality of processes, procedures and devices. It shall govern the structure, responsibilities,
p.000197: procedures, processes and management resources required to implement the principles and actions necessary
p.000197: to achieve compliance with the provisions of this Regulation.
p.000197:
p.000197: The quality management system shall address at least the following aspects:
p.000197:
p.000197: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures
p.000197: for management of modifications to the devices covered by the system;
p.000197:
p.000197: (b) identification of applicable general safety and performance requirements and exploration of options to address
p.000197: those requirements;
p.000197: (c) responsibility of the management;
p.000197: (d) resource management, including selection and control of suppliers and sub-contractors;
p.000197: (e) risk management as set out in Section 3 of Annex I;
p.000197: (f) performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF;
p.000197: (g) product realisation, including planning, design, development, production and service provision;
p.000197:
p.000197: (h) verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices
p.000197: and ensuring consistency and validity of information provided in accordance with Article 26;
p.000197: (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78;
p.000197:
p.000197: (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or
p.000197: other stakeholders;
p.000197: (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
p.000197: (l) management of corrective and preventive actions and verification of their effectiveness;
p.000197: (m) processes for monitoring and measurement of output, data analysis and product improvement.
p.000197:
p.000197: 9. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance
p.000197: with Article 78.
p.000197:
p.000197: 10. Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I
p.000197: in an official Union language(s) determined by the Member State in which the device is made available
p.000197: to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible
p.000197: to the intended user or patient.
p.000197:
p.000197: The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing
p.000197: shall be easily understandable and provided in the official Union language(s) determined by the Member State in which
p.000197: the device is made available to the user or patient.
p.000197:
p.000197: 11. Manufacturers that consider or have reason to believe that a device which they have placed on the market or
p.000197: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000197: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors
p.000197: of the device in question and, where applicable, the authorised representative and importers accordingly.
p.000197:
p.000197: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000197: of the Member States in which they made the device available and, where applicable, the notified body that issued a
p.000197: certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective
p.000197: action taken.
p.000197:
p.000198: L 117/198 EN
p.000198: Official Journal of the European Union
p.000198: 5.5.2017
p.000198:
p.000198: 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions
p.000198: as described in Articles 82 and 83.
p.000198:
p.000198: 13. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000198: and documen tation necessary to demonstrate the conformity of the device, in an official Union language determined by
p.000198: the Member State concerned. The competent authority of the Member State in which the manufacturer has its
p.000198: registered place of business may require that the manufacturer provide samples of the device free of charge or,
p.000198: where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent
p.000198: authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000198: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000198: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000198: overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
p.000198:
p.000198: The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the
p.000198: information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal
p.000198: proceedings.
p.000198:
p.000198: 14. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000198: person the information on the identity of that person shall be part of the information to be submitted in accordance
p.000198: with Article 27(1).
p.000198:
p.000198: 15. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000198: accordance with applicable Union and national law.
p.000198:
p.000198: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000198: of the enterprise, have measures in place to provide sufficient financial coverage in respect of their
p.000198: potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
p.000198:
p.000198: Article 11
p.000198:
p.000198: Authorised representative
p.000198:
p.000198: 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the
p.000198: Union market if the manufacturer designates a sole authorised representative.
p.000198:
p.000198: 2. The designation shall constitute the authorised representative's mandate, it shall be valid only
p.000198: when accepted in writing by the authorised representative and shall be effective at least for all devices of the same
p.000198: generic device group.
p.000198:
p.000198: 3. The authorised representative shall perform the tasks specified in the mandate agreed between it
p.000198: and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent
p.000198: authority, upon request.
p.000198:
p.000198: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000198: least the following tasks in relation to the devices that it covers:
p.000198: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and,
p.000198: where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
p.000198: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy
p.000198: of the relevant certificate, including any amendments and supplements, issued in accordance with Article
p.000198: 51, at the disposal of competent authorities for the period referred to in Article 10(7);
p.000198: (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied
p.000198: with the registration obligations laid down in Article 26;
p.000198:
p.000198: 5.5.2017 EN
p.000198: Official Journal of the European Union
p.000199: L 117/199
p.000199:
p.000199: (d) in response to a request from a competent authority, provide that competent authority with all the information and
p.000199: documentation necessary to demonstrate the conformity of a device, in an official Union language determined
p.000199: by the Member State concerned;
p.000199: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000199: resentative has its registered place of business for samples, or access to a device and verify that
p.000199: the competent authority receives the samples or is given access to the device;
p.000199: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is
p.000199: not possible, mitigate the risks posed by devices;
p.000199: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000199: patients and users about suspected incidents related to a device for which they have been designated;
p.000199: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000199: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid
p.000199: down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
p.000199:
p.000199: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000199: and has not complied with the obligations laid down in Article 10, the authorised representative shall be
p.000199: legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000199:
...
p.000199: Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its
p.000199: registered place of business.
p.000199:
p.000199: Article 12
p.000199:
p.000199: Change of authorised representative
p.000199:
p.000199: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000199: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000199: representative. That agreement shall address at least the following aspects:
p.000199: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000199: beginning of the mandate of the incoming authorised representative;
p.000199: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000199: supplied by the manufacturer, including any promotional material;
p.000199: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000199: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000199: forward to the manufacturer or incoming authorised representative any complaints or reports from
p.000199: healthcare professionals, patients or users about suspected incidents related to a device for which it had been
p.000199: designated as authorised rep resentative.
p.000199:
p.000199: Article 13
p.000199:
p.000199: General obligations of importers
p.000199: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000199: 2. In order to place a device on the market, importers shall verify that:
p.000199: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000199: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000199: designated by the manufacturer;
p.000199: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000199: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.
p.000199:
p.000200: L 117/200 EN
p.000200: Official Journal of the European Union
p.000200: 5.5.2017
p.000200:
p.000200: Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this
p.000200: Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the
p.000200: manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe
p.000200: that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the
p.000200: Member State in which the importer is established.
p.000200:
p.000200: 3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name,
p.000200: registered trade name or registered trade mark, their registered place of business and the address at which they can
p.000200: be contacted, so that their location can be established. They shall ensure that any additional label
p.000200: does not obscure any information on the label provided by the manufacturer.
p.000200:
p.000200: 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 26.
p.000200: Importers shall add their details to the registration in accordance with Article 28.
p.000200:
p.000200: 5. Importers shall ensure that, while a device is under their responsibility, storage or transport
p.000200: conditions do not jeopardise its compliance with the general safety and performance requirements set out
p.000200: in Annex I and shall comply with the conditions set by the manufacturer, where available.
p.000200:
p.000200: 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and
...
p.000200: eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000200: the market. Importers, upon request by a competent authority of the Member State in which the importer has its
p.000200: registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant
p.000200: access to the device.
p.000200:
p.000200:
p.000200: Article 14
p.000200:
p.000200: General obligations of distributors
p.000200:
p.000200: 1. When making a device available on the market, distributors shall, in the context of their
p.000200: activities, act with due care in relation to the requirements applicable.
p.000200:
p.000200: 2. Before making a device available on the market, distributors shall verify that all of the following
p.000200: requirements are met:
p.000200: (a) the device has been CE marked and the EU declaration of conformity of the device has been drawn up;
p.000200: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10);
p.000200: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000200: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000200: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000200: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000200:
p.000200: 5.5.2017 EN
p.000200: Official Journal of the European Union
p.000201: L 117/201
p.000201:
p.000201: Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this
p.000201: Regulation, it shall not make the device available on the market until it has been brought into
p.000201: conformity and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and
p.000201: the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a
p.000201: falsified device, it shall also inform the competent authority of the Member State in which it is established.
p.000201:
p.000201: 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions
p.000201: comply with the conditions set by the manufacturer.
p.000201:
p.000201: 4. Distributors that consider or have reason to believe that a device which they have made available on the market
p.000201: is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufac
p.000201: turer's authorised representative and the importer. Distributors shall co-operate with the manufacturer
p.000201: and, where applicable the manufacturer's authorised representative, and the importer, and with competent authorities
p.000201: to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as
p.000201: appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious
p.000201: risk, it shall also immediately inform the competent authorities of the Member States in which it made the
...
p.000201: regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical
p.000201: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000201:
p.000201: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or
p.000201: of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or
p.000201: another relevant scientific discipline, and at least one year of professional experience in regulatory
p.000201: affairs or in quality management systems relating to in vitro diagnostic medical devices;
p.000201: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000201: to in vitro
p.000201: diagnostic medical devices.
p.000201:
p.000201: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000201: not be required to have the person responsible for regulatory compliance within their organisation but shall have such
p.000201: person permanently and continuously at their disposal.
p.000201:
p.000201: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000201:
p.000201: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
p.000201: system under which the devices are manufactured, before a device is released;
p.000201:
p.000201: (1) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ
p.000201: L 124, 20.5.2003, p. 36).
p.000201:
p.000202: L 117/202 EN
p.000202: Official Journal of the European Union
p.000202: 5.5.2017
p.000202:
p.000202: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
p.000202: (c) the post-market surveillance obligations are complied with in accordance with Article 10(9);
p.000202: (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled;
p.000202:
p.000202: (e) in the case of devices for performance studies intended to be used in the context of
p.000202: interventional clinical performance studies or other performance studies involving risks for the subjects,
p.000202: the statement referred to in Section 4.1 of Annex XIV is issued.
p.000202:
p.000202: 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and
p.000202: 3, their respective areas of responsibility shall be stipulated in writing.
p.000202:
p.000202: 5. The person responsible for regulatory compliance shall suffer no disadvantage within the
p.000202: manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not
p.000202: they are employees of the organisation.
p.000202:
p.000202: 6. Authorised representatives shall have permanently and continuously at their disposal at least one
p.000202: person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory
p.000202: requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be
p.000202: demonstrated by either of the following qualifications:
p.000202:
p.000202: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or
p.000202: of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or
p.000202: another relevant scientific discipline, and at least one year of professional experience in regulatory
p.000202: affairs or in quality management systems relating to in vitro diagnostic medical devices;
p.000202: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000202: to in vitro
p.000202: diagnostic medical devices.
p.000202:
p.000202: Article 16
p.000202:
p.000202: Cases in which obligations of manufacturers apply to importers, distributors or other persons
p.000202:
p.000202: 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on
p.000202: manufacturers if it does any of the following:
p.000202:
p.000202: (a) makes available on the market a device under its own name, registered trade name or registered trade mark, except
p.000202: in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is
p.000202: identified as such on the label and is responsible for meeting the requirements placed on manufacturers
p.000202: in this Regulation;
p.000202: (b) changes the intended purpose of a device already placed on the market or put into service;
p.000202:
p.000202: (c) modifies a device already placed on the market or put into service in such a way that compliance with the
p.000202: applicable requirements may be affected.
p.000202:
p.000202: The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (23)
p.000202: of Article 2, assembles or adapts for an individual patient a device already on the market without changing its
p.000202: intended purpose.
p.000202:
p.000202: 2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a
p.000202: device that could affect its compliance with the applicable requirements:
p.000202:
p.000202: (a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 20
p.000202: of Annex I, relating to a device already placed on the market and of further information which is necessary in order to
p.000202: market the device in the relevant Member State;
p.000202:
p.000202: (b) changes to the outer packaging of a device already placed on the market, including a change of
p.000202: pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is
p.000202: carried out in such conditions that the original condition of the device cannot be affected by it. In the
p.000202: case of devices placed on the market in sterile condition, it shall be presumed that the original condition of
p.000202: the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened,
p.000202: damaged or otherwise negatively affected by the repackaging.
p.000202:
p.000202: 5.5.2017 EN
p.000202: Official Journal of the European Union
p.000203: L 117/203
p.000203:
p.000203: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2
p.000203: shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the
p.000203: device, the activity carried out together with its name, registered trade name or registered trade mark, registered
p.000203: place of business and the address at which it can be contacted, so that its location can be established.
p.000203:
p.000203: Distributors and importers shall ensure that they have in place a quality management system that includes procedures
p.000203: which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in
p.000203: points
p.000203: (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the
p.000203: device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
p.000203: The quality management system shall cover, inter alia, procedures ensuring that the distributor or
p.000203: importer is informed of any corrective action taken by the manufacturer in relation to the device in question in
p.000203: order to respond to safety issues or to bring it into conformity with this Regulation.
p.000203:
p.000203: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000203: distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall
p.000203: inform the manufacturer and the competent authority of the Member State in which they plan to make the device
p.000203: available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the
p.000203: manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device,
p.000203: including any translated label and instructions for use. Within the same period of 28 days, the
p.000203: distributor or importer shall submit to the competent authority a certificate, issued by a notified body
p.000203: designated for the type of devices that are subject to activities mentioned in points (a) and (b) of
p.000203: paragraph 2, attesting that the quality management system of the distributer or importer complies with the
p.000203: requirements laid down in paragraph 3.
p.000203:
p.000203:
p.000203: Article 17
p.000203:
p.000203: EU declaration of conformity
p.000203:
p.000203: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been
p.000203: fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of
p.000203: conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official
p.000203: Union language or languages required by the Member State(s) in which the device is made available.
p.000203:
p.000203: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000203: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000203: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in
p.000203: respect of all Union acts applicable to the device. The declaration shall contain all the information
p.000203: required for identification of the Union legislation to which the declaration relates.
p.000203:
p.000203: 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance
p.000203: with the requirements of this Regulation and all other Union legislation applicable to the device.
p.000203:
p.000203: 4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the
p.000203: minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
p.000203:
p.000203:
p.000203: Article 18
p.000203:
p.000203: CE marking of conformity
p.000203:
p.000203: 1. Devices, other than devices for performance studies, considered to be in conformity with the requirements of
p.000203: this Regulation shall bear the CE marking of conformity, as presented in Annex V.
p.000203:
p.000203: 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
p.000203:
p.000203: 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile
p.000203: packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE
p.000203: marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any
p.000203: sales packaging.
p.000203:
p.000204: L 117/204 EN
p.000204: Official Journal of the European Union
p.000204: 5.5.2017
p.000204:
p.000204: 4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or
p.000204: any other mark indicating a special risk or use.
p.000204:
p.000204: 5. Where applicable, the CE marking shall be followed by the identification number of the notified body
p.000204: responsible for the conformity assessment procedures set out in Article 48. The identification number shall also be
p.000204: indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.
p.000204:
p.000204: 6. Where devices are subject to other Union legislation which also provides for the affixing of the CE marking,
p.000204: the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
p.000204:
p.000204: Article 19
p.000204:
p.000204: Devices for special purposes
p.000204:
p.000204: 1. Member States shall not create obstacles to devices for performance study being supplied for that
p.000204: purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 57 to 76, and in the
p.000204: implementing acts adopted pursuant to Article 77.
p.000204:
p.000204: 2. The devices referred to in paragraph 1 shall not bear the CE marking, with the exception of the devices
p.000204: referred to in Article 70.
p.000204:
p.000204: 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create
p.000204: obstacles to the showing of devices which do not comply with this Regulation, provided that a visible
p.000204: sign clearly indicates that such devices are intended for presentation or demonstration purposes only and
p.000204: cannot be made available until they have been brought into compliance with this Regulation.
p.000204:
p.000204: Article 20
p.000204:
p.000204: Parts and components
p.000204:
p.000204: 1. Any natural or legal person who makes available on the market an item specifically intended to
p.000204: replace an identical or similar integral part or component of a device that is defective or worn in order to maintain
p.000204: or restore the function of the device without changing its performance or safety characteristics or its
p.000204: intended purpose, shall ensure that the item does not adversely affect the safety and performance of the
p.000204: device. Supporting evidence shall be kept available for the competent authorities of the Member States.
p.000204:
p.000204: 2. An item that is intended specifically to replace a part or component of a device and that significantly changes
p.000204: the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and
p.000204: shall meet the requirements laid down in this Regulation.
p.000204:
p.000204: Article 21
p.000204:
p.000204: Free movement
p.000204:
p.000204: Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making
p.000204: available on the market or putting into service within their territory of devices which comply with the requirements of
p.000204: this Regulation.
p.000204:
p.000204: CHAPTER III
p.000204: IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF
p.000204: SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
p.000204:
p.000204: Article 22
p.000204:
p.000204: Identification within the supply chain
p.000204:
p.000204: 1. Distributors and importers shall co-operate with manufacturers or authorised representatives to
p.000204: achieve an appropriate level of traceability of devices.
p.000204:
p.000204: 5.5.2017 EN
p.000204: Official Journal of the European Union
p.000205: L 117/205
p.000205:
p.000205: 2. Economic operators shall be able to identify the following to the competent authority, for the period referred
p.000205: to in Article 10(7):
p.000205: (a) any economic operator to whom they have directly supplied a device;
p.000205: (b) any economic operator who has directly supplied them with a device;
p.000205: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000205:
p.000205: Article 23
p.000205:
p.000205: Medical devices nomenclature
p.000205:
p.000205: To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in
p.000205: Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally
p.000205: recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal
p.000205: persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that
p.000205: nomenclature is available to other stakeholders free of charge, where reasonably practicable.
p.000205:
p.000205: Article 24
p.000205:
p.000205: Unique Device Identification system
p.000205:
p.000205: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000205: allow the identifi cation and facilitate the traceability of devices, other than devices for performance
p.000205: studies, and shall consist of the following:
p.000205: (a) production of a UDI that comprises the following:
p.000205: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
...
p.000205: 2. The Commission shall, by means of implementing acts, designate one or several entities to operate a
p.000205: system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those
p.000205: entities shall satisfy all of the following criteria:
p.000205: (a) the entity is an organisation with legal personality;
p.000205: (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution
p.000205: and use in accordance with the requirements of this Regulation;
p.000205: (c) its system for the assignment of UDIs conforms to the relevant international standards;
p.000205: (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance
p.000205: with a set of predetermined and transparent terms and conditions;
p.000205: (e) the entity undertakes to do the following:
p.000205: (i) operate its system for the assignment of UDIs for at least 10 years after its designation;
p.000205: (ii) make available to the Commission and to the Member States, upon request, information concerning its system for
p.000205: the assignment of UDIs;
p.000205: (iii) remain in compliance with the criteria for designation and the terms of designation.
p.000205: When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of
p.000205: Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to
p.000205: minimising financial and administrative burdens for economic operators, health institutions and healthcare
p.000205: professionals.
p.000205:
p.000206: L 117/206 EN
p.000206: Official Journal of the European Union
p.000206: 5.5.2017
p.000206:
p.000206: 3. Before placing a device, other than a device for performance study, on the market, the manufacturer shall
p.000206: assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules
p.000206: of the issuing entity designated by the Commission in accordance with paragraph 2.
p.000206:
p.000206: Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that
p.000206: the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to
p.000206: the UDI database referred to in Article 25.
p.000206:
p.000206: 4. UDI carriers shall be placed on the label of the device and on all higher levels of packaging.
p.000206: Higher levels of packaging shall not be understood to include shipping containers.
p.000206:
p.000206: 5. The UDI shall be used for reporting serious incidents and field safety corrective actions in
p.000206: accordance with Article 82.
p.000206:
p.000206: 6. The Basic UDI-DI, as defined in Part C of Annex VI of the device shall appear on the EU declaration of
p.000206: conformity referred to in Article 17.
p.000206:
p.000206: 7. As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list
p.000206: of all UDIs that it has assigned.
p.000206:
p.000206: 8. Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have
p.000206: supplied or with which they have been supplied, if those devices belong to the devices, categories or groups of devices
p.000206: determined by a measure referred to in point (a) of paragraph 11.
p.000206:
...
p.000206: procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the
p.000206: following:
p.000206: (a) determining the devices, categories or groups of devices to which the obligation laid down in
p.000206: paragraph 8 is to apply;
p.000206: (b) specifying the data to be included in the UDI-PI of specific devices or device groups.
p.000206: The implementing acts referred to in the first subparagraph shall be adopted in accordance with the
p.000206: examination procedure referred to in Article 107(3).
p.000206:
p.000206: 12. When adopting the measures referred to in paragraph 11, the Commission shall take into account
p.000206: all of the following:
p.000206: (a) confidentiality and data protection as referred to in Articles 102 and 103 respectively;
p.000206: (b) the risk-based approach;
p.000206: (c) the cost-effectiveness of the measures;
p.000206: (d) the convergence of UDI systems developed at international level;
p.000206: (e) the need to avoid duplications in the UDI system;
p.000206: (f) the needs of the health care systems of the Member States, and where possible, compatibility with
p.000206: other medical device identification systems that are used by stakeholders.
p.000206:
p.000206: Article 25
p.000206:
p.000206: UDI database
p.000206:
p.000206: The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with
p.000206: the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745.
p.000206:
p.000206: 5.5.2017 EN
p.000206: Official Journal of the European Union
p.000207: L 117/207
p.000207:
p.000207: Article 26
p.000207:
p.000207: Registration of devices
p.000207:
p.000207: 1. Before placing a device on the market, the manufacturer shall, in accordance with the rules of the issuing
p.000207: entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall
p.000207: provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to
p.000207: that device.
p.000207:
p.000207: 2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and
p.000207: (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article
p.000207: 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the
p.000207: manufacturer applies to a notified body for that assessment.
p.000207:
p.000207: For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI
p.000207: on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in
p.000207: Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the
p.000207: relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to
p.000207: the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
p.000207:
p.000207: 3. Before placing a device on the market, the manufacturer shall enter or, if already provided, verify in Eudamed
p.000207: the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2
...
p.000207: relevant entry/entries.
p.000207:
p.000207:
p.000207: Article 28
p.000207:
p.000207: Registration of manufacturers, authorised representatives and importers
p.000207:
p.000207: 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order
p.000207: to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part
p.000207: A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the
p.000207: conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information
p.000207: referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000207: notified body.
p.000207:
p.000207: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000207: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and
p.000207: issue it to the manufacturer, the authorised representative or the importer.
p.000207:
p.000207: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing
p.000207: Eudamed in order to fulfil its obligations under Article 26.
p.000207:
p.000207: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000207: Article, the economic operator shall update the data in the electronic system referred to in Article 27.
p.000207:
p.000208: L 117/208 EN
p.000208: Official Journal of the European Union
p.000208: 5.5.2017
p.000208:
p.000208: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000208: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure
p.000208: to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its
p.000208: territory until that economic operator complies with that obligation.
p.000208:
p.000208: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify
p.000208: the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000208:
p.000208: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27
p.000208: shall be accessible to the public.
p.000208:
p.000208: 8. The competent authority may use the data to charge the manufacturer, the authorised representative
p.000208: or the importer a fee pursuant to Article 104.
p.000208:
p.000208: Article 29
p.000208:
p.000208: Summary of safety and performance
p.000208:
p.000208: 1. For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary
p.000208: of safety and performance.
p.000208:
p.000208: The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to
p.000208: the patient and shall be made available to the public via Eudamed.
p.000208:
p.000208: The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified
...
p.000208: description of the differences, as well as, where relevant, a description of any accessories, other devices and
p.000208: products, which are intended to be used in combination with the device;
p.000208: (d) reference to any harmonised standards and CS applied;
p.000208: (e) the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
p.000208: (f) the metrological traceability of assigned values;
p.000208: (g) suggested profile and training for users;
p.000208: (h) information on any residual risks and any undesirable effects, warnings and precautions.
p.000208: 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements
p.000208: to be included in the summary of safety and performance. Those implementing acts shall be adopted in accordance with
p.000208: the advisory procedure referred to in Article 107(2).
p.000208:
p.000208: Article 30
p.000208:
p.000208: European database on medical devices
p.000208:
p.000208: 1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European
p.000208: database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by
p.000208: Articles 33 and 34 of Regulation (EU) 2017/745.
p.000208: 2. Eudamed shall include the following electronic systems:
p.000208: (a) the electronic system for registration of devices referred to in Article 26;
p.000208: (b) the UDI database referred to in Article 25;
p.000208: (c) the electronic system on registration of economic operators referred to in Article 27;
p.000208:
p.000208: 5.5.2017 EN
p.000208: Official Journal of the European Union
p.000209: L 117/209
p.000209:
p.000209: (d) the electronic system on notified bodies and on certificates referred to in Article 52;
p.000209: (e) the electronic system on performance studies referred to in Article 69,
p.000209: (f) the electronic system on vigilance and post-market surveillance referred to in Article 87;
p.000209: (g) the electronic system on market surveillance referred to in Article 95.
p.000209:
p.000209: CHAPTER IV
p.000209: NOTIFIED BODIES
p.000209:
p.000209: Article 31
p.000209:
p.000209: Authorities responsible for notified bodies
p.000209:
p.000209: 1. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated
p.000209: a notified body, to carry out conformity assessment activities under this Regulation shall appoint an
p.000209: authority (the ‘authority responsible for notified bodies’), which may consist of separate constituent
p.000209: entities under national law and shall be responsible for setting up and carrying out the necessary
p.000209: procedures for the assessment, designation and notification of conformity assessment bodies and for the
p.000209: monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.
p.000209:
p.000209: 2. The authority responsible for notified bodies shall be established, organised and operated so as
p.000209: to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with
p.000209: conformity assessment bodies.
p.000209:
...
p.000209: in vitro diagnostic medical devices, it shall ensure that the national authority responsible for in vitro
p.000209: diagnostic medical devices is consulted on relevant matters.
p.000209:
p.000209: 7. Member States shall make publicly available general information on their measures governing the
p.000209: assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and
p.000209: on changes which have a significant impact on such tasks.
p.000209:
p.000209: 8. The authority responsible for notified bodies shall participate in peer-review activities provided for in
p.000209: Article 44.
p.000209:
p.000209:
p.000209: Article 32
p.000209:
p.000209: Requirements relating to notified bodies
p.000209:
p.000209: 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They
p.000209: shall satisfy the organisational and general requirements and the quality management, resource and process requirements
p.000209: that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII.
p.000209:
p.000209: In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent
p.000209: availability of sufficient administrative, technical and scientific personnel in accordance with Section
p.000209: 3.1.1 of Annex VII, and personnel with relevant clinical expertise in accordance with Section 3.2.4 of
p.000209: Annex VII, where possible employed by the notified body itself.
p.000209:
p.000210: L 117/210 EN
p.000210: Official Journal of the European Union
p.000210: 5.5.2017
p.000210:
p.000210: The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified
p.000210: body itself and shall not be external experts or subcontractors.
p.000210:
p.000210: 2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufac
p.000210: turer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment,
p.000210: designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this
p.000210: Chapter.
p.000210:
p.000210: 3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt
p.000210: implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical
p.000210: application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in
p.000210: Article 107(3).
p.000210:
p.000210: Article 33
p.000210:
p.000210: Subsidiaries and subcontracting
p.000210:
p.000210: 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has
p.000210: recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that
p.000210: the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the
p.000210: authority responsible for notified bodies accordingly.
p.000210:
p.000210: 2. Notified bodies shall take full responsibility for the tasks performed on their behalf by
p.000210: subcontractors or subsidiaries.
p.000210:
...
p.000210: documentation demonstrating compliance with Annex VII.
p.000210:
p.000210: In respect of the organisational and general requirements and the quality management requirements set out
p.000210: in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation
p.000210: report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be
p.000210: submitted and shall be taken into consideration during the assessment described in Article 35. However,
p.000210: the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate
p.000210: compliance with those requirements upon request.
p.000210:
p.000210: 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in
p.000210: order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the
p.000210: requirements set out in Annex VII.
p.000210:
p.000210: Article 35
p.000210:
p.000210: Assessment of the application
p.000210:
p.000210: 1. The authority responsible for notified bodies shall within 30 days check that the application
p.000210: referred to in Article 34 is complete and shall request the applicant to provide any missing
p.000210: information. Once the application is complete that national authority shall send it to the Commission.
p.000210:
p.000210: 5.5.2017 EN
p.000210: Official Journal of the European Union
p.000211: L 117/211
p.000211:
p.000211: The authority responsible for notified bodies shall review the application and supporting documentation in accordance
p.000211: with its own procedures and shall draw up a preliminary assessment report.
p.000211:
p.000211: 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the
p.000211: Commission which shall immediately transmit it to the MDCG.
p.000211:
p.000211: 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction
p.000211: with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific
p.000211: circumstances require a different number of experts, chosen from the list referred to in Article 36. One of the
p.000211: experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team.
p.000211: The other two experts shall come from Member States other than the one in which the applicant conformity assessment
p.000211: body is established.
p.000211:
p.000211: The joint assessment team shall be comprised of competent experts who are competent to assess the
p.000211: conformity assessment activities and the types of devices which are the subject of the application or,
p.000211: in particular when the assessment procedure is initiated in accordance with Article 43(3) to ensure that
p.000211: the specific concern can be appropriately assessed.
p.000211:
p.000211: 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the
p.000211: application in accordance with Article 34. The joint assessment team may provide feedback to, or require clarification
p.000211: from, the authority responsible for notified bodies on the application and on the planned on-site assessment.
p.000211:
p.000211: The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site
p.000211: assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located
p.000211: inside or outside the Union, to be involved in the conformity assessment process.
p.000211:
p.000211: The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
p.000211:
p.000211: 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in
p.000211: Annex VII shall be raised during the assessment process and discussed between the authority responsible
p.000211: for notified bodies and the joint assessment team with a view to reaching consensus and resolving any
p.000211: diverging opinions, with respect to the assessment of the application.
p.000211:
p.000211: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant
p.000211: conformity assessment body the non-compliances resulting from the assessment and summarise of the
p.000211: assessment by the joint assessment team.
p.000211:
p.000211: Within a specified timeframe, the applicant conformity assessment body shall submit to the national
p.000211: authority a corrective and preventive action plan to address the non-compliances.
p.000211:
p.000211: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within
p.000211: 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000211:
p.000211: 7. The authority responsible for notified bodies shall, following receipt of a corrective and
p.000211: preventive action plan from the applicant body, assess whether non-compliances identified during the
p.000211: assessment have been appropriately addressed. This plan shall indicate the root cause of the identified
p.000211: non-compliances and shall include a timeframe for implementation of the actions therein.
p.000211:
p.000211: The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan,
p.000211: forward it and its opinion thereon to the joint assessment team. The joint assessment team may request
p.000211: of the authority responsible for notified bodies further clarification and modifications.
p.000211:
p.000211: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000211: — the result of the assessment,
p.000211:
p.000211: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000211: required, implemented,
p.000211: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000211: — the recommended scope of designation.
p.000211:
p.000212: L 117/212 EN
p.000212: Official Journal of the European Union
p.000212: 5.5.2017
p.000212:
p.000212: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000212: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000212:
p.000212: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the
p.000212: authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those
p.000212: documents to the Commission which shall immediately submit that final opinion to the MDCG. Within 42 days
p.000212: of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with
p.000212: regard to the draft designation, which the authority responsible for notified bodies shall duly take into
p.000212: consideration for its decision on the designation of the notified body.
p.000212:
p.000212: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000212: arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the
p.000212: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000212: accordance with the examination procedure referred to in Article 107(3).
p.000212:
p.000212:
p.000212: Article 36
p.000212:
p.000212: Nomination of experts for joint assessment of applications for notification
p.000212:
p.000212: 1. The Member States and the Commission shall nominate experts qualified in the assessment of
p.000212: conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the
p.000212: activities referred to in Articles 35 and 44.
p.000212:
p.000212: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article,
p.000212: together with information on their specific field of competence and expertise. That list shall be made available to
p.000212: Member States competent authorities through the electronic system referred to in Article 52.
p.000212:
p.000212:
p.000212: Article 37
p.000212:
p.000212: Language requirements
p.000212:
p.000212: All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which
p.000212: shall be determined by the Member State concerned.
p.000212:
p.000212: Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in
p.000212: the medical field, for all or part of the documentation concerned.
p.000212:
p.000212: The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an
p.000212: official Union language, such as is necessary for that documentation to be readily understood by the joint assessment
p.000212: team appointed in accordance with Article 35(3).
p.000212:
p.000212:
p.000212: Article 38
p.000212:
p.000212: Designation and notification procedure
p.000212:
p.000212: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35
p.000212: was completed and which comply with Annex VII.
p.000212:
p.000212: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000212: have designated, using the electronic notification tool within the database of notified bodies developed and managed by
p.000212: the Commission (NANDO).
p.000212:
p.000212: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope
p.000212: of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of
p.000212: devices which the notified body is authorised to assess and, without prejudice to Article 40, any
p.000212: conditions associated with the designation.
p.000212:
p.000212: 5.5.2017 EN
p.000212: Official Journal of the European Union
p.000213: L 117/213
p.000213:
p.000213: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000213: for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and
p.000213: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it
p.000213: shall provide a duly substantiated justification.
p.000213:
p.000213: 5. The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member
p.000213: States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in
p.000213: place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set
p.000213: out in Annex VII.
p.000213:
p.000213: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission
p.000213: may raise written objections, setting out its arguments, with regard either to the notified body or to
p.000213: its monitoring by the authority responsible for notified bodies. Where no objection is raised, the
p.000213: Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in
p.000213: paragraph 2.
p.000213:
p.000213: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
p.000213: bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph
...
p.000213: mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this
p.000213: Article.
p.000213:
p.000213: 11. The designation shall become valid the day after the notification is published in NANDO. The
p.000213: published notification shall state the scope of lawful conformity assessment activity of the notified body.
p.000213:
p.000213: 12. The conformity assessment body concerned may perform the activities of a notified body only
p.000213: after the designation has become valid in accordance with paragraph 11.
p.000213:
p.000213: 13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000213: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000213: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000213: referred to in Article 107(3). The Commission, after consulting the MDCG, may update this list based,
p.000213: inter alia, on information arising from the coordination activities described in Article 44.
p.000213:
p.000213:
p.000213: Article 39
p.000213:
p.000213: Identification number and list of notified bodies
p.000213:
p.000213: 1. The Commission shall assign an identification number to each notified body for which the notification
p.000213: becomes valid in accordance with Article 38(11). It shall assign a single identification number even when
p.000213: the body is notified under several Union acts. If they are successfully designated in accordance with this
p.000213: Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them
p.000213: pursuant to that Directive.
p.000213:
p.000213: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000213: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000213: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000213: It shall also make this list available on the electronic system referred to in Article 52. The Commission shall
p.000213: ensure that the list is kept up to date.
p.000213:
p.000214: L 117/214 EN
p.000214: Official Journal of the European Union
p.000214: 5.5.2017
p.000214:
p.000214: Article 40
p.000214:
p.000214:
p.000214: Monitoring and re-assessment of notified bodies
p.000214:
p.000214:
p.000214: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for
p.000214: notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or
p.000214: their ability to conduct the conformity assessment activities relating to the devices for which they have been
p.000214: designated.
p.000214:
p.000214: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their
p.000214: territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and
p.000214: the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by
p.000214: their authority responsible for notified bodies, supply all relevant information and documents, required to
p.000214: enable the authority, the Commission and other Member States to verify compliance.
p.000214:
p.000214: 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the
p.000214: territory of another Member State relating to a conformity assessment carried out by that notified body,
p.000214: it shall send a copy of that request to the authority responsible for notified bodies of that other
...
p.000214:
p.000214: 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider
p.000214: data arising from market surveillance, vigilance and post-market surveillance to help guide its activities.
p.000214:
p.000214: The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and
p.000214: other information, including from other Member States, which may indicate non-fulfilment of the obligations
p.000214: by a notified body or its deviation from common or best practice.
p.000214:
p.000214: 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments
p.000214: conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify
p.000214: compliance.
p.000214:
p.000214: 8. The authority responsible for notified bodies shall review the assessments by notified bodies of
p.000214: manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in
p.000214: Article 41.
p.000214:
p.000214: 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance
p.000214: of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of
p.000214: corrective and preventive actions.
p.000214:
p.000214: 5.5.2017 EN
p.000214: Official Journal of the European Union
p.000215: L 117/215
p.000215:
p.000215: 10. Three years after notification of a notified body, and again every fourth year thereafter, a complete
p.000215: re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be
p.000215: conducted by the authority responsible for notified bodies of the Member State in which the body is established and by
p.000215: a joint assessment team appointed for the purpose of the procedure described in Articles 34 and 35.
p.000215:
p.000215: 11. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to
p.000215: amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that
p.000215: paragraph is to be carried out.
p.000215:
p.000215: 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring
p.000215: and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and
p.000215: subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to
p.000215: paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain
p.000215: a summary which shall be made publicly available.
p.000215:
p.000215: The summary of the report shall be uploaded to the electronic system referred to in Article 52.
p.000215:
p.000215:
p.000215:
p.000215: Article 41
p.000215:
p.000215:
p.000215: Review of notified body assessment of technical documentation and performance evaluation documentation
p.000215:
p.000215:
...
p.000215: documentation of the manufacturer upon which the notified body has based its assessment. Such reviews
p.000215: shall be conducted utilising CS.
p.000215:
p.000215: 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 40(10)
p.000215: and the joint assessment activities referred to in Article 43(3). The reviews shall be conducted utilising appropriate
p.000215: expertise.
p.000215:
p.000215: 5. Based on the reports of the reviews and assessments by the authority responsible for notified
p.000215: bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance
p.000215: activities described in Chapter VII, or on the continuous monitoring of technical progress, or on the identification of
p.000215: concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that
p.000215: the sampling carried out under this Article cover a greater or lesser proportion of the technical
p.000215: documentation and performance evaluation documentation assessed by a notified body.
p.000215:
p.000215: 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000215: arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and
p.000215: performance evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in
p.000215: accordance with the examination procedure referred to in Article 107(3).
p.000215:
p.000216: L 117/216 EN
p.000216: Official Journal of the European Union
p.000216: 5.5.2017
p.000216:
p.000216: Article 42
p.000216:
p.000216: Changes to designations and notifications
p.000216:
p.000216: 1. The authority responsible for notified bodies shall notify the Commission and the other Member
p.000216: States of any relevant changes to the designation of a notified body.
p.000216:
p.000216: The procedures described in Article 35 and in Article 38 shall apply to extensions of the scope of the designation.
p.000216:
p.000216: For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs
p.000216: shall apply.
p.000216:
p.000216: 2. The Commission shall immediately publish the amended notification in NANDO. The
p.000216: Commission shall immediately enter information on the changes to the designation of the notified body in the
p.000216: electronic system referred to in Article 52.
p.000216:
p.000216: 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority
p.000216: responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned
p.000216: cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine
p.000216: months after cessation of the notified body's activities on condition that another notified body has
p.000216: confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new
p.000216: notified body shall complete a full assessment of the devices affected by the end of that period before issuing new
...
p.000216: market surveillance at their request.
p.000216:
p.000216: 7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified
p.000216: bodies shall:
p.000216:
p.000216: (a) assess the impact on the certificates issued by the notified body;
p.000216:
p.000216: (b) submit a report on its findings to the Commission and the other Member States within three months
p.000216: of having notified the changes to the designation;
p.000216:
p.000216: (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority,
p.000216: any certificates which were unduly issued to ensure the safety of devices on the market;
p.000216:
p.000216: (d) enter in the electronic system referred to in Article 52 information in relation to certificates of which it has
p.000216: required their suspension or withdrawal;
p.000216:
p.000216: (e) inform the competent authority for in vitro diagnostic medical devices of the Member State in
p.000216: which the manufacturer has its registered place of business through the electronic system referred to in
p.000216: Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall
p.000216: take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or
p.000216: others.
p.000216:
p.000216: 5.5.2017 EN
p.000216: Official Journal of the European Union
p.000217: L 117/217
p.000217:
p.000217: 8. With the exception of certificates unduly issued, and where a designation has been suspended or
p.000217: restricted, the certificates shall remain valid in the following circumstances:
p.000217:
p.000217: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction,
p.000217: that there is no safety issue in relation to certificates affected by the suspension or restriction and
p.000217: the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy
p.000217: the suspension or restriction; or
p.000217:
p.000217: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000217: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000217: whether the notified body has the capability of continuing to monitor, and remain responsible for, existing
p.000217: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000217: responsible for notified bodies determines that the notified body does not have the capability to support
p.000217: existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic
p.000217: medical devices of the Member State in which the manufacturer of the device covered by the certificate has its
...
p.000217: opportunity to investigate those concerns.
p.000217:
p.000217: 2. The notifying Member State shall provide the Commission, on request, with all information
p.000217: regarding the designation of the notified body concerned.
p.000217:
p.000217: 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described
p.000217: in Article 35(3) and (5) where there is reasonable concern about the ongoing compliance of a notified
p.000217: body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and
p.000217: where the investi gation by the authority responsible for notified bodies is not deemed to have fully
p.000217: addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome
p.000217: of that assessment shall follow the principles of Article 35. Alternatively, depending on the severity of the issue,
p.000217: the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the
p.000217: participation of up to two experts from the list established pursuant to Article 36 in an on-site assessment as
p.000217: part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual
p.000217: assessment plan described in Article 40(4) therein.
p.000217:
p.000218: L 117/218 EN
p.000218: Official Journal of the European Union
p.000218: 5.5.2017
p.000218:
p.000218: 4. Where the Commission ascertains that a notified body no longer meets the requirements for its
p.000218: designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective
p.000218: measures, including the suspension, restriction or withdrawal of the designation if necessary.
p.000218:
p.000218: Where the Member State fails to take the necessary corrective measures, the Commission may, by means
p.000218: of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be
p.000218: adopted in accordance with the examination procedure referred to in Article 107(3). It shall notify the Member State
p.000218: concerned of its decision and update NANDO and the electronic system referred to in Article 52.
p.000218:
p.000218: 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is
p.000218: treated accordingly.
p.000218:
p.000218:
p.000218: Article 44
p.000218:
p.000218: Peer review and exchange of experience between authorities responsible for notified bodies
p.000218:
p.000218: 1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative
p.000218: practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:
p.000218: (a) development of best practice documents relating to the activities of the authorities responsible for notified
p.000218: bodies;
p.000218: (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation;
p.000218: (c) training and qualification of the experts referred to in Article 36;
...
p.000218: year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be
p.000218: conducted in parallel with the on-site joint assessments described in Article 35. Alternatively, a national authority
p.000218: may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40.
p.000218:
p.000218: 3. The Commission shall participate in the organisation and provide support to the implementation of
p.000218: the peer review mechanism.
p.000218:
p.000218: 4. The Commission shall compile an annual summary report of the peer review activities, which shall
p.000218: be made publicly available.
p.000218:
p.000218: 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and
p.000218: related documents for the peer review mechanisms and training and qualification as referred to in paragraph 1 of
p.000218: this Article. Those implementing acts shall be adopted in accordance with the examination procedure
p.000218: referred to in Article 107(3).
p.000218:
p.000218:
p.000218: Article 45
p.000218:
p.000218: Coordination of notified bodies
p.000218:
p.000218: The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put
p.000218: in place and operated in the form of the coordination group of notified bodies, as referred to in Article 49 of
p.000218: Regulation (EU) 2017/745.
p.000218:
p.000218: The bodies notified under this Regulation shall participate in the work of that group.
p.000218:
p.000218: 5.5.2017 EN
p.000218: Official Journal of the European Union
p.000219: L 117/219
p.000219:
p.000219: Article 46
p.000219:
p.000219: List of standard fees
p.000219:
p.000219: Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry
p.000219: out and shall make those lists publicly available.
p.000219:
p.000219: CHAPTER V
p.000219: CLASSIFICATION AND CONFORMITY ASSESSMENT
p.000219:
p.000219: Section 1
p.000219: Classif ication
p.000219:
p.000219: Article 47
p.000219:
p.000219: Classification of devices
p.000219:
p.000219: 1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices
p.000219: and their inherent risks. Classification shall be carried out in accordance with Annex VIII.
p.000219:
p.000219: 2. Any dispute between the manufacturer and the notified body concerned, arising from the application
p.000219: of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the
p.000219: manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business
p.000219: in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent
p.000219: authority of the Member State in which the authorised representative referred to in the last indent of
p.000219: point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business.
p.000219: Where the notified body concerned is established in a Member State other than that of the manufacturer, the
p.000219: competent authority shall adopt its decision after consultation with the competent authority of the Member State that
p.000219: designated the notified body.
p.000219:
p.000219: The competent authority of the Member State in which the manufacturer has its registered place of business shall notify
p.000219: the MDCG and the Commission of its decision. The decision shall be made available upon request.
p.000219:
p.000219: 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by
p.000219: means of implementing acts, on the following:
p.000219: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the
p.000219: classifi cation of such devices;
p.000219: (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific
p.000219: evidence, or based on any information which becomes available in the course of the vigilance and market surveillance
p.000219: activities be reclassified, by way of derogation from Annex VIII.
p.000219: 4. The Commission may also, on its own initiative and after consulting the MDCG, decide,
p.000219: by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3.
p.000219:
p.000219: 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific
p.000219: opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent
p.000219: necessary to resolve issues of divergent interpretation and of practical application.
p.000219:
p.000219: 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with
p.000219: the examination procedure referred to in Article 107(3).
p.000219:
p.000219: Section 2
p.000219: Conformity assessment
p.000219:
p.000219: Article 48
p.000219:
p.000219: Conformity assessment procedures
p.000219:
p.000219: 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the
p.000219: conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to
p.000219: XI.
p.000219:
p.000220: L 117/220 EN
p.000220: Official Journal of the European Union
p.000220: 5.5.2017
p.000220:
p.000220: 2. Prior to putting into service a device that is not placed on the market, with the exception of
p.000220: in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity
p.000220: of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
p.000220:
p.000220: 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to
p.000220: a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000220: testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of
p.000220: Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the
p.000220: notified body shall consult a competent authority designated by the Member States in accordance with Directive
p.000220: 2001/83/EC of the European Parliament and of the Council (1) or the EMA, as applicable, in accordance with the
p.000220: procedure set out in Section 5.2 of Annex IX.
p.000220:
p.000220: 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the
p.000220: conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment
p.000220: as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
p.000220:
...
p.000220:
p.000220: 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to
p.000220: a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the
p.000220: technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per
p.000220: generic device group.
p.000220:
p.000220: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000220: testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of
p.000220: Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified
p.000220: body shall for every device follow the procedure for technical documentation assessment laid down in
p.000220: Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down
p.000220: in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member
p.000220: States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out
p.000220: in Section 5.2 of Annex IX.
p.000220:
p.000220: (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000220: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000220:
p.000220: 5.5.2017 EN
p.000220: Official Journal of the European Union
p.000221: L 117/221
p.000221:
p.000221: 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the
p.000221: conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as
p.000221: specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5.
p.000221:
p.000221: For companion diagnostics the notified body shall in particular for every device consult a competent
p.000221: authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as
p.000221: applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
p.000221:
p.000221: 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to
p.000221: a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical
p.000221: documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of
p.000221: devices.
p.000221:
p.000221: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000221: testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out
p.000221: in Section 5.1 of Annex IX.
p.000221:
p.000221: 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of
p.000221: their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical
p.000221: documen tation set out in Annexes II and III.
p.000221:
p.000221: However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures
p.000221: set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to
p.000221: establishing, securing and maintaining sterile conditions.
p.000221:
p.000221: 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.
p.000221:
p.000221: 12. The Member State in which the notified body is established may require that all or certain documents,
p.000221: including the technical documentation, audit, assessment and inspection reports, relating to the procedures
p.000221: referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State.
p.000221: In the absence of such requirement, those documents shall be available in any official Union language acceptable to the
p.000221: notified body.
p.000221:
p.000221: 13. The Commission may, by means of implementing acts, specify the detailed arrangements and procedural aspects
p.000221: with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies, for
p.000221: any of the following aspects:
p.000221:
p.000221: (a) the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as
p.000221: set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices;
p.000221:
p.000221: (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified
p.000221: bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
p.000221:
p.000221: (c) the frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU
p.000221: reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex
p.000221: XI; or
p.000221:
p.000221: (d) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests,
p.000221: assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and
p.000221: points
p.000221: (f) and (g) of Section 3. of Annex X.
p.000221:
p.000221: The implementing acts referred to in the first subparagraph shall be adopted in accordance with the
p.000221: examination procedure referred to in Article 107(3).
p.000221:
p.000221:
p.000221: Article 49
p.000221:
p.000221: Involvement of notified bodies in conformity assessment procedures
p.000221:
p.000221: 1. Where the conformity assessment procedure requires the involvement of a notified body, the
p.000221: manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for
p.000221: conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge
p.000221: an application in parallel with another notified body for the same conformity assessment procedure.
p.000221:
p.000222: L 117/222 EN
p.000222: Official Journal of the European Union
p.000222: 5.5.2017
p.000222:
p.000222: 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the
p.000222: other notified bodies of any manufacturer that withdraws its application prior to the notified body's
p.000222: decision regarding the conformity assessment.
p.000222:
p.000222: 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn
p.000222: an application with another notified body prior to the decision of that notified body and provide information about any
p.000222: previous application for the same conformity assessment that has been refused by another notified body.
p.000222:
p.000222: 4. The notified body may require any information or data from the manufacturer, which is necessary
p.000222: in order to properly conduct the chosen conformity assessment procedure.
p.000222:
p.000222: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities
p.000222: with the highest degree of professional integrity and the requisite technical and scientific competence in
p.000222: the specific field and shall be free from all pressures and inducements, particularly financial, which
p.000222: might influence their judgement or the results of their conformity assessment activities, especially as regards
p.000222: persons or groups with an interest in the results of those activities.
p.000222:
p.000222:
p.000222: Article 50
p.000222:
p.000222: Mechanism for scrutiny of conformity assessments of class D devices
p.000222:
p.000222: 1. A notified body shall notify the competent authority of certificates it has granted for class D
p.000222: devices, with the exception of applications to supplement or renew existing certificates. Such notification
p.000222: shall take place through the electronic system referred to in Article 52 and shall include the
p.000222: instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to
p.000222: in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the
p.000222: scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and
p.000222: where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106
p.000222: of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a
p.000222: full justification shall also be included.
p.000222:
p.000222: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further
p.000222: procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in
p.000222: accordance with to Articles 90 and 92.
p.000222:
p.000222: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice
p.000222: from the expert panels in relation to the safety and performance of any device.
p.000222:
p.000222:
p.000222: Article 51
p.000222:
p.000222: Certificates of conformity
p.000222:
p.000222: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000222: Union language determined by the Member State in which the notified body is established or otherwise in an
p.000222: official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out
p.000222: in Annex XII.
p.000222:
p.000222: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application
p.000222: by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five
p.000222: years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any
p.000222: supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
p.000222:
p.000222: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or
p.000222: users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII.
p.000222:
p.000222: 4. Where a notified body finds that the requirements of this Regulation are no longer met by the
p.000222: manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the
p.000222: certificate issued or impose any restrictions on it unless compliance with such requirements is ensured
p.000222: by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the
p.000222: notified body. The notified body shall give the reasons for its decision.
p.000222:
p.000222: 5.5.2017 EN
p.000222: Official Journal of the European Union
p.000223: L 117/223
p.000223:
p.000223: 5. The notified body shall enter in the electronic system referred to in Article 52 any information
p.000223: regarding certificates issued, including amendments and supplements thereto, and regarding suspended,
p.000223: reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be
p.000223: accessible to the public.
p.000223:
p.000223: 6. In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with
p.000223: Article 108 amending the minimum content of the certificates set out in Annex XII.
p.000223:
p.000223: Article 52
p.000223:
p.000223: Electronic system on notified bodies and on certificates of conformity
p.000223:
p.000223: For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57
p.000223: of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article:
p.000223: (a) the list of subsidiaries referred to in Article 33(2);
p.000223: (b) the list of experts referred to in Article 36(2);
p.000223: (c) the information relating to the notification referred to in Article 38(10) and the amended notifications referred
p.000223: to in Article 42(2);
p.000223: (d) the list of notified bodies referred to in Article 39(2);
p.000223: (e) the summary of the report referred to in Article 40(12);
p.000223: (f) the notifications for conformity assessments and certificates referred to in Article 50(1);
p.000223: (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and
p.000223: Section 4.3 of Annex VII;
p.000223: (h) the information regarding certificates referred to in Article 51(5);
p.000223: (i) the summary of safety and performance referred to in Article 29.
p.000223:
...
p.000223: and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
p.000223: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000223: (b) the date until which the identification number of the outgoing notified body may be indicated in the
p.000223: information supplied by the manufacturer, including any promotional material;
p.000223: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000223: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000223: the incoming notified body;
p.000223: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000223: 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date
p.000223: on which they become invalid.
p.000223:
p.000223: Article 54
p.000223:
p.000223: Derogation from the conformity assessment procedures
p.000223:
p.000223: 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified
p.000223: request, the placing on the market or putting into service, within the territory of the Member State concerned, of a
p.000223: specific device for which the procedures referred to in that Article have not been carried out but use
p.000223: of which is in the interest of public health or patient safety or health.
p.000223:
p.000224: L 117/224 EN
p.000224: Official Journal of the European Union
p.000224: 5.5.2017
p.000224:
p.000224: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000224: authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such
p.000224: authorisation is granted for use other than for a single patient.
p.000224:
p.000224: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating
p.000224: to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of
p.000224: time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the
p.000224: territory of the Union and set the conditions under which the device may be placed on the market or
p.000224: put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to
p.000224: in Article 107(3).
p.000224:
p.000224: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000224: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
p.000224: Article 107(4).
p.000224:
p.000224:
p.000224: Article 55
p.000224:
p.000224: Certificate of free sale
p.000224:
p.000224: 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State
p.000224: in which the manufacturer or the authorised representative has its registered place of business shall issue a
p.000224: certificate of free sale declaring that the manufacturer or the authorised representative, as applicable,
p.000224: has its registered place of business on its territory and that the device in question bearing the CE-marking in
p.000224: accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic
p.000224: UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate
p.000224: pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued
p.000224: by the notified body, as referred to in Section 3 of Chapter II of Annex XII.
p.000224:
p.000224: 2. The Commission may, by means of implementing acts, establish a model for certificates of free
p.000224: sale, taking into account international practice as regards the use of certificates of free sale. Those implementing
p.000224: acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
p.000224:
p.000224: CHAPTER VI
p.000224: CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
p.000224:
p.000224: Article 56
p.000224:
p.000224: Performance evaluation and clinical evidence
p.000224:
p.000224: 1. Confirmation of conformity with relevant general safety and performance requirements set out in
p.000224: Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of
p.000224: Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and
p.000224: cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of
p.000224: Annex I, shall be based on scientific validity, analytical and clinical performance data providing
p.000224: sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.
p.000224:
p.000224: The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate
p.000224: conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be
p.000224: appropriate in view of the characteristics of the device and its intended purpose.
p.000224:
p.000224: To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article
p.000224: and with Part A of Annex XIII.
p.000224:
p.000224: 2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be
p.000224: based on a continuous process of performance evaluation, following a performance evaluation plan.
p.000224:
p.000224: 3. A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of
p.000224: the following, in accordance with this Article and with Part A of Annex XIII:
p.000224: (a) scientific validity;
p.000224: (b) analytical performance;
p.000224: (c) clinical performance.
p.000224:
p.000224: 5.5.2017 EN
p.000224: Official Journal of the European Union
p.000225: L 117/225
p.000225:
p.000225: The data and conclusions drawn from the assessment of those elements shall constitute the clinical
p.000225: evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by
p.000225: reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that
p.000225: the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically
p.000225: valid assurance, that the relevant general safety and performance requirements set out in Annex I, are
p.000225: fulfilled, under normal conditions of use.
p.000225:
p.000225: 4. Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless
p.000225: it is duly justified to rely on other sources of clinical performance data.
p.000225:
p.000225: 5. The scientific validity data, the analytical performance data and the clinical performance data,
p.000225: their assessment and the clinical evidence derived therefrom, shall be documented in the performance
p.000225: evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be
p.000225: part of the technical documentation, referred to in Annex II, relating to the device concerned.
p.000225:
p.000225: 6. The performance evaluation and its documentation shall be updated throughout the life cycle of
p.000225: the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance
p.000225: with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79.
p.000225:
p.000225: The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually,
...
p.000225:
p.000225:
p.000225: Article 57
p.000225:
p.000225: General requirements regarding performance studies
p.000225:
p.000225: 1. The manufacturer shall ensure that a device for performance study complies with the general
p.000225: safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and
p.000225: that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient,
p.000225: user and other persons.
p.000225:
p.000225: 2. Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of
p.000225: use of the device.
p.000225:
p.000225: 3. Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and
p.000225: well-being of the subjects participating in such performance studies are protected and prevail over all other interests
p.000225: and the data generated are scientifically valid, reliable and robust.
p.000225:
p.000225: Performance studies, including performance studies that use left-over samples, shall be conducted in
p.000225: accordance with applicable law on data protection.
p.000225:
p.000225:
p.000225: Article 58
p.000225:
p.000225: Additional requirements for certain performance studies
p.000225:
p.000225: 1. Any performance study:
p.000225: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study;
p.000225: (b) that is an interventional clinical performance study as defined in point (46) of Article 2; or
p.000225:
p.000226: L 117/226 EN
p.000226: Official Journal of the European Union
p.000226: 5.5.2017
p.000226:
p.000226: (c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the
p.000226: studies,
p.000226:
p.000226: shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised,
p.000226: conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.
p.000226:
p.000226: 2. Performance studies involving companion diagnostics shall be subject to the same
p.000226: requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving
p.000226: companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority.
p.000226:
p.000226: 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by
p.000226: an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by
p.000226: ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application
p.000226: for auth orisation of a performance study. At least one lay person shall participate in the ethical review.
p.000226:
p.000226: 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a
p.000226: natural or legal person is established in the Union as its legal representative. Such legal representative shall be
p.000226: responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation. Any
p.000226: communication with that legal representative shall be deemed to be a communication with the sponsor.
p.000226:
p.000226: Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their
p.000226: territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor
p.000226: establishes at least a contact person on their territory in respect of that performance study who shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation.
p.000226:
p.000226: 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions
p.000226: are met:
p.000226:
p.000226: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is
p.000226: to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000226:
p.000226: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in
p.000226: relation to the performance study, which is valid for that entire Member State under its national law;
p.000226:
p.000226: (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;
p.000226:
p.000226: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
p.000226:
p.000226: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000226: inconveniences and compliance with this condition is constantly monitored;
p.000226:
p.000226: (f) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative has given informed consent, in accordance with Article 59;
p.000226:
p.000226: (g) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative, has been provided with the contact details of an entity where further information can be received in
p.000226: case of need;
p.000226:
p.000226: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data
p.000226: concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000226:
p.000226: (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable
p.000226: risk as possible for the subjects, and both the risk threshold and the degree of distress are
p.000226: specifically defined in the performance study plan and constantly monitored;
p.000226:
p.000226: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or,
p.000226: where appropriate, any other person entitled by national law to provide the relevant patient care under performance
p.000226: study conditions;
p.000226:
p.000226: 5.5.2017 EN
p.000226: Official Journal of the European Union
p.000227: L 117/227
p.000227:
p.000227: (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his
p.000227: or her legally designated representatives, to participate in the performance study;
p.000227:
p.000227: (l) where appropriate, biological safety testing reflecting the latest scientific knowledge or any other
p.000227: test deemed necessary in the light of the device's intended purpose has been conducted;
p.000227:
p.000227: (m) in the case of clinical performance studies, the analytical performance has been demonstrated, taking into
p.000227: considera tion the state of the art;
p.000227:
p.000227: (n) in the case of interventional clinical performance studies, the analytical performance and scientific validity
p.000227: has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics,
p.000227: the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
p.000227:
p.000227: (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of
p.000227: the art as well as provisions in the field of occupational safety and accident prevention;
p.000227:
p.000227: (p) the requirements of Annex XIV are fulfilled.
p.000227:
p.000227: 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000227: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000227: performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the
...
p.000227: document. The subject or, where the subject is not able to give informed consent, his or her legally designated
p.000227: representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent
p.000227: has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her
p.000227: legally designated representative to consider his or her decision to participate in the performance study.
p.000227:
p.000227: 2. Information given to the subject or, where the subject is not able to give informed consent,
p.000227: his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
p.000227:
p.000227: (a) enable the subject or his or her legally designated representative to understand:
p.000227:
p.000227: (i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study;
p.000227:
p.000227: (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her
p.000227: right to refuse to participate in and the right to withdraw from the performance study at any time
p.000227: without any resulting detriment and without having to provide any justification;
p.000227:
p.000228: L 117/228 EN
p.000228: Official Journal of the European Union
p.000228: 5.5.2017
p.000228:
p.000228: (iii) the conditions under which the performance study is to be conducted, including the expected duration of the
p.000228: subject's participation in the performance study; and
p.000228:
p.000228: (iv) the possible treatment alternatives, including the follow-up measures if the participation of the
p.000228: subject in the performance study is discontinued;
p.000228:
p.000228: (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her
p.000228: legally designated representative;
p.000228:
p.000228: (c) be provided in a prior interview with a member of the investigating team who is appropriately
p.000228: qualified under national law; and
p.000228:
p.000228: (d) include information about the applicable damage compensation system referred to in Article 65;
p.000228:
p.000228: (e) include the Union-wide unique single identification number for the performance study referred to in Article
p.000228: 66(1) and information about the availability of the performance study results in accordance with paragraph
p.000228: 6 of this Article.
p.000228:
p.000228: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or,
p.000228: where the subject is not able to give informed consent, his or her legally designated representative.
p.000228:
p.000228: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information
p.000228: needs of specific patient populations and of individual subjects, as well as to the methods used to give the
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
...
p.000228: set out in Article 58(5), all of the following conditions are met:
p.000228:
p.000228: (a) the informed consent of their legally designated representative has been obtained;
p.000228:
p.000228: (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in
p.000228: view of their capacity to understand it;
p.000228:
p.000228: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000228: the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the
p.000228: performance study at any time, is respected by the investigator;
p.000228:
p.000228: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000228: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000228: the performance study;
p.000228:
p.000228: (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot
p.000228: be obtained in performance studies on persons able to give informed consent, or by other research methods;
p.000228:
p.000228: (f) the performance study relates directly to a medical condition from which the subject suffers;
p.000228:
p.000228: 5.5.2017 EN
p.000228: Official Journal of the European Union
p.000229: L 117/229
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study
p.000229: will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
...
p.000229: minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
...
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
p.000230: condition, the subject is unable to provide prior informed consent and to receive prior information on the performance
p.000230: study;
p.000230:
p.000230: (b) there are scientific grounds to expect that participation of the subject in the performance study
p.000230: will have the potential to produce a direct clinically relevant benefit for the subject resulting in a
p.000230: measurable health-related improvement alleviating the suffering and/or improving the health of the subject,
p.000230: or in the diagnosis of its condition;
p.000230:
p.000230: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
p.000230: prior informed consent from his or her legally designated representative;
p.000230:
p.000230: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000230: performance study previously expressed by the subject;
p.000230:
p.000230: 5.5.2017 EN
p.000230: Official Journal of the European Union
p.000231: L 117/231
p.000231:
p.000231: (e) the performance study relates directly to the subject's medical condition because of which it is not possible
p.000231: within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated
p.000231: rep resentative and to supply prior information, and the performance study is of such a nature that it may be
p.000231: conducted exclusively in emergency situations;
p.000231:
p.000231: (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with
p.000231: the standard treatment of the subject's condition.
p.000231:
p.000231: 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article
p.000231: 59 shall be sought to continue the participation of the subject in the performance study, and
p.000231: information on the performance study shall be given, in accordance with the following requirements:
p.000231:
p.000231: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator
p.000231: from his or her legally designated representative without undue delay and the information referred to in Article
p.000231: 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
p.000231:
...
p.000231:
p.000231: 3. If the subject or, where applicable, his or her legally designated representative does not give
p.000231: consent, he or she shall be informed of the right to object to the use of data obtained from the performance study.
p.000231:
p.000231:
p.000231: Article 65
p.000231:
p.000231: Damage compensation
p.000231:
p.000231: 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from
p.000231: par ticipation in a performance study conducted on their territory are in place in the form of
p.000231: insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate
p.000231: to the nature and the extent of the risk.
p.000231:
p.000231: 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form
p.000231: appropriate for the Member State in which the performance study is conducted.
p.000231:
p.000231:
p.000231: Article 66
p.000231:
p.000231: Application for performance studies
p.000231:
p.000231: 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application
p.000231: to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article
p.000231: as ‘Member State concerned’) accompanied by the documentation referred to in Sections 2 and 3 of Annex
p.000231: XIII and in Annex XIV.
p.000231:
p.000231: The application shall be submitted by means of the electronic system referred to in Article 69, which
p.000231: shall generate a Union-wide unique single identification number for the performance study which shall be
p.000231: used for all relevant communication in relation to that performance study. Within 10 days of receiving
p.000231: the application, the Member State concerned shall notify the sponsor as to whether the performance study falls
p.000231: within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I
p.000231: of Annex XIV.
p.000231:
p.000231: 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV,
p.000231: the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to
p.000231: the documentation clearly identifiable. The Member State concerned shall be notified of the update by
p.000231: means of that electronic system.
p.000231:
p.000232: L 117/232 EN
p.000232: Official Journal of the European Union
p.000232: 5.5.2017
p.000232:
p.000232: 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of
p.000232: this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit
p.000232: of maximum 10 days for the sponsor to comment or to complete the application by means of the
p.000232: electronic system referred to in Article 69. The Member State concerned may extend this period by a
p.000232: maximum of 20 days where appropriate.
p.000232:
p.000232: Where the sponsor has not provided comments nor completed the application within the time limit referred to in the
p.000232: first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the
p.000232: application falls under the scope of this Regulation and/or is complete but the Member State concerned
p.000232: does not agree, the application shall be considered to have been rejected. The Member State concerned
p.000232: shall provide for an appeal procedure in respect of such refusal.
p.000232:
p.000232: The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested
p.000232: additional information, whether the performance study is considered as falling within the scope of this Regulation and
p.000232: the application is complete.
p.000232:
p.000232: 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five
p.000232: days.
p.000232:
p.000232: 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3
p.000232: shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the
...
p.000232: concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45
p.000232: days of the validation date of the application referred to in paragraph 5. The Member State may extend this
p.000232: period by a further 20 days for the purpose of consulting with experts.
p.000232:
p.000232: 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of
p.000232: technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV.
p.000232:
p.000232: 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex
p.000232: XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent
p.000232: interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination
p.000232: procedure referred to in Article 107(3).
p.000232:
p.000232:
p.000232: Article 67
p.000232:
p.000232: Assessment by Member States
p.000232:
p.000232: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not
p.000232: have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons
p.000232: financing the performance study, as well as free of any other undue influence.
p.000232:
p.000232: 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who
p.000232: collectively have the necessary qualifications and experience.
p.000232:
p.000232: 5.5.2017 EN
p.000232: Official Journal of the European Union
p.000233: L 117/233
p.000233:
p.000233: 3. Member States shall assess whether the performance study is designed in such a way that potential remaining
p.000233: risks to subjects or third persons, after risk minimization, are justified, when weighed against the
p.000233: clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards,
p.000233: examine in particular:
p.000233: (a) the demonstration of compliance of the device(s) for performance study with the applicable general
p.000233: safety and performance requirements, apart from the aspects covered by the performance study, and whether,
p.000233: with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This
p.000233: includes, in case of performance studies, the evaluation of the analytical performance, and in case of
p.000233: interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and
p.000233: scientific validity, taking into consideration the state of the art;
p.000233:
p.000233: (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards
p.000233: and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions
p.000233: provide a level of protection that is equivalent to that provided by harmonised standards;
p.000233: (c) whether the measures planned for the safe installation, putting into service and maintenance of the
...
p.000233: extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes
p.000233: into consideration all character istics of the performance study including the following:
p.000233: (a) the objective and methodology of the performance study; and
p.000233: (b) the degree of deviation of the intervention from normal clinical practice.
p.000233: 3. All performance study information shall be recorded, processed, handled, and stored by
p.000233: the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and
p.000233: verified while the confiden tiality of records and the personal data of the subjects remain protected in
p.000233: accordance with the applicable law on personal data protection.
p.000233:
p.000233: 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data
p.000233: processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental
p.000233: loss, in particular where the processing involves transmission over a network.
p.000233:
p.000233: 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance
p.000233: studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
p.000233:
p.000234: L 117/234 EN
p.000234: Official Journal of the European Union
p.000234: 5.5.2017
p.000234:
p.000234: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification
p.000234: and, where necessary, an immediate recall of the devices used in the study.
p.000234:
p.000234:
p.000234: Article 69
p.000234:
p.000234: Electronic system on performance studies
p.000234:
p.000234: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000234: electronic system:
p.000234: (a) to create the single identification numbers for performance studies referred to in Article 66(1);
p.000234: (b) to be used as an entry point for the submission of all applications or notifications for performance studies
p.000234: referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
p.000234: (c) for the exchange of information relating to performance studies in accordance with this Regulation
p.000234: between the Member States and between them and the Commission including the exchange of information
p.000234: referred to in to Articles 72 and 74;
p.000234: (d) for information to be provided by the sponsor in accordance with Article 73, including the
p.000234: performance study report and its summary as required in paragraph 5 of that Article;
p.000234: (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76.
p.000234: 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure
p.000234: that it is interoperable with the EU database for clinical trials on medicinal products for human use
p.000234: set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of
p.000234: the Council (1) as concerns performance studies of companion diagnostics.
p.000234:
p.000234: 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member
p.000234: States and the Commission. The information referred to in the other points of that paragraph shall be accessible to
p.000234: the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the
p.000234: following grounds:
p.000234: (a) protection of personal data in accordance with Regulation (EC) No 45/2001;
p.000234: (b) protection of commercially confidential information, especially in the investigators brochure, in
p.000234: particular through taking into account the status of the conformity assessment for the device, unless
p.000234: there is an overriding public interest in disclosure;
p.000234: (c) effective supervision of the conduct of the performance study by the Member State(s) concerned.
p.000234: 4. No personal data of subjects shall be publicly available.
p.000234:
p.000234: 5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official
p.000234: languages of the Union.
p.000234:
p.000234:
p.000234: Article 70
p.000234:
p.000234: Performance studies regarding devices bearing the CE marking
p.000234:
p.000234: 1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a
p.000234: device which already bears the CE marking in accordance with Article 18(1) (‘PMPF study’), and where the performance
p.000234: study would involve submitting subjects to procedures additional to those performed under the normal conditions of use
p.000234: of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the
p.000234: Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in
p.000234: Article 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex
p.000234: XIV. Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the
p.000234: relevant provisions of Annexes XIII and XIV shall apply to PMPF studies.
p.000234:
p.000234: 2. Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device
p.000234: which already bears the CE marking in accordance with Article 18(1), Articles 58 to 77 shall apply.
p.000234:
p.000234: (1) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on
p.000234: medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
p.000234:
p.000234: 5.5.2017 EN
p.000234: Official Journal of the European Union
p.000235: L 117/235
p.000235:
p.000235: Article 71
p.000235:
p.000235: Substantial modifications to performance studies
p.000235:
p.000235: 1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial
p.000235: impact on the safety, health or rights of the subjects or on the robustness or reliability of the data
p.000235: generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article
p.000235: 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for
p.000235: and the nature of those modifications. The sponsor shall include an updated version of the relevant
p.000235: documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation
p.000235: shall be clearly identifiable.
p.000235:
p.000235: 2. The Member State shall assess any substantial modification to the performance study in accordance
p.000235: with the procedure laid down in Article 67.
p.000235:
p.000235: 3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days
p.000235: after the notification referred to in paragraph 1, unless:
p.000235: (a) the Member State in which the performance study is being or is to be conducted has notified the
p.000235: sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of
p.000235: subject and user safety or health, or of public policy; or
p.000235: (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification
...
p.000235:
p.000235: 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has
p.000235: refused a performance study, or has been notified by the sponsor of the early termination of a
p.000235: performance study on safety grounds, that Member State shall communicate the corresponding decision and
p.000235: the grounds therefor to all Member States and the Commission by means of the electronic system referred to in
p.000235: Article 69.
p.000235:
p.000235: 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall
p.000235: be made available through the electronic system referred to in Article 69 to all Member States and the Commission.
p.000235:
p.000235: Article 73
p.000235:
p.000235: Information from the sponsor at the end of a performance study or in the event of a temporary halt or
p.000235: early termination
p.000235:
p.000235: 1. If the sponsor has temporarily halted a performance study or has terminated a performance study
p.000235: early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted
p.000235: or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early
p.000235: termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety
p.000235: grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours.
p.000235:
p.000236: L 117/236 EN
p.000236: Official Journal of the European Union
p.000236: 5.5.2017
p.000236:
p.000236: 2. The end of a performance study shall be deemed to coincide with the last visit of the last subject unless
p.000236: another point in time for such end is set out in the performance study plan.
p.000236:
p.000236: 3. The sponsor shall notify each Member State in which that performance study was being conducted of the end of
p.000236: that performance study in that Member State. That notification shall be made within 15 days of the end
p.000236: of the performance study in relation to that Member State.
p.000236:
p.000236: 4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that
p.000236: performance study was conducted of the end of the performance study in all Member States. That notification shall be
p.000236: made within 15 days of that end of the performance study.
p.000236:
p.000236: 5. Irrespective of the outcome of the performance study, within one year of the end of the
p.000236: performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the
p.000236: Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of
p.000236: Part A of Annex XIII.
p.000236:
p.000236: The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the
p.000236: intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system
p.000236: referred to in Article 69.
p.000236:
p.000236: Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of
p.000236: the study, it shall be submitted as soon as it is available. In such case, the clinical performance
...
p.000236:
p.000236: 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted
p.000236: in more than one Member State may submit, for the purpose of Article 66, a single application that, upon
p.000236: receipt, is transmitted electronically to all Member States in which the performance study is to be conducted.
p.000236:
p.000236: 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States
p.000236: in which the performance study is to be conducted acts as coordinating Member State. The Member States in
p.000236: which the performance study is to be conducted shall, within six days of submission of the application,
p.000236: agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating
p.000236: Member State, the coordinating Member State proposed by the sponsor shall assume that role.
p.000236:
p.000236: 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States
p.000236: concerned shall coordinate their assessment of the application, in particular of the documentation referred
p.000236: to in Chapter I of Annex XIV.
p.000236:
p.000236: However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of
p.000236: Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed
p.000236: separately by each Member State concerned in accordance with Article 66(1) to (5).
p.000236:
p.000236: 5.5.2017 EN
p.000236: Official Journal of the European Union
p.000237: L 117/237
p.000237:
p.000237: 4. With regard to documentation other than that referred to in the second subparagraph of paragraph
p.000237: 3, the coordinating Member State shall:
p.000237:
p.000237: (a) within six days of receipt of the single application, notify the sponsor that it is the
p.000237: coordinating Member State (‘notification date’);
p.000237:
p.000237: (b) for the purpose of the validation of the application, take into account any considerations submitted
p.000237: within seven days of the notification date by any Member State concerned;
p.000237:
p.000237: (c) within 10 days of the notification date, assess whether the performance study falls within the
p.000237: scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article
p.000237: 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
p.000237:
p.000237: (d) establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the
p.000237: validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned
p.000237: shall transmit their comments and proposals on the draft assessment report and the underlying application
p.000237: to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of
p.000237: the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and
p.000237: the other Member States concerned.
p.000237:
p.000237: The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's
...
p.000237: 107(3).
p.000237:
p.000237: 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the
p.000237: conduct of the performance study is acceptable or acceptable subject to compliance with specific
p.000237: conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) concerned.
p.000237:
p.000237: Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of
p.000237: the coordinating Member State concerning the area of coordinated assessment on the following grounds:
p.000237:
p.000237: (a) when it considers that participation in the performance study would lead to a subject receiving treatment inferior
p.000237: to that received in normal clinical practice in that Member State concerned;
p.000237:
p.000237: (b) infringement of national law; or
p.000237:
p.000237: (c) considerations as regards subject safety and data reliability and robustness submitted under point (d) of
p.000237: paragraph 4.
p.000237:
p.000237: Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this
p.000237: paragraph, it shall communicate its disagreement, together with a detailed justification, through the
p.000237: electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the
p.000237: sponsor.
p.000237:
p.000237: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the
p.000237: performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member
p.000237: States concerned.
p.000237:
p.000238: L 117/238 EN
p.000238: Official Journal of the European Union
p.000238: 5.5.2017
p.000238:
p.000238: 10. A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of
p.000238: the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or
p.000238: if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of
p.000238: Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation
p.000238: to that performance study which is valid in accordance with national law for that entire Member State. That Member
p.000238: State shall provide for an appeal procedure in respect of such refusal.
p.000238:
p.000238: 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69
p.000238: as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether
p.000238: authorisation has been refused. Notification shall be done by way of one single decision within five days of the
p.000238: transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final
p.000238: assessment report. Where an authorisation of a performance study is subject to conditions, those conditions may only be
p.000238: such that, by their nature, they cannot be fulfilled at the time of that authorisation.
p.000238:
p.000238: 12. Any substantial modifications as referred to in Article 71 shall be notified to the Member States
p.000238: concerned by means of the electronic system referred to in Article 69. Any assessment as to whether
...
p.000238: By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on
p.000238: the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and
p.000238: point (g) of Article 113(3).
p.000238:
p.000238:
p.000238: Article 76
p.000238:
p.000238: Recording and reporting of adverse events that occur during performance studies
p.000238:
p.000238: 1. The sponsor shall fully record all of the following:
p.000238: (a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the
p.000238: results of that performance study;
p.000238: (b) any serious adverse event;
p.000238: (c) any device deficiency that might have led to a serious adverse event if appropriate action had not
p.000238: been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000238: (d) any new findings in relation to any event referred to in points (a) to (c).
p.000238: 2. The sponsor shall report without delay to all Member States in which a performance study is being conducted all
p.000238: of the following by means of the electronic system referred to in Article 69:
p.000238: (a) any serious adverse event that has a causal relationship with the device, the comparator or the study procedure
p.000238: or where such causal relationship is reasonably possible;
p.000238: (b) any device deficiency that might have led to a serious adverse event if appropriate action had not
p.000238: been taken, intervention had not occurred, or circumstances had been less fortunate;
p.000238: (c) any new findings in relation to any event referred to in points (a) and (b).
p.000238:
p.000238: 5.5.2017 EN
p.000238: Official Journal of the European Union
p.000239: L 117/239
p.000239:
p.000239: The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting,
p.000239: the sponsor may submit an initial report that is incomplete followed up by a complete report.
p.000239:
p.000239: Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide
p.000239: all information referred to in paragraph 1.
p.000239:
p.000239: 3. The sponsor shall also report to the Member States in which the performance study is being conducted any event
p.000239: referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is
p.000239: performed under the same clinical performance study plan as the one applying to a performance study covered by this
p.000239: Regulation by means of the electronic system referred to in Article 69.
p.000239:
p.000239: 4. In the case of a performance study for which the sponsor has used the single application referred to in Article
p.000239: 74, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the
p.000239: electronic system referred to in Article 69. Upon receipt, this report shall be transmitted electronically to all
p.000239: Member States in which the performance study is being conducted.
p.000239:
p.000239: Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate
p.000239: their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate
p.000239: the performance study or whether to revoke the authorisation for that performance study.
p.000239:
...
p.000239:
p.000239:
p.000239: Article 77
p.000239:
p.000239: Implementing acts
p.000239:
p.000239: The Commission may, by means of implementing acts, establish the detailed arrangements and procedural
p.000239: aspects necessary for the implementation of this Chapter, as regards the following:
p.000239:
p.000239: (a) harmonised electronic forms for the application for performance studies and their assessment as
p.000239: referred to in Articles 66 and 74, taking into account specific categories or groups of devices;
p.000239: (b) the functioning of the electronic system referred to in Article 69;
p.000239:
p.000239: (c) harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of
p.000239: substantial modifications as referred to in Article 71;
p.000239: (d) the exchange of information between Member States as referred to in Article 72;
p.000239:
p.000239: (e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as
p.000239: referred to in Article 76;
p.000239:
p.000239: (f) the timelines for the reporting of serious adverse events and device deficiencies, taking into account the
p.000239: severity of the event to be reported as referred to in Article 76;
p.000239:
p.000239: (g) uniform application of the requirements regarding the clinical evidence/data needed to demonstrate compliance with
p.000239: the general safety and performance requirements set out in Annex I.
p.000239:
p.000239: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000239: referred to in Article 107(3).
p.000239:
p.000240: L 117/240 EN
p.000240: Official Journal of the European Union
p.000240: 5.5.2017
p.000240:
p.000240: CHAPTER VII
p.000240: POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
p.000240:
p.000240: Section 1
p.000240: Post- market sur veillance
p.000240:
p.000240: Article 78
p.000240:
p.000240: Post-market surveillance system of the manufacturer
p.000240:
p.000240: 1. For each device manufacturers shall plan, establish, document, implement, maintain and update a
p.000240: post-market surveillance system in a manner that is proportionate to the risk class and appropriate for
p.000240: the type of device. That system shall be an integral part of the manufacturer's quality management system referred
p.000240: to in Article 10(8).
p.000240:
p.000240: 2. The post-market surveillance system shall be suited to actively and systematically gathering,
p.000240: recording and analysing relevant data on the quality, performance and safety of a device throughout its entire
p.000240: lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and
p.000240: corrective actions.
p.000240:
p.000240: 3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
p.000240: (a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex
p.000240: I;
p.000240: (b) to update the design and manufacturing information, the instructions for use and the labelling;
p.000240: (c) to update the performance evaluation;
p.000240: (d) to update the summary of safety and performance referred to in Article 29;
p.000240: (e) for the identification of needs for preventive, corrective or field safety corrective action;
...
p.000240: (h) to detect and report trends in accordance with Article 83. The technical documentation shall be updated
p.000240: accordingly.
p.000240: 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is
p.000240: identified, the manufacturer shall implement the appropriate measures and inform the competent authorities
p.000240: concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety
p.000240: corrective action is implemented, it shall be reported in accordance with Article 82.
p.000240:
p.000240:
p.000240: Article 79
p.000240:
p.000240: Post-market surveillance plan
p.000240:
p.000240: The post-market surveillance system referred to in Article 78 shall be based on a post-market
p.000240: surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market
p.000240: surveillance plan shall be part of the technical documentation specified in Annex II.
p.000240:
p.000240:
p.000240: Article 80
p.000240:
p.000240: Post-market surveillance report
p.000240:
p.000240: Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the
p.000240: results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000240: surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective
p.000240: actions taken. The report shall be updated when necessary and made available to the notified body and
p.000240: the competent authority upon request.
p.000240:
p.000240: 5.5.2017 EN
p.000240: Official Journal of the European Union
p.000241: L 117/241
p.000241:
p.000241: Article 81
p.000241:
p.000241: Periodic safety update report
p.000241:
p.000241: 1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each
p.000241: device and where relevant for each category or group of devices summarising the results and conclusions of the analyses
p.000241: of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article
p.000241: 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime
p.000241: of the device concerned, that PSUR shall set out:
p.000241: (a) the conclusions of the benefit-risk determination;
p.000241: (b) the main findings of the PMPF; and
p.000241: (c) the volume of sales of the device and an estimate of the size and other characteristics of the population using
p.000241: the device and, where practicable, the usage frequency of the device.
p.000241: Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the
p.000241: technical documentation as specified in Annexes II and III.
p.000241:
p.000241: 2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87
p.000241: to the notified body involved in the conformity assessment of such devices in accordance with Article
p.000241: 48. The notified body shall review the report and add its evaluation to that electronic system with details of any
p.000241: action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities
p.000241: through that electronic system.
p.000241:
p.000241: 3. For class C devices, manufacturers shall make PSURs available to the notified body involved in
p.000241: the conformity assessment and, upon request, to competent authorities.
p.000241:
p.000241: Section 2
p.000241: Vigilance
p.000241:
p.000241: Article 82
p.000241:
p.000241: Reporting of serious incidents and field safety corrective actions
p.000241:
p.000241: 1. Manufacturers of devices, made available on the Union market, other than devices for performance
p.000241: study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
p.000241: (a) any serious incident involving devices made available on the Union market, except expected erroneous results which
p.000241: are clearly documented and quantified in the product information and in the technical documentation and
p.000241: are subject to trend reporting pursuant to Article 83;
p.000241: (b) any field safety corrective action in respect of devices made available on the Union market, including any field
p.000241: safety corrective action undertaken in a third country in relation to a device which is also legally made
p.000241: available on the Union market, if the reason for the field safety corrective action is not limited to the device
p.000241: made available in the third country.
p.000241: The reports referred to in the first subparagraph shall be submitted through the electronic system
p.000241: referred to in Article 87.
p.000241:
p.000241: 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity
p.000241: of the serious incident.
p.000241:
p.000241: 3. Manufacturers shall report any serious incident as referred to in point (a) immediately after they have
p.000241: established a causal relationship between that incident and their device or that such causal relationship is
p.000241: reasonably possible, and not later than 15 days after they become aware of the incident.
p.000241:
p.000241: 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph
p.000241: 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
p.000241:
p.000241: 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's
p.000241: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000241: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000241: after the date on which the manufacturer becomes aware of the serious incident.
p.000241:
p.000242: L 117/242 EN
p.000242: Official Journal of the European Union
p.000242: 5.5.2017
p.000242:
p.000242: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is
p.000242: incomplete followed up by a complete report.
p.000242:
p.000242: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about
p.000242: whether the incident is reportable, it shall nevertheless submit a report within the timeframe required
p.000242: in accordance with paragraphs 2 to 5.
p.000242:
p.000242: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000242: immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in
p.000242: point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
p.000242:
p.000242: 9. For similar serious incidents that occur with the same device or device type and for which the root cause has
p.000242: been identified or a field safety corrective action implemented or where the incidents are common and well documented,
p.000242: the manufacturer may provide periodic summary reports instead of individual serious incident reports, on
p.000242: condition that the coordinating competent authority referred to in Article 84(9), in consultation with the
p.000242: competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the
p.000242: manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent
...
p.000242: conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with
p.000242: paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance
p.000242: with Article 84.
p.000242:
p.000242:
p.000242: Article 83
p.000242:
p.000242: Trend reporting
p.000242:
p.000242: 1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically
p.000242: significant increase in the frequency or severity of incidents that are not serious incidents that could have a
p.000242: significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may
p.000242: lead to unacceptable risks to the health or safety of patients, users or other persons or of any
p.000242: significant increase in expected erroneous results established in comparison to the stated performance of the
p.000242: device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and
p.000242: product information.
p.000242:
p.000242: The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology
p.000242: used for determining any statistically significant increase in the frequency or severity of such events
p.000242: or change in performance, as well as the observation period, in the post-market surveillance plan referred to in
p.000242: Article 79.
p.000242:
p.000242: 5.5.2017 EN
p.000242: Official Journal of the European Union
p.000243: L 117/243
p.000243:
p.000243: 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and
p.000243: require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to
p.000243: ensure the protection of public health and patient safety. Each competent authority shall inform the
p.000243: Commission, the other competent authorities and the notified body that issued the certificate, of the
p.000243: results of such assessment and of the adoption of such measures.
p.000243:
p.000243:
p.000243:
p.000243: Article 84
p.000243:
p.000243: Analysis of serious incidents and field safety corrective actions
p.000243:
p.000243: 1. Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall,
p.000243: without delay, perform the necessary investigations in relation to the serious incident and the devices concerned.
p.000243: This shall include risk assessment of the incident and field safety corrective action taking into account the criteria
p.000243: as referred to in paragraph 3 of this Article as appropriate.
p.000243:
p.000243: The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned
p.000243: during the investigations referred to in the first subparagraph and shall not perform any investigation
p.000243: which involves altering the device or a sample of the batch concerned in a way which may affect any
p.000243: subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
p.000243:
...
p.000243: investi gation by means of the electronic system referred to in Article 87. The report shall set out
p.000243: conclusions and where relevant indicate corrective actions to be taken.
p.000243:
p.000243: 6. In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority
p.000243: referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member
p.000243: State that authorised the medicinal products or the EMA was consulted by the notified body in accordance
p.000243: with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent
p.000243: authority or the EMA, as appropriate.
p.000243:
p.000243: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating
p.000243: competent authority shall, through the electronic system referred to in Article 87, inform without delay
p.000243: the other competent authorities of the corrective action taken or envisaged by the manufacturer or
p.000243: required of it to minimise the risk of recurrence of the serious incident, including information on the
p.000243: underlying serious incidents and the outcome of its assessment.
p.000243:
p.000244: L 117/244 EN
p.000244: Official Journal of the European Union
p.000244: 5.5.2017
p.000244:
p.000244: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000244: brought without delay to the attention of users of the device in question by means of a field safety notice. The field
p.000244: safety notice shall be edited in an official Union language or languages determined by the Member State in which the
p.000244: field safety corrective action is taken. Except in cases of urgency, the content of the draft field
p.000244: safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph
p.000244: 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of
p.000244: the individual Member State, the content of the field safety notice shall be consistent in all Member States.
p.000244:
p.000244: The field safety notice shall allow the correct identification of the device or devices involved, in particular by
p.000244: including the relevant UDIs, and the correct identification, in particular by including the SRN, if
p.000244: already issued, of the manufacturer that has undertaken the field safety corrective action. The field
p.000244: safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for
p.000244: the field safety corrective action with reference to the device malfunction and associated risks for patients,
p.000244: users or other persons and shall clearly indicate all the actions to be taken by users.
p.000244:
p.000244: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which
p.000244: that notice shall be accessible to the public.
p.000244:
p.000244: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
p.000244: referred to in paragraph 3 in the following cases:
p.000244:
...
p.000244: competent authority and the Commission shall be kept informed of the outcome of any such assessment and the
p.000244: adoption of any such measures.
p.000244:
p.000244: 11. The Commission shall provide administrative support to the coordinating competent
p.000244: authority in the accomplishment of its tasks under this Chapter.
p.000244:
p.000244:
p.000244: Article 85
p.000244:
p.000244: Analysis of vigilance data
p.000244:
p.000244: The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor
p.000244: the data available in the electronic system referred to in Article 87, in order to identify trends, patterns or signals
p.000244: in the data that may reveal new risks or safety concerns.
p.000244:
p.000244: Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely
p.000244: changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating
p.000244: competent authority shall inform the manufacturer, or where applicable the authorised representative, which
p.000244: shall then take the necessary corrective actions.
p.000244:
p.000244: 5.5.2017 EN
p.000244: Official Journal of the European Union
p.000245: L 117/245
p.000245:
p.000245: Article 86
p.000245:
p.000245: Implementing acts
p.000245:
p.000245: The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the
p.000245: detailed arrangements and procedural aspects necessary for the implementation of Articles 80 to 85 and 87
p.000245: as regards the following:
p.000245: (a) the typology of serious incidents and field safety corrective actions in relation to specific devices,
p.000245: or categories or groups of devices;
p.000245: (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and
p.000245: the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers
p.000245: as referred to in Articles 80, 81, 82, 83 and 84 respectively;
p.000245: (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting
p.000245: of suspected serious incidents by healthcare professionals, users and patients;
p.000245: (d) timelines for the reporting of field safety corrective actions, and for the provision by
p.000245: manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be
p.000245: reported as referred to in Article 82;
p.000245: (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 84;
p.000245: (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process,
p.000245: including tasks and responsibilities of the coordinating competent authority and involvement of other competent
p.000245: authorities in this process.
...
p.000245: (c) the reports by manufacturers on trends referred to in Article 83;
p.000245: (d) the PSURs referred to in Article 81;
p.000245: (e) the field safety notices by manufacturers referred to in Article 84(8);
p.000245: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000245: them and the Commission in accordance with Article 84(7) and (9).
p.000245: That electronic system shall include relevant links to the UDI database.
p.000245:
p.000245: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000245: system to the competent authorities of the Member States and to the Commission. The notified bodies shall also
p.000245: have access to that information to the extent that it relates to devices for which they issued a certificate in
p.000245: accordance with Article 49.
p.000245:
p.000245: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to
p.000245: the electronic system referred to in paragraph 1.
p.000245:
p.000245: 4. On the basis of arrangements between the Commission and competent authorities of third countries or internat
p.000245: ional organisations, the Commission may grant those competent authorities or international organisations access to the
p.000245: electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity
p.000245: and make provision for confidentiality and data protection equivalent to those applicable in the Union.
p.000245:
p.000246: L 117/246 EN
p.000246: Official Journal of the European Union
p.000246: 5.5.2017
p.000246:
p.000246: 5. The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted,
p.000246: upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the
p.000246: Member State in which the incident occurred.
p.000246:
p.000246: 6. The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt
p.000246: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000246: the Member States in which the incidents occurred.
p.000246:
p.000246: 7. The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall
p.000246: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000246: competent authorities of the following Member States:
p.000246: (a) the Member State in which the field safety corrective action is being or is to be undertaken;
p.000246: (b) the Member State in which the manufacturer has its registered place of business.
p.000246: 8. The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via
p.000246: the electronic system referred to in paragraph 1 of this Article to the competent authority of:
p.000246:
p.000246: (a) the Member State or Member States participating in the coordination procedure in accordance with
p.000246: Article 84(9) and which have agreed on the periodic summary report;
p.000246: (b) the Member State in which the manufacturer has its registered place of business.
...
p.000246: (a) may require economic operators to, inter alia, make available the documentation and information necessary for
p.000246: the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of
p.000246: devices or access to devices free of charge; and
p.000246: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators,
p.000246: as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
p.000246:
p.000246: 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and
p.000246: make it accessible to other competent authorities by means of the electronic system referred to in Article 95.
p.000246:
p.000246: 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that
p.000246: present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the
p.000246: protection of public health.
p.000246:
p.000246: 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority
p.000246: shall draw up a report on the findings of the inspection that concern compliance with the legal and technical
p.000246: requirements applicable under this Regulation. The report shall set out any corrective actions needed.
p.000246:
p.000246: 5.5.2017 EN
p.000246: Official Journal of the European Union
p.000247: L 117/247
p.000247:
p.000247: 7. The competent authority which carried out the inspection shall communicate the content of the report referred
p.000247: to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting
p.000247: the final report, the competent authority shall give that economic operator the opportunity to submit comments. That
p.000247: final inspection report shall be entered in the electronic system provided for in Article 95.
p.000247:
p.000247: 8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews
p.000247: and assessments shall be carried out at least every four years and the results thereof shall be
p.000247: communicated to the other Member States and the Commission. Each Member State shall make a summary of the results
p.000247: accessible to the public by means of the electronic system referred to in Article 95.
p.000247:
p.000247: 9. The competent authorities of the Member States shall coordinate their market surveillance
p.000247: activities, cooperate with each other and share with each other and with the Commission the results thereof, to
p.000247: provide for a harmonised and high level of market surveillance in all Member States.
p.000247:
p.000247: Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint
p.000247: market surveillance activities and specialisation.
p.000247:
p.000247: 10. Where more than one authority in a Member State is responsible for market surveillance and
...
p.000247: the device presents an unacceptable risk to the health or safety of patients, users or other persons,
p.000247: or to other aspects of the protection of public health, they shall without delay require the manufacturer of
p.000247: the devices concerned, its authorised representative and all other relevant economic operators to take all
p.000247: appropriate and duly justified corrective action to bring the device into compliance with the requirements of
p.000247: this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature
p.000247: of the risk, to restrict the making available of the device on the market, to subject the making available of the
p.000247: device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period
p.000247: that is clearly defined and communicated to the relevant economic operator.
p.000247:
p.000247: 2. The competent authorities shall, without delay, notify the Commission, the other Member States
p.000247: and, where a certificate has been issued in accordance with Article 51 for the device concerned, the notified body
p.000247: that issued that certificate, of the results of the evaluation and of the actions which they have required the economic
p.000247: operators to take, by means of the electronic system referred to in Article 95.
p.000247:
p.000248: L 117/248 EN
p.000248: Official Journal of the European Union
p.000248: 5.5.2017
p.000248:
p.000248: 3. The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate
p.000248: corrective action is taken throughout the Union in respect of all the devices concerned that they have
p.000248: made available on the market.
p.000248:
p.000248: 4. Where the economic operator as referred to in paragraph 1 does not take adequate corrective action
p.000248: within the period referred to in paragraph 1, the competent authorities shall take all appropriate measures to
p.000248: prohibit or restrict the making available of the device on their national market, to withdraw the device from that
p.000248: market or to recall it.
p.000248:
p.000248: The competent authorities shall notify the Commission, the other Member States and the notified body
p.000248: referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic
p.000248: system referred to in Article 95.
p.000248:
p.000248: 5. The notification referred to in paragraph 4 shall include all available details, in particular the data
p.000248: necessary for the identification and tracing of the non-compliant device, the origin of the device, the
p.000248: nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration
p.000248: of the national measures taken and the arguments put forward by the relevant economic operator.
p.000248:
p.000248: 6. Member States other than the Member State initiating the procedure shall, without delay, inform the Commission
p.000248: and the other Member States, by means of the electronic system referred to in Article 95, of any
p.000248: additional relevant information at their disposal relating to the non-compliance of the device concerned and of any
p.000248: measures adopted by them in relation to the device concerned.
p.000248:
p.000248: In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and
p.000248: the other Member States of their objections, by means of the electronic system referred to in Article 95.
p.000248:
p.000248: 7. Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been
p.000248: raised by either a Member State or the Commission in respect of any measures taken by a Member State, those measures
p.000248: shall be deemed to be justified. In that case, all Member States shall ensure that corresponding
p.000248: appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the
p.000248: device on their national market are taken without delay in respect of the device concerned.
p.000248:
p.000248:
p.000248: Article 91
p.000248:
p.000248: Procedure for evaluating national measures at Union level
p.000248:
p.000248: 1. Where, within two months of receipt of the notification referred to in Article 90(4), objections
p.000248: are raised by a Member State against a measure taken by another Member State, or where the Commission considers the
p.000248: measure to be contrary to Union law, the Commission shall, after consulting the competent authorities
p.000248: concerned and, where necessary, the economic operators concerned, evaluate that national measure. On the
p.000248: basis of the results of that evaluation, the Commission may decide, by means of implementing acts,
p.000248: whether or not the national measure is justified. Those implementing acts shall be adopted in accordance
p.000248: with the examination procedure referred to in Article 107(3).
p.000248:
p.000248: 2. Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this
p.000248: Article, the second subparagraph of Article 90(7) shall apply. If the Commission considers the national
p.000248: measure to be unjustified, the Member State concerned shall withdraw the measure.
p.000248:
p.000248: Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt
p.000248: of the notification referred to in Article 90(4), the national measure shall be considered to be justified.
p.000248:
p.000248: 3. Where a Member State or the Commission considers that the risk to health and safety emanating from a device
p.000248: cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States
p.000248: concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of
p.000248: implementing acts, the necessary and duly justified measures to ensure the protection of health and safety,
p.000248: including measures restricting or prohibiting the placing on the market and putting into service of the device
p.000248: concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000248: 107(3).
p.000248:
p.000248: 5.5.2017 EN
p.000248: Official Journal of the European Union
p.000249: L 117/249
p.000249:
p.000249: Article 92
p.000249:
p.000249: Other non-compliance
p.000249:
p.000249: 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities of a Member State find
p.000249: that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable
p.000249: risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public
p.000249: health, they shall require the relevant economic operator to bring the non-compliance concerned to an end
p.000249: within a reasonable period that is clearly defined and communicated to the economic operator and that is
p.000249: proportionate to the non- compliance.
p.000249:
p.000249: 2. Where the economic operator does not bring the non-compliance to an end within the period
p.000249: referred to in paragraph 1 of this Article, the Member State concerned shall without delay take all appropriate
p.000249: measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or
p.000249: withdrawn from the market. That Member State shall inform the Commission and the other Member States
p.000249: without delay of those measures, by means of the electronic system referred to in Article 95.
p.000249:
p.000249: 3. In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts,
p.000249: specify appropriate measures to be taken by competent authorities to address given types of
p.000249: non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in
p.000249: Article 107(3).
p.000249:
...
p.000249: available on the market or putting into service of a device, specific category or group of devices should be
p.000249: prohibited, restricted or made subject to particular requirements or that such device or category or group of
p.000249: devices should be withdrawn from the market or recalled in all Member States in order to protect the health and
p.000249: safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing
p.000249: acts) to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance
p.000249: with the examination procedure referred to in Article 107(3).
p.000249:
p.000249:
p.000249: Article 94
p.000249:
p.000249: Good administrative practice
p.000249:
p.000249: 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state
p.000249: the exact grounds on which it is based. Where such a measure is addressed to a specific economic
p.000249: operator, the competent authority shall notify without delay the economic operator concerned of that measure, and
p.000249: shall at the same time inform that economic operator of the remedies available under the law or the
p.000249: administrative practice of the Member State concerned and of the time limits to which such remedies are subject.
p.000249: Where the measure is of general ap plicability, it shall be appropriately published.
p.000249:
p.000250: L 117/250 EN
p.000250: Official Journal of the European Union
p.000250: 5.5.2017
p.000250:
p.000250: 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human health
p.000250: or safety, the economic operator concerned shall be given the opportunity to make submissions to the
p.000250: competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
p.000250:
p.000250: Where action has been taken without the economic operator having had the opportunity to make submissions
p.000250: as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible
p.000250: and the action taken shall be reviewed promptly thereafter.
p.000250:
p.000250: 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that
p.000250: it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation.
p.000250:
p.000250: 4. Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified
p.000250: body has been involved in the conformity assessment, the competent authorities shall by means of the electronic
p.000250: system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body
p.000250: of the measure taken.
p.000250:
p.000250: Article 95
p.000250:
p.000250: Electronic system on market surveillance
p.000250:
p.000250: 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to
p.000250: collate and process the following information:
...
p.000250: electronic system to all competent authorities concerned and, where applicable, to the notified body that
p.000250: issued a certificate in accordance with Article 51 for the device concerned and be accessible to the Member States
p.000250: and to the Commission.
p.000250:
p.000250: 3. Information exchanged between Member States shall not be made public where to do so might impair
p.000250: market surveillance activities and co-operation between Member States.
p.000250:
p.000250: CHAPTER VIII
p.000250: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
p.000250:
p.000250: Article 96
p.000250:
p.000250: Competent authorities
p.000250:
p.000250: The Member States shall designate the competent authority or authorities responsible for the
p.000250: implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and
p.000250: knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States
p.000250: shall communicate the names and contact details of the competent authorities to the Commission which shall publish
p.000250: a list of competent authorities.
p.000250:
p.000250: Article 97
p.000250:
p.000250: Cooperation
p.000250:
p.000250: 1. The competent authorities of the Member States shall cooperate with each other and with the Commission. The
p.000250: Commission shall provide for the organisation of exchanges of information necessary to enable this
p.000250: Regulation to be applied uniformly.
p.000250:
p.000250: 5.5.2017 EN
p.000250: Official Journal of the European Union
p.000251: L 117/251
p.000251:
p.000251: 2. Member States shall with the support of the Commission participate, where appropriate, in initiatives developed
p.000251: at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical
p.000251: devices.
p.000251:
p.000251: Article 98
p.000251:
p.000251: Medical Device Coordination Group
p.000251:
p.000251: The Medical Device Coordination Group (MDCG) established in accordance with the conditions and
p.000251: detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support
p.000251: of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this
p.000251: Regulation as well as those under Regulation (EU) 2017/745.
p.000251:
p.000251: Article 99
p.000251:
p.000251: Tasks of the MDCG
p.000251:
p.000251: Under this Regulation, the MDCG shall have the following tasks:
p.000251: (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies
p.000251: pursuant to the provisions set out in Chapter IV;
p.000251: (b) to advise the Commission, at its request, in matters concerning the coordination group of notified
p.000251: bodies as established pursuant to Article 45;
p.000251: (c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation
p.000251: of this Regulation, in particular regarding the designation and monitoring of notified bodies, application
p.000251: of the general safety and performance requirements and conduct of performance evaluations by manufacturers,
p.000251: assessment by notified bodies and vigilance activities;
p.000251: (d) to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and
p.000251: performance requirements laid down in this Regulation and Regulation (EU) 2017/745 are adequate to ensure safety and
p.000251: performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this
p.000251: Regulation;
p.000251: (e) to contribute to the development of device standards and of CS;
p.000251: (f) to assist the competent authorities of the Member States in their coordination activities in particular in the
p.000251: fields of classification and the determination of the regulatory status of devices, performance studies,
p.000251: vigilance and market surveillance including the development and maintenance of a framework for a European
p.000251: market surveillance programme with the objective of achieving efficiency and harmonisation of market
p.000251: surveillance in the Union, in accordance with Article 88;
p.000251: (g) to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue
p.000251: related to the implementation of this Regulation;
p.000251: (h) to contribute to harmonised administrative practice with regard to devices in the Member States.
p.000251:
p.000251: Article 100
p.000251:
p.000251: The European Union reference laboratories
p.000251:
p.000251: 1. For specific devices, or a category or group of devices, or for specific hazards related to a
p.000251: category or group of devices, the Commission may designate, by means of implementing acts, one or more
p.000251: European Union reference laboratories (the ‘EU reference laboratories’), that satisfy the criteria set out in
p.000251: paragraph 4. The Commission shall only designate the EU reference laboratories for which a Member State or
p.000251: the Commission's Joint Research Centre have submitted an application for designation.
p.000251:
p.000251: 2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have
p.000251: the following tasks:
p.000251: (a) to verify the performance claimed by the manufacturer and the compliance of class D devices with the
p.000251: applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and
p.000251: performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);
p.000251: (b) to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as
p.000251: provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI;
p.000251:
p.000252: L 117/252 EN
p.000252: Official Journal of the European Union
p.000252: 5.5.2017
p.000252:
p.000252: (c) to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies
p.000252: in relation to the implementation of this Regulation;
p.000252:
p.000252: (d) to provide scientific advice regarding the state of the art in relation to specific devices, or a
p.000252: category or group of devices;
p.000252:
p.000252: (e) to set up and manage a network of national reference laboratories after consulting with the national authorities
p.000252: and publish a list of the participating national reference laboratories and their respective tasks;
p.000252:
p.000252: (f) to contribute to the development of appropriate testing and analysis methods to be applied for
p.000252: conformity assessment procedures and market surveillance;
p.000252:
p.000252: (g) to collaborate with notified bodies in the development of best practices for the performance of
p.000252: conformity assessment procedures;
p.000252:
p.000252: (h) to provide recommendations on suitable reference materials and reference measurement procedures of
p.000252: higher metrological order;
p.000252:
p.000252: (i) to contribute to the development of CS and of international standards;
p.000252:
p.000252: (j) to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation
p.000252: and publish them by electronic means having considered national provisions on confidentiality.
p.000252:
p.000252: 3. At the request of a Member State, the Commission may also designate the EU reference
p.000252: laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the
p.000252: performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when
...
p.000252: (c) have the necessary knowledge of international standards and best practices;
p.000252: (d) have an appropriate administrative organisation and structure;
p.000252: (e) ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks;
p.000252: (f) act in the public interest and in an independent manner;
p.000252:
p.000252: (g) ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device
p.000252: industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in
p.000252: vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs.
p.000252:
p.000252: 5. The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods
p.000252: as regards testing and assessment. That coordination and harmonisation shall involve:
p.000252:
p.000252: (a) applying coordinated methods, procedures and processes;
p.000252: (b) agreeing on the use of same reference materials and common test samples and seroconversion panels;
p.000252: (c) establishing common assessment and interpretation criteria;
p.000252:
p.000252: (d) using common testing protocols and assessing the test results using standardised and coordinated
p.000252: evaluation methods;
p.000252:
p.000252: (e) using standardised and coordinated test reports;
p.000252: (f) developing, applying and maintaining a peer review system;
p.000252: (g) organizing regular quality assessment tests (including mutual checks on the quality and comparability of test
p.000252: results);
p.000252:
p.000252: 5.5.2017 EN
p.000252: Official Journal of the European Union
p.000253: L 117/253
p.000253:
p.000253: (h) agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures;
p.000253: (i) coordinating the introduction of testing methods for new technologies and according to new or amended CS;
p.000253: (j) reassessing the state of the art on the basis of comparative test results or by further studies,
p.000253: as requested by a Member State or by the Commission.
p.000253: 6. The EU reference laboratories may be granted a Union financial contribution.
p.000253:
p.000253: The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a
p.000253: Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety
p.000253: protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in
p.000253: accordance with the examination procedure referred to in Article 107(3).
p.000253:
p.000253: 7. Where notified bodies or Member States request scientific or technical assistance or a scientific
p.000253: opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover
p.000253: the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent
p.000253: terms and conditions.
p.000253:
p.000253: 8. The Commission shall specify by means of implementing acts:
p.000253: (a) detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure
p.000253: compliance with the criteria referred to in paragraph 4 of this Article.
p.000253: (b) the structure and the level of the fees referred to in paragraph 7 of this Article which may be
p.000253: levied by an EU reference laboratory for providing scientific opinions in response to consultations by
p.000253: notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human
p.000253: health and safety protection, support of innovation and cost-effectiveness.
p.000253: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000253:
p.000253: 9. The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the
...
p.000253: EU reference laboratories.
p.000253:
p.000253:
p.000253: Article 101
p.000253:
p.000253: Device registers and databanks
p.000253:
p.000253: The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers
p.000253: and databanks for specific types of devices setting common principles to collect comparable information. Such registers
p.000253: and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices.
p.000253:
p.000253: CHAPTER IX
p.000253: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
p.000253:
p.000253: Article 102
p.000253:
p.000253: Confidentiality
p.000253:
p.000253: 1. Unless otherwise provided for in this Regulation and without prejudice to existing national
p.000253: provisions and practices in the Member States on confidentiality, all parties involved in the application of this
p.000253: Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to
p.000253: protect the following:
p.000253: (a) personal data in accordance with Article 103;
p.000253: (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual
p.000253: property rights unless disclosure is in the public interest;
p.000253: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000253: audits.
p.000253:
p.000254: L 117/254 EN
p.000254: Official Journal of the European Union
p.000254: 5.5.2017
p.000254:
p.000254: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities
p.000254: and between competent authorities and the Commission shall not be disclosed without the prior agreement
p.000254: of the originating authority.
p.000254:
p.000254: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000254: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000254: obligations of the persons concerned to provide information under criminal law.
p.000254:
p.000254: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000254: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000254:
p.000254: Article 103
p.000254:
p.000254: Data protection
p.000254:
p.000254: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member
p.000254: States pursuant to this Regulation.
p.000254:
p.000254: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000254: Commission pursuant to this Regulation.
p.000254:
p.000254: Article 104
p.000254:
p.000254: Levying of fees
p.000254:
p.000254: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities
p.000254: set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of
p.000254: cost-recovery principles.
p.000254:
...
p.000254: available on request.
p.000254:
p.000254: Article 105
p.000254:
p.000254: Funding of activities related to designation and monitoring of notified bodies
p.000254:
p.000254: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
p.000254: shall, by means of implementing acts, lay down the scale and structure of recoverable costs
p.000254: and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination
p.000254: procedure referred to in Article 107(3).
p.000254:
p.000254: Article 106
p.000254:
p.000254: Penalties
p.000254:
p.000254: The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this
p.000254: Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall
p.000254: be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those
p.000254: measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them.
p.000254:
p.000254: CHAPTER X
p.000254: FINAL PROVISIONS
p.000254:
p.000254: Article 107
p.000254:
p.000254: Committee procedure
p.000254:
p.000254: 1. The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation
p.000254: (EU) 2017/745. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011
p.000254: 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
p.000254:
p.000254: 5.5.2017 EN
p.000254: Official Journal of the European Union
p.000255: L 117/255
p.000255:
p.000255: 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
p.000255:
p.000255: Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and
p.000255: the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
p.000255:
p.000255: 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
p.000255: conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
p.000255:
p.000255:
p.000255: Article 108
p.000255:
p.000255: Exercise of the delegation
p.000255:
p.000255: 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid
p.000255: down in this Article.
p.000255:
p.000255: 2. The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be
p.000255: conferred on the Commission for a period of five years from 25 May 2017. The Commission shall draw up a report in
p.000255: respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of
p.000255: power shall be tacitly extended for periods of an identical duration, unless the European Parliament or
p.000255: the Council opposes such extension not later than three months before the end of each period.
p.000255:
p.000255: 3. The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any
p.000255: time by the European Parliament or by the Council. A decision to revoke shall put an end to the
p.000255: delegation of the power specified in that decision. It shall take effect the day following the publication of the
p.000255: decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the
p.000255: validity of any delegated acts already in force.
p.000255:
p.000255: 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member
p.000255: State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better
p.000255: Law-Making.
p.000255:
p.000255: 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament
p.000255: and to the Council.
p.000255:
p.000255: 6. A delegated act adopted pursuant to Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall enter into force only
p.000255: if no objection has been expressed either by the European Parliament or by the Council within a period of three months
p.000255: of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the
p.000255: European Parliament and the Council have both informed the Commission that they will not object. That period shall be
p.000255: extended by three months at the initiative of the European Parliament or of the Council.
p.000255:
p.000255:
p.000255: Article 109
p.000255:
p.000255: Separate delegated acts for different delegated powers
p.000255:
p.000255: The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant
p.000255: to this Regulation.
p.000255:
p.000255:
p.000255: Article 110
p.000255:
p.000255: Transitional provisions
p.000255:
p.000255: 1. From 26 May 2022, any publication of a notification in respect of a notified body in accordance with
p.000255: Directive 98/79/EC shall become void.
p.000255:
p.000255: 2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall
p.000255: remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance
p.000255: with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024.
p.000255:
p.000255: Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27
p.000255: May 2024.
p.000255:
p.000256: L 117/256 EN
p.000256: Official Journal of the European Union
p.000256: 5.5.2017
p.000256:
p.000256: 3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in
p.000256: accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on
p.000256: the market or put into service provided that from the date of application of this Regulation it
p.000256: continues to comply with that Directive, and provided there are no significant changes in the design and intended
p.000256: purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance,
p.000256: vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in
p.000256: that Directive.
p.000256:
p.000256: Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred
p.000256: to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect
p.000256: of all applicable requirements relating to the devices it has certified.
p.000256:
p.000256: 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed
p.000256: on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be
p.000256: made available on the market or put into service until 27 May 2025.
p.000256:
p.000256: 5. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the
p.000256: market before 26 May 2022.
p.000256:
p.000256: 6. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation
...
p.000256:
p.000256: 10. Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall
p.000256: be considered to be designated issuing entities.
p.000256:
p.000256:
p.000256: Article 111
p.000256:
p.000256: Evaluation
p.000256:
p.000256: By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the
p.000256: progress towards achievement of the objectives contained herein including an assessment of the resources required to
p.000256: implement this Regulation. Special attention shall be given to the traceability of devices through the storage,
p.000256: pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals. The evaluation
p.000256: shall also include a review on the functioning of Article 4.
p.000256:
p.000256:
p.000256: Article 112
p.000256:
p.000256: Repeal
p.000256:
p.000256: Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the
p.000256: Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the
p.000256: making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022
p.000256: with the exception of:
p.000256: (a) Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations
p.000256: relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect
p.000256: from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and
p.000256:
p.000256: 5.5.2017 EN
p.000256: Official Journal of the European Union
p.000257: L 117/257
p.000257:
p.000257: (b) Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to
p.000257: registration of devices and economic operators, and certificate notifications provided for in the corresponding
p.000257: Annexes, which are repealed with effect from 18 months after the later of the dates referred to in
p.000257: Article 113(2) and point (f) of Article 113(3) of this Regulation.
p.000257: As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC
p.000257: shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
p.000257:
p.000257: Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be
p.000257: repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of
p.000257: Article 113(3) of this Regulation.
p.000257:
p.000257: References to the repealed Directive shall be understood as references to this Regulation and shall be read in
p.000257: accordance with the correlation table laid down in Annex XV.
p.000257:
p.000257: Article 113
p.000257:
p.000257: Entry into force and date of application
p.000257:
p.000257: 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official
p.000257: Journal of the European Union.
p.000257: 2. It shall apply from 26 May 2022.
p.000257: 3. By way of derogation from paragraph 2:
p.000257: (a) Article 27(3) and Article 51(5) shall apply from 27 November 2023;
p.000257: (b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the
p.000257: obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an
p.000257: application for designation in accordance with Article 34;
p.000257: (c) Article 97 shall apply from 26 May 2018;
p.000257: (d) Article 100 shall apply from 25 November 2020;
p.000257: (e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4)
p.000257: shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;
p.000257: (f) without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU)
p.000257: 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan
p.000257: referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and
p.000257: requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of
p.000257: publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding
p.000257: sentence are:
p.000257: — Article 26,
p.000257: — Article 28,
p.000257: — Article 29,
p.000257: — the second sentence of Article 36(2),
p.000257: — Article 38(10),
p.000257: — Article 39(2),
p.000257: — the second subparagraph of Article 40(12),
p.000257: — points (d) and (e) of Article 42(7),
p.000257: — Article 49(2),
p.000257: — Article 50(1),
p.000257: — Articles 66 to 73,
p.000257: — paragraphs 1 to 13 of Article 74,
p.000257: — Articles 75 to 77,
p.000257: — Article 81(2),
p.000257:
p.000258: L 117/258 EN
p.000258: Official Journal of the European Union
p.000258: 5.5.2017
p.000258:
p.000258: — Articles 82 and 83,
p.000258: — Article 84(5) and (7) and the third subparagraph of Article 84(8),
p.000258: — Article 85,
p.000258: — Article 88(4), (7) and (8),
p.000258: — Article 90(2) and (4),
p.000258: — the last sentence of Article 92(2),
p.000258: — Article 94(4),
p.000258: — the second sentence of the first subparagraph of Article 110(3).
p.000258:
p.000258: Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the
p.000258: purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding
p.000258: exchange of information including, and in particular, information regarding performance studies, vigilance reporting,
p.000258: registration of devices and economic operators, and certificate notifications.
p.000258: (g) The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).
p.000258: (h) Article 110(10) shall apply from 26 May 2019.
p.000258:
p.000258:
p.000258: This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 5
p.000258: April 2017.
p.000258:
p.000258: For the European Parliament The President
p.000258: A. TAJANI
p.000258: For the Council The President
p.000258: I. BORG
p.000258:
p.000258: 5.5.2017 EN
p.000258: Official Journal of the European Union
p.000259: L 117/259
p.000259:
p.000259: ANNEXES
p.000259:
p.000259: I General safety and performance requirements II Technical documentation
p.000259: III Technical documentation on post-market surveillance IV EU declaration of conformity
p.000259: V CE marking of conformity
p.000259:
p.000259: VI Information to be submitted upon the registration of devices and economic operators in
p.000259: accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together
p.000259: with the UDI-DI in accordance with Articles 25 and 26 and the UDI system
p.000259:
p.000259: VII Requirements to be met by notified bodies VIII Classification rules
p.000259: IX Conformity assessment based on a quality management system and on assessment of technical documentation X
p.000259: Conformity assessment based on type examination
p.000259: XI Conformity assessment based on production quality assurance XII Certificates issued by a notified body
p.000259: XIII Performance evaluation, performance studies and post-market performance follow-up XIV Interventional clinical
p.000259: performance studies and certain other performance studies
p.000259: XV Correlation table
p.000259:
p.000260: L 117/260 EN
p.000260: Official Journal of the European Union
p.000260: 5.5.2017
p.000260:
p.000260: ANNEX I
p.000260:
p.000260: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000260:
p.000260: CHAPTER I
p.000260:
p.000260: GENERAL REQUIREMENTS
p.000260:
p.000260:
p.000260: 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in
p.000260: such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and
p.000260: effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users
p.000260: or, where applicable, other persons, provided that any risks which may be associated with their use
p.000260: constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of
p.000260: protection of health and safety, taking into account the generally acknowledged state of the art.
p.000260:
p.000260: 2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks
p.000260: as far as possible without adversely affecting the benefit-risk ratio.
p.000260:
p.000260: 3. Manufacturers shall establish, implement, document and maintain a risk management system.
p.000260:
p.000260: Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device,
p.000260: requiring regular systematic updating. In carrying out risk management manufacturers shall:
...
p.000260: shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged
p.000260: acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
p.000260: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000260:
p.000260: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000260: risks that cannot be eliminated; and
p.000260:
p.000260: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training
p.000260: to users.
p.000260: Manufacturers shall inform users of any residual risks.
p.000260:
p.000260: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000260:
p.000260: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000260: environment in which the device is intended to be used (design for patient safety), and
p.000260:
p.000260: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000260: where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or
p.000260: other users).
p.000260:
p.000260: 5.5.2017 EN
p.000260: Official Journal of the European Union
p.000261: L 117/261
p.000261:
p.000261: 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the
p.000261: health or safety of the patient or the user and, where applicable, of other persons are compromised during the
p.000261: lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur
p.000261: during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
p.000261:
p.000261: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000261: performance during their intended use are not adversely affected during transport and storage,
p.000261: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000261: information provided by the manufacturer.
p.000261:
p.000261: 8. All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed
p.000261: against the evaluated potential benefits to the patients and/or the user arising from the intended performance of
p.000261: the device during normal conditions of use.
p.000261:
p.000261: CHAPTER II
p.000261:
p.000261: REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
p.000261:
p.000261:
p.000261: 9. Performance characteristics
p.000261:
p.000261: 9.1. Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to
p.000261: in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the
p.000261: performance they are intended to achieve, taking account of the generally acknowledged state of the art.
...
p.000261: suitable reference measurement procedures and/or suitable reference materials of a higher metrological
p.000261: order. Where available, metrological traceability of values assigned to calibrators and control materials
p.000261: shall be assured to certified reference materials or reference measurement procedures.
p.000261:
p.000261: 9.4. The characteristics and performances of the device shall be specifically checked in the event
p.000261: that they may be affected when the device is used for the intended use under normal conditions:
p.000261:
p.000261: (a) for devices for self-testing, performances obtained by laypersons;
p.000261:
p.000261: (b) for devices for near-patient testing, performances obtained in relevant environments (for example,
p.000261: patient home, emergency units, ambulances).
p.000261:
p.000261: 10. Chemical, physical and biological properties
p.000261:
p.000261: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance
p.000261: requirements referred to in Chapter I are fulfilled.
p.000261:
p.000261: Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or
p.000261: chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as
p.000261: biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
p.000261:
p.000262: L 117/262 EN
p.000262: Official Journal of the European Union
p.000262: 5.5.2017
p.000262:
p.000262: 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed
p.000262: by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons
p.000262: involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to
p.000262: those contaminants and residues and to the duration and frequency of exposure.
p.000262:
p.000262: 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably
p.000262: practicable the risks posed by substances or particles, including wear debris, degradation products and
p.000262: processing residues, that may be released from the device. Special attention shall be given to substances
p.000262: which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex
p.000262: VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having
p.000262: endocrine disrupting properties for which there is scientific evidence of probable serious effects to human
p.000262: health and which are identified in accordance with the procedure set out in Article 59 of Regulation
p.000262: (EC) No 1907/2006 of the European Parliament and of the Council (2).
p.000262:
p.000262: 10.4. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the
p.000262: unintentional ingress of substances into the device, taking into account the device and the nature of
p.000262: the environment in which it is intended to be used.
p.000262:
p.000262: 11. Infection and microbial contamination
p.000262:
...
p.000262:
p.000262: 11.5. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the
p.000262: product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the
p.000262: packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
p.000262:
p.000262: 11.6. The labelling of the device shall distinguish between identical or similar devices placed on the
p.000262: market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are
p.000262: sterile.
p.000262:
p.000262: 12. Devices incorporating materials of biological origin
p.000262:
p.000262: Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the
p.000262: processing, preservation, testing and handling of tissues, cells and substances of such origin and
p.000262: control procedures shall be carried out so as to provide safety for user or other person.
p.000262:
p.000262: (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
p.000262: labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and
p.000262: amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
p.000262: (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the
p.000262: Registration,
p.000262: Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 136, 29.5.2007, p. 3).
p.000262:
p.000262: 5.5.2017 EN
p.000262: Official Journal of the European Union
p.000263: L 117/263
p.000263:
p.000263: In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of
p.000263: validated methods of elimination or inactivation in the course of the manufacturing process. This might
p.000263: not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the
p.000263: intended purpose of the device or when such elimination or inactivation process would compromise the performance of
p.000263: the device.
p.000263:
p.000263: 13. Construction of devices and interaction with their environment
p.000263:
p.000263: 13.1. If the device is intended for use in combination with other devices or equipment, the whole
p.000263: combination, including the connection system, shall be safe and shall not impair the specified performances of the
p.000263: devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in
p.000263: the instructions for use.
p.000263:
p.000263: 13.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
p.000263:
p.000263: (a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional
p.000263: and where appropriate ergonomic features;
p.000263:
p.000263: (b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic
p.000263: fields, external electrical and electromagnetic effects, electrostatic discharge, radiation
p.000263: associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and
p.000263: acceleration or radio signal interferences;
p.000263:
...
p.000263: use of which includes exposure to or use in association with flammable or explosive substances or
p.000263: substances which could cause combustion.
p.000263:
p.000263: 13.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be
p.000263: done safely and effectively.
p.000263:
p.000263: 13.5. Devices that are intended to be operated together with other devices or products shall be
p.000263: designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
p.000263:
p.000263: 13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe
p.000263: disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test
p.000263: procedures and measures as a result of which their devices can be safely disposed after use. Such
p.000263: procedures shall be described in the instructions for use.
p.000263:
p.000263: 13.7 The measuring, monitoring or display scale (including colour change and other visual indicators) shall be
p.000263: designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the
p.000263: en vironmental conditions in which the devices are intended to be used.
p.000263:
p.000263: 14. Devices with a measuring function
p.000263:
p.000263: 14.1. Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to
p.000263: provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I,
p.000263: taking into account the intended purpose of the device.
p.000263:
p.000264: L 117/264 EN
p.000264: Official Journal of the European Union
p.000264: 5.5.2017
p.000264:
p.000264: 14.2. The measurements made by devices with a measuring function shall be expressed in legal units conforming to the
p.000264: provisions of Council Directive 80/181/EEC (1).
p.000264:
p.000264: 15. Protection against radiation
p.000264:
p.000264: 15.1. Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to
p.000264: radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible
p.000264: with the intended purpose, whilst not restricting the application of appropriate specified levels for
p.000264: diagnostic purposes.
p.000264:
p.000264: 15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing
p.000264: radiation, they shall as far as possible be:
p.000264:
p.000264: (a) designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation
p.000264: emitted can be controlled and/or adjusted; and
p.000264: (b) fitted with visual displays and/or audible warnings of such emissions.
p.000264: 15.3. The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain
p.000264: detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of
p.000264: avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information
p.000264: regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure
p.000264: shall also be specified.
p.000264:
p.000264: 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that
p.000264: are devices in themselves
...
p.000264:
p.000264: 17. Devices connected to or equipped with an energy source
p.000264:
p.000264: 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition,
p.000264: appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
p.000264:
p.000264: 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of
p.000264: determining the state of the power supply and an appropriate warning or indication for when the capacity of the power
p.000264: supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming
p.000264: critical.
p.000264:
p.000264: 17.3. Devices shall be designed and manufactured in such a way as to reduce as far as possible the
p.000264: risks of creating electromagnetic interference which could impair the operation of the device in question
p.000264: or other devices or equipment in the intended environment.
p.000264:
p.000264: 17.4. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electro
p.000264: magnetic interference such that is adequate to enable them to operate as intended.
p.000264:
p.000264: (1) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating
p.000264: to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).
p.000264:
p.000264: 5.5.2017 EN
p.000264: Official Journal of the European Union
p.000265: L 117/265
p.000265:
p.000265: 17.5. Devices shall be designed and manufactured in such a way as to avoid as far as possible the
p.000265: risk of accidental electric shocks to the user, or other person both during normal use of the device and in the event
p.000265: of a single fault condition in the device, provided the device is installed and maintained as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18. Protection against mechanical and thermal risks
p.000265:
p.000265: 18.1. Devices shall be designed and manufactured in such a way as to protect users and other persons
p.000265: against mechanical risks.
p.000265:
p.000265: 18.2. Devices shall be sufficiently stable under the foreseen operating conditions. They shall be
p.000265: suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the
p.000265: expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the
p.000265: manufacturer.
p.000265:
p.000265: 18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or
p.000265: leakage of substances, then appropriate protection means shall be incorporated.
p.000265:
p.000265: Any guards or other means included with the device to provide protection, in particular against moving
...
p.000265:
p.000265: 19. Protection against the risks posed by devices intended for self-testing or near-patient testing
p.000265:
p.000265: 19.1. Devices intended for self-testing or near-patient testing shall be designed and manufactured in
p.000265: such a way that they perform appropriately for their intended purpose taking into account the skills and the
p.000265: means available to the intended user and the influence resulting from variation that can be reasonably
p.000265: anticipated in the intended user's technique and environment. The information and instructions provided by the
p.000265: manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result
p.000265: provided by the device and to avoid misleading information. In the case of near-patient testing, the information and
p.000265: the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience
p.000265: required by the user.
p.000265:
p.000265: 19.2. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as
p.000265: to:
p.000265:
p.000265: (a) ensure that the device can be used safely and accurately by the intended user at all stages of the procedure if
p.000265: necessary after appropriate training and/or information; and
p.000265:
p.000265: (b) reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable,
p.000265: the specimen, and also in the interpretation of the results.
p.000265:
p.000266: L 117/266 EN
p.000266: Official Journal of the European Union
p.000266: 5.5.2017
p.000266:
p.000266: 19.3. Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by
p.000266: which the intended user:
p.000266:
p.000266: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and
p.000266: (b) be warned if the device has failed to provide a valid result.
p.000266:
p.000266: CHAPTER III
p.000266:
p.000266: REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
p.000266:
p.000266:
p.000266: 20. Label and instructions for use
p.000266:
p.000266: 20.1. General requirements regarding the information supplied by the manufacturer
p.000266:
p.000266: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any
p.000266: safety and performance information relevant to the user or any other person, as appropriate. Such
p.000266: information may appear on the device itself, on the packaging or in the instructions for use, and
p.000266: shall, if the manufacturer has a website, be made available and kept up to date on the website, taking
p.000266: into account the following:
p.000266:
p.000266: (a) The medium, format, content, legibility, and location of the label and instructions for use shall
p.000266: be appropriate to the particular device, its intended purpose and the technical knowledge, experience,
p.000266: education or training of the intended user(s). In particular, instructions for use shall be written in
p.000266: terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
p.000266:
...
p.000266: (g) Residual risks which are required to be communicated to the user and/or other person shall be included as
p.000266: limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000266:
p.000266: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000266: internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used
p.000266: shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols
p.000266: and colours shall be described in the documentation supplied with the device.
p.000266:
p.000266: (i) In the case of devices containing a substance or a mixture which may be considered as being
p.000266: dangerous, taking account of the nature and quantity of its constituents and the form under which they
p.000266: are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where
p.000266: there is insufficient space to put all the information on the device itself or on its label, the relevant hazard
p.000266: pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given
p.000266: in the instructions for use.
p.000266:
p.000266: (j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all
p.000266: relevant information, as appropriate, is already made available in the instructions for use.
p.000266:
p.000266: 5.5.2017 EN
p.000266: Official Journal of the European Union
p.000267: L 117/267
p.000267:
p.000267: 20.2. Information on the label
p.000267:
p.000267: The label shall bear all of the following particulars:
p.000267: (a) the name or trade name of the device;
p.000267:
p.000267: (b) the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the
p.000267: intended purpose of the device;
p.000267:
p.000267: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000267: its registered place of business;
p.000267:
p.000267: (d) if the manufacturer has its registered place of business outside the Union, the name of its authorised rep
p.000267: resentative and the address of the registered place of business of the authorised representative;
p.000267:
p.000267: (e) an indication that the device is an in vitro diagnostic medical device, or if the device is a
p.000267: ‘device for performance study’, an indication of that fact;
p.000267:
p.000267: (f) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL
p.000267: NUMBER or an equivalent symbol, as appropriate;
p.000267:
p.000267: (g) the UDI carrier as referred to in Article 24 and Part C of Annex VI;
p.000267:
p.000267: (h) an unambiguous indication of the time limit for using the device safely, without
p.000267: degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that
p.000267: order;
p.000267:
p.000267: (i) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of
p.000267: manufacture may be included as part of the lot number or serial number, provided the date is clearly
p.000267: identifiable;
p.000267:
p.000267: (j) where relevant, an indication of the net quantity of contents, expressed in terms of weight or
p.000267: volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the
p.000267: package;
p.000267:
p.000267: (k) an indication of any special storage and/or handling condition that applies;
p.000267:
p.000267: (l) where appropriate, an indication of the sterile state of the device and the sterilisation method,
p.000267: or a statement indicating any special microbial state or state of cleanliness;
p.000267:
p.000267: (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device
p.000267: or to any other person. This information may be kept to a minimum in which case more detailed information shall
p.000267: appear in the instructions for use, taking into account the intended users;
p.000267:
p.000267: (n) if the instructions for use are not provided in paper form in accordance with point (f) of
p.000267: Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where
p.000267: they can be consulted;
p.000267:
p.000267: (o) where applicable, any particular operating instructions;
p.000267:
p.000267: (p) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use
p.000267: shall be consistent across the Union;
p.000267:
p.000267: (q) if the device is intended for self-testing or near-patient testing, an indication of that fact;
p.000267: (r) where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof;
p.000267:
p.000267: (s) where device kits include individual reagents and articles that are made available as separate devices, each of
p.000267: those devices shall comply with the labelling requirements contained in this Section and with the
p.000267: requirements of this Regulation;
p.000267:
p.000267: (t) the devices and separate components shall be identified, where applicable in terms of batches, to allow all
p.000267: appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable
p.000267: and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales
p.000267: packaging;
p.000267:
p.000268: L 117/268 EN
p.000268: Official Journal of the European Union
p.000268: 5.5.2017
p.000268:
p.000268: (u) the label for devices for self-testing shall bear the following particulars:
p.000268: (i) the type of specimen(s) required to perform the test (e.g. blood, urine or saliva);
p.000268: (ii) the need for additional materials for the test to function properly;
p.000268: (iii) contact details for further advice and assistance.
p.000268: The name of devices for self-testing shall not reflect an intended purpose other than that specified by the
p.000268: manufacturer.
p.000268: 20.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’):
p.000268:
p.000268: The following particulars shall appear on the sterile packaging:
p.000268: (a) an indication permitting the sterile packaging to be recognised as such,
p.000268: (b) a declaration that the device is in a sterile condition,
p.000268: (c) the method of sterilisation,
p.000268: (d) the name and address of the manufacturer,
p.000268: (e) a description of the device,
p.000268: (f) the month and year of manufacture,
p.000268: (g) an unambiguous indication of the time limit for using the device safely, expressed at least in terms of year and
p.000268: month and, where relevant, the day, in that order,
p.000268: (h) an instruction to check the instructions for use for what to do if the sterile packaging is
p.000268: damaged or unintentionally opened before use.
p.000268: 20.4. Information in the instructions for use
p.000268:
p.000268: 20.4.1. The instructions for use shall contain all of the following particulars:
p.000268: (a) the name or trade name of the device;
p.000268: (b) the details strictly necessary for the user to uniquely identify the device;
p.000268: (c) the device's intended purpose:
p.000268: (i) what is detected and/or measured;
p.000268: (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis,
p.000268: prediction, companion diagnostic);
p.000268: (iii) the specific information that is intended to be provided in the context of:
p.000268: — a physiological or pathological state;
p.000268: — congenital physical or mental impairments;
p.000268: — the predisposition to a medical condition or a disease;
p.000268: — the determination of the safety and compatibility with potential recipients;
p.000268: — the prediction of treatment response or reactions;
p.000268: — the definition or monitoring of therapeutic measures;
p.000268: (iv) whether it is automated or not;
p.000268: (v) whether it is qualitative, semi-quantitative or quantitative;
p.000268: (vi) the type of specimen(s) required;
p.000268: (vii) where applicable, the testing population; and
p.000268: (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for
p.000268: which it is a companion test.
p.000268:
p.000268: 5.5.2017 EN
p.000268: Official Journal of the European Union
p.000269: L 117/269
p.000269:
p.000269: (d) an indication that the device is an in vitro diagnostic medical device, or, if the device is a
p.000269: ‘device for performance study’, an indication of that fact;
p.000269:
p.000269: (e) the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare
p.000269: professionals);
p.000269:
p.000269: (f) the test principle;
p.000269:
p.000269: (g) a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated
p.000269: instrument only);
p.000269:
p.000269: (h) a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated
p.000269: instrument only) and the composition of the reagent product by nature and amount or concentration of the
p.000269: active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the
p.000269: device contains other ingredients which might influence the measurement;
p.000269:
p.000269: (i) a list of materials provided and a list of special materials required but not provided;
p.000269:
p.000269: (j) for devices intended for use in combination with or installed with or connected to other devices
p.000269: and/or general purpose equipment:
p.000269:
p.000269: — information to identify such devices or equipment, in order to obtain a validated and safe combination, including
p.000269: key performance characteristics, and/or
p.000269:
p.000269: — information on any known restrictions to combinations of devices and equipment.
p.000269:
p.000269: (k) an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling
p.000269: conditions which apply;
p.000269:
...
p.000269: (n) information that allows the user to be informed of any warnings, precautions, measures to be taken and
p.000269: limitations of use regarding the device. That information shall cover, where appropriate:
p.000269:
p.000269: (i) warnings, precautions and/or measures to be taken in the event of malfunction of the device or
p.000269: its degradation as suggested by changes in its appearance that may affect performance,
p.000269:
p.000269: (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external
p.000269: influences or environmental conditions, such as magnetic fields, external electrical and electro magnetic effects,
p.000269: electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or
p.000269: temperature,
p.000269:
p.000269: (iii) warnings, precautions and/or measures to be taken as regards the risks of interference posed by
p.000269: the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations,
p.000269: therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other
p.000269: equipment,
p.000269:
p.000269: (iv) precautions related to materials incorporated into the device that contain or consist of CMR
p.000269: substances, or endocrine disrupting substances or that could result in sensitisation or an allergic
p.000269: reaction by the patient or user,
p.000269:
p.000269: (v) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use
p.000269: shall be consistent across the Union,
p.000269:
p.000269: (vi) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning,
p.000269: disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterili sation.
p.000269: Information shall be provided to identify when the device should no longer be reused, such as signs of material
p.000269: degradation or the maximum number of allowable reuses;
p.000269:
p.000270: L 117/270 EN
p.000270: Official Journal of the European Union
p.000270: 5.5.2017
p.000270:
p.000270: (o) any warnings and/or precautions related to potentially infectious material that is included in the device;
p.000270:
p.000270: (p) where relevant, requirements for special facilities, such as a clean room environment, or special
p.000270: training, such as on radiation safety, or particular qualifications of the intended user;
p.000270: (q) conditions for collection, handling, and preparation of the specimen;
p.000270:
p.000270: (r) details of any preparatory treatment or handling of the device before it is ready for use, such as
p.000270: sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer;
p.000270:
p.000270: (s) the information needed to verify whether the device is properly installed and is ready to perform safely and as
p.000270: intended by the manufacturer, together with, where relevant:
p.000270:
p.000270: — details of the nature, and frequency, of preventive and regular maintenance, including cleaning and
p.000270: disinfection;
p.000270: — identification of any consumable components and how to replace them;
p.000270:
p.000270: — information on any necessary calibration to ensure that the device operates properly and safely during its intended
p.000270: lifetime;
p.000270:
p.000270: — methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices.
p.000270: (t) where applicable, recommendations for quality control procedures;
p.000270:
p.000270: (u) the metrological traceability of values assigned to calibrators and control materials, including identification
p.000270: of applied reference materials and/or reference measurement procedures of higher order and information
...
p.000270: (x) clinical performance characteristics as defined in Section 9.1 of this Annex;
p.000270: (y) the mathematical approach upon which the calculation of the analytical result is made;
p.000270:
p.000270: (z) where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity
p.000270: and diagnostic specificity, positive and negative predictive value;
p.000270: (aa) where relevant, reference intervals in normal and affected populations;
p.000270:
p.000270: (ab) information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age
p.000270: of specimen) that may affect the performance of the device;
p.000270:
p.000270: (ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and
p.000270: the consumables used with it, if any. This information shall cover, where appropriate:
p.000270:
p.000270: (i) infection or microbial hazards, such as consumables contaminated with potentially infectious
p.000270: substances of human origin;
p.000270:
p.000270: (ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of
p.000270: radiation);
p.000270: (iii) physical hazards such as explosion.
p.000270:
p.000270: (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000270: its registered place of business at which he can be contacted and its location be established, together
p.000270: with a telephone number and/or fax number and/or website address to obtain technical assistance;
p.000270:
p.000270: 5.5.2017 EN
p.000270: Official Journal of the European Union
p.000271: L 117/271
p.000271:
p.000271: (ae) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000271: identifier of the latest revision of the instructions for use, with a clear indication of the introduced
p.000271: modifications;
p.000271:
p.000271: (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to
p.000271: the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
p.000271:
p.000271: (ag) where device kits include individual reagents and articles that may be made available as separate devices,
p.000271: each of these devices shall comply with the instructions for use requirements contained in this Section and with the
p.000271: requirements of this Regulation;
p.000271:
p.000271: (ah) for devices that incorporate electronic programmable systems, including software, or software that
p.000271: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000271: security measures, including protection against unauthorised access, necessary to run the software as
p.000271: intended.
p.000271:
p.000271: 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the
p.000271: following principles:
p.000271:
p.000271: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection
p.000271: and/or preparation and information on how to run the test and interpret the results;
p.000271:
...
p.000271: (c) the device's intended purpose shall provide sufficient information to enable the user to understand
p.000271: the medical context and to allow the intended user to make a correct interpretation of the results;
p.000271: (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
p.000271: (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or
p.000271: indeterminate result), on the test limitations and on the possibility of false positive or false negative result.
p.000271: Information shall also be provided as to any factors that can affect the test result such as age,
p.000271: gender, menstruation, infection, exercise, fasting, diet or medication;
p.000271:
p.000271: (f) the information provided shall include a statement clearly directing that the user should not take
p.000271: any decision of medical relevance without first consulting the appropriate healthcare professional,
p.000271: information on disease effects and prevalence, and, where available, information specific to the Member
p.000271: State(s) where the device is placed on the market on where a user can obtain further advice such as
p.000271: national helplines, websites;
p.000271:
p.000271: (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing
p.000271: disease or condition, the information shall specify that the patient should only adapt the treatment if he has
p.000271: received the appropriate training to do so.
p.000271:
p.000272: L 117/272 EN
p.000272: Official Journal of the European Union
p.000272: 5.5.2017
p.000272:
p.000272: ANNEX II
p.000272:
p.000272: TECHNICAL DOCUMENTATION
p.000272:
p.000272: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000272: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular
p.000272: the elements listed in this Annex.
p.000272:
p.000272: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000272: 1.1. Device description and specification
p.000272:
p.000272: (a) product or trade name and a general description of the device including its intended purpose and intended users;
p.000272: (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the
p.000272: device in question, as soon as identification of this device becomes based on a UDI system, or
p.000272: otherwise a clear identification by means of product code, catalogue number or other unambiguous reference
p.000272: allowing traceability;
p.000272: (c) the intended purpose of the device which may include information on:
p.000272: (i) what is to be detected and/or measured;
p.000272: (ii) its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction,
p.000272: companion diagnostic;
p.000272: (iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differ
p.000272: entiate;
p.000272: (iv) whether it is automated or not;
p.000272: (v) whether it is qualitative, semi-quantitative or quantitative;
p.000272: (vi) the type of specimen(s) required;
p.000272: (vii) where applicable, the testing population;
p.000272: (viii) the intended user;
p.000272: (ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal
p.000272: product(s).
p.000272: (d) the description of the principle of the assay method or the principles of operation of the instrument;
p.000272: (e) the rationale for the qualification of the product as a device;
p.000272: (f) the risk class of the device and the justification for the classification rule(s) applied in
p.000272: accordance with Annex VIII;
p.000272: (g) the description of the components and where appropriate, the description of the reactive ingredients
p.000272: of relevant components such as antibodies, antigens, nucleic acid primers;
p.000272: and where applicable:
p.000272: (h) the description of the specimen collection and transport materials provided with the device or descriptions of
p.000272: specifications recommended for use;
p.000272: (i) for instruments of automated assays: the description of the appropriate assay characteristics or
p.000272: dedicated assays;
p.000272: (j) for automated assays: a description of the appropriate instrumentation characteristics or dedicated instru
p.000272: mentation;
p.000272: (k) a description of any software to be used with the device;
p.000272: (l) a description or complete list of the various configurations/variants of the device that are intended to be
p.000272: made available on the market;
p.000272: (m) a description of the accessories for a device, other devices and other products that are not devices, which are
p.000272: intended to be used in combination with the device.
p.000272:
p.000272: 5.5.2017 EN
p.000272: Official Journal of the European Union
p.000273: L 117/273
p.000273:
p.000273: 1.2. Reference to previous and similar generations of the device
p.000273:
p.000273: (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such
p.000273: devices exist;
p.000273: (b) an overview of identified similar devices available on the Union or international markets, where
p.000273: such devices exist.
p.000273:
p.000273: 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
p.000273:
p.000273: A complete set of
p.000273: (a) the label or labels on the device and on its packaging, such as single unit packaging, sales
p.000273: packaging, transport packaging in the case of specific management conditions, in the languages accepted in
p.000273: the Member States where the device is envisaged to be sold;
p.000273: (b) the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
p.000273:
p.000273: 3. DESIGN AND MANUFACTURING INFORMATION
p.000273:
p.000273: 3.1. Design information
p.000273:
p.000273: Information to allow the design stages applied to the device to be understood shall include:
p.000273: (a) a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid
p.000273: primers provided or recommended for use with the device;
p.000273: (b) for instruments, a description of major subsystems, analytical technology such as operating principles and
p.000273: control mechanisms, dedicated computer hardware and software;
p.000273: (c) for instruments and software, an overview of the entire system;
p.000273: (d) for software, a description of the data interpretation methodology, namely the algorithm;
p.000273: (e) for devices intended for self-testing or near-patient testing, a description of the design aspects
p.000273: that make them suitable for self-testing or near-patient testing.
p.000273:
p.000273: 3.2. Manufacturing information
p.000273:
p.000273: (a) information to allow the manufacturing processes such as production, assembly, final product testing, and
p.000273: packaging of the finished device to be understood. More detailed information shall be provided for the
p.000273: audit of the quality management system or other applicable conformity assessment procedures;
p.000273: (b) identification of all sites, including suppliers and sub-contractors, where manufacturing activities
p.000273: are performed.
p.000273:
p.000273: 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
p.000273:
p.000273: The documentation shall contain information for the demonstration of conformity with the general safety and performance
p.000273: requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall
p.000273: include a justification, validation and verification of the solutions adopted to meet those requirements.
p.000273: The demonstration of conformity shall also include:
p.000273: (a) the general safety and performance requirements that apply to the device and an explanation as to
p.000273: why others do not apply;
p.000273: (b) the method or methods used to demonstrate conformity with each applicable general safety
p.000273: and performance requirement;
p.000273: (c) the harmonised standards, CS or other solutions applied;
p.000273: (d) the precise identity of the controlled documents offering evidence of conformity with each harmonised
p.000273: standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements.
p.000273: The information referred to under this point shall incorporate a cross-reference to the location of such
p.000273: evidence within the full technical documentation and, if applicable, the summary technical documentation.
p.000273:
p.000274: L 117/274 EN
p.000274: Official Journal of the European Union
p.000274: 5.5.2017
p.000274:
p.000274: 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT
p.000274: The documentation shall contain information on:
p.000274: (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
p.000274: (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
p.000274: 6. PRODUCT VERIFICATION AND VALIDATION
p.000274:
p.000274: The documentation shall contain the results and critical analyses of all verifications and validation tests and/or
p.000274: studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and
p.000274: in particular the applicable general safety and performance requirements.
p.000274: This includes:
p.000274:
p.000274: 6.1. Information on analytical performance of the device
p.000274: 6.1.1. Specimen type
p.000274: This Section shall describe the different specimen types that can be analysed, including their stability
p.000274: such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis
p.000274: methods, information on the timeframe between taking the specimen and its analysis and storage conditions
p.000274: such as duration, temperature limits and freeze/thaw cycles.
p.000274:
p.000274: 6.1.2. Analytical performance characteristics
p.000274: 6.1.2.1. Accuracy of measurement
p.000274: (a) Trueness of measurement
p.000274: This Section shall provide information on the trueness of the measurement procedure and summarise the data in
...
p.000274: description of specimen type and preparation including matrix, analyte levels, and how levels were established. The
p.000274: number of replicates tested at each concentration shall also be provided as well as a description of the calculation
p.000274: used to determine assay sensitivity.
p.000274:
p.000274: 6.1.2.3. Analytical specificity
p.000274:
p.000274: This Section shall describe interference and cross reactivity studies performed to determine the
p.000274: analytical specificity in the presence of other substances/agents in the specimen.
p.000274: Information shall be provided on the evaluation of potentially interfering and cross-reacting substances
p.000274: or agents on the assay, on the tested substance or agent type and its concentration, specimen type,
p.000274: analyte test concentration, and results.
p.000274: Interferents and cross-reacting substances or agents, which vary greatly depending on the assay type and design, could
p.000274: derive from exogenous or endogenous sources such as:
p.000274: (a) substances used for patient treatment such as medicinal products;
p.000274: (b) substances ingested by the patient such as alcohol, foods;
p.000274: (c) substances added during specimen preparation such as preservatives, stabilisers;
p.000274: (d) substances encountered in specific specimen types such as haemoglobin, lipids, bilirubin, proteins;
p.000274: (e) analytes of similar structure such as precursors, metabolites or medical conditions unrelated to the
p.000274: test condition including specimens negative for the assay but positive for a condition that can mimic the
p.000274: test condition.
p.000274:
p.000274: 5.5.2017 EN
p.000274: Official Journal of the European Union
p.000275: L 117/275
p.000275:
p.000275: 6.1.2.4. Metrological traceability of calibrator and control material values
p.000275:
p.000275: 6.1.2.5. Measuring range of the assay
p.000275:
p.000275: This Section shall include information on the measuring range regardless of whether the measuring systems are linear or
p.000275: non-linear, including the limit of detection and describe information on how the range and detection limit were
p.000275: established.
p.000275:
p.000275: This information shall include a description of specimen type, number of specimens, number of replicates, and specimen
p.000275: preparation including information on the matrix, analyte levels and how levels were established. If
p.000275: applicable, a description of any high dose hook effect and the data supporting the mitigation such as dilution steps
p.000275: shall be added.
p.000275:
p.000275: 6.1.2.6. Definition of assay cut-off
p.000275:
p.000275: This Section shall provide a summary of analytical data with a description of the study design
p.000275: including methods for determining the assay cut-off, such as:
p.000275: (a) the population(s) studied: demographics, selection, inclusion and exclusion criteria, number of
p.000275: individuals included;
p.000275: (b) method or mode of characterisation of specimens; and
p.000275: (c) statistical methods such as Receiver Operator Characteristic (ROC) to generate results and if
p.000275: applicable, define grey-zone/equivocal zone.
p.000275:
p.000275: 6.1.3. The analytical performance report referred to in Annex XIII.
p.000275:
p.000275: 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report
p.000275:
p.000275: The documentation shall contain the performance evaluation report, which includes the reports on the
...
p.000275:
p.000275: The clinical performance study documents referred to in Section 2 of Part A of Annex XIII shall be included
p.000275: and/or fully referenced in the technical documentation.
p.000275:
p.000275: 6.3. Stability (excluding specimen stability)
p.000275:
p.000275: This Section shall describe claimed shelf life, in use stability and shipping stability studies.
p.000275:
p.000275: 6.3.1. Claimed shelf-life
p.000275:
p.000275: This Section shall provide information on stability testing studies to support the shelf life that is claimed for the
p.000275: device. Testing shall be performed on at least three different lots manufactured under conditions that
p.000275: are essentially equivalent to routine production conditions. The three lots do not need to be
p.000275: consecutive. Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claims
p.000275: but shall be followed up with real time stability studies.
p.000275: Such detailed information shall include:
p.000275: (a) the study report including the protocol, number of lots, acceptance criteria and testing intervals;
p.000275: (b) where accelerated studies have been performed in anticipation of the real time studies, the method used for
p.000275: accelerated studies shall be described;
p.000275: (c) the conclusions and claimed shelf life.
p.000275:
p.000275: 6.3.2. In-use stability
p.000275:
p.000275: This Section shall provide information on in-use stability studies for one lot reflecting actual routine use of the
p.000275: device, regardless of whether real or simulated. This may include open vial stability and/or, for
p.000275: automated instruments, on board stability.
p.000275:
p.000276: L 117/276 EN
p.000276: Official Journal of the European Union
p.000276: 5.5.2017
p.000276:
p.000276: In the case of automated instrumentation, if calibration stability is claimed, supporting data shall be included. Such
p.000276: detailed information shall include:
p.000276: (a) the study report (including the protocol, acceptance criteria and testing intervals);
p.000276: (b) the conclusions and claimed in-use stability.
p.000276:
p.000276: 6.3.3. Shipping stability
p.000276:
p.000276: This Section shall provide information on shipping stability studies for one lot of devices to evaluate
p.000276: the tolerance of devices to the anticipated shipping conditions.
p.000276:
p.000276: Shipping studies may be done under real and/or simulated conditions and shall include variable shipping
p.000276: conditions such as extreme heat and/or cold.
p.000276: Such information shall describe:
p.000276: (a) the study report (including the protocol, acceptance criteria);
p.000276: (b) the method used for simulated conditions;
p.000276: (c) the conclusion and recommended shipping conditions.
p.000276:
p.000276: 6.4. Software verification and validation
p.000276:
p.000276: The documentation shall contain evidence of the validation of the software, as it is used in the finished device. Such
p.000276: information shall typically include the summary results of all verification, validation and testing
p.000276: performed in-house and applicable in an actual user environment prior to final release. It shall also address all of
p.000276: the different hardware configurations and, where applicable, operating systems identified in the labelling.
p.000276:
p.000276: 6.5. Additional information required in specific cases
p.000276:
p.000276: (a) In the case of devices placed on the market in a sterile or defined microbiological condition, a description of
p.000276: the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a
p.000276: sterile condition, a description of the methods used, including the validation reports, with regard to
p.000276: packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen
p.000276: testing and, if applicable, testing for sterilant residues.
p.000276:
p.000276: (b) In the case of devices containing tissues, cells and substances of animal, human or microbial
p.000276: origin, information on the origin of such material and on the conditions in which it was collected.
p.000276:
p.000276: (c) In the case of devices placed on the market with a measuring function, a description of the methods used in order
p.000276: to ensure the accuracy as given in the specifications.
p.000276:
p.000276: (d) If the device is to be connected to other equipment in order to operate as intended, a description
p.000276: of the resulting combination including proof that it conforms to the general safety and performance requirements set
p.000276: out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer.
p.000276:
p.000276: 5.5.2017 EN
p.000276: Official Journal of the European Union
p.000277: L 117/277
p.000277:
p.000277: ANNEX III
p.000277:
p.000277: TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
p.000277:
p.000277: The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance
p.000277: with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and
p.000277: shall include in particular the elements described in this Annex.
p.000277:
p.000277: 1. The post-market surveillance plan drawn up in accordance with Article 79.
p.000277: The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation
p.000277: referred to in Article 78.
p.000277: (a) The post-market surveillance plan shall address the collection and utilisation of available
p.000277: information, in particular:
p.000277: — information concerning serious incidents, including information from PSURs, and field safety corrective
p.000277: actions,
p.000277: — records referring to non-serious incidents and data on any undesirable side-effects,
p.000277: — information from trend reporting,
p.000277: — relevant specialist or technical literature, databases and/or registers,
p.000277: — information, including feedbacks and complaints, provided by users, distributors and importers, and
p.000277: — publicly-available information about similar medical devices.
p.000277: (b) The post-market surveillance plan shall cover at least:
p.000277: — a proactive and systematic process to collect any information referred to in point (a). The process shall allow a
p.000277: correct characterisation of the performance of the devices and shall also allow a comparison to be made
p.000277: between the device and similar products available on the market;
p.000277: — effective and appropriate methods and processes to assess the collected data;
p.000277: — suitable indicators and threshold values that shall be used in the continuous reassessment of the
p.000277: benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
p.000277: — effective and appropriate methods and tools to investigate complaints and analyse market-related
p.000277: experience collected in the field;
p.000277: — methods and protocols to manage the events subject to the trend report as provided for in Article
p.000277: 83, including the methods and protocols to be used to establish any statistically significant increase in
p.000277: the frequency or severity of incidents as well as the observation period;
p.000277: — methods and protocols to communicate effectively with competent authorities, notified bodies, economic
p.000277: operators and users;
p.000277: — reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81;
p.000277: — systematic procedures to identify and initiate appropriate measures including corrective actions;
p.000277: — effective tools to trace and identify devices for which corrective actions might be necessary; and
p.000277: — a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable.
p.000277:
p.000277: 2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.
p.000277:
p.000278: L 117/278 EN
p.000278: Official Journal of the European Union
p.000278: 5.5.2017
p.000278:
p.000278: ANNEX IV
p.000278:
p.000278: EU DECLARATION OF CONFORMITY
p.000278:
p.000278: The EU declaration of conformity shall contain the following information:
p.000278:
p.000278: 1. Name, registered trade name or registered trade mark and, if already issued, SRN referred to in
p.000278: Article 28 of the manufacturer, and, if applicable, its authorised representative, and the address of their
p.000278: registered place of business where they can be contacted and their location be established;
p.000278: 2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
p.000278: 3. The Basic UDI-DI as referred to in Part C of Annex VI;
p.000278: 4. Product and trade name, product code, catalogue number or other unambiguous reference allowing
p.000278: identification and traceability of the device covered by the EU declaration of conformity, such as a
p.000278: photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information
p.000278: allowing identifi cation and traceability may be provided by the Basic UDI-DI referred to in point 3;
p.000278: 5. Risk class of the device in accordance with the rules set out in Annex VIII;
p.000278:
p.000278: 6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and,
p.000278: if applicable, with any other relevant Union legislation that provides for the issuing of an EU
p.000278: declaration of conformity;
p.000278: 7. References to any CS used and in relation to which conformity is declared;
p.000278:
p.000278: 8. Where applicable, the name and identification number of the notified body, a description of the
p.000278: conformity assessment procedure performed and identification of the certificate or certificates issued;
p.000278: 9. Where applicable, additional information;
p.000278:
p.000278: 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication
p.000278: for, and on behalf of whom, that person signed, signature.
p.000278:
p.000278: 5.5.2017 EN
p.000278: Official Journal of the European Union
p.000279: L 117/279
p.000279:
p.000279: ANNEX V
p.000279:
p.000279: CE MARKING OF CONFORMITY
p.000279:
p.000279: 1. The CE marking shall consist of the initials ‘CE’ taking the following form:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279:
p.000279: 2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected.
p.000279:
p.000279: 3. The various components of the CE marking shall have substantially the same vertical dimension, which
p.000279: may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
p.000279:
p.000280: L 117/280 EN
p.000280: Official Journal of the European Union
p.000280: 5.5.2017
p.000280:
p.000280: ANNEX VI
p.000280:
p.000280: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000280: WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN
p.000280: ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
p.000280:
p.000280: PART A
p.000280:
p.000280: INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE
p.000280: WITH ARTICLES 26(3) AND 28
p.000280:
p.000280: Manufacturers or, when applicable, authorised representatives, and, when applicable, importers
p.000280: shall submit the information referred to in Section 1 and shall ensure that the information on their
p.000280: devices referred to in Section 2 is complete, correct and updated by the relevant party.
p.000280:
p.000280: 1. Information relating to the economic operator
p.000280:
p.000280: 1.1. type of economic operator (manufacturer, authorised representative, or importer),
p.000280: 1.2. name, address and contact details of the economic operator,
p.000280:
p.000280: 1.3. where submission of information is carried out by another person on behalf of any of the
p.000280: economic operators mentioned under Section 1.1, the name, address and contact details of that person,
p.000280:
p.000280: 1.4. name address and contact details of the person or persons responsible for regulatory compliance
p.000280: referred to in Article 15,
p.000280:
p.000280: 2. Information relating to the device
p.000280:
p.000280: 2.1. Basic UDI-DI,
p.000280:
p.000280: 2.2. type, number and expiry date of the certificate issued by the notified body and the name or
p.000280: identification number of that notified body and the link to the information that appears on the
p.000280: certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
p.000280: 2.3. Member State in which the device shall or has been placed on the market in the Union,
p.000280: 2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made
p.000280: available,
p.000280: 2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n),
p.000280: 2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No
p.000280: 722/2012(y/n),
p.000280: 2.7. presence of cells or substances of microbial origin (y/n),
p.000280: 2.8. risk class of the device,
p.000280: 2.9. where applicable, the single identification number of the performance study,
p.000280:
p.000280: 2.10. in the case of devices designed and manufactured by another legal or natural person
p.000280: as referred in Article 10(14), the name, address and contact details of that legal or natural person,
p.000280: 2.11. in the case of class C or D devices, the summary of safety and performance,
p.000280:
p.000280: 2.12. status of the device (on the market, no longer placed on the market, recalled, field safety
p.000280: corrective Action initiated),
p.000280: 2.13. indication as to whether the device is a ‘new’ device. A device shall be considered to be ‘new’ if:
p.000280: (a) there has been no such device continuously available on the Union market during the previous three
p.000280: years for the relevant analyte or other parameter;
p.000280:
p.000280: 5.5.2017 EN
p.000280: Official Journal of the European Union
p.000281: L 117/281
p.000281:
p.000281: (b) the procedure involves analytical technology not continuously used in connection with a given analyte
p.000281: or other parameter on the Union market during the previous three years.
p.000281:
p.000281: 2.14. indication as to whether the device is intended for self-testing or near-patient testing.
p.000281:
p.000281:
p.000281: PART B
p.000281:
p.000281:
p.000281: CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH
p.000281: ARTICLES 25 AND 26
p.000281:
p.000281:
p.000281: The manufacturer shall provide to the UDI database the UDI-DI and the following information
p.000281: relating to the manufacturer and the device:
p.000281:
p.000281: 1. quantity per package configuration,
p.000281:
p.000281: 2. the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs,
p.000281:
p.000281: 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot
p.000281: number, serial number),
p.000281:
p.000281: 4. if applicable, the ‘unit of use’ UDI-DI (where a UDI is not labelled on the device at the level
p.000281: of its ‘unit of use’, a ‘unit of use’ UDI-DI shall be assigned so as to associate the use of a device with a
p.000281: patient),
p.000281:
p.000281: 5. name and address of the manufacturer, as indicated on the label,
p.000281:
p.000281: 6. the SRN issued in accordance with Article 28(2),
p.000281:
p.000281: 7. if applicable, name and address of the authorised representative (as indicated on the label),
p.000281:
p.000281: 8. the medical device nomenclature code as provided for in Article 23,
p.000281:
p.000281: 9. risk class of the device,
p.000281:
p.000281: 10. if applicable, name or trade name,
p.000281:
p.000281: 11. if applicable, device model, reference, or catalogue number,
p.000281:
p.000281: 12. additional product description (optional),
p.000281:
p.000281: 13. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
p.000281:
p.000281: 14. if applicable, additional trade names of the device,
p.000281:
p.000281: 15. labelled as a single use device (y/n),
p.000281:
p.000281: 16. if applicable, the maximum number of reuses,
p.000281:
p.000281: 17. device labelled sterile (y/n),
p.000281:
p.000281: 18. need for sterilisation before use (y/n),
p.000281:
p.000281: 19. URL for additional information, such as electronic instructions for use (optional),
p.000281:
p.000281: 20. if applicable, critical warnings or contra-indications,
p.000281:
p.000281: 21. status of the device (on the market, no longer placed on the market, recalled, field safety action initiated).
p.000281:
p.000282: L 117/282 EN
p.000282: Official Journal of the European Union
p.000282: 5.5.2017
p.000282:
p.000282: PART C
p.000282:
p.000282: THE UDI SYSTEM
p.000282:
p.000282: 1. Definitions
p.000282: Automatic identification and data capture (‘AIDC’)
p.000282:
p.000282: AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart
p.000282: cards, biometrics and RFID.
p.000282:
p.000282: Basic UDI-DI
p.000282:
p.000282: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of
p.000282: the device unit of use. It is the main key for records in the UDI database and is referenced in
p.000282: relevant certificates and EU declarations of conformity.
p.000282:
p.000282: Unit of Use DI
p.000282:
p.000282: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a
p.000282: UDI is not labelled on the individual device at the level of its unit of use, for example in the
p.000282: event of several units of the same device being packaged together.
p.000282:
p.000282: Configurable device
p.000282:
p.000282: A configurable device is a device that consists of several components which can be
p.000282: assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
p.000282:
p.000282: Configuration
p.000282:
p.000282: Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a
p.000282: device to achieve an intended purpose. The combination of items may be modified, adjusted or customised
p.000282: to meet specific needs.
p.000282:
p.000282: UDI-DI
p.000282:
p.000282: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the
p.000282: ‘access key’ to information stored in a UDI database.
p.000282:
p.000282: Human Readable Interpretation (HRI)
p.000282: HRI is a legible interpretation of the data characters encoded in the UDI carrier.
p.000282:
p.000282: Packaging levels
p.000282:
p.000282: Packaging levels means the various levels of device packaging that contain a fixed quantity of devices,
p.000282: such as a carton or case.
p.000282:
p.000282: Production Identifier (UDI-PI)
p.000282: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
p.000282:
p.000282: The different types of UDI-PI(s) include serial number, lot number, software identification and
p.000282: manufacturing or expiry date or both types of date.
p.000282:
p.000282: Radio Frequency Identification (‘RFID’)
p.000282:
p.000282: RFID is a technology that uses communication through the use of radio waves to exchange data between a
p.000282: reader and an electronic tag attached to an object, for the purpose of identification.
p.000282:
p.000282: Shipping containers
p.000282:
p.000282: A shipping container is a container in relation to which traceability is controlled by a process specific to logistics
p.000282: systems.
p.000282:
p.000282: 5.5.2017 EN
p.000282: Official Journal of the European Union
p.000283: L 117/283
p.000283:
p.000283: Unique Device Identifier (‘UDI’)
p.000283:
p.000283: The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted
p.000283: device identification and coding standard. It allows the unambiguous identification of a specific device
p.000283: on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
p.000283:
p.000283: The word ‘Unique’ does not imply serialisation of individual production units.
p.000283:
p.000283: UDI carrier
p.000283:
p.000283: The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include,
p.000283: inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
p.000283: 2. General requirements
p.000283:
p.000283: 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking
p.000283: or labelling requirements laid down in Annex I to this Regulation.
p.000283:
p.000283: 2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
p.000283:
p.000283: 2.3. Only the manufacturer may place the UDI on the device or its packaging.
p.000283:
p.000283: 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 24(2)
p.000283: may be used.
p.000283:
p.000283: 3. The UDI
p.000283:
p.000283: 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their
p.000283: own UDI.
p.000283:
p.000283: 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI
p.000283: shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the
...
p.000283:
p.000283: 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.
p.000283:
p.000283: 3.4. The UDI-DI shall be unique at each level of device packaging.
p.000283:
p.000283: 3.5. If a lot number, serial number, software identification or expiry date appears on the label,
p.000283: it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need
p.000283: to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the
p.000283: UDI-PI.
p.000283:
p.000283: 3.6. Each component that is considered to be a device and is commercially available on its own
p.000283: shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own
p.000283: UDI.
p.000283:
p.000283: 3.7. Kits shall be assigned and bear their own UDI.
p.000283:
p.000283: 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.
p.000283:
p.000283: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to
p.000283: misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the
p.000283: following UDI database data elements shall require a new UDI-DI:
p.000283: (a) Name or trade name,
p.000283: (b) device version or model,
p.000283: (c) labelled as single use,
p.000283: (d) packaged sterile,
p.000283: (e) need for sterilization before use,
p.000283:
p.000284: L 117/284 EN
p.000284: Official Journal of the European Union
p.000284: 5.5.2017
p.000284:
p.000284: (f) quantity of devices provided in a package,
p.000284: (g) critical warnings or contra-indications.
p.000284: 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of
p.000284: the original device manufacturer's UDI.
p.000284:
p.000284: 4. UDI carrier
p.000284:
p.000284: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and
p.000284: on all higher levels of device packaging. Higher levels do not include shipping containers.
p.000284:
p.000284: 4.2. In the event of there being significant space constraints on the unit of use packaging the
p.000284: UDI carrier may be placed on the next higher packaging level.
p.000284:
p.000284: 4.3. For single use class A and class B devices packaged and labelled individually, the UDI
p.000284: carrier shall not be required to appear on the packaging but it shall appear on a higher level of
p.000284: packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected
p.000284: to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI
p.000284: shall be placed on the packaging.
p.000284:
p.000284: 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be
p.000284: required to appear on the point of sale packaging.
p.000284:
p.000284: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be
p.000284: readily identifiable.
...
p.000284:
p.000284: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
p.000284: reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent
p.000284: and readable after each process performed to make the device ready for the subsequent use throughout the
p.000284: intended lifetime of the device.
p.000284:
p.000284: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
p.000284:
p.000284: 4.12. If the UDI carrier is readily readable or scannable through the device's packaging, the placing
p.000284: of the UDI carrier on the packaging shall not be required.
p.000284:
p.000284: 4.13. In the case of single finished devices made up of multiple parts that must be assembled
p.000284: before first use, it shall be sufficient to place the UDI carrier on only one part of each device.
p.000284:
p.000284: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal
p.000284: operation or storage.
p.000284:
p.000284: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for
p.000284: the device to operate or other data.
p.000284:
p.000284: 5. General principles of the UDI database
p.000284:
p.000284: 5.1. The UDI database shall support the use of all core UDI database data elements referred to in
p.000284: Part B of this Annex.
p.000284:
p.000284: 5.5.2017 EN
p.000284: Official Journal of the European Union
p.000285: L 117/285
p.000285:
p.000285: 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying
p.000285: information and other device data elements in the UDI database.
p.000285:
p.000285: 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.
p.000285:
p.000285: 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices
p.000285: they have placed on the market, except for devices that are no longer available on the market.
p.000285:
p.000285: 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the
p.000285: device is in conformity with this Regulation.
p.000285:
p.000285: 5.6. The database shall allow for the linking of all the packaging levels of the device.
p.000285:
p.000285: 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.
p.000285:
p.000285: 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being
p.000285: made to an element, which does not require a new UDI-DI.
p.000285:
p.000285: 5.9. Internationally accepted standards for data submission and updates shall, wherever possible, be
p.000285: used by the UDI database.
p.000285:
p.000285: 5.10. The user interface of the UDI database shall be available in all official languages of the
p.000285: Union. The use of free- text fields shall, however, be minimised in order to reduce translations.
p.000285:
p.000285: 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.
p.000285:
p.000285: 6. Rules for specific device types
p.000285:
p.000285: 6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or
p.000285: refurbishing between uses
p.000285:
p.000285: 6.1.1. The UDI of such devices shall be placed on the device and shall be readable after each
p.000285: procedure to make the device ready for the next use;
p.000285:
p.000285: 6.1.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
p.000285:
p.000285: 6.2. Device software
p.000285:
p.000285: 6.2.1. UDI assignment Criteria
p.000285:
p.000285: The UDI shall be assigned at the system level of the software. Only software which is commercially available on
p.000285: its own and software which constitutes a device in itself shall be subject to that requirement.
p.000285:
p.000285: The software identification shall be considered to be the manufacturing control mechanism and
p.000285: shall be displayed in the UDI-PI.
p.000285:
p.000285: 6.2.2. A new UDI-DI shall be required whenever there is a modification that changes:
p.000285: (a) the original performance,
p.000285: (b) the safety or the intended use of the software.
p.000285: (c) interpretation of data.
p.000285: Such modifications include new or modified algorithms, database structures, operating platform, architecture
p.000285: or new user interfaces or new channels for interoperability.
p.000285:
p.000285: 6.2.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI:
p.000285: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for
p.000285: safety purposes, security patches or operating efficiency.
p.000285: Minor software revisions shall be identified by a manufacturer-specific form of identification.
p.000285:
p.000286: L 117/286 EN
p.000286: Official Journal of the European Union
p.000286: 5.5.2017
p.000286:
p.000286: 6.2.4. UDI placement criteria for software
p.000286: (a) where the software is delivered on a physical medium, for example via a CD or DVD, each
p.000286: packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied
p.000286: to the physical medium containing the software and its packaging shall be identical to the UDI assigned
p.000286: to the system level software;
p.000286: (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable
p.000286: plain-text format such as an ‘about’ file, or included on the start-up screen;
p.000286: (c) software lacking a user interface such as middleware for image conversion, shall be capable of
p.000286: transmitting the UDI through an application programming interface (API);
p.000286: (d) only the human readable portion of the UDI shall be required in electronic displays of the
p.000286: software. The marking of UDI using AIDC shall not be required in the electronic displays such as
p.000286: ‘about’ menu, splash screen, etc.;
p.000286: (e) the human readable format of the UDI for the software shall include the application identifiers
p.000286: (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI
p.000286: and determining which standard is being used to create the UDI.
p.000286:
p.000286: 5.5.2017 EN
p.000286: Official Journal of the European Union
p.000287: L 117/287
p.000287:
p.000287: ANNEX VII
p.000287:
p.000287: REQUIREMENTS TO BE MET BY NOTIFIED BODIES
p.000287:
p.000287: 1. ORGANISATIONAL AND GENERAL REQUIREMENTS
p.000287:
p.000287: 1.1. Legal status and organisational structure
p.000287:
p.000287: 1.1.1. Each notified body shall be established under the national law of a Member State, or under the
p.000287: law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and
p.000287: status shall be fully documented. Such documentation shall include information about ownership and the legal
p.000287: or natural persons exercising control over the notified body.
p.000287:
p.000287: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that
p.000287: organisation as well as its organisational structure and governance, and the relationship with the notified
p.000287: body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both
p.000287: the notified body and the organisation to which it belongs.
p.000287:
p.000287: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country
p.000287: or is owned by another legal entity, the activities and responsibilities of those entities, as well as
p.000287: their legal and operational relationships with the notified body, shall be clearly defined and documented.
p.000287: Personnel of those entities performing conformity assessment activities under this Regulation shall be
p.000287: subject to the applicable requirements of this Regulation.
p.000287:
p.000287: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000287: body shall be such that they ensure that there is confidence in the performance by the notified body and in the
p.000287: results of the conformity assessment activities it conducts.
p.000287:
p.000287: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
...
p.000287: and responsi bility for each of the following:
p.000287:
p.000287: (a) provision of adequate resources for conformity assessment activities;
p.000287:
p.000287: (b) development of procedures and policies for the operation of the notified body;
p.000287:
p.000287: (c) supervision of implementation of the procedures, policies and quality management systems of the
p.000287: notified body;
p.000287:
p.000287: (d) supervision of the notified body's finances;
p.000287:
p.000287: (e) activities and decisions taken by the notified body, including contractual agreements;
p.000287:
p.000287: (f) delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000287: defined activities;
p.000287:
p.000287: (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with
p.000287: other competent authorities, the Commission and other notified bodies.
p.000287:
p.000287: 1.2. Independence and impartiality
p.000287:
p.000287: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation
p.000287: to which it performs conformity assessment activities. The notified body shall also be independent of any
p.000287: other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does
p.000287: not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
p.000287:
p.000288: L 117/288 EN
p.000288: Official Journal of the European Union
p.000288: 5.5.2017
p.000288:
p.000288: 1.2.2. The notified body shall be organised and operated so as to safeguard the independence,
p.000288: objectivity and impartiality of its activities. The notified body shall document and implement a structure
p.000288: and procedures for safeguarding impartiality and for promoting and applying the principles of
p.000288: impartiality throughout its organisation, personnel and assessment activities. Such procedures shall
p.000288: provide for the identification, investi gation and resolution of any case in which a conflict of interest may
p.000288: arise including involvement in consultancy services in the field of devices prior to taking up employment with the
p.000288: notified body. The investigation, outcome and its resolution shall be documented.
p.000288:
p.000288: 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the
p.000288: conformity assessment tasks shall not:
p.000288:
p.000288: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess,
p.000288: nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of
p.000288: assessed devices that are necessary for the operations of the notified body and the conduct of the
p.000288: conformity assessment, or the use of such devices for personal purposes;
p.000288:
p.000288: (b) be involved in the design, manufacture or construction, marketing, installation and use, or
p.000288: maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
p.000288:
p.000288: (c) engage in any activity that may conflict with their independence of judgement or integrity in
...
p.000288: shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a
p.000288: notified body and subcontractors involved in assessment activities shall not depend on the results of the
p.000288: assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management.
p.000288:
p.000288: 1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conflict of
p.000288: interests shall be ensured and documented between, on the one hand, the authority responsible for notified bodies
p.000288: and/or the competent authority and, on the other hand, the notified body.
p.000288:
p.000288: 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or
p.000288: subcontractors or of any associated body, including the activities of its owners do not affect its
p.000288: independence, impartiality or the objectivity of its conformity assessment activities.
p.000288:
p.000288: 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and
p.000288: conditions, taking into account the interests of small and medium-sized enterprises as defined in
p.000288: Recommendation 2003/361/EC in relation to fees.
p.000288:
p.000288: 1.2.9. The requirements laid down in this Section shall in no way preclude exchanges of technical
p.000288: information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
p.000288:
p.000288: 5.5.2017 EN
p.000288: Official Journal of the European Union
p.000289: L 117/289
p.000289:
p.000289: 1.3. Confidentiality
p.000289:
p.000289: 1.3.1. The notified body shall have documented procedures in place ensuring that its
p.000289: personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect
p.000289: the confidentiality of the information which comes into its possession during the performance of the conformity
p.000289: assessment activities, except when disclosure is required by law.
p.000289:
p.000289: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
p.000289: under this Regulation or any provision of national law giving effect to it, except in relation to the authorities
p.000289: responsible for notified bodies, competent authorities for devices in the Member States or the Commission.
p.000289: Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the
p.000289: requirement of this Section.
p.000289:
p.000289: 1.4. Liability
p.000289:
p.000289: 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment
p.000289: activities, unless liability is assumed by the Member State in question in accordance with national law
p.000289: or that Member State is directly responsible for their conformity assessment.
p.000289:
p.000289: 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic
p.000289: scope of activities of the notified body and be commensurate with the risk profile of the devices
p.000289: certified by the notified body. The liability insurance shall cover cases where the notified body may be
...
p.000289: stan dardisation activities and in the activities of the notified body coordination group referred to in
p.000289: Article 49 of Regulation (EU) 2017/745 and that its assessment and decision-making personnel are informed
p.000289: of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
p.000289:
p.000289: 1.6.2. The notified body shall take into consideration guidance and best practice documents.
p.000289:
p.000289: 2. QUALITY MANAGEMENT REQUIREMENTS
p.000289:
p.000289: 2.1. The notified body shall establish, document, implement, maintain and operate a quality management system that
p.000289: is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting
p.000289: and demonstrating the consistent fulfilment of the requirements of this Regulation.
p.000289:
p.000289: 2.2. The quality management system of the notified body shall address at least the following:
p.000289: (a) management system structure and documentation, including policies and objectives for its activities;
p.000289: (b) policies for assignment of activities and responsibilities to personnel;
p.000289: (c) assessment and decision-making processes in accordance with the tasks, responsibilities and role of
p.000289: the notified body's personnel and top-level management;
p.000289: (d) the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
p.000289: (e) control of documents;
p.000289: (f) control of records;
p.000289: (g) management reviews;
p.000289: (h) internal audits;
p.000289:
p.000290: L 117/290 EN
p.000290: Official Journal of the European Union
p.000290: 5.5.2017
p.000290:
p.000290: (i) corrective and preventive actions;
p.000290: (j) complaints and appeals;
p.000290: (k) continuous training.
p.000290:
p.000290: Where documents are used in various languages, the notified body shall ensure and control that they have
p.000290: the same content.
p.000290:
p.000290: 2.3. The top-level management of the notified body shall ensure that the quality management system is
p.000290: fully understood, implemented and maintained throughout the notified body organisation including subsidiaries
p.000290: and subcontractors involved in conformity assessment activities pursuant to this Regulation.
p.000290:
p.000290: 2.4. The notified body shall require all personnel to formally commit themselves by a signature or
p.000290: equivalent to comply with the procedures defined by the notified body. That commitment shall cover
p.000290: aspects relating to confidentiality and to independence from commercial and other interests, and any
p.000290: existing or prior association with clients. The personnel shall be required to complete written statements
p.000290: indicating their compliance with confidentiality, independence and impartiality principles.
p.000290:
p.000290: 3. RESOURCE REQUIREMENTS
p.000290:
p.000290: 3.1. General
p.000290:
p.000290: 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this
p.000290: Regulation with the highest degree of professional integrity and the requisite competence in the specific field,
p.000290: whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility.
p.000290:
...
p.000290: out in Section 4.1.
p.000290:
p.000290: Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices
p.000290: shall have appropriate knowledge to set up and operate a system for the selection of assessment and
p.000290: verification staff, for verification of their competence, for authorisation and allocation of their tasks,
p.000290: for organisation of their initial and ongoing training, and for their assignment of their duties and
p.000290: monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification
p.000290: operations are competent to fulfil the tasks required of them.
p.000290:
p.000290: The notified body shall identify at least one individual within its top-level management as having overall responsi
p.000290: bility for all conformity assessment activities in relation to devices.
p.000290:
p.000290: 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain their
p.000290: qualifi cation and expertise by implementing a system for exchange of experience and a continuous
p.000290: training and education programme.
p.000290:
p.000290: 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of
p.000290: auth orisation of to the personnel, including any subcontractors and external experts involved in
p.000290: conformity assessment activities and inform those personnel accordingly.
p.000290:
p.000290: 5.5.2017 EN
p.000290: Official Journal of the European Union
p.000291: L 117/291
p.000291:
p.000291: 3.2. Qualification criteria in relation to personnel
p.000291:
p.000291: 3.2.1. The notified body shall establish and document qualification criteria and procedures for selection and
p.000291: authoris ation of persons involved in conformity assessment activities, including as regards knowledge,
p.000291: experience and other competence required, and the required initial and ongoing training. The qualification criteria
p.000291: shall address the various functions within the conformity assessment process, such as auditing, product evaluation or
p.000291: testing, technical documentation review, decision-making, and batch release, as well as the devices,
p.000291: technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics
p.000291: and performance evaluation, covered by the scope of designation.
p.000291:
p.000291: 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's
p.000291: designation in accordance with the scope description used by the Member State for the notification referred to in
p.000291: Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the
p.000291: scope description.
p.000291: Specific qualification criteria shall be defined at least for the assessment of:
p.000291: — biological safety,
p.000291: — performance evaluation,
p.000291: — devices for self and near patient testing,
p.000291: — companion diagnostics,
p.000291: — functional safety,
p.000291: — software,
p.000291: — packaging, and
p.000291: — the different types of sterilisation processes.
p.000291:
p.000291: 3.2.3. The personnel responsible for establishing qualification criteria and for authorising other
p.000291: personnel to perform specific conformity assessment activities shall be employed by the notified body itself and
p.000291: shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the
p.000291: following:
p.000291: — Union devices legislation and relevant guidance documents;
p.000291: — the conformity assessment procedures provided for in this Regulation;
p.000291: — a broad base of knowledge of device technologies and the design and manufacture of devices;
p.000291: — the notified body's quality management system, related procedures and the required qualification criteria;
p.000291: — training relevant to personnel involved in conformity assessment activities in relation to devices;
p.000291:
p.000291: — adequate experience in conformity assessments under this Regulation or previously applicable law within
p.000291: a notified body.
p.000291:
p.000291: 3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise
p.000291: and where possible such personnel shall be employed by the notified body itself. Such personnel shall be
p.000291: integrated throughout the notified body's assessment and decision-making process in order to:
p.000291:
p.000291: — identify when specialist input is required for the assessment of the performance evaluation conducted by the
p.000291: manufacturer and identify appropriately qualified experts;
p.000291:
p.000291: — appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and
p.000291: harmonised standards and ensure that the external clinical experts are fully aware of the context and
p.000291: implications of their assessment and the advice they provide;
p.000291:
p.000291: — be able to review and scientifically challenge the clinical data contained within the performance
p.000291: evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment
p.000291: of the performance evaluation presented by the manufacturer;
p.000291:
p.000291: — be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented,
p.000291: and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
p.000291:
p.000292: L 117/292 EN
p.000292: Official Journal of the European Union
p.000292: 5.5.2017
p.000292:
p.000292: — be able to ascertain the comparability and consistency of the assessments of performance evaluation
p.000292: conducted by clinical experts;
p.000292:
p.000292: — be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion
p.000292: provided by any external expert and make a recommendation to the notified body's decision maker; and
p.000292:
p.000292: — be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been
p.000292: appropriately carried out.
p.000292:
p.000292: 3.2.5. The personnel responsible for carrying out product-related reviews, (product reviewers), such as
p.000292: technical documentation reviews or type examination, including aspects such as performance evaluation, biological
p.000292: safety, sterilisation and software validation, shall have all the following proven qualifications:
p.000292:
p.000292: — successful completion of a university or a technical college degree or an equivalent qualification in
p.000292: relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
p.000292:
p.000292: — four years' professional experience in the field of healthcare products or related activities, such as in manufac
p.000292: turing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or
p.000292: technology to be assessed or related to the scientific aspects to be assessed;
p.000292:
p.000292: — knowledge of device legislation, including the general safety and performance requirements set out in
p.000292: Annex I;
p.000292:
p.000292: — appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
p.000292:
...
p.000292: out those assessments;
p.000292:
p.000292: — the ability to draw up records and reports demonstrating that the relevant conformity assessment
p.000292: activities have been appropriately carried out.
p.000292:
p.000292: 3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system (site
p.000292: auditors) shall have all of the following proven qualifications:
p.000292:
p.000292: — successful completion of a university or a technical college degree or equivalent qualification in
p.000292: relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
p.000292:
p.000292: — four years' professional experience in the field of healthcare products or related activities, such as in manufac
p.000292: turing, auditing or research, of which two years shall be in the area of quality management;
p.000292:
p.000292: — appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance
p.000292: documents;
p.000292:
p.000292: — appropriate knowledge and experience of risk management and related device standards and guidance
p.000292: documents;
p.000292:
p.000292: — appropriate knowledge of quality management systems and related l devices standards and guidance
p.000292: documents;
p.000292:
p.000292: — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in
p.000292: particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying
p.000292: out those audits;
p.000292:
p.000292: 5.5.2017 EN
p.000292: Official Journal of the European Union
p.000293: L 117/293
p.000293:
p.000293: — training in auditing techniques enabling them to challenge quality management systems;
p.000293:
p.000293: — the ability to draw up records and reports demonstrating that the relevant conformity assessment
p.000293: activities have been appropriately carried out.
p.000293:
p.000293: 3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be
p.000293: employed by the notified body itself and shall not be external experts or be subcontracted. Those
p.000293: personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following:
p.000293: — devices legislation and relevant guidance documents;
p.000293: — device conformity assessments relevant to this Regulation;
p.000293: — the types of qualifications, experience and expertise relevant to device conformity assessment;
p.000293:
p.000293: — a broad base of knowledge of device technologies, including sufficient experience of the conformity
p.000293: assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
p.000293: — the notified body's quality system, related procedures and the required qualifications for personnel involved;
p.000293:
p.000293: — the ability to draw up records and reports demonstrating that the conformity assessment activities have been
p.000293: appropriately carried out.
p.000293:
p.000293: 3.3. Documentation of qualification, training and authorisation of personnel
p.000293:
p.000293: 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each
p.000293: member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria
...
p.000293: are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the
p.000293: assessment personnel and records of the conformity assessment activities carried out by each of them.
p.000293:
p.000293: 3.4. Subcontractors and external experts
p.000293:
p.000293: 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined
p.000293: component parts of a conformity assessment activity.
p.000293:
p.000293: The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be
p.000293: permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts
p.000293: working on behalf of the notified body. The notified body in question shall retain full responsibility for being able
p.000293: to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific
p.000293: tasks, for making a decision based on a subcontractor's assessment and for the work conducted by
p.000293: subcontractors and experts on its behalf.
p.000293: The following activities may not be subcontracted by notified bodies:
p.000293: — review of the qualifications and monitoring of the performance of external experts;
p.000293:
p.000293: — auditing and certification activities where the subcontracting in question is to auditing or certification organ
p.000293: isations;
p.000293: — allocation of work to external experts for specific conformity assessment activities;
p.000293: — final review and decision-making functions.
p.000293:
p.000294: L 117/294 EN
p.000294: Official Journal of the European Union
p.000294: 5.5.2017
p.000294:
p.000294: 3.4.2. Where a notified body subcontracts certain conformity assessment activities either to an
p.000294: organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take
p.000294: place, and shall ensure that:
p.000294: — the subcontractor meets the relevant requirements of this Annex;
p.000294: — subcontractors and external experts do not further subcontract work to organisations or personnel;
p.000294:
p.000294: — the natural or legal person that applied for conformity assessment has been informed of the
p.000294: requirements referred to in the first and second indent.
p.000294:
p.000294: Any subcontracting or consultation of external personnel shall be properly documented, shall not involve
p.000294: any intermediaries, and shall be subject to a written agreement covering, among other things,
p.000294: confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks
p.000294: performed by subcon tractors.
p.000294:
p.000294: 3.4.3. Where subcontractors or external experts are used in the context of a conformity assessment, in
p.000294: particular regarding novel devices or technologies, the notified body in question shall have adequate internal
p.000294: competence in each product area for which it is designated that is adequate for the purpose of leading the
p.000294: overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on
p.000294: certification.
p.000294:
p.000294: 3.5. Monitoring of competences, training and exchange of experience
p.000294:
p.000294: 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going
p.000294: monitoring of the competence, conformity assessment activities and performance of all internal and external
p.000294: personnel and subcon tractors, involved in conformity assessment activities.
p.000294:
p.000294: 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify
p.000294: training needs and draw up a training plan to maintain the required level of qualification and knowledge
p.000294: of individual personnel. That review shall as a minimum, verify that personnel:
p.000294:
p.000294: — are aware of the Union and national law in force on devices, relevant harmonised standards, CS,
p.000294: guidance documents and the results of the coordination activities referred to in Section 1.6;
p.000294:
p.000294: — take part in the internal exchange of experience and the continuous training and education programme
p.000294: referred to in Section 3.1.2.
p.000294:
p.000294: 4. PROCESS REQUIREMENTS
p.000294:
p.000294: 4.1. General
p.000294:
p.000294: The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of
p.000294: each conformity assessment activity for which it is designated, comprising the individual steps from pre-
p.000294: application activities up to decision making and surveillance and taking into account, when necessary,
p.000294: the respective specificities of the devices.
p.000294:
p.000294: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of
p.000294: notified bodies and shall not be subcontracted.
p.000294: 4.2. Notified body quotations and pre-application activities The notified body shall
p.000294:
p.000294: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000294: obtain certification from it. That description shall include which languages are acceptable for submission
p.000294: of documentation and for any related correspondence;
p.000294:
p.000294: (b) have documented procedures relating to, and documented details about, fees charged for specific conformity
p.000294: assessment activities and any other financial conditions relating to notified bodies' assessment activities
p.000294: for devices;,
p.000294:
p.000294: 5.5.2017 EN
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p.000295: L 117/295
p.000295:
p.000295: (c) have documented procedures in relation to advertising of its conformity assessment services.
p.000295: Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading
p.000295: to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier
p.000295: or less stringent than that of other notified bodies;
p.000295:
p.000295: (d) have documented procedures requiring the review of pre-application information including the
p.000295: preliminary verification that the product is covered by this Regulation and its classification prior to issuing any
p.000295: quotation to the manufacturer relating to a specific conformity assessment;
p.000295:
p.000295: (e) ensure that all contracts relating to the conformity assessment activities covered by this Regulation
p.000295: are concluded directly between the manufacturer and the notified body and not with any other organisation.
p.000295:
p.000295: 4.3. Application review and contract
p.000295:
p.000295: The notified body shall require a formal application signed by a manufacturer or an authorised
p.000295: representative containing all of the information and the manufacturer's declarations required by the
p.000295: relevant conformity assessment as referred to in Annexes IX to XI.
p.000295:
p.000295: The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both
p.000295: parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain
p.000295: obligations that enable the notified body to act as required under this Regulation, including an obligation on the
...
p.000295: (e) the availability of sufficient and appropriate resources.
p.000295:
p.000295: The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be
p.000295: notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies.
p.000295:
p.000295: 4.4. Allocation of resources
p.000295:
p.000295: The notified body shall have documented procedures to ensure that all conformity assessment activities
p.000295: are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of
p.000295: the devices, systems and processes and related documentation that are subject to conformity assessment.
p.000295:
p.000295: For each application, the notified body shall determine the resources needed and identify one individual
p.000295: responsible for ensuring that the assessment of that application is conducted in accordance with the
p.000295: relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the
p.000295: tasks of the assessment. The allocation of tasks required to be carried out as part of the conformity
p.000295: assessment and any changes subsequently made to this allocation shall be documented.
p.000295:
p.000295: 4.5. Conformity assessment activities
p.000295:
p.000295: 4.5.1. General
p.000295:
p.000295: The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of
p.000295: professional integrity and the requisite technical and scientific competence in the specific fields.
p.000295:
p.000296: L 117/296 EN
p.000296: Official Journal of the European Union
p.000296: 5.5.2017
p.000296:
p.000296: The notified body shall have expertise, facilities and documented procedures that are sufficient to
p.000296: effectively conduct the conformity assessment activities for which the notified body in question is
p.000296: designated, taking account of the relevant requirements set out in Annexes IX to XI and in particular the following
p.000296: requirements:
p.000296:
p.000296: — to appropriately plan the conduct of each individual project,
p.000296:
p.000296: — to ensure that the composition of the assessment teams is such that there is sufficient experience in relation to
p.000296: the technology concerned, and that there is continuous objectivity and independence, and to provide for rotation of
p.000296: the members of the assessment team at appropriate intervals,
p.000296:
p.000296: — to specify the rationale for fixing time limits for completion of conformity assessment activities,
p.000296:
p.000296: — to assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in
p.000296: Annex I,
p.000296:
p.000296: — to review the manufacturer's procedures and documentation relating to performance evaluation,
p.000296:
p.000296: — to address the interface between the manufacturer's risk management process and its appraisal and analysis of the
p.000296: performance evaluation and to evaluate their relevance for the demonstration of conformity with the
p.000296: relevant requirements in Annex I,
p.000296:
p.000296: — to carry out the ‘specific procedures’ referred to in Section 5 of Annex IX,
p.000296:
p.000296: — in the case of class B or C devices, to assess the technical documentation of devices selected on a representative
p.000296: basis,
p.000296:
...
p.000296:
p.000296: 4.5.2. Quality management system auditing
p.000296:
p.000296: (a) As part of the assessment of the quality management system a, a notified body shall prior to an audit and in
p.000296: accordance with its documented procedures:
p.000296:
p.000296: — assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw
p.000296: up an audit programme which clearly identifies the number and sequence of activities required to demonstrate
p.000296: complete coverage of a manufacturer's quality management system and to determine whether it meets the requirements of
p.000296: this Regulation,
p.000296:
p.000296: — identify links between and allocation of responsibilities among, the various manufacturing sites, and
p.000296: identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to
p.000296: specifically audit any of those suppliers or subcontractors or both,
p.000296:
p.000296: — clearly define, for each audit identified in the audit programme, the objectives, criteria and scope of the audit,
p.000296: and draw up an audit plan that adequately addresses and takes account of the specific requirements for the devices,
p.000296: technologies and processes involved,
p.000296:
p.000296: — draw up and keep up to date, for class B and class C devices, a sampling plan for the assessment
p.000296: of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the
p.000296: manufacturer's application. That plan shall ensure that all devices covered by the certificate are sampled
p.000296: over the period of validity of the certificate,
p.000296:
p.000296: 5.5.2017 EN
p.000296: Official Journal of the European Union
p.000297: L 117/297
p.000297:
p.000297: — select and assign appropriately qualified and authorised personnel for conducting the individual audits.
p.000297: The respective roles, responsibilities and authorities of the team members shall be clearly defined and
p.000297: documented.
p.000297:
p.000297: (b) Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented
p.000297: procedures:
p.000297:
p.000297: — audit the manufacturer's quality management system in order to verify that the quality management
p.000297: system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices
p.000297: at every stage, from design through final quality control to ongoing surveillance, and shall determine
p.000297: whether the requirements of this Regulation are met,
p.000297:
p.000297: — based on relevant technical documentation, and in order to determine whether the manufacturer meets the
p.000297: requirements referred to in the relevant conformity assessment Annex, review and audit the manufac turer's processes
p.000297: and subsystems,– in particular for:
p.000297:
p.000297: — design and development,
p.000297: — production and process controls,
p.000297: — product documentation,
p.000297: — purchasing controls including verification of purchased devices,
p.000297: — corrective and preventive actions including for post-market surveillance, and
p.000297: — PMPF,
p.000297:
p.000297: — and review and audit requirements and provisions adopted by the manufacturer, including those in
p.000297: relation to fulfilling the general safety and performance requirements set out in Annex I,
p.000297:
p.000297: — the documentation shall be sampled in such as a manner as to reflect the risks associated with the
...
p.000297: Section 4.5.4. for performance evaluation,
p.000297:
p.000297: — the notified body shall ensure that audit findings are appropriately and consistently classified in
p.000297: accordance with the requirements of this Regulation and with relevant standards, or with best practice
p.000297: documents developed or adopted by the MDCG.
p.000297:
p.000297: 4.5.3. Product verification
p.000297:
p.000297: Assessment of the technical documentation
p.000297:
p.000297: For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX,
p.000297: notified bodies shall have sufficient expertise, facilities and documented procedures for:
p.000297:
p.000297: — the allocation of appropriately qualified and authorised personnel for the examination of individual aspects,
p.000297: such as use of the device, biocompatibility, performance evaluation, risk management and sterilisation, and
p.000297:
p.000297: — the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4.
p.000297: and
p.000297: 4.5.5. This assessment shall include the examination of the implementation by manufacturers of incoming,
p.000297: in-process and final checks and the results thereof. If further tests or other evidence is required for
p.000297: the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out
p.000297: adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out
p.000297: such tests.
p.000297:
p.000298: L 117/298 EN
p.000298: Official Journal of the European Union
p.000298: 5.5.2017
p.000298:
p.000298: Type-examinations
p.000298:
p.000298: The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of
p.000298: devices in accordance with Annex X including the capacity to:
p.000298:
p.000298: — examine and assess the technical documentation, taking account of Sections 4.5.4. and 4.5.5, and verify that the
p.000298: type has been manufactured in conformity with that documentation;
p.000298:
p.000298: — establish a test plan identifying all relevant and critical parameters which need to be tested by
p.000298: the notified body or under its responsibility;
p.000298:
p.000298: — document its rationale for the selection of those parameters;
p.000298:
p.000298: — carry out the appropriate examinations and tests in order to verify that the solutions adopted by
p.000298: the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and
p.000298: tests shall include all tests necessary to verify that the manufacturer has in fact applied the
p.000298: relevant standards it has opted to use;
p.000298:
p.000298: — agree with the applicant as to where the necessary tests will be performed if they are not to be carried out
p.000298: directly by the notified body;
p.000298:
p.000298: — assume full responsibility for test results. Test reports submitted by the manufacturer shall only be taken into
p.000298: account if they have been issued by conformity assessment bodies which are competent and independent of the
p.000298: manufacturer.
p.000298: Verification by examination and testing of every product batch The notified body shall:
p.000298:
...
p.000298:
p.000298: (c) document its rationale for the selection of the parameters referred to in point (b);
p.000298:
p.000298: (d) have documented procedures to carry out the appropriate assessments and tests in order to verify
p.000298: the conformity of the device with the requirements of this Regulation by examining and testing every
p.000298: product batch as specified in Section 5 of Annex XI;
p.000298:
p.000298: (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and where
p.000298: necessary tests that are not to be carried out by the notified body itself are to be performed;
p.000298:
p.000298: (f) assume full responsibility for test results in accordance with documented procedures; test reports submitted by
p.000298: the manufacturer shall only be taken into account if they have been issued by conformity assessment
p.000298: bodies which are competent and independent of the manufacturer.
p.000298:
p.000298: 4.5.4. Performance evaluation assessment
p.000298:
p.000298: The assessment by notified bodies of procedures and documentation shall address the results of literature
p.000298: searches and all validation, verification and testing performed and conclusions drawn, and shall typically include
p.000298: considering the use of alternative materials and substances and take account of the packaging, stability including
p.000298: shelf life of the finished device. Where no new testing has been undertaken by a manufacturer or where
p.000298: there have been deviations from procedures, the notified body in question shall critically examine the
p.000298: justification presented by the manufacturer.
p.000298:
p.000298: 5.5.2017 EN
p.000298: Official Journal of the European Union
p.000299: L 117/299
p.000299:
p.000299: The notified body shall have documented procedures in place relating to the assessment of a
p.000299: manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment
p.000299: and on an ongoing basis. The notified body shall examine, validate and verify that the manufacturer's
p.000299: procedures and documentation adequately address:
p.000299:
p.000299: (a) the planning, conduct, assessment, reporting and updating of the performance evaluation as referred
p.000299: to in Annex XIII,
p.000299:
p.000299: (b) post-market surveillance and post-market performance follow up,
p.000299:
p.000299: (c) the interface with the risk management process,
p.000299:
p.000299: (d) the appraisal and analysis of the available data and its relevance with regard to demonstrating
p.000299: conformity with the relevant requirements in Annex I,
p.000299:
p.000299: (e) the conclusions drawn with regard to the clinical evidence and drawing up of the performance
p.000299: evaluation report.
p.000299:
p.000299: The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best
p.000299: practice documents.
p.000299:
p.000299: The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover:
p.000299:
p.000299: — the intended use specified by the manufacturer and claims for the device defined by it,
p.000299:
p.000299: — the planning of the performance evaluation,
p.000299:
p.000299: — the methodology for the literature search,
p.000299:
p.000299: — relevant documentation from the literature search,
p.000299:
p.000299: — the performance studies,
p.000299:
...
p.000299: and conclusions data from equivalent and similar devices,
p.000299:
p.000299: — the performance evaluation report,
p.000299:
p.000299: — justifications in relation to non-performance of performance studies or PMPF.
p.000299:
p.000299: In relation to data from performance studies included within the performance evaluation, the notified
p.000299: body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of
p.000299: the approved performance study plan.
p.000299:
p.000299: The notified body shall ensure that the performance evaluation adequately addresses the relevant safety
p.000299: and performance requirements provided for in Annex I, that it is appropriately aligned with the risk
p.000299: management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected
p.000299: in the information provided relating to the device.
p.000299:
p.000299:
p.000299: 4.5.5. Specific Procedures
p.000299:
p.000299: The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to
p.000299: in Section 5 of Annex IX, for which they are designated.
p.000299:
p.000299: In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil
p.000299: the requirements of this Regulation in relation to consultation of the EMA or a medicinal products
p.000299: competent authority during its assessment of such types of device.
p.000299:
p.000300: L 117/300 EN
p.000300: Official Journal of the European Union
p.000300: 5.5.2017
p.000300:
p.000300: 4.6. Reporting
p.000300:
p.000300: The notified body shall:
p.000300:
p.000300: — ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are
p.000300: clear and demonstrate compliance with the requirements of this Regulation and can represent objective
p.000300: evidence of such compliance to persons that are not themselves involved in the assessment, for example
p.000300: personnel in designating authorities,
p.000300:
p.000300: — ensure that records that are sufficient to provide a discernible audit trail are available for quality management
p.000300: system audits,
p.000300:
p.000300: — clearly document the conclusions of its assessment of performance evaluation in a performance
p.000300: evaluation assessment report,
p.000300:
p.000300: — for each specific project, provide a detailed report which shall be based on a standard format
p.000300: containing a minimum set of elements determined by the MDCG.
p.000300: The report of the notified body shall:
p.000300:
p.000300: — clearly document the outcome of its assessment and draw clear conclusions from the verification of
p.000300: the manufacturer's conformity with the requirements of this Regulation,
p.000300:
p.000300: — make a recommendation for a final review and for a final decision to be taken by the notified
p.000300: body; this recommendation shall be signed off by the member of personnel responsible in the notified body,
p.000300: — be provided to the manufacturer in question.
p.000300:
p.000300: 4.7. Final review
p.000300:
p.000300: The notified body shall prior to making a final decision:
p.000300:
p.000300: — ensure that the personnel assigned for the final review and decision making on specific projects are
...
p.000300:
p.000300: 4.8. Decisions and certifications
p.000300:
p.000300: The notified body shall have documented procedures for decision-making including as regards the allocation of
p.000300: responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those procedures
p.000300: shall include the notification requirements laid down in Chapter V of this Regulation. The procedures shall allow the
p.000300: notified body in question to:
p.000300:
p.000300: — decide, based on the assessment documentation and additional information available whether the
p.000300: requirements of this Regulation are fulfilled,
p.000300:
p.000300: — decide, based on the results of its assessment of the performance evaluation and risk management
p.000300: whether the post-market surveillance plan, including the PMPF plan, is adequate,
p.000300:
p.000300: — decide on specific milestones for further review by the notified body of the up to date performance
p.000300: evaluation,
p.000300: — decide whether specific conditions or provisions need to be defined for the certification,
p.000300:
p.000300: — decide, based on the novelty, risk classification, performance evaluation and conclusions from the risk
p.000300: analysis of the device, on a period of certification not exceeding five years,
p.000300:
p.000300: — clearly document decision making and approval steps including approval by signature of the members of
p.000300: personnel responsible,
p.000300:
p.000300: 5.5.2017 EN
p.000300: Official Journal of the European Union
p.000301: L 117/301
p.000301:
p.000301: — clearly document responsibilities and mechanisms for communication of decisions, in particular, where
p.000301: the final signatory of a certificate differs from the decision maker or decision makers or does not
p.000301: fulfil the requirements laid down in Section 3.2.7.,
p.000301:
p.000301: — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII
p.000301: for a period of validity not exceeding five years and shall indicate whether there are specific
p.000301: conditions or limitations associated with the certification,
p.000301:
p.000301: — issue a certificate or certificates for the applicant alone and shall not issue certificates covering
p.000301: multiple entities,
p.000301:
p.000301: — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they
p.000301: are entered into the electronic system referred to in Article 52.
p.000301:
p.000301: 4.9. Changes and modifications
p.000301:
p.000301: The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to
p.000301: the manufacturers' information obligations and the assessment of changes to:
p.000301: — the approved quality management system or systems or to the product-range covered,
p.000301: — the approved design of a device,
p.000301: — the approved type of a device,
p.000301: — any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific
p.000301: procedures in accordance with Section 4.5.5.
p.000301:
p.000301: The procedures and contractual arrangements referred to in the first paragraph shall include measures for
...
p.000301: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include
p.000301: arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers
p.000301: carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and
p.000301: associated with certification decisions, such as updates to clinical data at defined intervals,
p.000301:
p.000301: — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of
p.000301: their designation. Such information shall be taken into account in the planning and conduct of surveillance activities,
p.000301:
p.000301: — to review vigilance data to which they have access under to Article 87 in order to estimate its impact, if any, on
p.000301: the validity of existing certificates. The results of the evaluation and any decisions taken shall be
p.000301: thoroughly documented.
p.000301:
p.000301: The notified body in question shall, upon receipt of information about vigilance cases from a
p.000301: manufacturer or competent authorities, decide on which of the following options to apply:
p.000301: — not to take action on the basis that the vigilance case is clearly not related to the certification granted,
p.000301: — observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investi
p.000301: gation so as to determine whether the certification granted is at risk or whether adequate corrective
p.000301: action has been taken,
p.000301:
p.000302: L 117/302 EN
p.000302: Official Journal of the European Union
p.000302: 5.5.2017
p.000302:
p.000302: — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and
p.000302: product testing, where it is likely that the certification granted is at risk,
p.000302: — increase the frequency of surveillance audits,
p.000302: — review specific products or processes on the occasion of the next audit of the manufacturer, or
p.000302: — take any other relevant measure.
p.000302: In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
p.000302:
p.000302: — conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned
p.000302: and conducted in line with the relevant requirements in Section 4.5.,
p.000302:
p.000302: — ensure that it adequately assesses the manufacturer's documentation on, and application of, the provisions on
p.000302: vigilance, the post-market surveillance and PMPF,
p.000302:
p.000302: — sample and test devices and technical documentation, during audits, according to pre-defined sampling
p.000302: criteria and testing procedures to ensure that the manufacturer continuously applies the approved quality
p.000302: management system,
p.000302:
p.000302: — ensure that the manufacturer complies with the documentation and information obligations laid down in the relevant
p.000302: Annexes and that its procedures take into account best practices in the implementation of quality
p.000302: management systems,
p.000302:
p.000302: — ensure that the manufacturer does not use quality management system or device approvals in a
p.000302: misleading manner,
p.000302:
p.000302: — gather sufficient information to determine if the quality management system continues to comply with
...
p.000302: the condition being treated with the device or on clinical literature relevant to similar devices,
p.000302:
p.000302: — clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose
p.000302: any specific conditions on it,
p.000302:
p.000302: — ensure that the performance evaluation as most recently updated is appropriately reflected in the instructions for
p.000302: use and, where applicable, the summary of safety and performance.
p.000302:
p.000302: 4.11. Re-certification
p.000302:
p.000302: The notified body shall have documented procedures in place relating to the re-certification reviews and
p.000302: the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation
p.000302: assessment certificates or EU type-examination certificates shall occur at least every five years.
p.000302:
p.000302: The notified body shall have documented procedures relating to renewals of EU technical documentation
p.000302: assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in
p.000302: question to submit a summary of changes and scientific findings for the device, including:
p.000302: (a) all changes to the originally approved device, including changes not yet notified,
p.000302: (b) experience gained from post-market surveillance,
p.000302: (c) experience from risk-management,
p.000302:
p.000302: (d) experience from updating the proof of compliance with the general safety and performance requirements set out in
p.000302: Annex I,
p.000302:
p.000302: 5.5.2017 EN
p.000302: Official Journal of the European Union
p.000303: L 117/303
p.000303:
p.000303: (e) experience from reviews of the performance evaluation, including the results of any performance studies and PMPF,
p.000303: (f) changes to the requirements, to components of the device or to the scientific or regulatory environment,
p.000303: (g) changes to applied or new harmonised standards, CS or equivalent documents, and
p.000303: (h) changes in medical, scientific and technical knowledge, such as:
p.000303: — new treatments,
p.000303: — changes in test methods,
p.000303: — new scientific findings on materials and components, including findings on their biocompatibility,
p.000303: — experience from studies on comparable devices,
p.000303: — data from registers and registries,
p.000303: — experience from performance studies with comparable devices.
p.000303: The notified body shall have documented procedures to assess the information referred to in the second
p.000303: paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF
p.000303: activities undertaken since the previous certification or re-certification, including appropriate updates to
p.000303: manufacturers' performance evaluation reports.
p.000303:
p.000303: For the decision on the re-certification, the notified body in question shall use the same methods and principles as
p.000303: for the initial certification decision. If necessary, separate forms shall be established for re-certification taking
p.000303: into account the steps to be taken for certification, such as application and application review.
p.000303:
p.000304: L 117/304 EN
p.000304: Official Journal of the European Union
p.000304: 5.5.2017
p.000304:
p.000304: ANNEX VIII
p.000304:
p.000304: CLASSIFICATION RULES
p.000304:
p.000304: 1. IMPLEMENTING RULES
p.000304:
p.000304: 1.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.000304:
p.000304: 1.2. If the device in question is intended to be used in combination with another device, the
p.000304: classification rules shall apply separately to each of the devices.
p.000304:
p.000304: 1.3. Accessories for an in vitro diagnostic medical device shall be classified in their own right
p.000304: separately from the device with which they are used.
p.000304:
p.000304: 1.4. Software, which drives a device or influences the use of a device, shall fall within the same class as the
p.000304: device.
p.000304:
p.000304: If the software is independent of any other device, it shall be classified in its own right.
p.000304:
p.000304: 1.5. Calibrators intended to be used with a device shall be classified in the same class as the device.
p.000304:
p.000304: 1.6. Control materials with quantitative or qualitative assigned values intended for one specific
p.000304: analyte or multiple analytes shall be classified in the same class as the device.
p.000304:
p.000304: 1.7. The manufacturer shall take into consideration all classification and implementation rules in order to
p.000304: establish the proper classification for the device.
p.000304:
p.000304: 1.8. Where a manufacturer states multiple intended purposes for a device, and as a result the device
p.000304: falls into more than one class, it shall be classified in the higher class.
p.000304:
p.000304: 1.9. If several classification rules apply to the same device, the rule resulting in the higher classification
p.000304: shall apply.
p.000304:
...
p.000304:
p.000304: 2. CLASSIFICATION RULES
p.000304:
p.000304: 2.1. Rule 1
p.000304:
p.000304: Devices intended to be used for the following purposes are classified as class D:
p.000304: — detection of the presence of, or exposure to, a transmissible agent in blood, blood components,
p.000304: cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for
p.000304: transfusion, transplantation or cell administration;
p.000304: — detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening
p.000304: disease with a high or suspected high risk of propagation;
p.000304: — determining the infectious load of a life-threatening disease where monitoring is critical in the
p.000304: process of patient management.
p.000304:
p.000304: 2.2. Rule 2
p.000304:
p.000304: Devices intended to be used for blood grouping, or tissue typing to ensure the immunological
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
...
p.000305: (m) for screening for congenital disorders in new-born babies where failure to detect and treat such
p.000305: disorders could lead to life-threatening situations or severe disabilities.
p.000305:
p.000305: 2.4. Rule 4
p.000305: (a) Devices intended for self-testing are classified as class C, except for devices for the detection of
p.000305: pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of
p.000305: glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B.
p.000305: (b) Devices intended for near-patient testing are classified in their own right.
p.000305:
p.000305: 2.5. Rule 5
p.000305: The following devices are classified as class A:
p.000305: (a) products for general laboratory use, accessories which possess no critical characteristics, buffer
p.000305: solutions, washing solutions, and general culture media and histological stains, intended by the
p.000305: manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;
p.000305: (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
p.000305: (c) specimen receptacles.
p.000305:
p.000305: 2.6. Rule 6
p.000305: Devices not covered by the above-mentioned classification rules are classified as class B.
p.000305:
p.000305: 2.7. Rule 7
p.000305: Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
p.000305:
p.000306: L 117/306 EN
p.000306: Official Journal of the European Union
p.000306: 5.5.2017
p.000306:
p.000306: ANNEX IX
p.000306:
p.000306: CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
p.000306:
p.000306: CHAPTER I
p.000306:
p.000306: QUALITY MANAGEMENT SYSTEM
p.000306:
p.000306: 1. The manufacturer shall establish, document and implement a quality management system, as
p.000306: described in Article 10(8), and maintain its effectiveness throughout the life cycle of the
p.000306: devices concerned. The manufacturer shall ensure the application of the quality management system as specified in
p.000306: Section 2, and shall be subject to audit as laid down in Sections 2.3 and 2.4 and to surveillance as specified in
p.000306: Section 3.
p.000306:
p.000306:
p.000306: 2. Quality management system assessment
p.000306:
p.000306: 2.1. The manufacturer shall lodge an application for assessment of its quality management system with
p.000306: a notified body. The application shall include:
p.000306:
p.000306: — the name of the manufacturer and address of its registered place of business and any additional manufactur ing
p.000306: site covered by the quality management system, and, if the manufacturer's application is lodged by its
p.000306: authorised representative the name of the authorised representative and the address of the authorised
p.000306: representative's registered place of business,
p.000306:
p.000306: — all relevant information on the device or group of devices covered by the quality management system,
p.000306:
p.000306: — a written declaration that no application has been lodged with any other notified body for the same device- related
p.000306: quality management system, or information about any previous application for the same device- related
...
p.000306: in question to apply those procedures,
p.000306:
p.000306: — a description of the procedures in place to ensure that the quality management system remains
p.000306: adequate and effective, and the undertaking by the manufacturer to apply those procedures,
p.000306:
p.000306: — the documentation on the manufacturer's post-market surveillance system, and, where applicable, on the
p.000306: PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the
p.000306: provisions on vigilance set out in Articles 82 to 87,
p.000306:
p.000306: — a description of the procedures in place to keep up to date the post-market surveillance system and, where
p.000306: applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on
p.000306: vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures,
p.000306:
p.000306: — documentation on the performance evaluation plan, and
p.000306:
p.000306: — a description of the procedures in place to keep up to date the performance evaluation plan, taking
p.000306: into account the state of the art.
p.000306:
p.000306: 2.2. Implementation of the quality management system shall ensure compliance with this Regulation.
p.000306: All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be
p.000306: documented in a systematic and orderly manner in the form of a quality manual and written policies and
p.000306: procedures, such as quality programmes, quality plans and quality records.
p.000306:
p.000306: 5.5.2017 EN
p.000306: Official Journal of the European Union
p.000307: L 117/307
p.000307:
p.000307: Moreover, the documentation to be submitted for the assessment of the quality management system shall
p.000307: include an adequate description of, in particular:
p.000307:
p.000307: (a) the manufacturer's quality objectives;
p.000307:
p.000307: (b) the organisation of the business and in particular:
p.000307:
p.000307: — the organisational structures with the assignment of staff responsibilities in relation to
p.000307: critical procedures, the responsibilities of the managerial staff and their organisational authority,
p.000307:
p.000307: — the methods of monitoring whether the operation of the quality management system is efficient and in particular the
p.000307: ability of that system to achieve the desired design and device quality, including control of devices which fail to
p.000307: conform,
p.000307:
p.000307: — where the design, manufacture, and/or final verification and testing of the devices, or parts of any
p.000307: of those processes, is carried out by another party, the methods of monitoring the efficient operation of
p.000307: the quality management system and in particular the type and extent of control applied to the other
p.000307: party,
p.000307:
p.000307: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000307: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000307: representative to accept the mandate;
p.000307:
p.000307: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
...
p.000307:
p.000307: — risk management as referred to in Section 3 of Annex I,
p.000307:
p.000307: — the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding design and construction, including
p.000307: appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
p.000307:
p.000307: — solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the
p.000307: device, in particular the requirements of Chapter III of Annex I,
p.000307:
p.000307: — the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant
p.000307: documents at every stage of manufacture, and
p.000307:
p.000307: — management of design or quality management system changes;
p.000307:
p.000307: (d) the verification and quality assurance techniques at the manufacturing stage and in particular the processes and
p.000307: procedures which are to be used, particularly as regards sterilisation, and the relevant documents, and
p.000307:
p.000307: (e) the appropriate tests and trials which are to be carried out before, during and after manufacture,
p.000307: the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back
p.000307: adequately the calibration of that test equipment.
p.000307:
p.000307: In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in
p.000307: Annexes II and III.
p.000307:
p.000308: L 117/308 EN
p.000308: Official Journal of the European Union
p.000308: 5.5.2017
p.000308:
p.000308: 2.3. Audit
p.000308:
p.000308: The notified body shall audit the quality management system to determine whether it meets the requirements referred
p.000308: to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related to a quality
p.000308: management system, the notified body shall assess conformity with those standards or CS. The notified
p.000308: body shall assume that a quality management system which satisfies the relevant harmonised standards or
p.000308: CS conforms to the requirements covered by those standards or CS, unless it duly substantiate not doing so.
p.000308:
p.000308: The audit team of the notified body shall include at least one member with past experience of assessments of the
p.000308: technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is
p.000308: not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of
p.000308: that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the
p.000308: premises of the manufacturer's suppliers and/or subcontractors to verify the manufac turing and other relevant
p.000308: processes.
p.000308:
p.000308: Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the
p.000308: assessment of the technical documentation for devices selected on a representative basis in accordance with provisions
p.000308: in Sections 4.4 to 4.8. In choosing representative samples the notified body shall take into account the published
p.000308: guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology,
...
p.000308: conclusions of additional audits. The approval of any substantial change to the quality management system or the
p.000308: device-range covered shall take the form of a supplement to the EU quality management system certificate.
p.000308:
p.000308:
p.000308: 3. Surveillance assessment applicable to class C and class D devices
p.000308:
p.000308: 3.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the
p.000308: approved quality management system.
p.000308:
p.000308: 3.2. The manufacturer shall give authorisation to the notified body to carry out all the necessary audits,
p.000308: including on-site audits, and supply it with all relevant information, in particular:
p.000308:
p.000308: — the documentation on its quality management system,
p.000308:
p.000308: — the documentation on any findings and conclusions resulting from the application of the post-market
p.000308: surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance
p.000308: set out in Articles 82 to 87,
p.000308:
p.000308: — the data stipulated in the part of the quality management system relating to design, such as the results
p.000308: of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in
p.000308: Section 4 of Annex I,
p.000308:
p.000308: — the data stipulated in the part of the quality management system relating to manufacture, such as
p.000308: quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned.
p.000308:
p.000308: 5.5.2017 EN
p.000308: Official Journal of the European Union
p.000309: L 117/309
p.000309:
p.000309: 3.3. Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and
p.000309: assessments to make sure that the manufacturer in question applies the approved quality management system and the post-
p.000309: market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if
p.000309: appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the notified
p.000309: body shall, where necessary, carry out or ask for tests in order to check that the quality management system is
p.000309: working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried
p.000309: out, with a test report.
p.000309:
p.000309: 3.4. The notified body shall randomly perform at least once every five years unannounced audits on the site of
p.000309: the manufacturer and, where appropriate, the site of the manufacturer's suppliers and/or subcontractors, which may be
p.000309: combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that
p.000309: surveillance assessment. The notified body shall establish a plan for such unannounced on-site audits but shall not
p.000309: disclose it to the manufacturer.
p.000309:
p.000309: Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices
p.000309: produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity
p.000309: with the technical documentation. Prior to unannounced on-site audits, the notified body shall specify the relevant
p.000309: sampling criteria and testing procedure.
p.000309:
...
p.000309: is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous
p.000309: objectivity and neutrality; this shall include a rotation of the members of the assessment team at
p.000309: appropriate intervals. As a general rule, a lead auditor shall neither lead nor attend audits for more
p.000309: than three consecutive years in respect of the same manufacturer.
p.000309:
p.000309: 3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the
p.000309: market and the specifications laid down in the technical documentation or the approved design, it shall
p.000309: suspend or withdraw the relevant certificate or impose restrictions on it.
p.000309:
p.000309:
p.000309: CHAPTER II
p.000309:
p.000309: ASSESSMENT OF THE TECHNICAL DOCUMENTATION
p.000309:
p.000309:
p.000309: 4. Assessment of the technical documentation of class B, C and D devices and batch verification
p.000309: applicable to class D devices
p.000309:
p.000309: 4.1. In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the
p.000309: notified body an application for the assessment of the technical documentation relating to the device which it plans to
p.000309: place on the market or put into service and which is covered by the quality management system referred to in Section 2.
p.000309:
p.000309: 4.2. The application shall describe the design, manufacture and performance of the device in
p.000309: question. It shall include the technical documentation as referred to in Annexes II and III.
p.000309:
p.000310: L 117/310 EN
p.000310: Official Journal of the European Union
p.000310: 5.5.2017
p.000310:
p.000310: In the case of devices for self-testing or near-patient testing, the application shall also include the
p.000310: aspects referred to in point (b) of Section 5.1.
p.000310:
p.000310:
p.000310: 4.3. The notified body shall examine the application by using staff, employed by it, with proven
p.000310: knowledge and experience in the evaluation of the technology, and the devices concerned and the
p.000310: evaluation of clinical evidence. The notified body may require the application to be completed by having further
p.000310: tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant
p.000310: requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to
p.000310: the device or request the manufacturer to carry out such tests.
p.000310:
p.000310:
p.000310: 4.4. The notified body shall review the clinical evidence presented by the manufacturer in the
p.000310: performance evaluation report and the related performance evaluation that was conducted. The notified body
p.000310: shall use employed device reviewers with sufficient clinical expertise and including external clinical
p.000310: experts with direct and current experience relating to the clinical application of the device in question
p.000310: for the purposes of that review.
p.000310:
p.000310:
p.000310: 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data
p.000310: from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such
p.000310: data, taking into account factors such as new indications and innovation. The notified body shall
...
p.000310: chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The
p.000310: verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5).
p.000310:
p.000310:
p.000310: In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation,
p.000310: consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure
p.000310: laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
p.000310:
p.000310: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000310:
p.000310: The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted,
p.000310: pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in
p.000310: the documentation of the notified body concerning the device. The notified body shall, when making its decision, give
p.000310: due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and,
p.000310: where applicable, to the views expressed by the experts consulted pursuant to Article 48(6). The notified body shall
p.000310: not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable.
p.000310:
p.000310: 5.5.2017 EN
p.000310: Official Journal of the European Union
p.000311: L 117/311
p.000311:
p.000311: 4.10. The notified body shall provide the manufacturer with a report on the technical documentation
p.000311: assessment, including a performance evaluation assessment report. If the device conforms to the relevant provisions of
p.000311: this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The
p.000311: certificate shall contain the conclusions of the technical documentation assessment, the conditions of the
p.000311: certificate's validity, the data needed for identification of the approved device, and, where appropriate, a
p.000311: description of the intended purpose of the device.
p.000311:
p.000311: 4.11. Changes to the approved device shall require approval from the notified body which issued the
p.000311: EU technical documentation assessment certificate, where such changes could affect the safety and performance of the
p.000311: device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-
p.000311: mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate
p.000311: thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new
p.000311: conformity assessment in accordance with Article 48 or whether they could be addressed by means of a
p.000311: supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall
p.000311: assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide
p.000311: it with a supplement to the EU technical documentation assessment certificate.
p.000311:
...
p.000311: the notified body about its findings.
p.000311:
p.000311: 4.13. The manufacturer may place the devices on the market, unless the notified body communicates to
p.000311: the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other
p.000311: decision, including in particular any condition of validity of delivered certificates.
p.000311:
p.000311:
p.000311: 5. Assessment of the technical documentation of specific types of devices
p.000311:
p.000311: 5.1. Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient
p.000311: testing
p.000311:
p.000311: (a) The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge
p.000311: with the notified body an application for the assessment of the technical documentation.
p.000311:
p.000311: (b) The application shall enable the design of the device characteristics and performance(s) to be
p.000311: understood and shall enable conformity with the design-related requirements of this Regulation to be assessed. It
p.000311: shall include:
p.000311:
p.000311: (i) test reports, including results of studies carried out with intended users;
p.000311:
p.000311: (ii) where practicable, an example of the device; if required, the device shall be returned on completion of the
p.000311: technical documentation assessment;
p.000311:
p.000311: (iii) data showing the suitability of the device in view of its intended purpose for self-testing or near patient-
p.000311: testing;
p.000311:
p.000311: (iv) the information to be provided with the device on its label and its instructions for use.
p.000311:
p.000312: L 117/312 EN
p.000312: Official Journal of the European Union
p.000312: 5.5.2017
p.000312:
p.000312: The notified body may require the application to be completed by carrying out further tests or by providing further
p.000312: proof to allow assessment of conformity with the requirements of this Regulation.
p.000312:
p.000312: (c) The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of
p.000312: this Regulation.
p.000312:
p.000312: (d) The notified body shall assess the application, by using staff, employed by it, with proven knowledge
p.000312: and experience regarding the technology concerned and the intended purpose of the device and provide the
p.000312: manufacturer with a technical documentation assessment report.
p.000312:
p.000312: (e) If the device conforms to the relevant provisions of this Regulation, the notified body shall issue
p.000312: an EU technical documentation assessment certificate. The certificate shall contain the conclusions
p.000312: of the assessment, the conditions of its validity, the data needed for the identification of the approved devices
p.000312: and, where appropriate, a description of the intended purpose of the device.
p.000312:
p.000312: (f) Changes to the approved device shall require approval from the notified body which issued the EU technical
p.000312: documentation assessment certificate, where such changes could affect the safety and performance of the
p.000312: device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the
p.000312: above-mentioned changes, it shall inform the notified body which issued the EU technical documen tation
p.000312: assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned
...
p.000312: medicinal product concerned is already authorised, or if an application for its authorisation has been submitted,
p.000312: the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the
p.000312: authorisation.
p.000312:
p.000312: (d) The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of
p.000312: all the necessary documentation. This 60-day period may be extended once for a further 60 days on
p.000312: justified grounds. The opinion and any possible update shall be included in the documentation of the notified body
p.000312: concerning the device.
p.000312:
p.000312: (e) The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its
p.000312: decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU
p.000312: technical documentation assessment certificate shall be delivered in accordance with point (e) of Section
p.000312: 5.1.
p.000312:
p.000312: (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.000312: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000312: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000312:
p.000312: 5.5.2017 EN
p.000312: Official Journal of the European Union
p.000313: L 117/313
p.000313:
p.000313: (f) Before changes affecting the performance and/or the intended use and/or the suitability of the
p.000313: device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of
p.000313: the changes. The notified body shall assess the planned changes and decide whether the planned changes
p.000313: require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a
p.000313: supplement to the EU technical documentation assessment certificate. In the latter case, the notified body
p.000313: shall assess the changes and seek the opinion of the medicinal products authority consulted. The medicinal products
p.000313: authority consulted shall give its opinion within 30 days of receipt of the all the necessary
p.000313: documentation regarding the changes. A supplement to the EU technical documentation assessment
p.000313: certificate shall be issued in accordance with point (f) of Section 5.1.
p.000313:
p.000313: CHAPTER III
p.000313: ADMINISTRATIVE PROVISIONS
p.000313:
p.000313: 6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000313: it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been
p.000313: placed on the market, keep at the disposal of the competent authorities:
p.000313: — the EU declaration of conformity,
p.000313: — the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and
p.000313: records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
p.000313: — information on the changes referred to in Section 2.4.,
p.000313: — the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
p.000313: — the decisions and reports from the notified body as referred to in this Annex.
p.000313:
p.000313: 7. Each Member State shall require that the documentation referred to in Section 6 is kept at
p.000313: the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its
p.000313: authorised represen tative, established within its territory goes bankrupt or ceases its business activity
p.000313: prior to the end of that period.
p.000313:
p.000314: L 117/314 EN
p.000314: Official Journal of the European Union
p.000314: 5.5.2017
p.000314:
p.000314: ANNEX X
p.000314:
p.000314: CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
p.000314:
p.000314: 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including
p.000314: its technical documentation and relevant life cycle processes and a corresponding representative sample of the device
p.000314: production envisaged, fulfils the relevant provisions of this Regulation.
p.000314:
p.000314:
p.000314: 2. Application
p.000314:
p.000314: The manufacturer shall lodge an application for assessment with a notified body. The application shall include:
p.000314:
p.000314: — the name of the manufacturer and the address of its registered place of business and, if the application is lodged
p.000314: by the authorised representative, the name of the authorised representative and the address of its
p.000314: registered place of business,
p.000314:
p.000314: — the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample of
p.000314: the device production envisaged (‘type’) available to the notified body. The notified body may request other samples as
p.000314: necessary,
p.000314:
p.000314: — in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried
p.000314: out with intended users, and data showing the handling suitability of the device in relation to its intended purpose
p.000314: for self-testing or near patient-testing,
p.000314:
p.000314: — where practicable, an example of the device. If required, the device shall be returned on completion
p.000314: of the technical documentation assessment;
p.000314:
p.000314: — data showing the suitability of the device in relation to its intended purpose for self-testing or
p.000314: near-patient testing,
...
p.000314:
p.000314: The notified body shall:
p.000314:
p.000314: (a) examine the application, by using staff with proven knowledge and experience in the evaluation of
p.000314: the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the
p.000314: application to be completed by having further tests carried out or requesting further evidence to be
p.000314: provided to allow assessment of conformity with the relevant requirements of this Regulation. The
p.000314: notified body shall carry out adequate physical or laboratory tests in relation to the device or request the
p.000314: manufacturer to carry out such tests;
p.000314:
p.000314: (b) examine and assess the technical documentation for conformity with the requirements of this Regulation that are
p.000314: applicable to the device and verify that the type has been manufactured in conformity with that documen tation; it
p.000314: shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with
p.000314: applicable CS, and record items not designed on the basis of the relevant standards referred to in
p.000314: Article 8 or of the relevant CS;
p.000314:
p.000314: (c) review the clinical evidence presented by the manufacturer in the performance evaluation report in accordance with
p.000314: Section 1.3.2 of Annex XIII. The notified body shall employ device reviewers with sufficient clinical
p.000314: expertise and, if necessary, use external clinical experts with direct and current experience relating to
p.000314: the clinical application of the device in question for the purposes of that review;
p.000314:
p.000314: 5.5.2017 EN
p.000314: Official Journal of the European Union
p.000315: L 117/315
p.000315:
p.000315: (d) in circumstances in which the clinical evidence is partly or totally based on data from devices
p.000315: which are claimed to be similar or equivalent to the device under assessment, assess the suitability of
p.000315: using such data, taking into account factors such as new indications and innovation. The notified body shall clearly
p.000315: document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating
p.000315: conformity;
p.000315:
p.000315: (e) clearly document the outcome of its assessment in the performance evaluation assessment report referred to in
p.000315: Section 4.8 of Annex IX;
p.000315:
p.000315: (f) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary
p.000315: to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid
p.000315: down in this Regulation in the event that the standards referred to in Article 8 or the CS have not
p.000315: been applied. Where the device has to be connected to another device or devices in order to operate as
p.000315: intended, proof shall be provided that it conforms to the general safety and performance requirements when connected
p.000315: to any such device or devices having the characteristics specified by the manufacturer;
p.000315:
p.000315: (g) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary
p.000315: to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised
p.000315: standards, those standards have actually been applied;
p.000315:
...
p.000315: EMA. If the medicinal product concerned is already authorised, or if an application for its
p.000315: authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the
p.000315: EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its
p.000315: opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a
p.000315: further 60 days on justified grounds. The opinion of the medicinal products authority consulted and any
p.000315: possible update shall be included in the documentation of the notified body concerning the device. The notified body
p.000315: shall give due consideration to the opinion expressed by the medicinal products authority consulted when
p.000315: making its decision. It shall convey its final decision to the medicinal products authority consulted; and
p.000315:
p.000315: (l) draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific
p.000315: opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D
p.000315: devices or covered by the third indent of Section 2.
p.000315:
p.000316: L 117/316 EN
p.000316: Official Journal of the European Union
p.000316: 5.5.2017
p.000316:
p.000316: 4. Certificate
p.000316:
p.000316: If the type conforms to this Regulation, the notified body shall issue an EU type-examination
p.000316: certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of
p.000316: the type examination assessment, the conditions of certificate's validity and the data needed for identification of
p.000316: the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of
p.000316: the documentation shall be annexed to the certificate and a copy kept by the notified body.
p.000316:
p.000316: 5. Changes to the type
p.000316:
p.000316: 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of
p.000316: any planned change to the approved type or of its intended purpose and conditions of use.
p.000316:
p.000316: 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use
p.000316: shall require further approval from the notified body which issued the EU type-examination certificate where such
p.000316: changes may affect conformity with the general safety and performance requirements or with the conditions prescribed
p.000316: for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision
p.000316: and provide him with a supplement to the EU type-examination report. The approval of any change to the approved
p.000316: type shall take the form of a supplement to the EU type-examination certificate.
p.000316:
p.000316: 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations
...
p.000316:
p.000316: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000316:
p.000316: 5.5. Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU
p.000316: type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the
p.000316: medicinal products competent authority that was involved in the initial consultation or the EMA. The
p.000316: medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid
p.000316: documentation regarding the changes. The approval of any change to the approved type shall take the form of a
p.000316: supplement to the initial EU type-examination certificate.
p.000316:
p.000316: 6. Administrative provisions
p.000316:
p.000316: The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its
p.000316: authorised representative shall, for a period ending no sooner than 10 years, after the last device has been placed on
p.000316: the market, keep at the disposal of the competent authorities:
p.000316: — the documentation referred to in the second indent of Section 2,
p.000316: — information on the changes referred to in Section 5,
p.000316: — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section
p.000316: 7 of Annex IX shall apply.
p.000316:
p.000316: 5.5.2017 EN
p.000316: Official Journal of the European Union
p.000317: L 117/317
p.000317:
p.000317: ANNEX XI
p.000317:
p.000317: CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
p.000317:
p.000317: 1. The manufacturer shall ensure that the quality management system approved for the manufacture of
p.000317: the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and
p.000317: shall be subject to the surveillance referred to in Section 4.
p.000317:
p.000317: 2. When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU
p.000317: declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the
p.000317: conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to
p.000317: ensure, and to declare, that the device concerned meets the requirements of this Regulation which apply to the device,
p.000317: and in the case of class C and class D devices that undergo a type examination, conforms to the type
p.000317: described in the EU type- examination certificate.
p.000317:
p.000317:
p.000317: 3. Quality management system
p.000317:
p.000317: 3.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body.
p.000317:
p.000317: The application shall include:
p.000317:
p.000317: — all elements listed in Section 2.1 of Annex IX,
p.000317:
p.000317: — the technical documentation referred to in Annexes II and III for the types approved,
p.000317:
p.000317: — a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination
p.000317: certificates have been issued by the same notified body with which the application is lodged, a reference to the
...
p.000317: manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of
p.000317: a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records.
p.000317:
p.000317: That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d)
p.000317: and (e) of Section 2.2. of Annex IX.
p.000317:
p.000317: 3.3. The first and second paragraphs of Section 2.3 of Annex IX shall apply.
p.000317:
p.000317: If the quality management system is such that it ensures that the devices conform to the type described in the EU
p.000317: type-examination certificate and conform to the relevant provisions of this Regulation, the notified body shall issue
p.000317: an EU production quality assurance certificate. The notified body shall notify the manufacturer of its
p.000317: decision to issue the certificate. That decision shall contain the conclusions of the notified body's
p.000317: audit and a reasoned assessment.
p.000317:
p.000317: 3.4. Section 2.4 of Annex IX shall apply.
p.000317:
p.000317:
p.000317: 4. Surveillance
p.000317:
p.000317: 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.000317: Annex IX shall apply.
p.000317:
p.000317:
p.000317: 5. Verification of manufactured class D devices
p.000317:
p.000317: 5.1. In the case of class D devices, the manufacturer shall carry out tests on each manufactured batch of devices.
p.000317: After the conclusion of the controls and tests, it shall forward to the notified body without delay the relevant
p.000317: reports on
p.000317:
p.000318: L 117/318 EN
p.000318: Official Journal of the European Union
p.000318: 5.5.2017
p.000318:
p.000318: those tests. Furthermore, the manufacturer shall make samples of manufactured devices or batches of
p.000318: devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements
p.000318: which shall include that the notified body or the manufacturer, shall send samples of the manufactured
p.000318: devices or batches of devices to an EU reference laboratory, where such a laboratory has been designated in
p.000318: accordance with Article 100, to carry out appropriate laboratory tests. The EU reference laboratory shall
p.000318: inform the notified body about its findings.
p.000318:
p.000318: 5.2. The manufacturer may place the devices on the market, unless the notified body
p.000318: communicates to the manufacturer within the agreed timeframe, but not later than 30 days after
p.000318: reception of the samples, any other decision, including in particular any condition of validity of delivered
p.000318: certificates.
p.000318:
p.000318: 6. Administrative provisions
p.000318:
p.000318: The manufacturer or, where the manufacturer does not have a registered place of business in a Member
p.000318: State, its authorised representative shall, for a period ending no sooner than 10 years after the last device
p.000318: has been placed on the market, keep at the disposal of the competent authorities:
p.000318:
p.000318: — the EU declaration of conformity,
p.000318:
p.000318: — the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
p.000318:
p.000318: — the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU
p.000318: type- examination certificate referred to in Annex X,
p.000318:
p.000318: — information on the changes referred to in Section 2.4 of Annex IX, and
p.000318:
p.000318: — the decisions and reports from the notified body as referred to in Sections 2.3., 3.3. and 3.4. of Annex IX. Section
p.000318: 7 of Annex IX shall apply.
p.000318:
p.000318: 5.5.2017 EN
p.000318: Official Journal of the European Union
p.000319: L 117/319
p.000319:
p.000319: ANNEX XII
p.000319:
p.000319: CERTIFICATES ISSUED BY A NOTIFIED BODY
p.000319:
p.000319: CHAPTER I
p.000319:
p.000319: GENERAL REQUIREMENTS
p.000319:
p.000319:
p.000319: 1. Certificates shall be drawn up in one of the official languages of the Union.
p.000319:
p.000319: 2. Each certificate shall refer to only one conformity assessment procedure.
p.000319:
p.000319: 3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer
p.000319: included in the certificate shall be the same as that registered in the electronic system referred to in Article 27.
p.000319:
p.000319: 4. The scope of the certificates shall unambiguously describe the device or devices covered:
p.000319:
p.000319: (a) EU technical documentation assessment certificates and EU type-examination certificates shall include
p.000319: a clear identification, including the name, model and type, of the device or devices, the intended purpose
p.000319: as indicated by the manufacturer in the instructions for use and in relation to which the device has
p.000319: been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in
p.000319: Article 24(6).
p.000319:
p.000319: (b) EU quality management system certificates and EU production quality assurance certificates shall
p.000319: include the identification of the devices or groups of devices, the risk classification and the intended purpose.
p.000319:
p.000319: 5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the
p.000319: certificate. The notified body shall set up a system that enables the determination of the devices, including their
p.000319: classification, covered by the certificate.
p.000319:
p.000319: 6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device or
p.000319: devices it covers, another certificate issued in accordance with this Regulation is required.
p.000319:
p.000319: 7. EU quality management system certificates and EU production quality assurance certificates for
p.000319: class A sterile devices shall include a statement that the audit by the notified body was limited to
p.000319: the aspects of manufacture concerned with securing and maintaining sterile conditions.
p.000319:
p.000319: 8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a
p.000319: reference to the preceding certificate and its date of issue with identification of the changes.
p.000319:
p.000319:
p.000319: CHAPTER II
p.000319:
p.000319: MINIMUM CONTENT OF THE CERTIFICATES
p.000319:
p.000319:
p.000319: 1. name, address and identification number of the notified body;
p.000319:
p.000319: 2. name and address of the manufacturer and, if applicable, of the authorised representative;
p.000319:
p.000319: 3. unique number identifying the certificate;
p.000319:
p.000319: 4. if already issued, the SRN of the manufacturer referred to in Article 28(2);
p.000319:
p.000319: 5. date of issue;
p.000319:
p.000319: 6. date of expiry;
p.000319:
p.000319: 7. data needed for the unambiguous identification of the device or devices where applicable as
p.000319: specified in Section 4 of this Annex;
p.000319:
p.000320: L 117/320 EN
p.000320: Official Journal of the European Union
p.000320: 5.5.2017
p.000320:
p.000320: 8. if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
p.000320:
p.000320: 9. reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has
p.000320: been carried out;
p.000320:
p.000320: 10. examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports
p.000320: and audit report(s);
p.000320:
p.000320: 11. if applicable, reference to the relevant parts of the technical documentation or other
p.000320: certificates required for the placing on the market of the device or devices covered;
p.000320:
p.000320: 12. if applicable, information about the surveillance by the notified body;
p.000320:
p.000320: 13. conclusions of the notified body's conformity assessment with regard to the relevant Annex;
p.000320:
p.000320: 14. conditions for or limitations to the validity of the certificate;
p.000320:
p.000320: 15. legally binding signature of the notified body in accordance with the applicable national law.
p.000320:
p.000320: 5.5.2017 EN
p.000320: Official Journal of the European Union
p.000321: L 117/321
p.000321:
p.000321: ANNEX XIII
p.000321:
p.000321: PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP
p.000321:
p.000321: PART A
p.000321:
p.000321: PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
p.000321:
p.000321: 1. PERFORMANCE EVALUATION
p.000321:
p.000321: Performance evaluation of a device is a continuous process by which data are assessed and analysed to
p.000321: demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended
p.000321: purpose as stated by the manufacturer. To plan, continuously conduct and document a performance evaluation, the
p.000321: manufacturer shall establish and update a performance evaluation plan. The performance evaluation plan
p.000321: shall specify the characteristics and the performance of the device and the process and criteria applied
p.000321: to generate the necessary clinical evidence.
p.000321:
p.000321: The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data.
p.000321:
p.000321: Its depth and extent shall be proportionate and appropriate to the characteristics of the device
p.000321: including the risks, risk class, performance and its intended purpose.
p.000321:
p.000321:
p.000321: 1.1. Performance evaluation plan
p.000321:
p.000321: As a general rule, the performance evaluation plan shall include at least:
p.000321:
p.000321: — a specification of the intended purpose of the device;
p.000321:
p.000321: — a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in
p.000321: point (c) of Section 20.4.1. of Chapter III of Annex I;
p.000321:
p.000321: — a specification of the analyte or marker to be determined by the device;
p.000321:
p.000321: — a specification of the intended use of the device;
p.000321:
p.000321: — identification of certified reference materials or reference measurement procedures to allow for metrological
p.000321: traceability;
p.000321:
p.000321: — a clear identification of specified target patient groups with clear indications, limitations and
p.000321: contra- indications;
p.000321:
p.000321: — an identification of the general safety and performance requirements as laid down in Sections 1 to 9
p.000321: of Annex I that require support from relevant scientific validity and analytical and clinical performance data;
p.000321:
p.000321: — a specification of methods, including the appropriate statistical tools, used for the examination of
p.000321: the analytical and clinical performance of the device and of the limitations of the device and
p.000321: information provided by it;
p.000321:
p.000321: — a description of the state of the art, including an identification of existing relevant standards, CS, guidance or
p.000321: best practices documents;
p.000321:
p.000321: — an indication and specification of parameters to be used to determine, based on the state of the
p.000321: art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and
p.000321: for the analytical and clinical performance of the device;
p.000321:
p.000321: — for software qualified as a device, an identification and specification of reference databases and other sources of
p.000321: data used as the basis for its decision making;
p.000321:
p.000322: L 117/322 EN
p.000322: Official Journal of the European Union
p.000322: 5.5.2017
p.000322:
p.000322: — an outline of the different development phases including the sequence and means of determination of
p.000322: the scientific validity, the analytical and clinical performance, including an indication of
p.000322: milestones and a description of potential acceptance criteria;
p.000322: — the PMPF planning as referred to in Part B of this Annex.
p.000322:
p.000322: Where any of the above mentioned elements are not deemed appropriate in the Performance Evaluation Plan due to the
p.000322: specific device characteristics a justification shall be provided in the plan.
p.000322: 1.2. Demonstration of the scientific validity and the analytical and clinical performance: As a general
p.000322: methodological principle the manufacturer shall:
p.000322:
p.000322: — identify through a systematic scientific literature review the available data relevant to the device
p.000322: and its intended purpose and identify any remaining unaddressed issues or gaps in the data;
p.000322:
p.000322: — appraise all relevant data by evaluating their suitability for establishing the safety and performance
p.000322: of the device;
p.000322: — generate any new or additional data necessary to address outstanding issues.
p.000322:
p.000322: 1.2.1. Demonstration of the scientific validity
p.000322:
p.000322: The manufacturer shall demonstrate the scientific validity based on one or a combination of the
p.000322: following sources:
p.000322: — relevant information on the scientific validity of devices measuring the same analyte or marker;
p.000322: — scientific (peer-reviewed) literature;
p.000322: — consensus expert opinions/positions from relevant professional associations;
p.000322: — results from proof of concept studies;
p.000322: — results from clinical performance studies.
p.000322:
p.000322: The scientific validity of the analyte or marker shall be demonstrated and documented in the scientific
p.000322: validity report.
p.000322:
p.000322: 1.2.2. Demonstration of the analytical performance
p.000322:
p.000322: The manufacturer shall demonstrate the analytical performance of the device in relation to all the
p.000322: parameters described in point (a) of Section 9.1 of Annex I, unless any omission can be justified as not applicable.
p.000322:
p.000322: As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance
p.000322: studies.
p.000322:
p.000322: For novel markers or other markers without available certified reference materials or reference
p.000322: measurement procedures, it may not be possible to demonstrate trueness. If there are no comparative
p.000322: methods, different approaches may be used if demonstrated to be appropriate, such as comparison to some other
p.000322: well-documented methods or the composite reference standard. In the absence of such approaches, a clinical
p.000322: performance study comparing performance of the novel device to the current clinical standard practice is required.
p.000322:
p.000322: Analytical performance shall be demonstrated and documented in the analytical performance report.
p.000322:
p.000322: 1.2.3. Demonstration of the clinical performance
p.000322:
p.000322: The manufacturer shall demonstrate the clinical performance of the device in relation to all the
p.000322: parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable.
p.000322:
p.000322: 5.5.2017 EN
p.000322: Official Journal of the European Union
p.000323: L 117/323
p.000323:
p.000323: Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources:
p.000323: — clinical performance studies;
p.000323: — scientific peer-reviewed literature;
p.000323: — published experience gained by routine diagnostic testing.
p.000323:
p.000323: Clinical performance studies shall be performed unless due justification is provided for relying on other sources of
p.000323: clinical performance data.
p.000323:
p.000323: Clinical performance shall be demonstrated and documented in the clinical performance report.
p.000323:
p.000323: 1.3. Clinical evidence and performance evaluation report
p.000323:
p.000323: 1.3.1. The manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to
p.000323: verify the conformity of its device with the general safety and performance requirements as referred to
p.000323: in Annex I. The amount and quality of that data shall allow the manufacturer to make a qualified assessment whether
p.000323: the device will achieve the intended clinical benefit or benefits and safety, when used as intended by the
p.000323: manufacturer. The data and conclusions drawn from this assessment shall constitute the clinical evidence for the
p.000323: device. The clinical evidence shall scientifically demonstrate that the intended clinical benefit or benefits and
p.000323: safety will be achieved according to the state of the art in medicine.
p.000323:
p.000323: 1.3.2. Performance evaluation report
p.000323:
p.000323: The clinical evidence shall be documented in a performance evaluation report. This report shall include
p.000323: the scientific validity report, the analytical performance report, the clinical performance report and an assessment of
p.000323: those reports allowing demonstration of the clinical evidence.
...
p.000323:
p.000323: — the literature search methodology and the literature search protocol and literature search report of a literature
p.000323: review;
p.000323:
p.000323: — the technology on which the device is based, the intended purpose of the device and any claims made about the
p.000323: device's performance or safety;
p.000323:
p.000323: — the nature and extent of the scientific validity and the analytical and clinical performance data that has been
p.000323: evaluated;
p.000323: — the clinical evidence as the acceptable performances against the state of the art in medicine;
p.000323: — any new conclusions derived from PMPF reports in accordance with Part B of this Annex.
p.000323:
p.000323: 1.3.3. The clinical evidence and its assessment in the performance evaluation report shall be updated
p.000323: throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's
p.000323: PMPF plan in accordance with Part B of this Annex, as part of the performance evaluation and the post-market
p.000323: surveillance system referred to in Article 10(9). The performance evaluation report shall be part of the technical
p.000323: documen tation. Both favourable and unfavourable data considered in the performance evaluation shall be included in
p.000323: the technical documentation.
p.000323:
p.000323: 2. CLINICAL PERFORMANCE STUDIES
p.000323:
p.000323: 2.1. Purpose of clinical performance studies
p.000323:
p.000323: The purpose of clinical performance studies is to establish or confirm aspects of device performance
p.000323: which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine
p.000323:
p.000324: L 117/324 EN
p.000324: Official Journal of the European Union
p.000324: 5.5.2017
p.000324:
p.000324: diagnostic testing. This information is used to demonstrate compliance with the relevant general safety
p.000324: and performance requirements with respect to clinical performance. When clinical performance
p.000324: studies are conducted, the data obtained shall be used in the performance evaluation process and be
p.000324: part of the clinical evidence for the device.
p.000324:
p.000324:
p.000324: 2.2. Ethical considerations for clinical performance studies
p.000324:
p.000324: Each step in the clinical performance study, from the initial consideration of the need for and justification of the
p.000324: study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
p.000324:
p.000324:
p.000324: 2.3. Methods for clinical performance studies
p.000324:
p.000324: 2.3.1. Clinical performance study design type
p.000324:
p.000324: Clinical performance studies shall be designed in such a way as to maximize the relevance of the data
p.000324: while minimising potential bias.
p.000324:
p.000324:
p.000324: 2.3.2. Clinical performance study plan
p.000324:
p.000324: Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP).
p.000324:
p.000324: The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and
p.000324: record-keeping of the clinical performance study. It shall contain in particular the following information:
p.000324:
p.000324: (a) the single identification number of the clinical performance study, as referred to in Article 66(1);
p.000324:
p.000324: (b) identification of the sponsor, including the name, address of the registered place of business and
p.000324: contact details of the sponsor and, if applicable, the name, address of the registered place of business and contact
p.000324: details of its contact person or legal representative pursuant to Article 58(4) established in the Union;
p.000324:
p.000324: (c) information on the investigator or investigators, namely principal, coordinating or other investigator; qualifi
p.000324: cations; contact details, and investigation site or sites, such as number, qualification, contact details and, in the
p.000324: case of devices for self-testing, the location and number of lay persons involved;
p.000324:
p.000324: (d) the starting date and scheduled duration for the clinical performance study;
p.000324:
p.000324: (e) identification and description of the device, its intended purpose, the analyte or analytes or
p.000324: marker or markers, the metrological traceability, and the manufacturer;
p.000324:
p.000324: (f) information about the type of specimens under investigation;
p.000324:
p.000324: (g) overall synopsis of the clinical performance study, its design type, such as observational,
p.000324: interventional, together with the objectives and hypotheses of the study, reference to the current state
p.000324: of the art in diagnosis and/or medicine;
p.000324:
p.000324: (h) a description of the expected risks and benefits of the device and of the clinical performance study in the
p.000324: context of the state of the art in clinical practice, and with the exception of studies using left-over samples, the
p.000324: medical procedures involved and patient management;
p.000324:
p.000324: (i) the instructions for use of the device or test protocol, the necessary training and experience of the user, the
p.000324: appropriate calibration procedures and means of control, the indication of any other devices, medical
p.000324: devices, medicinal product or other articles to be included or excluded and the specifications on any
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
...
p.000325:
p.000325: (w) criteria and procedures for suspension or early termination of the clinical performance study;
p.000325:
p.000325: (x) criteria and procedures for follow up of subjects following completion of a performance study, procedures for
p.000325: follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have
p.000325: withdrawn their consent and procedures for subjects lost to follow up;
p.000325:
p.000325: (y) procedures for communication of test results outside the study, including communication of test results to the
p.000325: performance study subjects;
p.000325:
p.000325: (z) policy as regards the establishment of the clinical performance study report and publication of
p.000325: results in accordance with the legal requirements and the ethical principles referred to in Section 2.2;
p.000325:
p.000325: (aa) list of the technical and functional features of the device indicating those that are covered by
p.000325: the performance study;
p.000325:
p.000325: (ab) bibliography.
p.000325:
p.000325: If part of the information referred to in the second paragraph is submitted in a separate document, it shall
p.000325: be referenced in the CPSP. For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
p.000325:
p.000325: Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due
p.000325: to the specific study design chosen, such as use of left-over samples versus interventional clinical
p.000325: performance studies, a justification shall be provided.
p.000325:
p.000326: L 117/326 EN
p.000326: Official Journal of the European Union
p.000326: 5.5.2017
p.000326:
p.000326: 2.3.3. Clinical performance study report
p.000326:
p.000326: A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall
p.000326: contain documented information on the clinical performance study protocol plan, results and conclusions of the
p.000326: clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias
p.000326: and clinically relevant. The report shall contain sufficient information to enable it to be understood by an
p.000326: independent party without reference to other documents. The report shall also include as appropriate any protocol
p.000326: amendments or deviations, and data exclusions with the appropriate rationale.
p.000326:
p.000326:
p.000326: 3. OTHER PERFORMANCE STUDIES
p.000326:
p.000326: By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in
p.000326: Section 2.3.3, shall be documented for other performance studies than clinical performance studies.
p.000326:
p.000326:
p.000326: PART B
p.000326:
p.000326: POST-MARKET PERFORMANCE FOLLOW-UP
p.000326:
p.000326: 4. PMPF shall be understood to be a continuous process that updates the performance evaluation
p.000326: referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the
p.000326: manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect
p.000326: and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is
p.000326: placed on the market or put into service within its intended purpose as referred to in the relevant conformity
...
p.000326:
p.000326: (a) confirming the safety and performance of the device throughout its expected lifetime,
p.000326: (b) identifying previously unknown risks or limits to performance and contra-indications,
p.000326: (c) identifying and analysing emergent risks on the basis of factual evidence,
p.000326:
p.000326: (d) ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred
p.000326: to in Sections 1 and 8 of Chapter I of Annex I, and
p.000326:
p.000326: (e) identifying possible systematic misuse.
p.000326: 5.2. The PMPF plan shall include at least:
p.000326:
p.000326: (a) the general methods and procedures of the PMPF to be applied, such as gathering of clinical
p.000326: experience gained, feedback from users, screening of scientific literature and of other sources of
p.000326: performance or scientific data;
p.000326:
p.000326: (b) the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance
p.000326: activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks
p.000326: or post-market clinical performance studies;
p.000326:
p.000326: (c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
p.000326:
p.000326: (d) a reference to the relevant parts of the performance evaluation report referred to in Section 1.3
p.000326: of this Annex and to the risk management referred to in Section 3 of Annex I;
p.000326:
p.000326: (e) the specific objectives to be addressed by the PMPF;
p.000326:
p.000326: 5.5.2017 EN
p.000326: Official Journal of the European Union
p.000327: L 117/327
p.000327:
p.000327: (f) an evaluation of the performance data relating to equivalent or similar devices, and the current state of the
p.000327: art;
p.000327:
p.000327: (g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance
p.000327: on PMPF, and;
p.000327:
p.000327: (h) a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF
p.000327: data and reporting, to be undertaken by the manufacturer.
p.000327:
p.000327: 6. The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report
p.000327: that shall update the performance evaluation report and be part of the technical documentation.
p.000327:
p.000327: 7. The conclusions of the PMPF evaluation report shall be taken into account for the performance
p.000327: evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of
p.000327: Annex
p.000327: I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall
p.000327: implement them.
p.000327:
p.000327: 8. If PMPF is not deemed appropriate for a specific device then a justification shall be provided
p.000327: and documented within the performance evaluation report.
p.000327:
p.000328: L 117/328 EN
p.000328: Official Journal of the European Union
p.000328: 5.5.2017
p.000328:
p.000328: ANNEX XIV
p.000328:
p.000328: INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
p.000328:
p.000328: CHAPTER I
p.000328:
p.000328: DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE
p.000328: STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
p.000328:
p.000328: For devices intended to be used in the context of interventional clinical performance studies or other
p.000328: performance studies involving risks for the subjects of the studies, the sponsor shall draw up and
p.000328: submit the application in accordance with Article 58 accompanied by the following documents:
p.000328:
p.000328: 1. Application form
p.000328:
p.000328: The application form shall be duly filled in, containing the following information:
p.000328:
p.000328: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact
p.000328: details of its contact person or legal representative in accordance with Article 58(4) established in the Union;
p.000328:
p.000328: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
p.000328: of the device intended for performance evaluation and, if applicable, of its authorised representative;
p.000328:
p.000328: 1.3. title of the performance study;
p.000328:
p.000328: 1.4. single identification number in accordance with Article 66(1);
p.000328:
p.000328: 1.5. status of the performance study, such as. the first submission, resubmission, significant amendment;
p.000328:
p.000328: 1.6. details and/ or reference to the performance study plan, such as including details of the
p.000328: design phase of the performance study;
p.000328:
p.000328: 1.7. if the application is a resubmission with regard to a device for which an application has been already
p.000328: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000328: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000328: changes from the previous application together with a rationale for those changes, in particular, whether any
p.000328: changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000328:
p.000328: 1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with
p.000328: Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
p.000328:
p.000328: 1.9. identification of the Member States and third countries in which the clinical performance study
p.000328: is to be conducted as part of a multicentre or multinational study at the time of application;
p.000328:
p.000328: 1.10. brief description of the device for performance study, its classification and other information necessary for
p.000328: the identification of the device and device type;
p.000328:
p.000328: 1.11. summary of the performance study plan;
p.000328:
p.000328: 1.12. if applicable, information regarding a comparator device, its classification and other information
p.000328: necessary for the identification of the comparator device;
p.000328:
p.000328: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are capable
p.000328: of conducting the clinical performance study in accordance with the performance study plan;
p.000328:
p.000328: 1.14. details of the anticipated start date and duration of the performance study;
p.000328:
p.000328: 1.15. details to identify the notified body, if already involved at the stage of application for the performance
p.000328: study;
p.000328:
p.000328: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is
p.000328: assessing or has assessed the application;
p.000328:
p.000328: 5.5.2017 EN
p.000328: Official Journal of the European Union
p.000329: L 117/329
p.000329:
p.000329: 1.17. the statement referred to in Section 4.1.
p.000329:
p.000329: 2. Investigator's brochure
p.000329:
p.000329: The investigator's brochure (IB) shall contain the information on the device for performance study that
p.000329: is relevant for the study and available at the time of application. Any updates to the IB or other
p.000329: relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.
p.000329: The IB shall be clearly identified and contain in particular the following information:
p.000329:
p.000329: 2.1. Identification and description of the device, including information on the intended purpose, the
p.000329: risk classifi cation and applicable classification rule pursuant to Annex VIII, design and manufacturing
p.000329: of the device and reference to previous and similar generations of the device.
p.000329:
p.000329: 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use,
p.000329: including storage and handling requirements, as well as, to the extent that such information is available, information
p.000329: to be placed the label, and instructions for use to be provided with the device when placed on the
p.000329: market. In addition, information relating to any relevant training required.
p.000329:
p.000329: 2.3. Analytical performance.
p.000329:
p.000329: 2.4. Existing clinical data, in particular:
p.000329:
p.000329: — from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from
p.000329: relevant professional associations relating to the safety, performance, clinical benefits to patients,
...
p.000329: the performance study and in particular information on any deviation from normal clinical practice.
p.000329:
p.000329: 3. Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
p.000329:
p.000329: 4. Other information
p.000329:
p.000329: 4.1. A signed statement by the natural or legal person responsible for the manufacture of the device for
p.000329: performance study that the device in question conforms to the general safety and performance requirements
p.000329: laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those
p.000329: aspects, every precaution has been taken to protect the health and safety of the subject.
p.000329:
p.000329: 4.2. Where applicable according to national law, a copy of the opinion or opinions of the ethics
p.000329: committee or committees concerned. Where under national law the opinion or opinions of the ethics
p.000329: committee or committees is not required at the time of the submission of the application, a copy of the opinion or
p.000329: opinions shall be submitted as soon as available.
p.000329:
p.000329: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article
p.000329: 65 and the corresponding national law.
p.000329:
p.000330: L 117/330 EN
p.000330: Official Journal of the European Union
p.000330: 5.5.2017
p.000330:
p.000330: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the
p.000330: informed consent document.
p.000330:
p.000330: 4.5 Description of the arrangements to comply with the applicable rules on the protection and
p.000330: confidentiality of personal data, in particular:
p.000330:
p.000330: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000330: dissemination, alteration or loss of information and personal data processed;
p.000330:
p.000330: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000330: subjects;
p.000330:
p.000330: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000330: possible adverse effects.
p.000330:
p.000330: 4.6. Full details of the available technical documentation, for example detailed risk analysis/management
p.000330: documen tation or specific test reports shall be submitted to the competent authority reviewing an
p.000330: application upon request.
p.000330:
p.000330: CHAPTER II
p.000330: OTHER OBLIGATIONS OF THE SPONSOR
p.000330:
p.000330: 1. The sponsor shall undertake to keep available for the competent national authorities any
p.000330: documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the
p.000330: sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance
p.000330: study, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000330:
p.000330: 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event
p.000330: as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
p.000330:
p.000330: 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10
p.000330: years after the clinical performance study with the device in question has ended, or, in the event that the device is
p.000330: subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
p.000330:
p.000330: Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the
p.000330: competent authorities for the period indicated in the first subparagraph in case the sponsor, or his
p.000330: contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
p.000330:
p.000330: 4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure
p.000330: that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the
p.000330: principles of good clinical practice and this Regulation.
p.000330: 5. The sponsor shall complete the follow-up of investigation subjects.
p.000330:
p.000330: 5.5.2017 EN
p.000330: Official Journal of the European Union
p.000331: L 117/331
p.000331:
p.000331: ANNEX XV
p.000331:
p.000331: CORRELATION TABLE
p.000331:
p.000331:
p.000331:
p.000331:
p.000331: Article 1(1)
p.000331: Article 1(2)
p.000331: Directive 98/79/EC
p.000331:
p.000331:
p.000331: Article 1(1)
p.000331: Article 2
p.000331: This Regulation
p.000331:
p.000331: Article 1(3)
p.000331: Article 1(4)
p.000331: Article 1(5)
p.000331: Article 1(6)
p.000331: Article 1(7)
p.000331: Article 2
p.000331: Article 3
p.000331: Article 4(1)
p.000331: Article 4(2)
p.000331: Article 4(3)
p.000331: Article 4(4)
p.000331: Article 4(5)
p.000331: Article 5(1)
p.000331: Article 5(2)
p.000331: Article 5(3)
p.000331: Article 6
p.000331: Article 7
p.000331: Article 8
p.000331: Article 9(1) first subparagraph Article 9(1) second subparagraph
p.000331:
p.000331: Article 9(2)
p.000331: Article 9(3)
p.000331: Article 9(4)
p.000331: Article 9(5)
p.000331: Article 9(6)
p.000331: Article 9(7)
p.000331: Article 9(8)
p.000331: Article 9(9)
p.000331: points (54) and (55) of Article 2
p.000331: —
p.000331: Article 5(4) and (5)
p.000331: Article 1(9)
p.000331: Article 1(5)
p.000331: Article 5(1)
p.000331: Article 5(2)
p.000331: Article 21
p.000331: Article 19(1) and (2)
p.000331: Article 19(3)
p.000331: Article 10(10)
p.000331: Article 18(6)
p.000331: Article 8(1)
p.000331: —
p.000331: Article 9
p.000331: —
p.000331: Article 107
p.000331: Articles 89 and 92
p.000331: Article 48(10) first subparagraph
p.000331:
p.000331: Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph
p.000331: Article 48(3) to (6)
p.000331: Article 48(3) to (9)
p.000331: Article 5(6)
p.000331: —
p.000331: Article 11(3) and (4)
p.000331: Article 10(7)
p.000331: Article 49(1)
p.000331: Article 49(4)
p.000331:
p.000332: L 117/332 EN
p.000332: Official Journal of the European Union
p.000332: 5.5.2017
p.000332:
p.000332:
p.000332:
p.000332:
p.000332: Article 9(10)
p.000332: Article 9(11)
p.000332: Article 9(12)
p.000332: Article 9(13)
p.000332: Directive 98/79/EC
p.000332:
p.000332:
p.000332: Article 51(2)
p.000332: Article 48(12)
p.000332: Article 54(1)
p.000332: Article 48(2)
p.000332: This Regulation
p.000332:
p.000332:
p.000332: Article 10(1) and (2), second sentence of Article 10(3) and Article 10(4)
p.000332: Article 10(3), first sentence Article 11(1)
p.000332: Article 11(2)
p.000332: Article 11(3)
p.000332: Article 11(4)
p.000332: Article 11(5)
p.000332: Article 12
p.000332: Article 13 Article 14(1)(a) Article 14(1)(b) Article 14(2)
p.000332: Article 14(3)
p.000332: Article 15(1)
p.000332: Article 15(2)
p.000332: Article 15(3)
p.000332: Article 15(4)
p.000332: Article 15(5)
p.000332: Article 15(6)
p.000332: Article 15(7)
p.000332: Article 16
p.000332: Article 17
p.000332: Article 18
p.000332: Article 19
p.000332: Article 20
p.000332: Article 21
p.000332: Article 22
p.000332: Article 23
p.000332: Article 24
p.000332: Articles 26(3), 27 and 28
p.000332:
p.000332: Article 11(1)
p.000332: Articles 82(1) and 84(2)
p.000332: Article 82(10) and Article 82(11) first subparagraph Article 84(7)
p.000332: —
p.000332: Article 86
p.000332: Article 30
p.000332: Article 93
p.000332: —
p.000332: Article 47(3) and (6)
p.000332: —
p.000332: —
p.000332: Article 38 and Article 39
p.000332: Article 32
p.000332: Article 40(2) and (4)
p.000332: —
p.000332: Article 51(5)
p.000332: Article 51(4)
p.000332: Article 34(2) and Article 40(2)
p.000332: Article 18
p.000332: Articles 89 to 92
p.000332: Article 94
p.000332: Article 102
p.000332: Article 97
p.000332: —
p.000332: —
p.000332: —
...
Social / Women
Searching for indicator women:
(return to top)
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
...
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
p.000305: (h) to be used in screening, diagnosis, or staging of cancer;
p.000305: (i) for human genetic testing;
p.000305: (j) for monitoring of levels of medicinal products, substances or biological components, when there is
p.000305: a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation
p.000305: for the patient or for the patient's offspring;
p.000305: (k) for management of patients suffering from a life-threatening disease or condition;
p.000305: (l) for screening for congenital disorders in the embryo or foetus;
p.000305: (m) for screening for congenital disorders in new-born babies where failure to detect and treat such
p.000305: disorders could lead to life-threatening situations or severe disabilities.
p.000305:
p.000305: 2.4. Rule 4
...
p.000324: devices, medicinal product or other articles to be included or excluded and the specifications on any
p.000324: comparator or comparative method used as reference;
p.000324:
p.000324: (j) description of and justification for the design of the clinical performance study, its scientific robustness
p.000324: and validity, including the statistical design, and details of measures to be taken to minimise bias,
p.000324: such as randomisation, and management of potential confounding factors;
p.000324:
p.000324: 5.5.2017 EN
p.000324: Official Journal of the European Union
p.000325: L 117/325
p.000325:
p.000325: (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justifi
p.000325: cation for any omission;
p.000325:
p.000325: (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined,
p.000325: with justification for any omission; and with the exception of studies using left-over samples the specified clinical
p.000325: outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health
p.000325: and/or public health management decisions;
p.000325:
p.000325: (m) information on the performance study population: specifications of the subjects, selection criteria,
p.000325: size of performance study population, representativity of target population and, if applicable, information
p.000325: on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
p.000325:
p.000325: (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or
p.000325: disease registries etc. with description of reliability and representativity and statistical analysis approach;
p.000325: assurance of relevant method for determining the true clinical status of patient specimens;
p.000325:
p.000325: (o) monitoring plan;
p.000325:
p.000325: (p) data management;
p.000325:
p.000325: (q) decision algorithms;
p.000325:
p.000325: (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP,
p.000325: with a clear prohibition of use of waivers from the CPSP;
p.000325:
p.000325: (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the
p.000325: device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
p.000325:
p.000325: (t) statement of compliance with the recognised ethical principles for medical research involving humans and the
p.000325: principles of good clinical practice in the field of clinical performance studies as well as with the
p.000325: applicable regulatory requirements;
p.000325:
p.000325: (u) description of the informed consent process, including a copy of the patient information sheet and consent
p.000325: forms;
p.000325:
p.000325: (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000228: 66(1) and information about the availability of the performance study results in accordance with paragraph
p.000228: 6 of this Article.
p.000228:
p.000228: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or,
p.000228: where the subject is not able to give informed consent, his or her legally designated representative.
p.000228:
p.000228: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information
p.000228: needs of specific patient populations and of individual subjects, as well as to the methods used to give the
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
p.000228: by the legally designated representative, a minor who is capable of forming an opinion and assessing the information
p.000228: given to him or her, shall also assent in order to participate in a performance study.
p.000228:
p.000228:
p.000228: Article 60
p.000228:
p.000228: Performance studies on incapacitated subjects
p.000228:
p.000228: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before
p.000228: the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions
p.000228: set out in Article 58(5), all of the following conditions are met:
p.000228:
p.000228: (a) the informed consent of their legally designated representative has been obtained;
p.000228:
p.000228: (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in
p.000228: view of their capacity to understand it;
p.000228:
p.000228: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000228: the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the
p.000228: performance study at any time, is respected by the investigator;
p.000228:
...
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
p.000229: (a) the informed consent of their legally designated representative has been obtained;
p.000229:
p.000229: (b) the minors have received the information referred to in Article 59(2) in a way adapted to their
p.000229: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000229: experienced in working with children;
p.000229:
p.000229: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000229: referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is
p.000229: respected by the investigator;
p.000229:
p.000229: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000229: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000229: the performance study;
p.000229:
p.000229: (e) the performance study is intended to investigate treatments for a medical condition that only occurs in
p.000229: minors or the performance study is essential with respect to minors to validate data obtained in
p.000229: performance studies on persons able to give informed consent or by other research methods;
p.000229:
p.000229: (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is
p.000229: of such a nature that it can only be carried out on minors;
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the minor concerned when the performance study will pose only
p.000229: minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard
p.000229: treatment of the minor's condition;
p.000229:
p.000229: (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental
p.000229: maturity;
p.000229:
p.000229: (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
...
p.000285:
p.000285: 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.
p.000285:
p.000285: 6. Rules for specific device types
p.000285:
p.000285: 6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or
p.000285: refurbishing between uses
p.000285:
p.000285: 6.1.1. The UDI of such devices shall be placed on the device and shall be readable after each
p.000285: procedure to make the device ready for the next use;
p.000285:
p.000285: 6.1.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
p.000285:
p.000285: 6.2. Device software
p.000285:
p.000285: 6.2.1. UDI assignment Criteria
p.000285:
p.000285: The UDI shall be assigned at the system level of the software. Only software which is commercially available on
p.000285: its own and software which constitutes a device in itself shall be subject to that requirement.
p.000285:
p.000285: The software identification shall be considered to be the manufacturing control mechanism and
p.000285: shall be displayed in the UDI-PI.
p.000285:
p.000285: 6.2.2. A new UDI-DI shall be required whenever there is a modification that changes:
p.000285: (a) the original performance,
p.000285: (b) the safety or the intended use of the software.
p.000285: (c) interpretation of data.
p.000285: Such modifications include new or modified algorithms, database structures, operating platform, architecture
p.000285: or new user interfaces or new channels for interoperability.
p.000285:
p.000285: 6.2.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI:
p.000285: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for
p.000285: safety purposes, security patches or operating efficiency.
p.000285: Minor software revisions shall be identified by a manufacturer-specific form of identification.
p.000285:
p.000286: L 117/286 EN
p.000286: Official Journal of the European Union
p.000286: 5.5.2017
p.000286:
p.000286: 6.2.4. UDI placement criteria for software
p.000286: (a) where the software is delivered on a physical medium, for example via a CD or DVD, each
p.000286: packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied
p.000286: to the physical medium containing the software and its packaging shall be identical to the UDI assigned
p.000286: to the system level software;
p.000286: (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable
p.000286: plain-text format such as an ‘about’ file, or included on the start-up screen;
p.000286: (c) software lacking a user interface such as middleware for image conversion, shall be capable of
p.000286: transmitting the UDI through an application programming interface (API);
p.000286: (d) only the human readable portion of the UDI shall be required in electronic displays of the
p.000286: software. The marking of UDI using AIDC shall not be required in the electronic displays such as
p.000286: ‘about’ menu, splash screen, etc.;
p.000286: (e) the human readable format of the UDI for the software shall include the application identifiers
p.000286: (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI
p.000286: and determining which standard is being used to create the UDI.
p.000286:
p.000286: 5.5.2017 EN
...
Social / education
Searching for indicator education:
(return to top)
p.000189: into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;
p.000189:
p.000190: L 117/190 EN
p.000190: Official Journal of the European Union
p.000190: 5.5.2017
p.000190:
p.000190: (25) ‘authorised representative’ means any natural or legal person established within the Union who has
p.000190: received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's
p.000190: behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
p.000190:
p.000190: (26) ‘importer’ means any natural or legal person established within the Union that places a device from a third
p.000190: country on the Union market;
p.000190:
p.000190: (27) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the
p.000190: importer, that makes a device available on the market, up until the point of putting into service;
p.000190:
p.000190: (28) ‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
p.000190:
p.000190: (29) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or
p.000190: the promotion of public health;
p.000190:
p.000190: (30) ‘user’ means any healthcare professional or lay person who uses a device;
p.000190:
p.000190: (31) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical
p.000190: discipline;
p.000190:
p.000190: (32) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to
p.000190: a device have been fulfilled;
p.000190:
p.000190: (33) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities
p.000190: including calibration, testing, certification and inspection;
p.000190:
p.000190: (34) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
p.000190:
p.000190: (35) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in
p.000190: conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation
p.000190: legislation providing for its affixing;
p.000190:
p.000190: (36) ‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device
p.000190: of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the
p.000190: intended clinical benefit(s), when used as intended by the manufacturer;
p.000190:
p.000190: (37) ‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening,
p.000190: monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
p.000190:
p.000190: (38) ‘scientific validity of an analyte’ means the association of an analyte with a clinical condition
p.000190: or a physiological state;
p.000190:
p.000190: (39) ‘performance of a device’ means the ability of a device to achieve its intended purpose as
...
p.000227: has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics,
p.000227: the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
p.000227:
p.000227: (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of
p.000227: the art as well as provisions in the field of occupational safety and accident prevention;
p.000227:
p.000227: (p) the requirements of Annex XIV are fulfilled.
p.000227:
p.000227: 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000227: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000227: performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the
p.000227: withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained
p.000227: based on informed consent before its withdrawal.
p.000227:
p.000227: 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned,
p.000227: as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in
p.000227: patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably
p.000227: qualified, by education, training or experience in the relevant medical field and in clinical research
p.000227: methodology, to perform their tasks.
p.000227:
p.000227: 8. Where appropriate, the facilities where the performance study involving subjects is to be
p.000227: conducted shall be suitable for the performance study and shall be similar to the facilities where the device is
p.000227: intended to be used.
p.000227:
p.000227:
p.000227:
p.000227: Article 59
p.000227:
p.000227: Informed consent
p.000227:
p.000227: 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point
p.000227: (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent,
p.000227: his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where
p.000227: the subject is unable to write, consent may be given and recorded through appropriate alternative means in
p.000227: the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent
p.000227: document. The subject or, where the subject is not able to give informed consent, his or her legally designated
p.000227: representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent
...
p.000260: measures in line with the requirements of Section 4.
p.000260:
p.000260: 4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to
p.000260: safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturers
p.000260: shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged
p.000260: acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
p.000260: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000260:
p.000260: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000260: risks that cannot be eliminated; and
p.000260:
p.000260: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training
p.000260: to users.
p.000260: Manufacturers shall inform users of any residual risks.
p.000260:
p.000260: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000260:
p.000260: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000260: environment in which the device is intended to be used (design for patient safety), and
p.000260:
p.000260: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000260: where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or
p.000260: other users).
p.000260:
p.000260: 5.5.2017 EN
p.000260: Official Journal of the European Union
p.000261: L 117/261
p.000261:
p.000261: 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the
p.000261: health or safety of the patient or the user and, where applicable, of other persons are compromised during the
p.000261: lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur
p.000261: during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
p.000261:
p.000261: 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and
p.000261: performance during their intended use are not adversely affected during transport and storage,
p.000261: for example, through fluctuations of temperature and humidity, taking account of the instructions and
p.000261: information provided by the manufacturer.
p.000261:
p.000261: 8. All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed
p.000261: against the evaluated potential benefits to the patients and/or the user arising from the intended performance of
p.000261: the device during normal conditions of use.
p.000261:
p.000261: CHAPTER II
p.000261:
p.000261: REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
p.000261:
p.000261:
p.000261: 9. Performance characteristics
p.000261:
...
p.000265: the specimen, and also in the interpretation of the results.
p.000265:
p.000266: L 117/266 EN
p.000266: Official Journal of the European Union
p.000266: 5.5.2017
p.000266:
p.000266: 19.3. Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by
p.000266: which the intended user:
p.000266:
p.000266: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and
p.000266: (b) be warned if the device has failed to provide a valid result.
p.000266:
p.000266: CHAPTER III
p.000266:
p.000266: REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
p.000266:
p.000266:
p.000266: 20. Label and instructions for use
p.000266:
p.000266: 20.1. General requirements regarding the information supplied by the manufacturer
p.000266:
p.000266: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any
p.000266: safety and performance information relevant to the user or any other person, as appropriate. Such
p.000266: information may appear on the device itself, on the packaging or in the instructions for use, and
p.000266: shall, if the manufacturer has a website, be made available and kept up to date on the website, taking
p.000266: into account the following:
p.000266:
p.000266: (a) The medium, format, content, legibility, and location of the label and instructions for use shall
p.000266: be appropriate to the particular device, its intended purpose and the technical knowledge, experience,
p.000266: education or training of the intended user(s). In particular, instructions for use shall be written in
p.000266: terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
p.000266:
p.000266: (b) The information required on the label shall be provided on the device itself. If this is not
p.000266: practicable or appropriate, some or all of the information may appear on the packaging for each unit.
p.000266: If individual full labelling of each unit is not practicable, the information shall be set out on the
p.000266: packaging of multiple devices.
p.000266:
p.000266: (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable
p.000266: information, such as radio-frequency identification or bar codes.
p.000266:
p.000266: (d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases
p.000266: instructions for use shall not be required or may be abbreviated if the device can be used safely and
p.000266: as intended by the manufacturer without any such instructions for use.
p.000266:
p.000266: (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient
p.000266: testing, are supplied to a single user and/or location, a single copy of the instructions for use may
p.000266: be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
p.000266:
p.000266: (f) When the device is intended for professional use only, instructions for use may be provided to the user in
...
p.000290: it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex
p.000290: I.
p.000290:
p.000290: A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is
p.000290: designated. The notified body shall have sufficient internal competence to critically evaluate assessments
p.000290: conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set
p.000290: out in Section 4.1.
p.000290:
p.000290: Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices
p.000290: shall have appropriate knowledge to set up and operate a system for the selection of assessment and
p.000290: verification staff, for verification of their competence, for authorisation and allocation of their tasks,
p.000290: for organisation of their initial and ongoing training, and for their assignment of their duties and
p.000290: monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification
p.000290: operations are competent to fulfil the tasks required of them.
p.000290:
p.000290: The notified body shall identify at least one individual within its top-level management as having overall responsi
p.000290: bility for all conformity assessment activities in relation to devices.
p.000290:
p.000290: 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain their
p.000290: qualifi cation and expertise by implementing a system for exchange of experience and a continuous
p.000290: training and education programme.
p.000290:
p.000290: 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of
p.000290: auth orisation of to the personnel, including any subcontractors and external experts involved in
p.000290: conformity assessment activities and inform those personnel accordingly.
p.000290:
p.000290: 5.5.2017 EN
p.000290: Official Journal of the European Union
p.000291: L 117/291
p.000291:
p.000291: 3.2. Qualification criteria in relation to personnel
p.000291:
p.000291: 3.2.1. The notified body shall establish and document qualification criteria and procedures for selection and
p.000291: authoris ation of persons involved in conformity assessment activities, including as regards knowledge,
p.000291: experience and other competence required, and the required initial and ongoing training. The qualification criteria
p.000291: shall address the various functions within the conformity assessment process, such as auditing, product evaluation or
p.000291: testing, technical documentation review, decision-making, and batch release, as well as the devices,
p.000291: technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics
p.000291: and performance evaluation, covered by the scope of designation.
p.000291:
p.000291: 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's
p.000291: designation in accordance with the scope description used by the Member State for the notification referred to in
p.000291: Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the
p.000291: scope description.
...
p.000294: performed by subcon tractors.
p.000294:
p.000294: 3.4.3. Where subcontractors or external experts are used in the context of a conformity assessment, in
p.000294: particular regarding novel devices or technologies, the notified body in question shall have adequate internal
p.000294: competence in each product area for which it is designated that is adequate for the purpose of leading the
p.000294: overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on
p.000294: certification.
p.000294:
p.000294: 3.5. Monitoring of competences, training and exchange of experience
p.000294:
p.000294: 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going
p.000294: monitoring of the competence, conformity assessment activities and performance of all internal and external
p.000294: personnel and subcon tractors, involved in conformity assessment activities.
p.000294:
p.000294: 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify
p.000294: training needs and draw up a training plan to maintain the required level of qualification and knowledge
p.000294: of individual personnel. That review shall as a minimum, verify that personnel:
p.000294:
p.000294: — are aware of the Union and national law in force on devices, relevant harmonised standards, CS,
p.000294: guidance documents and the results of the coordination activities referred to in Section 1.6;
p.000294:
p.000294: — take part in the internal exchange of experience and the continuous training and education programme
p.000294: referred to in Section 3.1.2.
p.000294:
p.000294: 4. PROCESS REQUIREMENTS
p.000294:
p.000294: 4.1. General
p.000294:
p.000294: The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of
p.000294: each conformity assessment activity for which it is designated, comprising the individual steps from pre-
p.000294: application activities up to decision making and surveillance and taking into account, when necessary,
p.000294: the respective specificities of the devices.
p.000294:
p.000294: The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of
p.000294: notified bodies and shall not be subcontracted.
p.000294: 4.2. Notified body quotations and pre-application activities The notified body shall
p.000294:
p.000294: (a) publish a publicly available description of the application procedure by which manufacturers can
p.000294: obtain certification from it. That description shall include which languages are acceptable for submission
p.000294: of documentation and for any related correspondence;
p.000294:
p.000294: (b) have documented procedures relating to, and documented details about, fees charged for specific conformity
p.000294: assessment activities and any other financial conditions relating to notified bodies' assessment activities
p.000294: for devices;,
p.000294:
p.000294: 5.5.2017 EN
p.000294: Official Journal of the European Union
p.000295: L 117/295
p.000295:
p.000295: (c) have documented procedures in relation to advertising of its conformity assessment services.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000229: in the national law, his or her express informed consent shall be obtained before that subject can
p.000229: continue to participate in the performance study.
p.000229:
p.000229: 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on minors, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000230: L 117/230 EN
p.000230: Official Journal of the European Union
p.000230: 5.5.2017
p.000230:
p.000230: Article 62
p.000230:
p.000230: Performance studies on pregnant or breastfeeding women
p.000230:
p.000230: A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set
p.000230: out in Article 58(5), all of the following conditions are met:
p.000230:
p.000230: (a) the performance study has the potential to produce a direct benefit for the pregnant or
p.000230: breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
p.000230:
p.000230: (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman
p.000230: concerned, or her embryo, foetus or child after birth, it can be conducted only if:
p.000230:
p.000230: (i) a performance study of comparable effectiveness cannot be carried out on women who are not
p.000230: pregnant or breastfeeding;
p.000230:
p.000230: (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding
p.000230: women or other women in relation to reproduction or other embryos, foetuses or children; and
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
...
p.000304: process of patient management.
p.000304:
p.000304: 2.2. Rule 2
p.000304:
p.000304: Devices intended to be used for blood grouping, or tissue typing to ensure the immunological
p.000304: compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or
p.000304: transplantation or cell administration, are classified as class C, except when intended to determine any of the
p.000304: following markers:
p.000304: — ABO system [A (ABO1), B (ABO2), AB (ABO3)];
p.000304: — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
p.000304: — Kell system [Kel1 (K)];
p.000304: — Kidd system [JK1 (Jka), JK2 (Jkb)];
p.000304: — Duffy system [FY1 (Fya), FY2 (Fyb)];
p.000304: in which case they are classified as class D.
p.000304:
p.000304: 5.5.2017 EN
p.000304: Official Journal of the European Union
p.000305: L 117/305
p.000305:
p.000305: 2.3. Rule 3
p.000305: Devices are classified as class C if they are intended:
p.000305: (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
p.000305: (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high
p.000305: or suspected high risk of propagation;
p.000305: (c) for detecting the presence of an infectious agent, if there is a significant risk that an
p.000305: erroneous result would cause death or severe disability to the individual, foetus or embryo being tested,
p.000305: or to the individual's offspring;
p.000305: (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
p.000305: (e) for determining infective disease status or immune status, where there is a risk that an
p.000305: erroneous result would lead to a patient management decision resulting in a life-threatening situation for the
p.000305: patient or for the patient's offspring;
p.000305: (f) to be used as companion diagnostics;
p.000305: (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a
p.000305: patient management decision resulting in a life-threatening situation for the patient or for the patient's
p.000305: offspring;
p.000305: (h) to be used in screening, diagnosis, or staging of cancer;
p.000305: (i) for human genetic testing;
p.000305: (j) for monitoring of levels of medicinal products, substances or biological components, when there is
p.000305: a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation
p.000305: for the patient or for the patient's offspring;
p.000305: (k) for management of patients suffering from a life-threatening disease or condition;
p.000305: (l) for screening for congenital disorders in the embryo or foetus;
p.000305: (m) for screening for congenital disorders in new-born babies where failure to detect and treat such
p.000305: disorders could lead to life-threatening situations or severe disabilities.
p.000305:
p.000305: 2.4. Rule 4
p.000305: (a) Devices intended for self-testing are classified as class C, except for devices for the detection of
p.000305: pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of
p.000305: glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B.
p.000305: (b) Devices intended for near-patient testing are classified in their own right.
p.000305:
p.000305: 2.5. Rule 5
p.000305: The following devices are classified as class A:
p.000305: (a) products for general laboratory use, accessories which possess no critical characteristics, buffer
p.000305: solutions, washing solutions, and general culture media and histological stains, intended by the
p.000305: manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;
p.000305: (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
p.000305: (c) specimen receptacles.
p.000305:
p.000305: 2.6. Rule 6
p.000305: Devices not covered by the above-mentioned classification rules are classified as class B.
p.000305:
p.000305: 2.7. Rule 7
p.000305: Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
p.000305:
p.000306: L 117/306 EN
p.000306: Official Journal of the European Union
p.000306: 5.5.2017
p.000306:
p.000306: ANNEX IX
p.000306:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000201:
p.000201: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000201:
p.000201: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
p.000201: system under which the devices are manufactured, before a device is released;
p.000201:
p.000201: (1) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ
p.000201: L 124, 20.5.2003, p. 36).
p.000201:
p.000202: L 117/202 EN
p.000202: Official Journal of the European Union
p.000202: 5.5.2017
p.000202:
p.000202: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
p.000202: (c) the post-market surveillance obligations are complied with in accordance with Article 10(9);
p.000202: (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled;
p.000202:
p.000202: (e) in the case of devices for performance studies intended to be used in the context of
p.000202: interventional clinical performance studies or other performance studies involving risks for the subjects,
p.000202: the statement referred to in Section 4.1 of Annex XIV is issued.
p.000202:
p.000202: 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and
p.000202: 3, their respective areas of responsibility shall be stipulated in writing.
p.000202:
p.000202: 5. The person responsible for regulatory compliance shall suffer no disadvantage within the
p.000202: manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not
p.000202: they are employees of the organisation.
p.000202:
p.000202: 6. Authorised representatives shall have permanently and continuously at their disposal at least one
p.000202: person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory
p.000202: requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be
p.000202: demonstrated by either of the following qualifications:
p.000202:
p.000202: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or
p.000202: of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or
p.000202: another relevant scientific discipline, and at least one year of professional experience in regulatory
p.000202: affairs or in quality management systems relating to in vitro diagnostic medical devices;
p.000202: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000202: to in vitro
p.000202: diagnostic medical devices.
p.000202:
p.000202: Article 16
p.000202:
p.000202: Cases in which obligations of manufacturers apply to importers, distributors or other persons
p.000202:
p.000202: 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on
p.000202: manufacturers if it does any of the following:
p.000202:
p.000202: (a) makes available on the market a device under its own name, registered trade name or registered trade mark, except
p.000202: in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is
p.000202: identified as such on the label and is responsible for meeting the requirements placed on manufacturers
...
Social / gender
Searching for indicator gender:
(return to top)
p.000271: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000271: security measures, including protection against unauthorised access, necessary to run the software as
p.000271: intended.
p.000271:
p.000271: 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the
p.000271: following principles:
p.000271:
p.000271: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection
p.000271: and/or preparation and information on how to run the test and interpret the results;
p.000271:
p.000271: (b) specific particulars may be omitted provided that the other information supplied by the manufacturer
p.000271: is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
p.000271:
p.000271: (c) the device's intended purpose shall provide sufficient information to enable the user to understand
p.000271: the medical context and to allow the intended user to make a correct interpretation of the results;
p.000271: (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
p.000271: (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or
p.000271: indeterminate result), on the test limitations and on the possibility of false positive or false negative result.
p.000271: Information shall also be provided as to any factors that can affect the test result such as age,
p.000271: gender, menstruation, infection, exercise, fasting, diet or medication;
p.000271:
p.000271: (f) the information provided shall include a statement clearly directing that the user should not take
p.000271: any decision of medical relevance without first consulting the appropriate healthcare professional,
p.000271: information on disease effects and prevalence, and, where available, information specific to the Member
p.000271: State(s) where the device is placed on the market on where a user can obtain further advice such as
p.000271: national helplines, websites;
p.000271:
p.000271: (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing
p.000271: disease or condition, the information shall specify that the patient should only adapt the treatment if he has
p.000271: received the appropriate training to do so.
p.000271:
p.000272: L 117/272 EN
p.000272: Official Journal of the European Union
p.000272: 5.5.2017
p.000272:
p.000272: ANNEX II
p.000272:
p.000272: TECHNICAL DOCUMENTATION
p.000272:
p.000272: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer
p.000272: shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular
p.000272: the elements listed in this Annex.
p.000272:
p.000272: 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
p.000272: 1.1. Device description and specification
p.000272:
p.000272: (a) product or trade name and a general description of the device including its intended purpose and intended users;
p.000272: (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000176: L 117/176 EN
p.000176: Official Journal of the European Union
p.000176: 5.5.2017
p.000176:
p.000176: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.000176: of 5 April 2017
p.000176: on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
p.000176:
p.000176: (Text with EEA relevance)
p.000176:
p.000176: THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
p.000176:
p.000176: Having regard to the Treaty on the Functioning of the European Union, and in particular
p.000176: Article 114 and Article 168(4)(c) thereof,
p.000176:
p.000176: Having regard to the proposal from the European Commission,
p.000176:
p.000176: After transmission of the draft legislative act to the national parliaments,
p.000176:
p.000176: Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the
p.000176: Regions,
p.000176: Acting in accordance with the ordinary legislative procedure (2), Whereas:
p.000176: (1) Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the
p.000176: Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that
p.000176: Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for
p.000176: in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation.
p.000176:
p.000176: (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in
p.000176: vitro diagnostic medical devices, taking as a base a high level of protection of health for patients
p.000176: and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the
p.000176: same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order
p.000176: to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are
p.000176: inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on
p.000176: the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on
p.000176: the market and putting into service of in vitro diagnostic medical devices and their accessories on the
p.000176: Union market thus allowing them to benefit from the principle of free movement of goods. As regards
p.000176: Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic
p.000176: medical devices by ensuring, among other things, that data generated in performance studies are reliable and
p.000176: robust and that the safety of subjects participating in performance studies is protected.
p.000176:
p.000176: (3) This Regulation does not seek to harmonise rules relating to the further making available on the
p.000176: market of in vitro diagnostic medical devices after they have already been put into service, such as in the
p.000176: context of second- hand sales.
p.000176:
p.000176: (4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk
p.000176: classification, conformity assessment procedures, performance evaluation and performance studies, vigilance
p.000176: and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability
p.000176: regarding in vitro diagnostic medical devices should be introduced, to improve health and safety.
p.000176:
p.000176: (5) To the extent possible, guidance developed for in vitro diagnostic medical devices at
p.000176: international level, in particular in the context of the Global Harmonization Task Force and its follow-up
p.000176: initiative, the International Medical Devices Regulators Forum, should be taken into account to promote
p.000176: the global convergence of
p.000176:
p.000176: (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
p.000176: (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of
p.000176: the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
p.000176: (3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical
p.000176: devices (OJ L 331,
p.000176: 7.12.1998, p. 1).
p.000176:
p.000176: 5.5.2017 EN
p.000176: Official Journal of the European Union
p.000177: L 117/177
p.000177:
p.000177: regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in
p.000177: the provisions on Unique Device Identification, general safety and performance requirements, technical
p.000177: documentation, classification rules, conformity assessment procedures and clinical evidence.
p.000177:
p.000177: (6) There are specific features of in vitro diagnostic medical devices, in particular in terms of
p.000177: risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic
p.000177: medical device sector which require the adoption of specific legislation, distinct from the legislation on other
p.000177: medical devices, whereas the horizontal aspects common to both sectors should be aligned.
p.000177:
p.000177: (7) The scope of application of this Regulation should be clearly delimited from other legislation
p.000177: concerning products, such as medical devices, general laboratory products and products for research use only.
p.000177:
...
p.000186:
p.000186: (98) Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the
p.000186: placing of in vitro diagnostic medical devices on the market and the related aspects covered by this
p.000186: Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they
p.000186: placed on the market and manufacturers' and Member States' obligations as regards vigilance activities
p.000186: for devices placed on the market pursuant to that Directive should however continue to apply. While it should be
p.000186: left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility
p.000186: of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools
p.000186: as those for reporting on devices placed on the market pursuant to this Regulation. However, Decision 2010/227/EU
p.000186: adopted in implemen tation of that Directive and Council Directives 90/385/EEC (1) and 93/42/EEC (2) should also be
p.000186: repealed as from the date when Eudamed becomes fully functional.
p.000186:
p.000186: (99) The requirements of this Regulation should be applicable to all devices placed on the market or put into
p.000186: service from the date of application of this Regulation. However, in order to provide for a smooth transition it should
p.000186: be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by
p.000186: virtue of a valid certificate issued pursuant to Directive 98/79/EC.
p.000186:
p.000186: (100) The European Data Protection Supervisor has given an opinion (3) pursuant to Article 28(2) of Regulation (EC)
p.000186: No 45/2001.
p.000186:
p.000186: (1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
p.000186: active implantable medical devices (OJ L 189, 20.7.1990, p. 17)
p.000186: (2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) (3) OJ C 358,
p.000186: 7.12.2013, p. 10.
p.000186:
p.000186: 5.5.2017 EN
p.000186: Official Journal of the European Union
p.000187: L 117/187
p.000187:
p.000187: (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal
p.000187: market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical
p.000187: devices, thus ensuring a high level of protection of health and safety of patients, users and other
p.000187: persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be
p.000187: better achieved at Union level, the Union may adopt measures, in accordance with the principle of
p.000187: subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of
p.000187: proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve
p.000187: those objectives,
p.000187:
p.000187:
p.000187: HAVE ADOPTED THIS REGULATION:
p.000187: CHAPTER I
p.000187:
p.000187: INTRODUCTORY PROVISIONS
p.000187:
p.000187: Section 1
...
p.000211: diverging opinions, with respect to the assessment of the application.
p.000211:
p.000211: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant
p.000211: conformity assessment body the non-compliances resulting from the assessment and summarise of the
p.000211: assessment by the joint assessment team.
p.000211:
p.000211: Within a specified timeframe, the applicant conformity assessment body shall submit to the national
p.000211: authority a corrective and preventive action plan to address the non-compliances.
p.000211:
p.000211: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within
p.000211: 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000211:
p.000211: 7. The authority responsible for notified bodies shall, following receipt of a corrective and
p.000211: preventive action plan from the applicant body, assess whether non-compliances identified during the
p.000211: assessment have been appropriately addressed. This plan shall indicate the root cause of the identified
p.000211: non-compliances and shall include a timeframe for implementation of the actions therein.
p.000211:
p.000211: The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan,
p.000211: forward it and its opinion thereon to the joint assessment team. The joint assessment team may request
p.000211: of the authority responsible for notified bodies further clarification and modifications.
p.000211:
p.000211: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000211: — the result of the assessment,
p.000211:
p.000211: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000211: required, implemented,
p.000211: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000211: — the recommended scope of designation.
p.000211:
p.000212: L 117/212 EN
p.000212: Official Journal of the European Union
p.000212: 5.5.2017
p.000212:
p.000212: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000212: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000212:
p.000212: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the
p.000212: authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those
p.000212: documents to the Commission which shall immediately submit that final opinion to the MDCG. Within 42 days
p.000212: of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with
p.000212: regard to the draft designation, which the authority responsible for notified bodies shall duly take into
p.000212: consideration for its decision on the designation of the notified body.
p.000212:
p.000212: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000212: arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the
p.000212: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000212: accordance with the examination procedure referred to in Article 107(3).
p.000212:
p.000212:
p.000212: Article 36
p.000212:
p.000212: Nomination of experts for joint assessment of applications for notification
p.000212:
p.000212: 1. The Member States and the Commission shall nominate experts qualified in the assessment of
p.000212: conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the
p.000212: activities referred to in Articles 35 and 44.
p.000212:
p.000212: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article,
p.000212: together with information on their specific field of competence and expertise. That list shall be made available to
p.000212: Member States competent authorities through the electronic system referred to in Article 52.
p.000212:
p.000212:
p.000212: Article 37
p.000212:
p.000212: Language requirements
p.000212:
...
p.000212: official Union language, such as is necessary for that documentation to be readily understood by the joint assessment
p.000212: team appointed in accordance with Article 35(3).
p.000212:
p.000212:
p.000212: Article 38
p.000212:
p.000212: Designation and notification procedure
p.000212:
p.000212: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35
p.000212: was completed and which comply with Annex VII.
p.000212:
p.000212: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000212: have designated, using the electronic notification tool within the database of notified bodies developed and managed by
p.000212: the Commission (NANDO).
p.000212:
p.000212: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope
p.000212: of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of
p.000212: devices which the notified body is authorised to assess and, without prejudice to Article 40, any
p.000212: conditions associated with the designation.
p.000212:
p.000212: 5.5.2017 EN
p.000212: Official Journal of the European Union
p.000213: L 117/213
p.000213:
p.000213: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000213: for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and
p.000213: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it
p.000213: shall provide a duly substantiated justification.
p.000213:
p.000213: 5. The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member
p.000213: States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in
p.000213: place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set
p.000213: out in Annex VII.
p.000213:
p.000213: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission
p.000213: may raise written objections, setting out its arguments, with regard either to the notified body or to
p.000213: its monitoring by the authority responsible for notified bodies. Where no objection is raised, the
p.000213: Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in
p.000213: paragraph 2.
p.000213:
p.000213: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
p.000213: bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph
p.000213: 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter
p.000213: having been brought before it. Where the MDCG is of the opinion that the notification can be accepted,
p.000213: the Commission shall publish in NANDO the notification within 14 days.
p.000213:
p.000213: 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or
p.000213: raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40
p.000213: days of its receipt. The response shall address the objections raised in the opinion, and set out the
p.000213: reasons for the notifying Member State's decision to designate or not designate the conformity assessment body.
p.000213:
p.000213: 9. Where the notifying Member State decides to uphold its decision to designate the conformity
p.000213: assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in
p.000213: NANDO the notification within 14 days of being informed thereof.
p.000213:
p.000213: 10. When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in
p.000213: Article 52 the information relating to the notification of the notified body along with the documents
p.000213: mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this
p.000213: Article.
p.000213:
p.000213: 11. The designation shall become valid the day after the notification is published in NANDO. The
p.000213: published notification shall state the scope of lawful conformity assessment activity of the notified body.
p.000213:
p.000213: 12. The conformity assessment body concerned may perform the activities of a notified body only
p.000213: after the designation has become valid in accordance with paragraph 11.
p.000213:
p.000213: 13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of
p.000213: codes and corresponding types of devices for the purpose of specifying the scope of the designation of
p.000213: notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure
p.000213: referred to in Article 107(3). The Commission, after consulting the MDCG, may update this list based,
p.000213: inter alia, on information arising from the coordination activities described in Article 44.
p.000213:
p.000213:
p.000213: Article 39
p.000213:
p.000213: Identification number and list of notified bodies
p.000213:
p.000213: 1. The Commission shall assign an identification number to each notified body for which the notification
p.000213: becomes valid in accordance with Article 38(11). It shall assign a single identification number even when
p.000213: the body is notified under several Union acts. If they are successfully designated in accordance with this
p.000213: Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them
...
p.000220: referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been
p.000220: designated in accordance with Article 100, the notified body performing the conformity assessment shall
p.000220: request one of the EU reference laboratories to verify by laboratory testing the performance claimed by
p.000220: the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen
p.000220: by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in
p.000220: Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference
p.000220: laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available
p.000220: reference materials.
p.000220:
p.000220: 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are
p.000220: available for class D devices and where it is also the first certification for that type of device,
p.000220: the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU)
p.000220: 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide
p.000220: the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the
p.000220: manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance
p.000220: with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within
p.000220: the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein.
p.000220:
p.000220: 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to
p.000220: a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the
p.000220: technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per
p.000220: generic device group.
p.000220:
p.000220: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000220: testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of
p.000220: Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified
p.000220: body shall for every device follow the procedure for technical documentation assessment laid down in
p.000220: Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down
p.000220: in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member
p.000220: States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out
p.000220: in Section 5.2 of Annex IX.
p.000220:
p.000220: (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000220: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000220:
p.000220: 5.5.2017 EN
p.000220: Official Journal of the European Union
p.000221: L 117/221
p.000221:
...
p.000222: previous application for the same conformity assessment that has been refused by another notified body.
p.000222:
p.000222: 4. The notified body may require any information or data from the manufacturer, which is necessary
p.000222: in order to properly conduct the chosen conformity assessment procedure.
p.000222:
p.000222: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities
p.000222: with the highest degree of professional integrity and the requisite technical and scientific competence in
p.000222: the specific field and shall be free from all pressures and inducements, particularly financial, which
p.000222: might influence their judgement or the results of their conformity assessment activities, especially as regards
p.000222: persons or groups with an interest in the results of those activities.
p.000222:
p.000222:
p.000222: Article 50
p.000222:
p.000222: Mechanism for scrutiny of conformity assessments of class D devices
p.000222:
p.000222: 1. A notified body shall notify the competent authority of certificates it has granted for class D
p.000222: devices, with the exception of applications to supplement or renew existing certificates. Such notification
p.000222: shall take place through the electronic system referred to in Article 52 and shall include the
p.000222: instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to
p.000222: in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the
p.000222: scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and
p.000222: where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106
p.000222: of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a
p.000222: full justification shall also be included.
p.000222:
p.000222: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further
p.000222: procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in
p.000222: accordance with to Articles 90 and 92.
p.000222:
p.000222: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice
p.000222: from the expert panels in relation to the safety and performance of any device.
p.000222:
p.000222:
p.000222: Article 51
p.000222:
p.000222: Certificates of conformity
p.000222:
p.000222: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000222: Union language determined by the Member State in which the notified body is established or otherwise in an
p.000222: official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out
p.000222: in Annex XII.
p.000222:
p.000222: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application
...
p.000226:
p.000226: 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a
p.000226: natural or legal person is established in the Union as its legal representative. Such legal representative shall be
p.000226: responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation. Any
p.000226: communication with that legal representative shall be deemed to be a communication with the sponsor.
p.000226:
p.000226: Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their
p.000226: territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor
p.000226: establishes at least a contact person on their territory in respect of that performance study who shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation.
p.000226:
p.000226: 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions
p.000226: are met:
p.000226:
p.000226: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is
p.000226: to be conducted, in accordance with this Regulation, unless otherwise stated;
p.000226:
p.000226: (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in
p.000226: relation to the performance study, which is valid for that entire Member State under its national law;
p.000226:
p.000226: (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;
p.000226:
p.000226: (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
p.000226:
p.000226: (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and
p.000226: inconveniences and compliance with this condition is constantly monitored;
p.000226:
p.000226: (f) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative has given informed consent, in accordance with Article 59;
p.000226:
p.000226: (g) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative, has been provided with the contact details of an entity where further information can be received in
p.000226: case of need;
p.000226:
p.000226: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data
p.000226: concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000226:
p.000226: (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable
...
p.000228: 66(1) and information about the availability of the performance study results in accordance with paragraph
p.000228: 6 of this Article.
p.000228:
p.000228: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or,
p.000228: where the subject is not able to give informed consent, his or her legally designated representative.
p.000228:
p.000228: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information
p.000228: needs of specific patient populations and of individual subjects, as well as to the methods used to give the
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
p.000228: by the legally designated representative, a minor who is capable of forming an opinion and assessing the information
p.000228: given to him or her, shall also assent in order to participate in a performance study.
p.000228:
p.000228:
p.000228: Article 60
p.000228:
p.000228: Performance studies on incapacitated subjects
p.000228:
p.000228: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before
p.000228: the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions
p.000228: set out in Article 58(5), all of the following conditions are met:
p.000228:
p.000228: (a) the informed consent of their legally designated representative has been obtained;
p.000228:
p.000228: (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in
p.000228: view of their capacity to understand it;
p.000228:
p.000228: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000228: the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the
p.000228: performance study at any time, is respected by the investigator;
p.000228:
p.000228: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000228: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000228: the performance study;
p.000228:
p.000228: (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot
p.000228: be obtained in performance studies on persons able to give informed consent, or by other research methods;
p.000228:
p.000228: (f) the performance study relates directly to a medical condition from which the subject suffers;
p.000228:
p.000228: 5.5.2017 EN
p.000228: Official Journal of the European Union
p.000229: L 117/229
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study
p.000229: will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
p.000229: (a) the informed consent of their legally designated representative has been obtained;
p.000229:
p.000229: (b) the minors have received the information referred to in Article 59(2) in a way adapted to their
p.000229: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000229: experienced in working with children;
p.000229:
p.000229: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000229: referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is
p.000229: respected by the investigator;
p.000229:
p.000229: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000229: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000229: the performance study;
p.000229:
p.000229: (e) the performance study is intended to investigate treatments for a medical condition that only occurs in
p.000229: minors or the performance study is essential with respect to minors to validate data obtained in
p.000229: performance studies on persons able to give informed consent or by other research methods;
p.000229:
p.000229: (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is
p.000229: of such a nature that it can only be carried out on minors;
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the minor concerned when the performance study will pose only
p.000229: minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard
...
p.000232: shall provide for an appeal procedure in respect of such refusal.
p.000232:
p.000232: The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested
p.000232: additional information, whether the performance study is considered as falling within the scope of this Regulation and
p.000232: the application is complete.
p.000232:
p.000232: 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five
p.000232: days.
p.000232:
p.000232: 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3
p.000232: shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the
p.000232: last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
p.000232:
p.000232: 6. During the period when the application is being assessed the Member State may request additional
p.000232: information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended
p.000232: from the date of the first request until such time as the additional information has been received.
p.000232:
p.000232: 7. The sponsor may start the performance study in the following circumstances:
p.000232:
p.000232: (a) in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where
p.000232: the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated
p.000232: by national law, immediately after the validation date of application described in paragraph 5 of this Article,
p.000232: provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by
p.000232: an ethics committee in the Member State concerned in respect of the performance study;
p.000232:
p.000232: (b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2)
p.000232: or performance studies other than those referred to in point (a) of this paragraph, as soon as the
p.000232: Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is
p.000232: valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State
p.000232: concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45
p.000232: days of the validation date of the application referred to in paragraph 5. The Member State may extend this
p.000232: period by a further 20 days for the purpose of consulting with experts.
p.000232:
p.000232: 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of
p.000232: technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV.
p.000232:
p.000232: 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex
p.000232: XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent
p.000232: interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination
p.000232: procedure referred to in Article 107(3).
p.000232:
p.000232:
p.000232: Article 67
p.000232:
p.000232: Assessment by Member States
p.000232:
p.000232: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not
p.000232: have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons
p.000232: financing the performance study, as well as free of any other undue influence.
p.000232:
p.000232: 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who
...
p.000235: L 117/235
p.000235:
p.000235: Article 71
p.000235:
p.000235: Substantial modifications to performance studies
p.000235:
p.000235: 1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial
p.000235: impact on the safety, health or rights of the subjects or on the robustness or reliability of the data
p.000235: generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article
p.000235: 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for
p.000235: and the nature of those modifications. The sponsor shall include an updated version of the relevant
p.000235: documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation
p.000235: shall be clearly identifiable.
p.000235:
p.000235: 2. The Member State shall assess any substantial modification to the performance study in accordance
p.000235: with the procedure laid down in Article 67.
p.000235:
p.000235: 3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days
p.000235: after the notification referred to in paragraph 1, unless:
p.000235: (a) the Member State in which the performance study is being or is to be conducted has notified the
p.000235: sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of
p.000235: subject and user safety or health, or of public policy; or
p.000235: (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification
p.000235: to the performance study, which, in accordance with national law, is valid for that entire Member State.
p.000235: 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the
p.000235: purpose of consulting with experts.
p.000235:
p.000235: Article 72
p.000235:
p.000235: Corrective measures to be taken by Member States and information exchange between Member States on
p.000235: performance studies
p.000235:
p.000235: 1. Where a Member State in which a performance study is being or is to be conducted has grounds for considering
p.000235: that the requirements set out in this Regulation are not met, it may take at least any of the following measures on
p.000235: its territory:
p.000235: (a) revoke the authorisation for the performance study;
p.000235: (b) suspend or terminate the performance study;
p.000235: (c) require the sponsor to modify any aspect of the performance study.
p.000235: 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall,
p.000235: except where immediate action is required, ask the sponsor or the investigator or both for their
p.000235: opinion. That opinion shall be delivered within seven days.
p.000235:
p.000235: 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has
p.000235: refused a performance study, or has been notified by the sponsor of the early termination of a
p.000235: performance study on safety grounds, that Member State shall communicate the corresponding decision and
p.000235: the grounds therefor to all Member States and the Commission by means of the electronic system referred to in
p.000235: Article 69.
p.000235:
p.000235: 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall
p.000235: be made available through the electronic system referred to in Article 69 to all Member States and the Commission.
p.000235:
p.000235: Article 73
p.000235:
p.000235: Information from the sponsor at the end of a performance study or in the event of a temporary halt or
p.000235: early termination
p.000235:
p.000235: 1. If the sponsor has temporarily halted a performance study or has terminated a performance study
p.000235: early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted
p.000235: or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early
p.000235: termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety
p.000235: grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours.
p.000235:
p.000236: L 117/236 EN
p.000236: Official Journal of the European Union
p.000236: 5.5.2017
p.000236:
...
p.000237:
p.000237: (a) when it considers that participation in the performance study would lead to a subject receiving treatment inferior
p.000237: to that received in normal clinical practice in that Member State concerned;
p.000237:
p.000237: (b) infringement of national law; or
p.000237:
p.000237: (c) considerations as regards subject safety and data reliability and robustness submitted under point (d) of
p.000237: paragraph 4.
p.000237:
p.000237: Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this
p.000237: paragraph, it shall communicate its disagreement, together with a detailed justification, through the
p.000237: electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the
p.000237: sponsor.
p.000237:
p.000237: 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the
p.000237: performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member
p.000237: States concerned.
p.000237:
p.000238: L 117/238 EN
p.000238: Official Journal of the European Union
p.000238: 5.5.2017
p.000238:
p.000238: 10. A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of
p.000238: the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or
p.000238: if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of
p.000238: Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation
p.000238: to that performance study which is valid in accordance with national law for that entire Member State. That Member
p.000238: State shall provide for an appeal procedure in respect of such refusal.
p.000238:
p.000238: 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69
p.000238: as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether
p.000238: authorisation has been refused. Notification shall be done by way of one single decision within five days of the
p.000238: transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final
p.000238: assessment report. Where an authorisation of a performance study is subject to conditions, those conditions may only be
p.000238: such that, by their nature, they cannot be fulfilled at the time of that authorisation.
p.000238:
p.000238: 12. Any substantial modifications as referred to in Article 71 shall be notified to the Member States
p.000238: concerned by means of the electronic system referred to in Article 69. Any assessment as to whether
p.000238: there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this
p.000238: Article shall be carried out under the direction of the coordinating Member State, except for substantial
p.000238: modifications concerning sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of
p.000238: Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned.
p.000238:
p.000238: 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of
...
p.000252: evaluation methods;
p.000252:
p.000252: (e) using standardised and coordinated test reports;
p.000252: (f) developing, applying and maintaining a peer review system;
p.000252: (g) organizing regular quality assessment tests (including mutual checks on the quality and comparability of test
p.000252: results);
p.000252:
p.000252: 5.5.2017 EN
p.000252: Official Journal of the European Union
p.000253: L 117/253
p.000253:
p.000253: (h) agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures;
p.000253: (i) coordinating the introduction of testing methods for new technologies and according to new or amended CS;
p.000253: (j) reassessing the state of the art on the basis of comparative test results or by further studies,
p.000253: as requested by a Member State or by the Commission.
p.000253: 6. The EU reference laboratories may be granted a Union financial contribution.
p.000253:
p.000253: The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a
p.000253: Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety
p.000253: protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in
p.000253: accordance with the examination procedure referred to in Article 107(3).
p.000253:
p.000253: 7. Where notified bodies or Member States request scientific or technical assistance or a scientific
p.000253: opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover
p.000253: the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent
p.000253: terms and conditions.
p.000253:
p.000253: 8. The Commission shall specify by means of implementing acts:
p.000253: (a) detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure
p.000253: compliance with the criteria referred to in paragraph 4 of this Article.
p.000253: (b) the structure and the level of the fees referred to in paragraph 7 of this Article which may be
p.000253: levied by an EU reference laboratory for providing scientific opinions in response to consultations by
p.000253: notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human
p.000253: health and safety protection, support of innovation and cost-effectiveness.
p.000253: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000253:
p.000253: 9. The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the
p.000253: Commission to verify compliance with the requirements of this Regulation. If those controls find that an EU reference
p.000253: laboratory is not complying with the requirements for which it has been designated, the Commission, by means
p.000253: of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the
p.000253: designation.
p.000253:
p.000253: 10. The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the
p.000253: EU reference laboratories.
p.000253:
...
p.000254:
p.000254: The costs associated with joint assessment activities shall be covered by the Commission. The Commission
p.000254: shall, by means of implementing acts, lay down the scale and structure of recoverable costs
p.000254: and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination
p.000254: procedure referred to in Article 107(3).
p.000254:
p.000254: Article 106
p.000254:
p.000254: Penalties
p.000254:
p.000254: The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this
p.000254: Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall
p.000254: be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those
p.000254: measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them.
p.000254:
p.000254: CHAPTER X
p.000254: FINAL PROVISIONS
p.000254:
p.000254: Article 107
p.000254:
p.000254: Committee procedure
p.000254:
p.000254: 1. The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation
p.000254: (EU) 2017/745. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011
p.000254: 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
p.000254:
p.000254: 5.5.2017 EN
p.000254: Official Journal of the European Union
p.000255: L 117/255
p.000255:
p.000255: 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
p.000255:
p.000255: Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and
p.000255: the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
p.000255:
p.000255: 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
p.000255: conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
p.000255:
p.000255:
p.000255: Article 108
p.000255:
p.000255: Exercise of the delegation
p.000255:
p.000255: 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid
p.000255: down in this Article.
p.000255:
p.000255: 2. The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be
p.000255: conferred on the Commission for a period of five years from 25 May 2017. The Commission shall draw up a report in
p.000255: respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of
p.000255: power shall be tacitly extended for periods of an identical duration, unless the European Parliament or
p.000255: the Council opposes such extension not later than three months before the end of each period.
p.000255:
p.000255: 3. The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any
p.000255: time by the European Parliament or by the Council. A decision to revoke shall put an end to the
p.000255: delegation of the power specified in that decision. It shall take effect the day following the publication of the
p.000255: decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the
p.000255: validity of any delegated acts already in force.
p.000255:
...
p.000291: and where possible such personnel shall be employed by the notified body itself. Such personnel shall be
p.000291: integrated throughout the notified body's assessment and decision-making process in order to:
p.000291:
p.000291: — identify when specialist input is required for the assessment of the performance evaluation conducted by the
p.000291: manufacturer and identify appropriately qualified experts;
p.000291:
p.000291: — appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and
p.000291: harmonised standards and ensure that the external clinical experts are fully aware of the context and
p.000291: implications of their assessment and the advice they provide;
p.000291:
p.000291: — be able to review and scientifically challenge the clinical data contained within the performance
p.000291: evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment
p.000291: of the performance evaluation presented by the manufacturer;
p.000291:
p.000291: — be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented,
p.000291: and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
p.000291:
p.000292: L 117/292 EN
p.000292: Official Journal of the European Union
p.000292: 5.5.2017
p.000292:
p.000292: — be able to ascertain the comparability and consistency of the assessments of performance evaluation
p.000292: conducted by clinical experts;
p.000292:
p.000292: — be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion
p.000292: provided by any external expert and make a recommendation to the notified body's decision maker; and
p.000292:
p.000292: — be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been
p.000292: appropriately carried out.
p.000292:
p.000292: 3.2.5. The personnel responsible for carrying out product-related reviews, (product reviewers), such as
p.000292: technical documentation reviews or type examination, including aspects such as performance evaluation, biological
p.000292: safety, sterilisation and software validation, shall have all the following proven qualifications:
p.000292:
p.000292: — successful completion of a university or a technical college degree or an equivalent qualification in
p.000292: relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
p.000292:
p.000292: — four years' professional experience in the field of healthcare products or related activities, such as in manufac
p.000292: turing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or
p.000292: technology to be assessed or related to the scientific aspects to be assessed;
p.000292:
p.000292: — knowledge of device legislation, including the general safety and performance requirements set out in
p.000292: Annex I;
p.000292:
p.000292: — appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
p.000292:
p.000292: — appropriate knowledge and experience of risk management and related device standards and guidance
p.000292: documents;
p.000292:
p.000292: — appropriate knowledge and experience of performance evaluation;
p.000292:
p.000292: — appropriate knowledge of the devices which they are assessing;
p.000292:
...
p.000310: where applicable.
p.000310:
p.000310:
p.000310: 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the
p.000310: performance evaluation and the benefit-risk determination, and whether specific milestones need to be
p.000310: defined to allow the notified body to review updates to the clinical evidence that result from post-market
p.000310: surveillance and PMPF data.
p.000310:
p.000310:
p.000310: 4.8. The notified body shall clearly document the outcome of its assessment in the performance
p.000310: evaluation assessment report.
p.000310:
p.000310:
p.000310: 4.9. Before issuing an EU technical documentation assessment certificate, the notified body shall
p.000310: request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance
p.000310: claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions
p.000310: chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The
p.000310: verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5).
p.000310:
p.000310:
p.000310: In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation,
p.000310: consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure
p.000310: laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
p.000310:
p.000310: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000310:
p.000310: The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted,
p.000310: pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in
p.000310: the documentation of the notified body concerning the device. The notified body shall, when making its decision, give
p.000310: due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and,
p.000310: where applicable, to the views expressed by the experts consulted pursuant to Article 48(6). The notified body shall
p.000310: not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable.
p.000310:
p.000310: 5.5.2017 EN
p.000310: Official Journal of the European Union
p.000311: L 117/311
p.000311:
p.000311: 4.10. The notified body shall provide the manufacturer with a report on the technical documentation
p.000311: assessment, including a performance evaluation assessment report. If the device conforms to the relevant provisions of
p.000311: this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The
p.000311: certificate shall contain the conclusions of the technical documentation assessment, the conditions of the
p.000311: certificate's validity, the data needed for identification of the approved device, and, where appropriate, a
p.000311: description of the intended purpose of the device.
p.000311:
p.000311: 4.11. Changes to the approved device shall require approval from the notified body which issued the
p.000311: EU technical documentation assessment certificate, where such changes could affect the safety and performance of the
p.000311: device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-
p.000311: mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate
p.000311: thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new
p.000311: conformity assessment in accordance with Article 48 or whether they could be addressed by means of a
p.000311: supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall
p.000311: assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide
p.000311: it with a supplement to the EU technical documentation assessment certificate.
p.000311:
p.000311: Where the changes could affect compliance with the CS or with other solutions chosen by the
p.000311: manufacturer which were approved through the EU technical documentation assessment certificate, the notified
p.000311: body shall consult the EU reference laboratory that was involved in the initial consultation, in order
p.000311: to confirm that compliance with the CS or with other solutions chosen by the manufacturer, to ensure a
p.000311: level of safety and performance that is at least equivalent, is maintained.
p.000311:
p.000311: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000311:
p.000311: 4.12. To verify conformity of manufactured class D devices, the manufacturer shall carry out tests on
p.000311: each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to
p.000311: the notified body, without delay, the relevant reports on those tests. Furthermore, the manufacturer shall make the
p.000311: samples of manufactured batches of devices available to the notified body in accordance with pre-agreed conditions and
p.000311: detailed arrangements which shall include that the notified body or the manufacturer shall send samples of the
p.000311: manufactured batches of devices to the EU reference laboratory, where such a laboratory has been designated in
p.000311: accordance with Article 100, to carry out appropriate tests. The EU reference laboratory shall inform
p.000311: the notified body about its findings.
p.000311:
p.000311: 4.13. The manufacturer may place the devices on the market, unless the notified body communicates to
p.000311: the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other
p.000311: decision, including in particular any condition of validity of delivered certificates.
p.000311:
p.000311:
p.000311: 5. Assessment of the technical documentation of specific types of devices
p.000311:
p.000311: 5.1. Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient
p.000311: testing
p.000311:
p.000311: (a) The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge
p.000311: with the notified body an application for the assessment of the technical documentation.
p.000311:
...
p.000312: above-mentioned changes, it shall inform the notified body which issued the EU technical documen tation
p.000312: assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned
p.000312: changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed
p.000312: by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified
p.000312: body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide
p.000312: it with a supplement to the EU technical documentation assessment certificate.
p.000312:
p.000312:
p.000312: 5.2. Assessment of the technical documentation of companion diagnostics
p.000312:
p.000312: (a) The manufacturer of a companion diagnostic shall lodge with the notified body an application for
p.000312: the assessment of the technical documentation. The notified body shall assess that application in
p.000312: accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex.
p.000312:
p.000312: (b) The application shall enable the characteristics and performance of the device to be understood, and shall
p.000312: enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to
p.000312: the suitability of the device in relation to the medicinal product concerned.
p.000312:
p.000312: (c) The notified body shall, before issuing an EU technical documentation assessment certificate for the
p.000312: companion diagnostic and on the basis of the draft summary of safety and performance and the draft
p.000312: instructions for use, seek a scientific opinion from one of the competent authorities designated by the
p.000312: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this
p.000312: Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this
p.000312: point, regarding the suitability of the device in relation to the medicinal product concerned. Where the
p.000312: medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No
p.000312: 726/2004 of the European Parliament and of the Council (1), the notified body shall seek the opinion of the EMA. If the
p.000312: medicinal product concerned is already authorised, or if an application for its authorisation has been submitted,
p.000312: the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the
p.000312: authorisation.
p.000312:
p.000312: (d) The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of
p.000312: all the necessary documentation. This 60-day period may be extended once for a further 60 days on
p.000312: justified grounds. The opinion and any possible update shall be included in the documentation of the notified body
p.000312: concerning the device.
p.000312:
p.000312: (e) The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its
p.000312: decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU
p.000312: technical documentation assessment certificate shall be delivered in accordance with point (e) of Section
p.000312: 5.1.
p.000312:
p.000312: (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.000312: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000312: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000312:
p.000312: 5.5.2017 EN
p.000312: Official Journal of the European Union
p.000313: L 117/313
p.000313:
p.000313: (f) Before changes affecting the performance and/or the intended use and/or the suitability of the
p.000313: device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of
p.000313: the changes. The notified body shall assess the planned changes and decide whether the planned changes
p.000313: require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a
p.000313: supplement to the EU technical documentation assessment certificate. In the latter case, the notified body
p.000313: shall assess the changes and seek the opinion of the medicinal products authority consulted. The medicinal products
p.000313: authority consulted shall give its opinion within 30 days of receipt of the all the necessary
p.000313: documentation regarding the changes. A supplement to the EU technical documentation assessment
p.000313: certificate shall be issued in accordance with point (f) of Section 5.1.
p.000313:
p.000313: CHAPTER III
p.000313: ADMINISTRATIVE PROVISIONS
p.000313:
p.000313: 6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000313: it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been
p.000313: placed on the market, keep at the disposal of the competent authorities:
p.000313: — the EU declaration of conformity,
p.000313: — the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and
p.000313: records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
p.000313: — information on the changes referred to in Section 2.4.,
p.000313: — the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
p.000313: — the decisions and reports from the notified body as referred to in this Annex.
p.000313:
p.000313: 7. Each Member State shall require that the documentation referred to in Section 6 is kept at
p.000313: the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its
p.000313: authorised represen tative, established within its territory goes bankrupt or ceases its business activity
p.000313: prior to the end of that period.
p.000313:
p.000314: L 117/314 EN
p.000314: Official Journal of the European Union
p.000314: 5.5.2017
p.000314:
p.000314: ANNEX X
p.000314:
p.000314: CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
...
p.000315: intended, proof shall be provided that it conforms to the general safety and performance requirements when connected
p.000315: to any such device or devices having the characteristics specified by the manufacturer;
p.000315:
p.000315: (g) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary
p.000315: to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised
p.000315: standards, those standards have actually been applied;
p.000315:
p.000315: (h) agree with the applicant on the place where the necessary assessments and tests are to be carried out;
p.000315:
p.000315: (i) draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to
p.000315: (g);
p.000315:
p.000315: (j) in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article
p.000315: 100, to verify the performance claimed by the manufacturer and the compliance of the device with the
p.000315: CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety
p.000315: and performance that is at least equivalent. The verification shall include laboratory tests by the EU
p.000315: reference laboratory in accordance with Article 48(5).
p.000315:
p.000315: In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation,
p.000315: consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down
p.000315: in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
p.000315:
p.000315: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000315:
p.000315: The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article
p.000315: 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the
p.000315: documentation of the notified body concerning the device. The notified body shall give due consideration
p.000315: to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views
p.000315: expressed by the experts consulted in accordance with Article 48(6), when making its decision. The notified body
p.000315: shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable;
p.000315:
p.000315: (k) for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the
p.000315: draft instructions for use, of one of the competent authorities designated by the Member States in
p.000315: accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the
p.000315: medicinal products authority consulted’ depending on which has been consulted under this point) on the
p.000315: suitability of the device in relation to the medicinal product concerned. Where the medicinal product
p.000315: falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the
p.000315: EMA. If the medicinal product concerned is already authorised, or if an application for its
p.000315: authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the
p.000315: EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its
p.000315: opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a
p.000315: further 60 days on justified grounds. The opinion of the medicinal products authority consulted and any
p.000315: possible update shall be included in the documentation of the notified body concerning the device. The notified body
p.000315: shall give due consideration to the opinion expressed by the medicinal products authority consulted when
p.000315: making its decision. It shall convey its final decision to the medicinal products authority consulted; and
p.000315:
p.000315: (l) draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific
p.000315: opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D
p.000315: devices or covered by the third indent of Section 2.
p.000315:
p.000316: L 117/316 EN
p.000316: Official Journal of the European Union
p.000316: 5.5.2017
p.000316:
p.000316: 4. Certificate
p.000316:
p.000316: If the type conforms to this Regulation, the notified body shall issue an EU type-examination
p.000316: certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of
p.000316: the type examination assessment, the conditions of certificate's validity and the data needed for identification of
p.000316: the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of
p.000316: the documentation shall be annexed to the certificate and a copy kept by the notified body.
p.000316:
p.000316: 5. Changes to the type
p.000316:
p.000316: 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of
p.000316: any planned change to the approved type or of its intended purpose and conditions of use.
p.000316:
p.000316: 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use
p.000316: shall require further approval from the notified body which issued the EU type-examination certificate where such
p.000316: changes may affect conformity with the general safety and performance requirements or with the conditions prescribed
p.000316: for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision
p.000316: and provide him with a supplement to the EU type-examination report. The approval of any change to the approved
p.000316: type shall take the form of a supplement to the EU type-examination certificate.
p.000316:
p.000316: 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations
p.000316: of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment.
p.000316:
p.000316: 5.4. Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with
p.000316: other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the
p.000316: notified body shall consult the EU reference laboratory that was involved in the initial consultation,
p.000316: in order to confirm that compliance with the CS, when available, or with other solutions chosen by the
p.000316: manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
p.000316:
p.000316: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000316:
p.000316: 5.5. Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU
p.000316: type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the
p.000316: medicinal products competent authority that was involved in the initial consultation or the EMA. The
p.000316: medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid
p.000316: documentation regarding the changes. The approval of any change to the approved type shall take the form of a
p.000316: supplement to the initial EU type-examination certificate.
p.000316:
p.000316: 6. Administrative provisions
p.000316:
p.000316: The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its
p.000316: authorised representative shall, for a period ending no sooner than 10 years, after the last device has been placed on
p.000316: the market, keep at the disposal of the competent authorities:
p.000316: — the documentation referred to in the second indent of Section 2,
p.000316: — information on the changes referred to in Section 5,
p.000316: — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section
p.000316: 7 of Annex IX shall apply.
p.000316:
p.000316: 5.5.2017 EN
p.000316: Official Journal of the European Union
p.000317: L 117/317
p.000317:
p.000317: ANNEX XI
p.000317:
p.000317: CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
p.000317:
p.000317: 1. The manufacturer shall ensure that the quality management system approved for the manufacture of
p.000317: the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and
p.000317: shall be subject to the surveillance referred to in Section 4.
p.000317:
p.000317: 2. When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU
p.000317: declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the
...
p.000329: detailed information on the tissues, cells and substances, and on the compliance with the relevant
p.000329: general safety and performance requirements and the specific risk management in relation to those tissues, cells and
p.000329: substances.
p.000329:
p.000329: 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements set out in
p.000329: Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for
p.000329: fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or
p.000329: have only been partly fulfilled or are lacking.
p.000329:
p.000329: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000329: the performance study and in particular information on any deviation from normal clinical practice.
p.000329:
p.000329: 3. Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
p.000329:
p.000329: 4. Other information
p.000329:
p.000329: 4.1. A signed statement by the natural or legal person responsible for the manufacture of the device for
p.000329: performance study that the device in question conforms to the general safety and performance requirements
p.000329: laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those
p.000329: aspects, every precaution has been taken to protect the health and safety of the subject.
p.000329:
p.000329: 4.2. Where applicable according to national law, a copy of the opinion or opinions of the ethics
p.000329: committee or committees concerned. Where under national law the opinion or opinions of the ethics
p.000329: committee or committees is not required at the time of the submission of the application, a copy of the opinion or
p.000329: opinions shall be submitted as soon as available.
p.000329:
p.000329: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article
p.000329: 65 and the corresponding national law.
p.000329:
p.000330: L 117/330 EN
p.000330: Official Journal of the European Union
p.000330: 5.5.2017
p.000330:
p.000330: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the
p.000330: informed consent document.
p.000330:
p.000330: 4.5 Description of the arrangements to comply with the applicable rules on the protection and
p.000330: confidentiality of personal data, in particular:
p.000330:
p.000330: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000330: dissemination, alteration or loss of information and personal data processed;
p.000330:
p.000330: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000330: subjects;
p.000330:
p.000330: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000330: possible adverse effects.
p.000330:
p.000330: 4.6. Full details of the available technical documentation, for example detailed risk analysis/management
p.000330: documen tation or specific test reports shall be submitted to the competent authority reviewing an
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000202: pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is
p.000202: carried out in such conditions that the original condition of the device cannot be affected by it. In the
p.000202: case of devices placed on the market in sterile condition, it shall be presumed that the original condition of
p.000202: the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened,
p.000202: damaged or otherwise negatively affected by the repackaging.
p.000202:
p.000202: 5.5.2017 EN
p.000202: Official Journal of the European Union
p.000203: L 117/203
p.000203:
p.000203: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2
p.000203: shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the
p.000203: device, the activity carried out together with its name, registered trade name or registered trade mark, registered
p.000203: place of business and the address at which it can be contacted, so that its location can be established.
p.000203:
p.000203: Distributors and importers shall ensure that they have in place a quality management system that includes procedures
p.000203: which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in
p.000203: points
p.000203: (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the
p.000203: device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
p.000203: The quality management system shall cover, inter alia, procedures ensuring that the distributor or
p.000203: importer is informed of any corrective action taken by the manufacturer in relation to the device in question in
p.000203: order to respond to safety issues or to bring it into conformity with this Regulation.
p.000203:
p.000203: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000203: distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall
p.000203: inform the manufacturer and the competent authority of the Member State in which they plan to make the device
p.000203: available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the
p.000203: manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device,
p.000203: including any translated label and instructions for use. Within the same period of 28 days, the
p.000203: distributor or importer shall submit to the competent authority a certificate, issued by a notified body
p.000203: designated for the type of devices that are subject to activities mentioned in points (a) and (b) of
p.000203: paragraph 2, attesting that the quality management system of the distributer or importer complies with the
p.000203: requirements laid down in paragraph 3.
p.000203:
p.000203:
p.000203: Article 17
p.000203:
p.000203: EU declaration of conformity
p.000203:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000179: device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the
p.000179: facilitation, by a competent authority, of the provision of information to persons who may have been injured by a
p.000179: defective device.
p.000179:
p.000179:
p.000179: (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of
p.000179: this Regulation and that experience from the use of the devices they manufacture is taken into account for the
p.000179: production process, all manufacturers should have a quality management system and a post-market surveillance system in
p.000179: place which should be proportionate to the risk class and the type of the device in question. In
p.000179: addition, in order to minimize risks or prevent incidents related to devices, manufacturers should
p.000179: establish a system for risk management and a system for reporting incidents and field safety corrective actions.
p.000179:
p.000179:
p.000179: (32) The risk management system should be carefully aligned with and reflected in the performance
p.000179: evaluation process for the device, including the clinical risks to be addressed as part of performance
p.000179: studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation
p.000179: processes should be inter-dependent and should be regularly updated.
p.000179:
p.000179:
p.000179: (33) It should be ensured that supervision and control of the manufacture of devices, as well as
p.000179: post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's
p.000179: organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
p.000179:
p.000179:
p.000179: (34) For manufacturers who are not established in the Union, the authorised representative plays a
p.000179: pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their
p.000179: contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to
p.000179: make the authorised representative legally liable for defective devices in the event that a manufacturer established
p.000179: outside the Union has not complied with its general obligations. The liability of the authorised
p.000179: representative provided for in this Regulation is without prejudice to the provisions of Directive
p.000179: 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer
p.000179: and the manufacturer. The tasks of an authorised representative should be defined in a written mandate.
p.000179: Considering the role of authorised representatives, the minimum requirements they should meet should
p.000179: be clearly defined, including the requirement of having available a person who fulfils minimum
...
p.000182: scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured
p.000182: and transparent process, generating reliable and robust data, sourcing and assessment of available scientific
p.000182: information and data generated in performance studies should be based on a performance evaluation plan.
p.000182:
p.000182: (62) As a general rule, clinical evidence should be sourced from performance studies that have been carried out
p.000182: under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or
p.000182: legal person to be the sponsor taking responsibility for the performance study.
p.000182:
p.000182: (63) It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such
p.000182: updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer.
p.000182: Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety
p.000182: and performance through a continuous process of performance evaluation.
p.000182:
p.000182: (64) It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is
p.000182: fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical
p.000182: devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical
p.000182: information on patients, where appropriate, assessed against medical information obtained through the use
p.000182: of other diagnostic options and technologies, whereas the final clinical outcome for the patient is
p.000182: dependent on further diagnostic and/or therapeutic options which could be available.
p.000182:
p.000182: 5.5.2017 EN
p.000182: Official Journal of the European Union
p.000183: L 117/183
p.000183:
p.000183: (65) Where specific devices have no analytical or clinical performance or specific performance requirements are
p.000183: not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions
p.000183: relating to such requirements.
p.000183:
p.000183:
p.000183: (66) The rules on performance studies should be in line with well-established international guidance in this field,
p.000183: such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of
p.000183: medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the
p.000183: Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies
p.000183: conducted outside the Union in accordance with international guidelines to be accepted within the Union.
p.000183: In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of
p.000183: Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
p.000183:
p.000183:
p.000183: (67) It should be left to the Member State where a performance study is to be conducted to determine the
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000191:
p.000191: (52) ‘positive predictive value’ means the ability of a device to separate true positive results from false positive
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (53) ‘negative predictive value’ means the ability of a device to separate true negative results from false negative
p.000191: results for a given attribute in a given population;
p.000191:
p.000191: (54) ‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical
p.000191: condition or physiological state compared to the likelihood of the same result arising in an individual
p.000191: without that clinical condition or physiological state;
p.000191:
p.000191: (55) ‘calibrator’ means a measurement reference material used in the calibration of a device;
p.000191:
p.000191: (56) ‘control material’ means a substance, material or article intended by its manufacturer to be used
p.000191: to verify the performance characteristics of a device;
p.000191:
p.000191: (57) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the
p.000191: initiation, for the management and setting up of the financing of the performance study;
p.000191:
p.000191: (58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to
p.000191: participate in a particular performance study, after having been informed of all aspects of the
p.000191: performance study that are relevant to the subject's decision to participate or, in the case of minors and of
p.000191: incapacitated subjects, an authoris ation or agreement from their legally designated representative to include them in
p.000191: the performance study;
p.000191:
p.000191: (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that
p.000191: Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of
p.000191: laypersons, in particular patients or patients' organisations;
p.000191:
p.000191: (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision,
p.000191: unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in
p.000191: subjects, users or other persons, in the context of a performance study, whether or not related to the device for
p.000191: performance study;
p.000191:
p.000191: (61) ‘serious adverse event’ means any adverse event that led to any of the following:
p.000191:
p.000191: (a) a patient management decision resulting in death or an imminent life-threatening situation for the
p.000191: individual being tested, or in the death of the individual's offspring,
p.000191:
p.000191: (b) death,
p.000191:
p.000191: (c) serious deterioration in the health of the individual being tested or the recipient of tested
p.000191: donations or materials, that resulted in any of the following:
p.000191:
p.000191: (i) life-threatening illness or injury,
p.000191:
p.000191: (ii) permanent impairment of a body structure or a body function,
p.000191:
p.000192: L 117/192 EN
p.000192: Official Journal of the European Union
...
p.000228: 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or,
p.000228: where the subject is not able to give informed consent, his or her legally designated representative.
p.000228:
p.000228: 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information
p.000228: needs of specific patient populations and of individual subjects, as well as to the methods used to give the
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
p.000228: by the legally designated representative, a minor who is capable of forming an opinion and assessing the information
p.000228: given to him or her, shall also assent in order to participate in a performance study.
p.000228:
p.000228:
p.000228: Article 60
p.000228:
p.000228: Performance studies on incapacitated subjects
p.000228:
p.000228: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before
p.000228: the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions
p.000228: set out in Article 58(5), all of the following conditions are met:
p.000228:
p.000228: (a) the informed consent of their legally designated representative has been obtained;
p.000228:
p.000228: (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in
p.000228: view of their capacity to understand it;
p.000228:
p.000228: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000228: the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the
p.000228: performance study at any time, is respected by the investigator;
p.000228:
p.000228: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000228: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000228: the performance study;
p.000228:
p.000228: (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot
p.000228: be obtained in performance studies on persons able to give informed consent, or by other research methods;
p.000228:
p.000228: (f) the performance study relates directly to a medical condition from which the subject suffers;
p.000228:
p.000228: 5.5.2017 EN
p.000228: Official Journal of the European Union
p.000229: L 117/229
p.000229:
p.000229: (g) there are scientific grounds for expecting that participation in the performance study will produce:
p.000229:
p.000229: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
p.000229:
p.000229: (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study
p.000229: will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned
p.000229: in comparison with the standard treatment of the incapacitated subject's condition.
p.000229:
p.000229: 2. The subject shall as far as possible take part in the informed consent procedure.
p.000229:
p.000229: 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the
p.000229: conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that
p.000229: participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens
p.000229: involved.
p.000229:
p.000229:
p.000229: Article 61
p.000229:
p.000229: Performance studies on minors
p.000229:
p.000229: 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58
p.000229: (5), all of the following conditions are met:
p.000229:
p.000229: (a) the informed consent of their legally designated representative has been obtained;
p.000229:
p.000229: (b) the minors have received the information referred to in Article 59(2) in a way adapted to their
p.000229: age and mental maturity and from investigators or members of the investigating team who are trained or
p.000229: experienced in working with children;
p.000229:
p.000229: (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information
p.000229: referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is
p.000229: respected by the investigator;
p.000229:
p.000229: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000229: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000229: the performance study;
p.000229:
p.000229: (e) the performance study is intended to investigate treatments for a medical condition that only occurs in
...
p.000230: prior informed consent from his or her legally designated representative;
p.000230:
p.000230: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000230: performance study previously expressed by the subject;
p.000230:
p.000230: 5.5.2017 EN
p.000230: Official Journal of the European Union
p.000231: L 117/231
p.000231:
p.000231: (e) the performance study relates directly to the subject's medical condition because of which it is not possible
p.000231: within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated
p.000231: rep resentative and to supply prior information, and the performance study is of such a nature that it may be
p.000231: conducted exclusively in emergency situations;
p.000231:
p.000231: (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with
p.000231: the standard treatment of the subject's condition.
p.000231:
p.000231: 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article
p.000231: 59 shall be sought to continue the participation of the subject in the performance study, and
p.000231: information on the performance study shall be given, in accordance with the following requirements:
p.000231:
p.000231: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator
p.000231: from his or her legally designated representative without undue delay and the information referred to in Article
p.000231: 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
p.000231:
p.000231: (b) regarding other subjects, the informed consent shall be sought by the investigator without undue
p.000231: delay from the subject or his or her legally designated representative, whichever can be done sooner, and the
p.000231: information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally
p.000231: designated representative, as applicable.
p.000231:
p.000231: For the purposes of point (b) where informed consent has been obtained from the legally designated
p.000231: representative, informed consent to continue the participation in the performance study shall be obtained from the
p.000231: subject as soon as he or she is capable of giving informed consent.
p.000231:
p.000231: 3. If the subject or, where applicable, his or her legally designated representative does not give
p.000231: consent, he or she shall be informed of the right to object to the use of data obtained from the performance study.
p.000231:
p.000231:
p.000231: Article 65
p.000231:
p.000231: Damage compensation
p.000231:
p.000231: 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from
...
Searching for indicator incapacity:
(return to top)
p.000228: information.
p.000228:
p.000228: 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the
p.000228: subject has understood the information.
p.000228:
p.000228: 6. The subject shall be informed that a report of the performance study and a summary presented in
p.000228: terms understandable to the intended user will be made available pursuant to Article 73(5) in the
p.000228: electronic system on performance studies referred to in Article 69, irrespective of the outcome of the
p.000228: performance study, and shall be informed, to the extent possible, when they have become available.
p.000228:
p.000228: 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given
p.000228: by the legally designated representative, a minor who is capable of forming an opinion and assessing the information
p.000228: given to him or her, shall also assent in order to participate in a performance study.
p.000228:
p.000228:
p.000228: Article 60
p.000228:
p.000228: Performance studies on incapacitated subjects
p.000228:
p.000228: 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before
p.000228: the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions
p.000228: set out in Article 58(5), all of the following conditions are met:
p.000228:
p.000228: (a) the informed consent of their legally designated representative has been obtained;
p.000228:
p.000228: (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in
p.000228: view of their capacity to understand it;
p.000228:
p.000228: (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing
p.000228: the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the
p.000228: performance study at any time, is respected by the investigator;
p.000228:
p.000228: (d) no incentives or financial inducements are given to subjects or their legally designated
p.000228: representatives, except for compensation for expenses and loss of earnings directly related to the participation in
p.000228: the performance study;
p.000228:
p.000228: (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot
p.000228: be obtained in performance studies on persons able to give informed consent, or by other research methods;
p.000228:
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000187: devices and accessories conducted in the Union.
p.000187:
p.000187: 2. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in
p.000187: vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.
p.000187:
p.000187: 3. This Regulation does not apply to:
p.000187:
p.000187: (a) products for general laboratory use or research-use only products, unless such products, in view of their
p.000187: character istics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
p.000187:
p.000187: (b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a
p.000187: specimen;
p.000187: (c) internationally certified reference materials;
p.000187: (d) materials used for external quality assessment schemes.
p.000187:
p.000187: 4. Any device which, when placed on the market or put into service, incorporates, as an integral
p.000187: part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be
p.000187: governed by that Regulation. The requirements of this Regulation shall apply to the in vitro diagnostic medical
p.000187: device part.
p.000187:
p.000187: 5. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
p.000187:
p.000187: 6. Devices which are also machinery within the meaning of point (a) of the second paragraph of
p.000187: Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a
p.000187: hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex
p.000187: I to that Directive to the extent to which those requirements are more specific than the general safety and performance
p.000187: requirements set out in Chapter II of Annex I to this Regulation.
p.000187:
p.000187: 7. This Regulation shall not affect the application of Directive 2013/59/Euratom.
p.000187:
p.000187: 8. This Regulation shall not affect the right of a Member State to restrict the use of any
p.000187: specific type of device in relation to aspects not covered by this Regulation.
p.000187:
p.000187: (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157,
p.000187: 9.6.2006, p. 24).
p.000187:
p.000188: L 117/188 EN
p.000188: Official Journal of the European Union
p.000188: 5.5.2017
p.000188:
p.000188: 9. This Regulation shall not affect national law concerning the organisation, delivery or financing of health
p.000188: services and medical care, such as the requirement that certain devices may only be supplied on a
p.000188: medical prescription, the requirement that only certain health professionals or health care institutions may dispense
p.000188: or use certain devices or that their use be accompanied by specific professional counselling.
p.000188:
p.000188: 10. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media
p.000188: in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under
p.000188: Article 11 of the Charter of Fundamental Rights of the European Union.
...
p.000260: requiring regular systematic updating. In carrying out risk management manufacturers shall:
p.000260: (a) establish and document a risk management plan for each device;
p.000260: (b) identify and analyse the known and foreseeable hazards associated with each device;
p.000260:
p.000260: (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably
p.000260: foreseeable misuse;
p.000260: (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
p.000260:
p.000260: (e) evaluate the impact of information from the production phase and, in particular, from the
p.000260: post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated
p.000260: risks, as well as on the overall risk, the benefit-risk ratio and risk acceptability; and
p.000260:
p.000260: (f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control
p.000260: measures in line with the requirements of Section 4.
p.000260:
p.000260: 4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to
p.000260: safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturers
p.000260: shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged
p.000260: acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
p.000260: (a) eliminate or reduce risks as far as possible through safe design and manufacture;
p.000260:
p.000260: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
p.000260: risks that cannot be eliminated; and
p.000260:
p.000260: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training
p.000260: to users.
p.000260: Manufacturers shall inform users of any residual risks.
p.000260:
p.000260: 5. In eliminating or reducing risks related to use error, the manufacturer shall:
p.000260:
p.000260: (a) reduce as far as possible the risks related to the ergonomic features of the device and the
p.000260: environment in which the device is intended to be used (design for patient safety), and
p.000260:
p.000260: (b) give consideration to the technical knowledge, experience, education, training and use environment,
p.000260: where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or
p.000260: other users).
p.000260:
p.000260: 5.5.2017 EN
p.000260: Official Journal of the European Union
p.000261: L 117/261
p.000261:
p.000261: 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the
...
p.000266:
p.000266: (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient
p.000266: testing, are supplied to a single user and/or location, a single copy of the instructions for use may
p.000266: be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
p.000266:
p.000266: (f) When the device is intended for professional use only, instructions for use may be provided to the user in
p.000266: non-paper format (e.g. electronic), except when the device is intended for near-patient testing.
p.000266:
p.000266: (g) Residual risks which are required to be communicated to the user and/or other person shall be included as
p.000266: limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
p.000266:
p.000266: (h) Where appropriate, the information supplied by the manufacturer shall take the form of
p.000266: internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used
p.000266: shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols
p.000266: and colours shall be described in the documentation supplied with the device.
p.000266:
p.000266: (i) In the case of devices containing a substance or a mixture which may be considered as being
p.000266: dangerous, taking account of the nature and quantity of its constituents and the form under which they
p.000266: are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where
p.000266: there is insufficient space to put all the information on the device itself or on its label, the relevant hazard
p.000266: pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given
p.000266: in the instructions for use.
p.000266:
p.000266: (j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all
p.000266: relevant information, as appropriate, is already made available in the instructions for use.
p.000266:
p.000266: 5.5.2017 EN
p.000266: Official Journal of the European Union
p.000267: L 117/267
p.000267:
p.000267: 20.2. Information on the label
p.000267:
p.000267: The label shall bear all of the following particulars:
p.000267: (a) the name or trade name of the device;
p.000267:
p.000267: (b) the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the
p.000267: intended purpose of the device;
p.000267:
p.000267: (c) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000267: its registered place of business;
p.000267:
p.000267: (d) if the manufacturer has its registered place of business outside the Union, the name of its authorised rep
p.000267: resentative and the address of the registered place of business of the authorised representative;
p.000267:
p.000267: (e) an indication that the device is an in vitro diagnostic medical device, or if the device is a
p.000267: ‘device for performance study’, an indication of that fact;
p.000267:
p.000267: (f) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL
p.000267: NUMBER or an equivalent symbol, as appropriate;
p.000267:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000230:
p.000230: (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding
p.000230: woman concerned, her embryo, foetus or child after birth;
p.000230:
p.000230: (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the
p.000230: health of the child;
p.000230:
p.000230: (d) no incentives or financial inducements are given to subjects, except for compensation for expenses
p.000230: and loss of earnings directly related to the participation in the performance study.
p.000230:
p.000230:
p.000230: Article 63
p.000230:
p.000230: Additional national measures
p.000230:
p.000230: Member States may maintain additional measures regarding persons performing mandatory military service,
p.000230: persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance
p.000230: studies, or persons in residential care institutions.
p.000230:
p.000230:
p.000230: Article 64
p.000230:
p.000230: Performance studies in emergency situations
p.000230:
p.000230: 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points
p.000230: (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information
p.000230: on the performance studies may be given, after the decision to include the subject in the performance study, provided
p.000230: that that decision is taken at the time of the first intervention on the subject, in accordance with the
p.000230: clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
p.000230:
p.000230: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical
p.000230: condition, the subject is unable to provide prior informed consent and to receive prior information on the performance
p.000230: study;
p.000230:
p.000230: (b) there are scientific grounds to expect that participation of the subject in the performance study
p.000230: will have the potential to produce a direct clinically relevant benefit for the subject resulting in a
p.000230: measurable health-related improvement alleviating the suffering and/or improving the health of the subject,
p.000230: or in the diagnosis of its condition;
p.000230:
p.000230: (c) it is not possible within the therapeutic window to supply all prior information to and obtain
p.000230: prior informed consent from his or her legally designated representative;
p.000230:
p.000230: (d) the investigator certifies that he or she is not aware of any objections to participate in the
p.000230: performance study previously expressed by the subject;
p.000230:
p.000230: 5.5.2017 EN
p.000230: Official Journal of the European Union
p.000231: L 117/231
p.000231:
p.000231: (e) the performance study relates directly to the subject's medical condition because of which it is not possible
p.000231: within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated
p.000231: rep resentative and to supply prior information, and the performance study is of such a nature that it may be
p.000231: conducted exclusively in emergency situations;
p.000231:
p.000231: (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with
p.000231: the standard treatment of the subject's condition.
p.000231:
p.000231: 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article
p.000231: 59 shall be sought to continue the participation of the subject in the performance study, and
p.000231: information on the performance study shall be given, in accordance with the following requirements:
p.000231:
p.000231: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator
p.000231: from his or her legally designated representative without undue delay and the information referred to in Article
p.000231: 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
p.000231:
p.000231: (b) regarding other subjects, the informed consent shall be sought by the investigator without undue
p.000231: delay from the subject or his or her legally designated representative, whichever can be done sooner, and the
p.000231: information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally
p.000231: designated representative, as applicable.
p.000231:
p.000231: For the purposes of point (b) where informed consent has been obtained from the legally designated
...
p.000233: into consideration all character istics of the performance study including the following:
p.000233: (a) the objective and methodology of the performance study; and
p.000233: (b) the degree of deviation of the intervention from normal clinical practice.
p.000233: 3. All performance study information shall be recorded, processed, handled, and stored by
p.000233: the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and
p.000233: verified while the confiden tiality of records and the personal data of the subjects remain protected in
p.000233: accordance with the applicable law on personal data protection.
p.000233:
p.000233: 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data
p.000233: processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental
p.000233: loss, in particular where the processing involves transmission over a network.
p.000233:
p.000233: 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance
p.000233: studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
p.000233:
p.000234: L 117/234 EN
p.000234: Official Journal of the European Union
p.000234: 5.5.2017
p.000234:
p.000234: 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification
p.000234: and, where necessary, an immediate recall of the devices used in the study.
p.000234:
p.000234:
p.000234: Article 69
p.000234:
p.000234: Electronic system on performance studies
p.000234:
p.000234: 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an
p.000234: electronic system:
p.000234: (a) to create the single identification numbers for performance studies referred to in Article 66(1);
p.000234: (b) to be used as an entry point for the submission of all applications or notifications for performance studies
p.000234: referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
p.000234: (c) for the exchange of information relating to performance studies in accordance with this Regulation
p.000234: between the Member States and between them and the Commission including the exchange of information
p.000234: referred to in to Articles 72 and 74;
p.000234: (d) for information to be provided by the sponsor in accordance with Article 73, including the
p.000234: performance study report and its summary as required in paragraph 5 of that Article;
p.000234: (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76.
p.000234: 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure
p.000234: that it is interoperable with the EU database for clinical trials on medicinal products for human use
p.000234: set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of
...
p.000261: detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for
p.000261: specimen collection and handling and control of known relevant endogenous and exogenous interference,
p.000261: cross- reactions; and
p.000261:
p.000261: (b) the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value,
p.000261: negative predictive value, likelihood ratio, expected values in normal and affected populations.
p.000261:
p.000261: 9.2. The performance characteristics of the device shall be maintained during the lifetime of the device as
p.000261: indicated by the manufacturer.
p.000261:
p.000261: 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the
p.000261: metrological traceability of values assigned to calibrators and/or control materials shall be assured through
p.000261: suitable reference measurement procedures and/or suitable reference materials of a higher metrological
p.000261: order. Where available, metrological traceability of values assigned to calibrators and control materials
p.000261: shall be assured to certified reference materials or reference measurement procedures.
p.000261:
p.000261: 9.4. The characteristics and performances of the device shall be specifically checked in the event
p.000261: that they may be affected when the device is used for the intended use under normal conditions:
p.000261:
p.000261: (a) for devices for self-testing, performances obtained by laypersons;
p.000261:
p.000261: (b) for devices for near-patient testing, performances obtained in relevant environments (for example,
p.000261: patient home, emergency units, ambulances).
p.000261:
p.000261: 10. Chemical, physical and biological properties
p.000261:
p.000261: 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance
p.000261: requirements referred to in Chapter I are fulfilled.
p.000261:
p.000261: Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or
p.000261: chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as
p.000261: biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
p.000261:
p.000262: L 117/262 EN
p.000262: Official Journal of the European Union
p.000262: 5.5.2017
p.000262:
p.000262: 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed
p.000262: by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons
p.000262: involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to
p.000262: those contaminants and residues and to the duration and frequency of exposure.
p.000262:
p.000262: 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably
p.000262: practicable the risks posed by substances or particles, including wear debris, degradation products and
p.000262: processing residues, that may be released from the device. Special attention shall be given to substances
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000177: risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic
p.000177: medical device sector which require the adoption of specific legislation, distinct from the legislation on other
p.000177: medical devices, whereas the horizontal aspects common to both sectors should be aligned.
p.000177:
p.000177: (7) The scope of application of this Regulation should be clearly delimited from other legislation
p.000177: concerning products, such as medical devices, general laboratory products and products for research use only.
p.000177:
p.000177: (8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a
p.000177: product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard
p.000177: across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
p.000177: initiative or at the duly substantiated request of a Member State, having consulted the Medical Device
p.000177: Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category
p.000177: or group of products falls within the scope of this Regulation. When deliberating on the regulatory
p.000177: status of products in borderline cases involving medicinal products, human tissues and cells, biocidal
p.000177: products or food products, the Commission should ensure an appropriate level of consultation of the European
p.000177: Medicines Agency, the European Chemicals Agency and the European Food Safety Authority, as relevant.
p.000177:
p.000177: (9) It appears that it is possible that divergent national rules regarding the provision of information and
p.000177: counselling in relation to genetic testing might only have an impact on the smooth functioning of the
p.000177: internal market to a limited extent. Therefore, it is appropriate to lay down only limited requirements
p.000177: in this regard in this Regulation, having regard to the need to ensure constant respect of the
p.000177: principles of proportionality and subsidiarity.
p.000177:
p.000177: (10) It should be made clear that all tests that provide information on the predisposition to a
p.000177: medical condition or a disease, such as genetic tests, and tests that provide information to predict
p.000177: treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices.
p.000177:
p.000177: (11) Companion diagnostics are essential for defining patients' eligibility for specific treatment with
p.000177: a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at
p.000177: a higher risk of developing an adverse reaction to the medicinal product in question or identifying
p.000177: patients in the population for whom the therapeutic product has been adequately studied, and found safe
p.000177: and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients.
p.000177:
p.000177: (12) Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the
...
p.000179: be met at the appropriate level of performance by an equivalent device available on the market. In that
p.000179: context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used
p.000179: only within health institutions, including hospitals as well as institutions, such as laboratories and public health
p.000179: institutes that support the health care system and/or address patient needs, but which do not treat or care for
p.000179: patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
p.000179: It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue
p.000179: health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result,
p.000179: the exemption applicable to health institutions does not apply to such establishments.
p.000179:
p.000179:
p.000179: (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective
p.000179: device in accordance with applicable Union and national law, it is appropriate to require manufacturers
p.000179: to have measures in place to provide sufficient financial coverage in respect of their potential
p.000179: liability under Council Directive 85/374/EEC (1). Such measures should be proportionate to the risk class, type of
p.000179: device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the
p.000179: facilitation, by a competent authority, of the provision of information to persons who may have been injured by a
p.000179: defective device.
p.000179:
p.000179:
p.000179: (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of
p.000179: this Regulation and that experience from the use of the devices they manufacture is taken into account for the
p.000179: production process, all manufacturers should have a quality management system and a post-market surveillance system in
p.000179: place which should be proportionate to the risk class and the type of the device in question. In
p.000179: addition, in order to minimize risks or prevent incidents related to devices, manufacturers should
p.000179: establish a system for risk management and a system for reporting incidents and field safety corrective actions.
p.000179:
p.000179:
p.000179: (32) The risk management system should be carefully aligned with and reflected in the performance
p.000179: evaluation process for the device, including the clinical risks to be addressed as part of performance
p.000179: studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation
p.000179: processes should be inter-dependent and should be regularly updated.
p.000179:
p.000179:
p.000179: (33) It should be ensured that supervision and control of the manufacture of devices, as well as
...
p.000181: European Parliament and of the Council (1) applies to the processing of personal data carried out in the Member States,
p.000181: under the supervision of the Member States' competent authorities, in particular the public independent authorities
p.000181: designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (2) applies
p.000181: to the processing of personal data carried out by the Commission within the framework of this
p.000181: Regulation, under the supervision of the European Data Protection Supervisor. In accordance with
p.000181: Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its
p.000181: electronic systems.
p.000181:
p.000181: (45) For class C and D devices, manufacturers should summarise the main safety and performance
p.000181: aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.
p.000181:
p.000181: (46) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection
p.000181: and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member
p.000181: States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
p.000181:
p.000181: (47) Notified bodies' assessments of manufacturers' technical documentation, in particular
p.000181: documentation on performance evaluation, should be critically evaluated by the authority responsible for
p.000181: notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities
p.000181: of notified bodies and should be based on sampling of the relevant documentation.
p.000181:
p.000181: (48) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with
p.000181: regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on
p.000181: devices to ensure continuous compliance by manufacturers after receipt of the original certification.
p.000181:
p.000181: (49) To increase transparency with regard to the oversight of notified bodies by national authorities,
p.000181: the authorities responsible for notified bodies should publish information on the national measures
p.000181: governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative
p.000181: practice, this information should be kept up to date by those authorities in particular to reflect relevant,
p.000181: significant or substantive changes to the procedures in question.
p.000181:
p.000181: (50) The Member State in which a notified body is established should be responsible for enforcing the requirements
p.000181: of this Regulation with regard to that notified body.
p.000181:
p.000181: (51) In view, in particular, of the responsibility of Member States for the organisation and delivery of health
p.000181: services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for
p.000181: the conformity assessment of devices and established on their territory as far as issues that are not regulated in
...
p.000182:
p.000182: 5.5.2017 EN
p.000182: Official Journal of the European Union
p.000183: L 117/183
p.000183:
p.000183: (65) Where specific devices have no analytical or clinical performance or specific performance requirements are
p.000183: not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions
p.000183: relating to such requirements.
p.000183:
p.000183:
p.000183: (66) The rules on performance studies should be in line with well-established international guidance in this field,
p.000183: such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of
p.000183: medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the
p.000183: Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies
p.000183: conducted outside the Union in accordance with international guidelines to be accepted within the Union.
p.000183: In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of
p.000183: Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
p.000183:
p.000183:
p.000183: (67) It should be left to the Member State where a performance study is to be conducted to determine the
p.000183: appropriate authority to be involved in the assessment of the application to conduct a performance study and to
p.000183: organise the involvement of ethics committees within the timelines for the authorisation of that performance study as
p.000183: set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that
p.000183: context, Member States should ensure the involvement of laypersons, in particular patients or patients'
p.000183: organisations. They should also ensure that the necessary expertise is available.
p.000183:
p.000183:
p.000183: (68) An electronic system should be set up at Union level to ensure that every interventional
p.000183: clinical performance study and other performance study involving risks for the subjects of the studies is
p.000183: recorded and reported in a publicly accessible database. To protect the right to protection of personal data,
p.000183: recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data
p.000183: of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with
p.000183: the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable
p.000183: with the EU database to be set up for clinical trials on medicinal products for human use.
p.000183:
p.000183:
p.000183: (69) Where an interventional clinical performance study or another performance study involving risks for the
...
p.000184:
p.000184: (83) An expert committee, the MDCG, composed of persons designated by the Member States based on their role and
p.000184: expertise in the field of medical devices including in vitro diagnostic medical devices, should be
p.000184: established in
p.000184:
p.000184: (1) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals
p.000184: used for scientific purposes (OJ L 276, 20.10.2010. p. 33).
p.000184:
p.000184: 5.5.2017 EN
p.000184: Official Journal of the European Union
p.000185: L 117/185
p.000185:
p.000185: accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it
p.000185: by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission
p.000185: and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able
p.000185: to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical
p.000185: devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate con sideration
p.000185: should be given to the possibility of involving existing groups at Union level in the field of medical
p.000185: devices.
p.000185:
p.000185:
p.000185: (84) Closer coordination between national competent authorities through information exchange and
p.000185: coordinated assessments under the direction of a coordinating authority is essential for ensuring a
p.000185: uniform high level of health and safety protection within the internal market, in particular in the
p.000185: areas of performance studies and vigilance. The principle of coordinated exchange and assessment should
p.000185: also apply across other authority activities described in this Regulation, such as the designation of notified
p.000185: bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and
p.000185: communication of activities should also lead to more efficient use of resources and expertise at national level.
p.000185:
p.000185:
p.000185: (85) The Commission should provide scientific, technical and corresponding logistical support to
p.000185: coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly
p.000185: implemented at Union level based on sound scientific evidence.
p.000185:
p.000185:
p.000185: (86) The Union and, where appropriate, the Member States should actively participate in international
p.000185: regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding
p.000185: devices and foster the further development of international regulatory guidelines that promote the adoption
p.000185: in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to
p.000185: that set by this Regulation.
p.000185:
p.000185:
p.000185: (87) Member States should take all necessary measures to ensure that the provisions of this
p.000185: Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their
p.000185: infringement.
p.000185:
p.000185:
p.000185: (88) Whilst this Regulation should not affect the right of Member States to levy fees for activities
...
p.000193:
p.000193: Regulatory status of products
p.000193:
p.000193: 1. Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device
p.000193: Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of
p.000193: implementing acts, determine whether or not a specific product, or category or group of products, falls
p.000193: within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical
p.000193: device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
p.000193: 107(3) of this Regulation.
p.000193:
p.000193: 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of
p.000193: implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be
p.000193: adopted in accordance with the examination procedure referred to in Article 107(3).
p.000193:
p.000193: 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical
p.000193: devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary,
p.000193: other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
p.000193:
p.000193: 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human
p.000193: tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of
p.000193: consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food
p.000193: Safety Authority, as relevant.
p.000193:
p.000193: Article 4
p.000193:
p.000193: Genetic information, counselling and informed consent
p.000193:
p.000193: 1. Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as
p.000193: defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council (1) and for the
p.000193: medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested
p.000193: or, where applicable, his or her legally designated representative is provided with relevant information on
p.000193: the nature, the significance and the implications of the genetic test, as appropriate.
p.000193:
p.000193: 2. In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that
p.000193: there is appropriate access to counselling in the case of the use of genetic tests that provide information on the
p.000193: genetic predispo sition for medical conditions and/or diseases which are generally considered to be untreatable
p.000193: according to the state of science and technology.
p.000193:
p.000193: 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease
p.000193: which the individual being tested is already known to have is confirmed by a genetic test or in cases where a
p.000193: companion diagnostic is used.
p.000193:
p.000193: 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at
p.000193: national level which are more protective of patients, more specific or which deal with informed consent.
p.000193:
...
p.000194: 5.5.2017
p.000194:
p.000194: 2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it,
p.000194: taking into account its intended purpose.
p.000194:
p.000194: 3. Demonstration of conformity with the general safety and performance requirements shall include a
p.000194: performance evaluation in accordance with Article 56.
p.000194:
p.000194: 4. Devices that are manufactured and used within health institutions, with the exception of devices for
p.000194: performance studies, shall be considered as having been put into service.
p.000194:
p.000194: 5. With the exception of the relevant general safety and performance requirements set out in Annex
p.000194: I, the requirements of this Regulation shall not apply to devices manufactured and used only within
p.000194: health institutions established in the Union, provided that all of the following conditions are met:
p.000194:
p.000194: (a) the devices are not transferred to another legal entity;
p.000194:
p.000194: (b) manufacture and use of the devices occur under appropriate quality management systems;
p.000194:
p.000194: (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where
p.000194: applicable national provisions, including national provisions regarding accreditation;
p.000194:
p.000194: (d) the health institution justifies in its documentation that the target patient group's specific needs cannot be
p.000194: met, or cannot be met at the appropriate level of performance by an equivalent device available on the market;
p.000194:
p.000194: (e) the health institution provides information upon request on the use of such devices to its
p.000194: competent authority, which shall include a justification of their manufacturing, modification and use;
p.000194:
p.000194: (f) the health institution draws up a declaration which it shall make publicly available, including:
p.000194:
p.000194: (i) the name and address of the manufacturing health institution,
p.000194:
p.000194: (ii) the details necessary to identify the devices,
p.000194:
p.000194: (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this
p.000194: Regulation and, where applicable, information on which requirements are not fully met with a reasoned justifi cation
p.000194: therefor;
p.000194:
p.000194: (g) as regards class D devices in accordance with the rules set out in Annex VIII, the health
p.000194: institution draws up documentation that makes it possible to have an understanding of the manufacturing
p.000194: facility, the manufacturing process, the design and performance data of the devices, including the
p.000194: intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the
p.000194: general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply
p.000194: this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
p.000194:
p.000194: (h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with
p.000194: the documentation referred to in point (g); and
p.000194:
p.000194: (i) the health institution reviews experience gained from clinical use of the devices and takes all
p.000194: necessary corrective actions.
p.000194:
p.000194: Member States may require that such health institutions submit to the competent authority any further
p.000194: relevant information about such devices which have been manufactured and used on their territory. Member States shall
p.000194: retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access
p.000194: to inspect the activities of the health institutions.
p.000194:
p.000194: This paragraph shall not apply to devices that are manufactured on an industrial scale.
p.000194:
p.000194: 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing
p.000194: acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those
p.000194: implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
p.000194:
p.000194: 5.5.2017 EN
p.000194: Official Journal of the European Union
p.000195: L 117/195
p.000195:
p.000195: Article 6
p.000195:
p.000195: Distance sales
p.000195:
p.000195: 1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive
p.000195: (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
p.000195: 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed
p.000195: on the market but used in the context of a commercial activity, whether in return for payment or free of charge,
p.000195: for the provision of a diagnostic or therapeutic service offered by means of information society services, as defined
p.000195: in point (b) of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication, directly or through
p.000195: intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
p.000195:
p.000195: 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with
p.000195: paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of
p.000195: conformity of the device concerned.
p.000195:
p.000195: 4. A Member State may, on grounds of protection of public health, require a provider of information society
p.000195: services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
p.000195:
p.000195:
p.000195: Article 7
p.000195:
p.000195: Claims
p.000195:
p.000195: In the labelling, instructions for use, making available, putting into service and advertising of
p.000195: devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may
p.000195: mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
p.000195: (a) ascribing functions and properties to the device which the device does not have;
p.000195: (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not
p.000195: have;
p.000195:
p.000195: (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its
p.000195: intended purpose;
p.000195:
p.000195: (d) suggesting uses for the device other than those stated to form part of the intended purpose for
p.000195: which the conformity assessment was carried out.
p.000195:
p.000195:
p.000195: Article 8
p.000195:
p.000195: Use of harmonised standards
p.000195:
p.000195: 1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of
...
p.000196: and Annex XIII, including a PMPF.
p.000196:
p.000196: 4. Manufacturers shall draw up and keep up to date the technical documentation for those devices.
p.000196: The technical documentation shall be such as to allow the conformity of the device with the requirements
p.000196: of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and
p.000196: III.
p.000196:
p.000196: The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the
p.000196: light of technical progress, the Annexes II and III.
p.000196:
p.000196: 5. Where compliance with the applicable requirements has been demonstrated following the applicable
p.000196: conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall
p.000196: draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of
p.000196: conformity in accordance with Article 18.
p.000196:
p.000196: 6. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with
p.000196: the registration obligations referred to in Article 26 and 28.
p.000196:
p.000196: 7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a
p.000196: copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51,
p.000196: available for the competent authorities for a period of at least 10 years after the last device covered
p.000196: by the EU declaration of conformity has been placed on the market.
p.000196:
p.000196: Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that
p.000196: technical documen tation in its entirety or a summary thereof.
p.000196:
p.000196: A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised
p.000196: representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the
p.000196: necessary documentation permanently available.
p.000196:
p.000196: 5.5.2017 EN
p.000196: Official Journal of the European Union
p.000197: L 117/197
p.000197:
p.000197: 8. Manufacturers shall ensure that procedures are in place to keep series production in conformity
p.000197: with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised
p.000197: standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in
p.000197: a timely manner. Manufacturers of devices, other than devices for performance study, shall establish,
p.000197: document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure
p.000197: compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class
p.000197: and the type of device.
p.000197:
p.000197: The quality management system shall cover all parts and elements of a manufacturer's organisation dealing
p.000197: with the quality of processes, procedures and devices. It shall govern the structure, responsibilities,
p.000197: procedures, processes and management resources required to implement the principles and actions necessary
...
p.000197:
p.000197: The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing
p.000197: shall be easily understandable and provided in the official Union language(s) determined by the Member State in which
p.000197: the device is made available to the user or patient.
p.000197:
p.000197: 11. Manufacturers that consider or have reason to believe that a device which they have placed on the market or
p.000197: put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to
p.000197: bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors
p.000197: of the device in question and, where applicable, the authorised representative and importers accordingly.
p.000197:
p.000197: Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities
p.000197: of the Member States in which they made the device available and, where applicable, the notified body that issued a
p.000197: certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective
p.000197: action taken.
p.000197:
p.000198: L 117/198 EN
p.000198: Official Journal of the European Union
p.000198: 5.5.2017
p.000198:
p.000198: 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions
p.000198: as described in Articles 82 and 83.
p.000198:
p.000198: 13. Manufacturers shall, upon request by a competent authority, provide it with all the information
p.000198: and documen tation necessary to demonstrate the conformity of the device, in an official Union language determined by
p.000198: the Member State concerned. The competent authority of the Member State in which the manufacturer has its
p.000198: registered place of business may require that the manufacturer provide samples of the device free of charge or,
p.000198: where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent
p.000198: authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the
p.000198: risks posed by devices which they have placed on the market or put into service.
p.000198:
p.000198: If the manufacturer fails to cooperate or the information and documentation provided is incomplete or
p.000198: incorrect, the competent authority may, in order to ensure the protection of public health and patient
p.000198: safety, take all appropriate measures to prohibit or restrict the device's being made available on its national
p.000198: market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete
p.000198: and correct information.
p.000198:
p.000198: If a competent authority considers or has reason to believe that a device has caused damage, it shall,
p.000198: upon request, facilitate the provision of the information and documentation referred to in the first
p.000198: subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's
p.000198: successor in title, the patient's or user's health insurance company or other third parties affected by the
p.000198: damage caused to the patient or user, without prejudice to data protection rules and, unless there is an
p.000198: overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
p.000198:
p.000198: The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the
p.000198: information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal
p.000198: proceedings.
p.000198:
p.000198: 14. Where manufacturers have their devices designed or manufactured by another legal or natural
p.000198: person the information on the identity of that person shall be part of the information to be submitted in accordance
p.000198: with Article 27(1).
p.000198:
p.000198: 15. Natural or legal persons may claim compensation for damage caused by a defective device in
p.000198: accordance with applicable Union and national law.
p.000198:
p.000198: Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size
p.000198: of the enterprise, have measures in place to provide sufficient financial coverage in respect of their
p.000198: potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
p.000198:
p.000198: Article 11
p.000198:
p.000198: Authorised representative
p.000198:
p.000198: 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the
p.000198: Union market if the manufacturer designates a sole authorised representative.
p.000198:
p.000198: 2. The designation shall constitute the authorised representative's mandate, it shall be valid only
p.000198: when accepted in writing by the authorised representative and shall be effective at least for all devices of the same
p.000198: generic device group.
p.000198:
p.000198: 3. The authorised representative shall perform the tasks specified in the mandate agreed between it
p.000198: and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent
p.000198: authority, upon request.
p.000198:
p.000198: The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at
p.000198: least the following tasks in relation to the devices that it covers:
p.000198: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and,
p.000198: where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
p.000198: (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy
p.000198: of the relevant certificate, including any amendments and supplements, issued in accordance with Article
p.000198: 51, at the disposal of competent authorities for the period referred to in Article 10(7);
p.000198: (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied
p.000198: with the registration obligations laid down in Article 26;
p.000198:
p.000198: 5.5.2017 EN
p.000198: Official Journal of the European Union
p.000199: L 117/199
p.000199:
p.000199: (d) in response to a request from a competent authority, provide that competent authority with all the information and
p.000199: documentation necessary to demonstrate the conformity of a device, in an official Union language determined
p.000199: by the Member State concerned;
p.000199: (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep
p.000199: resentative has its registered place of business for samples, or access to a device and verify that
p.000199: the competent authority receives the samples or is given access to the device;
p.000199: (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is
p.000199: not possible, mitigate the risks posed by devices;
p.000199: (g) immediately inform the manufacturer about complaints and reports from healthcare professionals,
p.000199: patients and users about suspected incidents related to a device for which they have been designated;
p.000199: (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
p.000199: 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid
p.000199: down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
p.000199:
p.000199: 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State
p.000199: and has not complied with the obligations laid down in Article 10, the authorised representative shall be
p.000199: legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
p.000199:
p.000199: 6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3
p.000199: shall immediately inform the competent authority of the Member State in which it is established and, where applicable,
p.000199: the notified body that was involved in the conformity assessment for the device of the termination of the mandate and
p.000199: the reasons therefor.
p.000199:
p.000199: 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has
p.000199: its registered place of business shall be understood as a reference to the competent authority of the
p.000199: Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its
p.000199: registered place of business.
p.000199:
p.000199: Article 12
p.000199:
p.000199: Change of authorised representative
p.000199:
p.000199: The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between
p.000199: the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised
p.000199: representative. That agreement shall address at least the following aspects:
p.000199: (a) the date of termination of the mandate of the outgoing authorised representative and date of
p.000199: beginning of the mandate of the incoming authorised representative;
p.000199: (b) the date until which the outgoing authorised representative may be indicated in the information
p.000199: supplied by the manufacturer, including any promotional material;
p.000199: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000199: (d) the obligation of the outgoing authorised representative after the end of the mandate to
p.000199: forward to the manufacturer or incoming authorised representative any complaints or reports from
p.000199: healthcare professionals, patients or users about suspected incidents related to a device for which it had been
p.000199: designated as authorised rep resentative.
p.000199:
p.000199: Article 13
p.000199:
p.000199: General obligations of importers
p.000199: 1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
p.000199: 2. In order to place a device on the market, importers shall verify that:
p.000199: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
p.000199: (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been
p.000199: designated by the manufacturer;
p.000199: (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
p.000199: (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.
p.000199:
p.000200: L 117/200 EN
p.000200: Official Journal of the European Union
p.000200: 5.5.2017
p.000200:
p.000200: Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this
p.000200: Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the
p.000200: manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe
p.000200: that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the
p.000200: Member State in which the importer is established.
p.000200:
p.000200: 3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name,
p.000200: registered trade name or registered trade mark, their registered place of business and the address at which they can
p.000200: be contacted, so that their location can be established. They shall ensure that any additional label
p.000200: does not obscure any information on the label provided by the manufacturer.
p.000200:
p.000200: 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 26.
p.000200: Importers shall add their details to the registration in accordance with Article 28.
p.000200:
p.000200: 5. Importers shall ensure that, while a device is under their responsibility, storage or transport
p.000200: conditions do not jeopardise its compliance with the general safety and performance requirements set out
p.000200: in Annex I and shall comply with the conditions set by the manufacturer, where available.
p.000200:
p.000200: 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and
p.000200: withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested
p.000200: by them, in order to allow them to investigate complaints.
p.000200:
p.000200: 7. Importers who consider or have reason to believe that a device which they have placed on the market is not
p.000200: in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative.
p.000200: Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the
p.000200: competent authorities to ensure that the necessary corrective action to bring that device into conformity, to
p.000200: withdraw or recall it, is taken. Where the device presents a serious risk, they shall also immediately inform the
p.000200: competent authorities of the Member States in which they made the device available and, if applicable, the
p.000200: notified body that issued a certificate in accordance with Article 51 for the device in question, giving
p.000200: details, in particular, of the non-compliance and of any corrective action taken.
p.000200:
p.000200: 8. Importers who have received complaints or reports from healthcare professionals, patients or users
p.000200: about suspected incidents related to a device which they have placed on the market shall immediately forward this
p.000200: information to the manufacturer and its authorised representative.
p.000200:
p.000200: 9. Importers shall, for the period referred to in Article 10(7), keep a copy of the EU declaration of conformity
p.000200: and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued
p.000200: in accordance with Article 51.
p.000200:
p.000200: 10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to
p.000200: eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on
p.000200: the market. Importers, upon request by a competent authority of the Member State in which the importer has its
p.000200: registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant
p.000200: access to the device.
p.000200:
p.000200:
p.000200: Article 14
p.000200:
p.000200: General obligations of distributors
p.000200:
p.000200: 1. When making a device available on the market, distributors shall, in the context of their
p.000200: activities, act with due care in relation to the requirements applicable.
p.000200:
p.000200: 2. Before making a device available on the market, distributors shall verify that all of the following
p.000200: requirements are met:
p.000200: (a) the device has been CE marked and the EU declaration of conformity of the device has been drawn up;
p.000200: (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10);
p.000200: (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
p.000200: (d) that, where applicable, a UDI has been assigned by the manufacturer.
p.000200: In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph
p.000200: the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
p.000200:
p.000200: 5.5.2017 EN
p.000200: Official Journal of the European Union
p.000201: L 117/201
p.000201:
p.000201: Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this
p.000201: Regulation, it shall not make the device available on the market until it has been brought into
p.000201: conformity and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and
p.000201: the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a
p.000201: falsified device, it shall also inform the competent authority of the Member State in which it is established.
p.000201:
p.000201: 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions
p.000201: comply with the conditions set by the manufacturer.
p.000201:
p.000201: 4. Distributors that consider or have reason to believe that a device which they have made available on the market
p.000201: is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufac
p.000201: turer's authorised representative and the importer. Distributors shall co-operate with the manufacturer
p.000201: and, where applicable the manufacturer's authorised representative, and the importer, and with competent authorities
p.000201: to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as
p.000201: appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious
p.000201: risk, it shall also immediately inform the competent authorities of the Member States in which it made the
p.000201: device available, giving details, in particular, of the non-compliance and of any corrective action taken.
p.000201:
p.000201: 5. Distributors that have received complaints or reports from healthcare professionals, patients or
p.000201: users about suspected incidents related to a device they have made available, shall immediately forward
p.000201: this information to the manufacturer and, where applicable, the manufacturer's authorised representative,
p.000201: and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and
p.000201: withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer
p.000201: informed of such monitoring and provide them with any information upon their request.
p.000201:
p.000201: 6. Distributors shall, upon request by a competent authority, provide it with all the information and
p.000201: documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
p.000201:
p.000201: Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph
p.000201: when the manufacturer or, where applicable, the authorised representative for the device in question
p.000201: provides the required information. Distributors shall cooperate with competent authorities, at their request, on any
p.000201: action taken to eliminate the risks posed by devices which they have made available on the market.
p.000201: Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is
p.000201: impracticable, grant access to the device.
p.000201:
p.000201:
p.000201: Article 15
p.000201:
p.000201: Person responsible for regulatory compliance
p.000201:
p.000201: 1. Manufacturers shall have available within their organisation at least one person responsible for
p.000201: regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical
p.000201: devices. The requisite expertise shall be demonstrated by either of the following qualifications:
p.000201:
p.000201: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or
p.000201: of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or
p.000201: another relevant scientific discipline, and at least one year of professional experience in regulatory
p.000201: affairs or in quality management systems relating to in vitro diagnostic medical devices;
p.000201: (b) four years of professional experience in regulatory affairs or in quality management systems relating
p.000201: to in vitro
p.000201: diagnostic medical devices.
p.000201:
p.000201: 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall
p.000201: not be required to have the person responsible for regulatory compliance within their organisation but shall have such
p.000201: person permanently and continuously at their disposal.
p.000201:
p.000201: 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
p.000201:
p.000201: (a) the conformity of the devices is appropriately checked, in accordance with the quality management
...
p.000202: Official Journal of the European Union
p.000203: L 117/203
p.000203:
p.000203: 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2
p.000203: shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the
p.000203: device, the activity carried out together with its name, registered trade name or registered trade mark, registered
p.000203: place of business and the address at which it can be contacted, so that its location can be established.
p.000203:
p.000203: Distributors and importers shall ensure that they have in place a quality management system that includes procedures
p.000203: which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in
p.000203: points
p.000203: (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the
p.000203: device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
p.000203: The quality management system shall cover, inter alia, procedures ensuring that the distributor or
p.000203: importer is informed of any corrective action taken by the manufacturer in relation to the device in question in
p.000203: order to respond to safety issues or to bring it into conformity with this Regulation.
p.000203:
p.000203: 4. At least 28 days prior to making the relabelled or repackaged device available on the market,
p.000203: distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall
p.000203: inform the manufacturer and the competent authority of the Member State in which they plan to make the device
p.000203: available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the
p.000203: manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device,
p.000203: including any translated label and instructions for use. Within the same period of 28 days, the
p.000203: distributor or importer shall submit to the competent authority a certificate, issued by a notified body
p.000203: designated for the type of devices that are subject to activities mentioned in points (a) and (b) of
p.000203: paragraph 2, attesting that the quality management system of the distributer or importer complies with the
p.000203: requirements laid down in paragraph 3.
p.000203:
p.000203:
p.000203: Article 17
p.000203:
p.000203: EU declaration of conformity
p.000203:
p.000203: 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been
p.000203: fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of
p.000203: conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official
p.000203: Union language or languages required by the Member State(s) in which the device is made available.
p.000203:
p.000203: 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union
p.000203: legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the
p.000203: requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in
p.000203: respect of all Union acts applicable to the device. The declaration shall contain all the information
p.000203: required for identification of the Union legislation to which the declaration relates.
p.000203:
...
p.000204: intended purpose, shall ensure that the item does not adversely affect the safety and performance of the
p.000204: device. Supporting evidence shall be kept available for the competent authorities of the Member States.
p.000204:
p.000204: 2. An item that is intended specifically to replace a part or component of a device and that significantly changes
p.000204: the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and
p.000204: shall meet the requirements laid down in this Regulation.
p.000204:
p.000204: Article 21
p.000204:
p.000204: Free movement
p.000204:
p.000204: Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making
p.000204: available on the market or putting into service within their territory of devices which comply with the requirements of
p.000204: this Regulation.
p.000204:
p.000204: CHAPTER III
p.000204: IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF
p.000204: SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
p.000204:
p.000204: Article 22
p.000204:
p.000204: Identification within the supply chain
p.000204:
p.000204: 1. Distributors and importers shall co-operate with manufacturers or authorised representatives to
p.000204: achieve an appropriate level of traceability of devices.
p.000204:
p.000204: 5.5.2017 EN
p.000204: Official Journal of the European Union
p.000205: L 117/205
p.000205:
p.000205: 2. Economic operators shall be able to identify the following to the competent authority, for the period referred
p.000205: to in Article 10(7):
p.000205: (a) any economic operator to whom they have directly supplied a device;
p.000205: (b) any economic operator who has directly supplied them with a device;
p.000205: (c) any health institution or healthcare professional to which they have directly supplied a device.
p.000205:
p.000205: Article 23
p.000205:
p.000205: Medical devices nomenclature
p.000205:
p.000205: To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in
p.000205: Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally
p.000205: recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal
p.000205: persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that
p.000205: nomenclature is available to other stakeholders free of charge, where reasonably practicable.
p.000205:
p.000205: Article 24
p.000205:
p.000205: Unique Device Identification system
p.000205:
p.000205: 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall
p.000205: allow the identifi cation and facilitate the traceability of devices, other than devices for performance
p.000205: studies, and shall consist of the following:
p.000205: (a) production of a UDI that comprises the following:
p.000205: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to
p.000205: the information laid down in Part B of Annex VI;
p.000205: (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the
...
p.000207: representative and the importer. The details regarding the information to be provided to that electronic system by
p.000207: the economic operators are laid down in Section 1 of Part A of Annex VI.
p.000207:
p.000207: 2. Member States may maintain or introduce national provisions on registration of distributors of devices which
p.000207: have been made available on their territory.
p.000207:
p.000207: 3. Within two weeks of placing a device on the market, importers shall verify that the manufacturer or
p.000207: authorised representative has provided to the electronic system the information referred to in paragraph 1.
p.000207:
p.000207: Where applicable, importers shall inform the relevant authorised representative or manufacturer if the
p.000207: information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the
p.000207: relevant entry/entries.
p.000207:
p.000207:
p.000207: Article 28
p.000207:
p.000207: Registration of manufacturers, authorised representatives and importers
p.000207:
p.000207: 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order
p.000207: to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part
p.000207: A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the
p.000207: conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information
p.000207: referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the
p.000207: notified body.
p.000207:
p.000207: 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall
p.000207: obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and
p.000207: issue it to the manufacturer, the authorised representative or the importer.
p.000207:
p.000207: 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing
p.000207: Eudamed in order to fulfil its obligations under Article 26.
p.000207:
p.000207: 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this
p.000207: Article, the economic operator shall update the data in the electronic system referred to in Article 27.
p.000207:
p.000208: L 117/208 EN
p.000208: Official Journal of the European Union
p.000208: 5.5.2017
p.000208:
p.000208: 5. Not later than one year after submission of the information in accordance with paragraph 1, and
p.000208: every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure
p.000208: to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its
p.000208: territory until that economic operator complies with that obligation.
p.000208:
p.000208: 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify
p.000208: the confirmed data referred to in Section 1 of Part A of Annex VI.
p.000208:
p.000208: 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27
p.000208: shall be accessible to the public.
p.000208:
p.000208: 8. The competent authority may use the data to charge the manufacturer, the authorised representative
p.000208: or the importer a fee pursuant to Article 104.
p.000208:
p.000208: Article 29
p.000208:
p.000208: Summary of safety and performance
p.000208:
p.000208: 1. For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary
p.000208: of safety and performance.
p.000208:
p.000208: The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to
p.000208: the patient and shall be made available to the public via Eudamed.
p.000208:
p.000208: The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified
p.000208: body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body.
p.000208: After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall
p.000208: mention on the label or instructions for use where the summary is available.
p.000208: 2. The summary of safety and performance shall include at least the following aspects:
p.000208: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
p.000208: (b) the intended purpose of the device and any indications, contra-indications and target populations;
p.000208: (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a
p.000208: description of the differences, as well as, where relevant, a description of any accessories, other devices and
p.000208: products, which are intended to be used in combination with the device;
p.000208: (d) reference to any harmonised standards and CS applied;
...
p.000208: the advisory procedure referred to in Article 107(2).
p.000208:
p.000208: Article 30
p.000208:
p.000208: European database on medical devices
p.000208:
p.000208: 1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European
p.000208: database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by
p.000208: Articles 33 and 34 of Regulation (EU) 2017/745.
p.000208: 2. Eudamed shall include the following electronic systems:
p.000208: (a) the electronic system for registration of devices referred to in Article 26;
p.000208: (b) the UDI database referred to in Article 25;
p.000208: (c) the electronic system on registration of economic operators referred to in Article 27;
p.000208:
p.000208: 5.5.2017 EN
p.000208: Official Journal of the European Union
p.000209: L 117/209
p.000209:
p.000209: (d) the electronic system on notified bodies and on certificates referred to in Article 52;
p.000209: (e) the electronic system on performance studies referred to in Article 69,
p.000209: (f) the electronic system on vigilance and post-market surveillance referred to in Article 87;
p.000209: (g) the electronic system on market surveillance referred to in Article 95.
p.000209:
p.000209: CHAPTER IV
p.000209: NOTIFIED BODIES
p.000209:
p.000209: Article 31
p.000209:
p.000209: Authorities responsible for notified bodies
p.000209:
p.000209: 1. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated
p.000209: a notified body, to carry out conformity assessment activities under this Regulation shall appoint an
p.000209: authority (the ‘authority responsible for notified bodies’), which may consist of separate constituent
p.000209: entities under national law and shall be responsible for setting up and carrying out the necessary
p.000209: procedures for the assessment, designation and notification of conformity assessment bodies and for the
p.000209: monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.
p.000209:
p.000209: 2. The authority responsible for notified bodies shall be established, organised and operated so as
p.000209: to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with
p.000209: conformity assessment bodies.
p.000209:
p.000209: 3. The authority responsible for notified bodies shall be organised in a manner such that each
p.000209: decision relating to designation or notification is taken by personnel different from those who carried out the
p.000209: assessment.
p.000209:
p.000209: 4. The authority responsible for notified bodies shall not perform any activities that notified
p.000209: bodies perform on a commercial or competitive basis.
p.000209:
p.000209: 5. The authority responsible for notified bodies shall safeguard the confidential aspects of the information it
p.000209: obtains. However, it shall exchange information on notified bodies with other Member States, the
p.000209: Commission and, when required, with other regulatory authorities.
p.000209:
p.000209: 6. The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently
p.000209: available for the proper performance of its tasks.
p.000209:
p.000209: Where the authority responsible for notified bodies is a different authority from the national competent authority for
p.000209: in vitro diagnostic medical devices, it shall ensure that the national authority responsible for in vitro
p.000209: diagnostic medical devices is consulted on relevant matters.
p.000209:
p.000209: 7. Member States shall make publicly available general information on their measures governing the
p.000209: assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and
p.000209: on changes which have a significant impact on such tasks.
p.000209:
p.000209: 8. The authority responsible for notified bodies shall participate in peer-review activities provided for in
p.000209: Article 44.
p.000209:
p.000209:
p.000209: Article 32
p.000209:
p.000209: Requirements relating to notified bodies
p.000209:
p.000209: 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They
p.000209: shall satisfy the organisational and general requirements and the quality management, resource and process requirements
p.000209: that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII.
p.000209:
p.000209: In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent
p.000209: availability of sufficient administrative, technical and scientific personnel in accordance with Section
p.000209: 3.1.1 of Annex VII, and personnel with relevant clinical expertise in accordance with Section 3.2.4 of
p.000209: Annex VII, where possible employed by the notified body itself.
p.000209:
p.000210: L 117/210 EN
p.000210: Official Journal of the European Union
p.000210: 5.5.2017
p.000210:
p.000210: The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified
p.000210: body itself and shall not be external experts or subcontractors.
p.000210:
p.000210: 2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufac
p.000210: turer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment,
p.000210: designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this
p.000210: Chapter.
p.000210:
p.000210: 3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt
p.000210: implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical
p.000210: application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in
p.000210: Article 107(3).
p.000210:
p.000210: Article 33
p.000210:
p.000210: Subsidiaries and subcontracting
p.000210:
p.000210: 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has
p.000210: recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that
p.000210: the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the
p.000210: authority responsible for notified bodies accordingly.
p.000210:
p.000210: 2. Notified bodies shall take full responsibility for the tasks performed on their behalf by
p.000210: subcontractors or subsidiaries.
p.000210:
p.000210: 3. Notified bodies shall make publicly available a list of their subsidiaries.
p.000210:
p.000210: 4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that
p.000210: the legal or natural person that applied for conformity assessment has been informed accordingly.
p.000210:
p.000210: 5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all
p.000210: relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the
p.000210: work carried out by them under this Regulation.
p.000210:
p.000210: Article 34
p.000210:
p.000210: Application by conformity assessment bodies for designation
p.000210:
p.000210: 1. Conformity assessment bodies shall submit an application for designation to the authority responsible for
p.000210: notified bodies.
p.000210:
p.000210: 2. The application shall specify the conformity assessment activities as defined in this Regulation,
p.000210: and the types of devices for which the body is applying to be designated, and shall be supported by
p.000210: documentation demonstrating compliance with Annex VII.
p.000210:
p.000210: In respect of the organisational and general requirements and the quality management requirements set out
p.000210: in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation
p.000210: report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be
p.000210: submitted and shall be taken into consideration during the assessment described in Article 35. However,
p.000210: the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate
p.000210: compliance with those requirements upon request.
p.000210:
p.000210: 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in
p.000210: order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the
p.000210: requirements set out in Annex VII.
p.000210:
p.000210: Article 35
p.000210:
p.000210: Assessment of the application
p.000210:
p.000210: 1. The authority responsible for notified bodies shall within 30 days check that the application
p.000210: referred to in Article 34 is complete and shall request the applicant to provide any missing
p.000210: information. Once the application is complete that national authority shall send it to the Commission.
p.000210:
p.000210: 5.5.2017 EN
p.000210: Official Journal of the European Union
p.000211: L 117/211
p.000211:
p.000211: The authority responsible for notified bodies shall review the application and supporting documentation in accordance
p.000211: with its own procedures and shall draw up a preliminary assessment report.
p.000211:
p.000211: 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the
p.000211: Commission which shall immediately transmit it to the MDCG.
p.000211:
p.000211: 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction
p.000211: with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific
p.000211: circumstances require a different number of experts, chosen from the list referred to in Article 36. One of the
p.000211: experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team.
p.000211: The other two experts shall come from Member States other than the one in which the applicant conformity assessment
p.000211: body is established.
p.000211:
p.000211: The joint assessment team shall be comprised of competent experts who are competent to assess the
p.000211: conformity assessment activities and the types of devices which are the subject of the application or,
p.000211: in particular when the assessment procedure is initiated in accordance with Article 43(3) to ensure that
p.000211: the specific concern can be appropriately assessed.
p.000211:
p.000211: 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the
p.000211: application in accordance with Article 34. The joint assessment team may provide feedback to, or require clarification
p.000211: from, the authority responsible for notified bodies on the application and on the planned on-site assessment.
p.000211:
p.000211: The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site
p.000211: assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located
p.000211: inside or outside the Union, to be involved in the conformity assessment process.
p.000211:
p.000211: The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
p.000211:
p.000211: 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in
p.000211: Annex VII shall be raised during the assessment process and discussed between the authority responsible
p.000211: for notified bodies and the joint assessment team with a view to reaching consensus and resolving any
p.000211: diverging opinions, with respect to the assessment of the application.
p.000211:
p.000211: At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant
p.000211: conformity assessment body the non-compliances resulting from the assessment and summarise of the
p.000211: assessment by the joint assessment team.
p.000211:
p.000211: Within a specified timeframe, the applicant conformity assessment body shall submit to the national
p.000211: authority a corrective and preventive action plan to address the non-compliances.
p.000211:
p.000211: 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within
p.000211: 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
p.000211:
p.000211: 7. The authority responsible for notified bodies shall, following receipt of a corrective and
p.000211: preventive action plan from the applicant body, assess whether non-compliances identified during the
p.000211: assessment have been appropriately addressed. This plan shall indicate the root cause of the identified
p.000211: non-compliances and shall include a timeframe for implementation of the actions therein.
p.000211:
p.000211: The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan,
p.000211: forward it and its opinion thereon to the joint assessment team. The joint assessment team may request
p.000211: of the authority responsible for notified bodies further clarification and modifications.
p.000211:
p.000211: The authority responsible for notified bodies shall draw up its final assessment report which shall include:
p.000211: — the result of the assessment,
p.000211:
p.000211: — confirmation that the corrective and preventive actions have been appropriately addressed and, where
p.000211: required, implemented,
p.000211: — any remaining diverging opinion with the joint assessment team, and, where applicable,
p.000211: — the recommended scope of designation.
p.000211:
p.000212: L 117/212 EN
p.000212: Official Journal of the European Union
p.000212: 5.5.2017
p.000212:
p.000212: 8. The authority responsible for notified bodies shall submit its final assessment report and, if
p.000212: applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
p.000212:
p.000212: 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the
p.000212: authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those
p.000212: documents to the Commission which shall immediately submit that final opinion to the MDCG. Within 42 days
p.000212: of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with
p.000212: regard to the draft designation, which the authority responsible for notified bodies shall duly take into
p.000212: consideration for its decision on the designation of the notified body.
p.000212:
p.000212: 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000212: arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the
p.000212: assessment of the application set out in this Article. Those implementing acts shall be adopted in
p.000212: accordance with the examination procedure referred to in Article 107(3).
p.000212:
p.000212:
p.000212: Article 36
p.000212:
p.000212: Nomination of experts for joint assessment of applications for notification
p.000212:
p.000212: 1. The Member States and the Commission shall nominate experts qualified in the assessment of
p.000212: conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the
p.000212: activities referred to in Articles 35 and 44.
p.000212:
p.000212: 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article,
p.000212: together with information on their specific field of competence and expertise. That list shall be made available to
p.000212: Member States competent authorities through the electronic system referred to in Article 52.
p.000212:
p.000212:
p.000212: Article 37
p.000212:
p.000212: Language requirements
p.000212:
p.000212: All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which
p.000212: shall be determined by the Member State concerned.
p.000212:
...
p.000212: the medical field, for all or part of the documentation concerned.
p.000212:
p.000212: The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an
p.000212: official Union language, such as is necessary for that documentation to be readily understood by the joint assessment
p.000212: team appointed in accordance with Article 35(3).
p.000212:
p.000212:
p.000212: Article 38
p.000212:
p.000212: Designation and notification procedure
p.000212:
p.000212: 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35
p.000212: was completed and which comply with Annex VII.
p.000212:
p.000212: 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they
p.000212: have designated, using the electronic notification tool within the database of notified bodies developed and managed by
p.000212: the Commission (NANDO).
p.000212:
p.000212: 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope
p.000212: of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of
p.000212: devices which the notified body is authorised to assess and, without prejudice to Article 40, any
p.000212: conditions associated with the designation.
p.000212:
p.000212: 5.5.2017 EN
p.000212: Official Journal of the European Union
p.000213: L 117/213
p.000213:
p.000213: 4. The notification shall be accompanied by the final assessment report of the authority responsible
p.000213: for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and
p.000213: the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it
p.000213: shall provide a duly substantiated justification.
p.000213:
p.000213: 5. The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member
p.000213: States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in
p.000213: place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set
p.000213: out in Annex VII.
p.000213:
p.000213: 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission
p.000213: may raise written objections, setting out its arguments, with regard either to the notified body or to
p.000213: its monitoring by the authority responsible for notified bodies. Where no objection is raised, the
p.000213: Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in
p.000213: paragraph 2.
p.000213:
p.000213: 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall
p.000213: bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph
p.000213: 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter
p.000213: having been brought before it. Where the MDCG is of the opinion that the notification can be accepted,
p.000213: the Commission shall publish in NANDO the notification within 14 days.
p.000213:
p.000213: 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or
p.000213: raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40
p.000213: days of its receipt. The response shall address the objections raised in the opinion, and set out the
p.000213: reasons for the notifying Member State's decision to designate or not designate the conformity assessment body.
p.000213:
p.000213: 9. Where the notifying Member State decides to uphold its decision to designate the conformity
p.000213: assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in
p.000213: NANDO the notification within 14 days of being informed thereof.
p.000213:
...
p.000213: inter alia, on information arising from the coordination activities described in Article 44.
p.000213:
p.000213:
p.000213: Article 39
p.000213:
p.000213: Identification number and list of notified bodies
p.000213:
p.000213: 1. The Commission shall assign an identification number to each notified body for which the notification
p.000213: becomes valid in accordance with Article 38(11). It shall assign a single identification number even when
p.000213: the body is notified under several Union acts. If they are successfully designated in accordance with this
p.000213: Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them
p.000213: pursuant to that Directive.
p.000213:
p.000213: 2. The Commission shall make the list of the bodies notified under this Regulation, including the
p.000213: identification numbers that have been assigned to them and the conformity assessment activities as defined in this
p.000213: Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
p.000213: It shall also make this list available on the electronic system referred to in Article 52. The Commission shall
p.000213: ensure that the list is kept up to date.
p.000213:
p.000214: L 117/214 EN
p.000214: Official Journal of the European Union
p.000214: 5.5.2017
p.000214:
p.000214: Article 40
p.000214:
p.000214:
p.000214: Monitoring and re-assessment of notified bodies
p.000214:
p.000214:
p.000214: 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for
p.000214: notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or
p.000214: their ability to conduct the conformity assessment activities relating to the devices for which they have been
p.000214: designated.
p.000214:
p.000214: 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their
p.000214: territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and
p.000214: the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by
p.000214: their authority responsible for notified bodies, supply all relevant information and documents, required to
p.000214: enable the authority, the Commission and other Member States to verify compliance.
p.000214:
p.000214: 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the
p.000214: territory of another Member State relating to a conformity assessment carried out by that notified body,
p.000214: it shall send a copy of that request to the authority responsible for notified bodies of that other
p.000214: Member State. The notified body concerned shall respond without delay and within 15 days at the latest
p.000214: to the request. The authority responsible for notified bodies of the Member State in which the body is
p.000214: established shall ensure that requests submitted by authorities of any other Member State or by the Commission are
p.000214: resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be
p.000214: referred to the MDCG.
p.000214:
p.000214: 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether the
p.000214: notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors
p.000214: under the responsi bility of those notified bodies still satisfy the requirements and fulfil their obligations set out
p.000214: in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its
p.000214: subsidiaries and subcontractors.
p.000214:
p.000214: The authority responsible for notified bodies shall conduct its monitoring and assessment activities
p.000214: according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the
p.000214: notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the
p.000214: frequency of assessment of the notified body and, in particular, associated subsidiaries and
p.000214: subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body
p.000214: for which it is responsible to the MDCG and to the Commission.
p.000214:
p.000214: 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include observed
p.000214: audits of notified body personnel, including where necessary any personnel from subsidiaries and
p.000214: subcontractors, as that personnel in the process of conducting quality management system assessments at a
p.000214: manufacturer's facility.
p.000214:
p.000214: 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider
p.000214: data arising from market surveillance, vigilance and post-market surveillance to help guide its activities.
p.000214:
p.000214: The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and
p.000214: other information, including from other Member States, which may indicate non-fulfilment of the obligations
p.000214: by a notified body or its deviation from common or best practice.
p.000214:
p.000214: 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments
p.000214: conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify
p.000214: compliance.
p.000214:
p.000214: 8. The authority responsible for notified bodies shall review the assessments by notified bodies of
p.000214: manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in
p.000214: Article 41.
p.000214:
p.000214: 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance
p.000214: of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of
p.000214: corrective and preventive actions.
p.000214:
p.000214: 5.5.2017 EN
p.000214: Official Journal of the European Union
p.000215: L 117/215
p.000215:
p.000215: 10. Three years after notification of a notified body, and again every fourth year thereafter, a complete
p.000215: re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be
p.000215: conducted by the authority responsible for notified bodies of the Member State in which the body is established and by
p.000215: a joint assessment team appointed for the purpose of the procedure described in Articles 34 and 35.
p.000215:
p.000215: 11. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to
p.000215: amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that
p.000215: paragraph is to be carried out.
p.000215:
p.000215: 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring
p.000215: and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and
p.000215: subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to
p.000215: paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain
p.000215: a summary which shall be made publicly available.
p.000215:
p.000215: The summary of the report shall be uploaded to the electronic system referred to in Article 52.
p.000215:
p.000215:
p.000215:
p.000215: Article 41
p.000215:
p.000215:
p.000215: Review of notified body assessment of technical documentation and performance evaluation documentation
p.000215:
p.000215:
p.000215: 1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall
p.000215: review an appropriate number of notified body assessments of manufacturers' technical documentation,
p.000215: in particular the performance evaluation documentation to verify the conclusions drawn by the notified body based
p.000215: on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be
p.000215: conducted both off- site and on-site.
p.000215:
p.000215: 2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and
p.000215: representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and
p.000215: be appropriately justified and documented in a sampling plan, which shall be made available by the authority
p.000215: responsible for notified bodies to the MDCG upon request.
p.000215:
p.000215: 3. The authority responsible for notified bodies shall review whether the assessment by the notified
p.000215: body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions
p.000215: drawn by the notified body. Such checking shall include the technical documentation and performance evaluation
p.000215: documentation of the manufacturer upon which the notified body has based its assessment. Such reviews
p.000215: shall be conducted utilising CS.
p.000215:
p.000215: 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 40(10)
p.000215: and the joint assessment activities referred to in Article 43(3). The reviews shall be conducted utilising appropriate
p.000215: expertise.
p.000215:
p.000215: 5. Based on the reports of the reviews and assessments by the authority responsible for notified
p.000215: bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance
p.000215: activities described in Chapter VII, or on the continuous monitoring of technical progress, or on the identification of
p.000215: concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that
p.000215: the sampling carried out under this Article cover a greater or lesser proportion of the technical
p.000215: documentation and performance evaluation documentation assessed by a notified body.
p.000215:
p.000215: 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed
p.000215: arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and
p.000215: performance evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in
p.000215: accordance with the examination procedure referred to in Article 107(3).
p.000215:
p.000216: L 117/216 EN
p.000216: Official Journal of the European Union
p.000216: 5.5.2017
p.000216:
p.000216: Article 42
p.000216:
p.000216: Changes to designations and notifications
p.000216:
p.000216: 1. The authority responsible for notified bodies shall notify the Commission and the other Member
p.000216: States of any relevant changes to the designation of a notified body.
p.000216:
p.000216: The procedures described in Article 35 and in Article 38 shall apply to extensions of the scope of the designation.
p.000216:
p.000216: For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs
p.000216: shall apply.
p.000216:
p.000216: 2. The Commission shall immediately publish the amended notification in NANDO. The
p.000216: Commission shall immediately enter information on the changes to the designation of the notified body in the
p.000216: electronic system referred to in Article 52.
p.000216:
p.000216: 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority
p.000216: responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned
p.000216: cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine
p.000216: months after cessation of the notified body's activities on condition that another notified body has
p.000216: confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new
p.000216: notified body shall complete a full assessment of the devices affected by the end of that period before issuing new
p.000216: certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified
p.000216: bodies shall withdraw the designation.
p.000216:
p.000216: 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer
p.000216: meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has
p.000216: not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or
p.000216: partially withdraw the designation, depending on the seriousness of the failure to meet those requirements
p.000216: or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same
p.000216: period.
p.000216:
p.000216: The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of
p.000216: any suspension, restriction or withdrawal of a designation.
p.000216:
p.000216: 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the
p.000216: notified body shall inform the manufacturers concerned at the latest within 10 days.
p.000216:
p.000216: 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified
p.000216: bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them
p.000216: available to authorities in other Member States responsible for notified bodies and to authorities responsible for
p.000216: market surveillance at their request.
p.000216:
p.000216: 7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified
p.000216: bodies shall:
p.000216:
p.000216: (a) assess the impact on the certificates issued by the notified body;
p.000216:
p.000216: (b) submit a report on its findings to the Commission and the other Member States within three months
p.000216: of having notified the changes to the designation;
p.000216:
p.000216: (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority,
p.000216: any certificates which were unduly issued to ensure the safety of devices on the market;
p.000216:
p.000216: (d) enter in the electronic system referred to in Article 52 information in relation to certificates of which it has
p.000216: required their suspension or withdrawal;
p.000216:
p.000216: (e) inform the competent authority for in vitro diagnostic medical devices of the Member State in
p.000216: which the manufacturer has its registered place of business through the electronic system referred to in
p.000216: Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall
p.000216: take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or
p.000216: others.
p.000216:
p.000216: 5.5.2017 EN
p.000216: Official Journal of the European Union
p.000217: L 117/217
p.000217:
p.000217: 8. With the exception of certificates unduly issued, and where a designation has been suspended or
p.000217: restricted, the certificates shall remain valid in the following circumstances:
p.000217:
p.000217: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction,
p.000217: that there is no safety issue in relation to certificates affected by the suspension or restriction and
p.000217: the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy
p.000217: the suspension or restriction; or
p.000217:
p.000217: (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the
p.000217: suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states
p.000217: whether the notified body has the capability of continuing to monitor, and remain responsible for, existing
p.000217: certificates issued for the period of the suspension or restriction. In the event that the authority
p.000217: responsible for notified bodies determines that the notified body does not have the capability to support
p.000217: existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic
p.000217: medical devices of the Member State in which the manufacturer of the device covered by the certificate has its
p.000217: registered place of business, within three months of the suspension or restriction, a written confirmation that
p.000217: another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain
p.000217: responsible for the certificates during the period of suspension or restriction.
p.000217:
p.000217: 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates
p.000217: shall remain valid for a period of nine months in the following circumstances:
p.000217:
p.000217: (a) where the competent authority for in vitro diagnostic medical devices of the Member State
p.000217: in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed
p.000217: that there is no safety issue associated with the devices in question; and
p.000217:
p.000217: (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices
p.000217: and will have completed assessment of them within twelve months of the withdrawal of the designation.
p.000217:
p.000217: In the circumstances referred to in the first subparagraph, the national competent authority for in
p.000217: vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the
p.000217: certificate has its registered place of business may extend the provisional validity of the certificates for
p.000217: further periods of three months, which altogether shall not exceed twelve months.
p.000217:
p.000217: The authority or the notified body assuming the functions of the notified body affected by the change of
p.000217: designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
p.000217:
p.000217:
p.000217:
p.000217: Article 43
p.000217:
p.000217: Challenge to the competence of notified bodies
p.000217:
p.000217: 1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to
p.000217: its attention regarding the continued fulfilment by a notified body, or of one or more of its
p.000217: subsidiaries or subcon tractors, of the requirements set out in Annex VII or the obligations to which they are
p.000217: subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an
p.000217: opportunity to investigate those concerns.
p.000217:
p.000217: 2. The notifying Member State shall provide the Commission, on request, with all information
p.000217: regarding the designation of the notified body concerned.
p.000217:
p.000217: 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described
p.000217: in Article 35(3) and (5) where there is reasonable concern about the ongoing compliance of a notified
p.000217: body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and
p.000217: where the investi gation by the authority responsible for notified bodies is not deemed to have fully
p.000217: addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome
p.000217: of that assessment shall follow the principles of Article 35. Alternatively, depending on the severity of the issue,
p.000217: the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the
p.000217: participation of up to two experts from the list established pursuant to Article 36 in an on-site assessment as
p.000217: part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual
p.000217: assessment plan described in Article 40(4) therein.
p.000217:
p.000218: L 117/218 EN
p.000218: Official Journal of the European Union
p.000218: 5.5.2017
p.000218:
p.000218: 4. Where the Commission ascertains that a notified body no longer meets the requirements for its
p.000218: designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective
p.000218: measures, including the suspension, restriction or withdrawal of the designation if necessary.
p.000218:
p.000218: Where the Member State fails to take the necessary corrective measures, the Commission may, by means
p.000218: of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be
p.000218: adopted in accordance with the examination procedure referred to in Article 107(3). It shall notify the Member State
p.000218: concerned of its decision and update NANDO and the electronic system referred to in Article 52.
p.000218:
p.000218: 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is
p.000218: treated accordingly.
p.000218:
p.000218:
p.000218: Article 44
p.000218:
p.000218: Peer review and exchange of experience between authorities responsible for notified bodies
p.000218:
p.000218: 1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative
p.000218: practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:
p.000218: (a) development of best practice documents relating to the activities of the authorities responsible for notified
p.000218: bodies;
p.000218: (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation;
p.000218: (c) training and qualification of the experts referred to in Article 36;
p.000218: (d) monitoring of trends relating to changes to notified body designations and notifications, and trends
p.000218: in certificate withdrawals and transfers between notified bodies;
p.000218: (e) monitoring of the application and applicability of scope codes referred to in Article 38(13);
p.000218: (f) development of a mechanism for peer reviews between authorities and the Commission;
p.000218: (g) methods of communication to the public on the monitoring and surveillance activities of authorities
p.000218: and the Commission on notified bodies.
p.000218:
p.000218: 2. The authorities responsible for notified bodies shall participate in a peer review every third
p.000218: year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be
p.000218: conducted in parallel with the on-site joint assessments described in Article 35. Alternatively, a national authority
p.000218: may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40.
p.000218:
p.000218: 3. The Commission shall participate in the organisation and provide support to the implementation of
p.000218: the peer review mechanism.
p.000218:
p.000218: 4. The Commission shall compile an annual summary report of the peer review activities, which shall
p.000218: be made publicly available.
p.000218:
p.000218: 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and
p.000218: related documents for the peer review mechanisms and training and qualification as referred to in paragraph 1 of
p.000218: this Article. Those implementing acts shall be adopted in accordance with the examination procedure
p.000218: referred to in Article 107(3).
p.000218:
p.000218:
p.000218: Article 45
p.000218:
p.000218: Coordination of notified bodies
p.000218:
p.000218: The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put
p.000218: in place and operated in the form of the coordination group of notified bodies, as referred to in Article 49 of
p.000218: Regulation (EU) 2017/745.
p.000218:
p.000218: The bodies notified under this Regulation shall participate in the work of that group.
p.000218:
p.000218: 5.5.2017 EN
p.000218: Official Journal of the European Union
p.000219: L 117/219
p.000219:
p.000219: Article 46
p.000219:
p.000219: List of standard fees
p.000219:
p.000219: Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry
p.000219: out and shall make those lists publicly available.
p.000219:
p.000219: CHAPTER V
p.000219: CLASSIFICATION AND CONFORMITY ASSESSMENT
p.000219:
p.000219: Section 1
p.000219: Classif ication
p.000219:
p.000219: Article 47
p.000219:
p.000219: Classification of devices
p.000219:
p.000219: 1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices
p.000219: and their inherent risks. Classification shall be carried out in accordance with Annex VIII.
p.000219:
p.000219: 2. Any dispute between the manufacturer and the notified body concerned, arising from the application
p.000219: of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the
p.000219: manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business
p.000219: in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent
p.000219: authority of the Member State in which the authorised representative referred to in the last indent of
p.000219: point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business.
p.000219: Where the notified body concerned is established in a Member State other than that of the manufacturer, the
p.000219: competent authority shall adopt its decision after consultation with the competent authority of the Member State that
p.000219: designated the notified body.
p.000219:
p.000219: The competent authority of the Member State in which the manufacturer has its registered place of business shall notify
p.000219: the MDCG and the Commission of its decision. The decision shall be made available upon request.
p.000219:
p.000219: 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by
p.000219: means of implementing acts, on the following:
p.000219: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the
p.000219: classifi cation of such devices;
p.000219: (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific
p.000219: evidence, or based on any information which becomes available in the course of the vigilance and market surveillance
p.000219: activities be reclassified, by way of derogation from Annex VIII.
p.000219: 4. The Commission may also, on its own initiative and after consulting the MDCG, decide,
p.000219: by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3.
p.000219:
p.000219: 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific
p.000219: opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent
p.000219: necessary to resolve issues of divergent interpretation and of practical application.
p.000219:
p.000219: 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with
p.000219: the examination procedure referred to in Article 107(3).
p.000219:
p.000219: Section 2
p.000219: Conformity assessment
p.000219:
p.000219: Article 48
p.000219:
p.000219: Conformity assessment procedures
p.000219:
p.000219: 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the
p.000219: conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to
p.000219: XI.
p.000219:
p.000220: L 117/220 EN
p.000220: Official Journal of the European Union
p.000220: 5.5.2017
p.000220:
p.000220: 2. Prior to putting into service a device that is not placed on the market, with the exception of
p.000220: in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity
p.000220: of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
p.000220:
p.000220: 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to
p.000220: a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000220: testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of
p.000220: Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the
p.000220: notified body shall consult a competent authority designated by the Member States in accordance with Directive
p.000220: 2001/83/EC of the European Parliament and of the Council (1) or the EMA, as applicable, in accordance with the
p.000220: procedure set out in Section 5.2 of Annex IX.
p.000220:
p.000220: 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the
p.000220: conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment
p.000220: as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
p.000220:
p.000220: For companion diagnostics, the notified body shall in particular consult a competent authority designated
p.000220: by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the
p.000220: procedure set out in point (k) of Section 3 of Annex X.
p.000220:
p.000220: 5. In particular, and without prejudice to any of the obligations pursuant to the other procedures
p.000220: referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been
p.000220: designated in accordance with Article 100, the notified body performing the conformity assessment shall
p.000220: request one of the EU reference laboratories to verify by laboratory testing the performance claimed by
p.000220: the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen
p.000220: by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in
p.000220: Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference
p.000220: laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available
p.000220: reference materials.
p.000220:
p.000220: 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are
p.000220: available for class D devices and where it is also the first certification for that type of device,
p.000220: the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU)
p.000220: 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide
p.000220: the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the
p.000220: manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance
p.000220: with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within
p.000220: the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein.
p.000220:
p.000220: 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to
p.000220: a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the
p.000220: technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per
p.000220: generic device group.
p.000220:
p.000220: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000220: testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of
p.000220: Annex IX.
p.000220:
p.000220: In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified
p.000220: body shall for every device follow the procedure for technical documentation assessment laid down in
p.000220: Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down
p.000220: in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member
p.000220: States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out
p.000220: in Section 5.2 of Annex IX.
p.000220:
p.000220: (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000220: Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
p.000220:
p.000220: 5.5.2017 EN
p.000220: Official Journal of the European Union
p.000221: L 117/221
p.000221:
p.000221: 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the
p.000221: conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as
p.000221: specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5.
p.000221:
p.000221: For companion diagnostics the notified body shall in particular for every device consult a competent
p.000221: authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as
p.000221: applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
p.000221:
p.000221: 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to
p.000221: a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical
p.000221: documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of
p.000221: devices.
p.000221:
p.000221: In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient
p.000221: testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out
p.000221: in Section 5.1 of Annex IX.
p.000221:
p.000221: 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of
p.000221: their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical
p.000221: documen tation set out in Annexes II and III.
p.000221:
p.000221: However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures
p.000221: set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to
p.000221: establishing, securing and maintaining sterile conditions.
p.000221:
p.000221: 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.
p.000221:
p.000221: 12. The Member State in which the notified body is established may require that all or certain documents,
...
p.000222: 5.5.2017
p.000222:
p.000222: 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the
p.000222: other notified bodies of any manufacturer that withdraws its application prior to the notified body's
p.000222: decision regarding the conformity assessment.
p.000222:
p.000222: 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn
p.000222: an application with another notified body prior to the decision of that notified body and provide information about any
p.000222: previous application for the same conformity assessment that has been refused by another notified body.
p.000222:
p.000222: 4. The notified body may require any information or data from the manufacturer, which is necessary
p.000222: in order to properly conduct the chosen conformity assessment procedure.
p.000222:
p.000222: 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities
p.000222: with the highest degree of professional integrity and the requisite technical and scientific competence in
p.000222: the specific field and shall be free from all pressures and inducements, particularly financial, which
p.000222: might influence their judgement or the results of their conformity assessment activities, especially as regards
p.000222: persons or groups with an interest in the results of those activities.
p.000222:
p.000222:
p.000222: Article 50
p.000222:
p.000222: Mechanism for scrutiny of conformity assessments of class D devices
p.000222:
p.000222: 1. A notified body shall notify the competent authority of certificates it has granted for class D
p.000222: devices, with the exception of applications to supplement or renew existing certificates. Such notification
p.000222: shall take place through the electronic system referred to in Article 52 and shall include the
p.000222: instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to
p.000222: in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the
p.000222: scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and
p.000222: where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106
p.000222: of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a
p.000222: full justification shall also be included.
p.000222:
p.000222: 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further
p.000222: procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in
p.000222: accordance with to Articles 90 and 92.
p.000222:
p.000222: 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice
p.000222: from the expert panels in relation to the safety and performance of any device.
p.000222:
p.000222:
p.000222: Article 51
p.000222:
p.000222: Certificates of conformity
p.000222:
p.000222: 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official
p.000222: Union language determined by the Member State in which the notified body is established or otherwise in an
p.000222: official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out
p.000222: in Annex XII.
p.000222:
p.000222: 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application
p.000222: by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five
p.000222: years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any
p.000222: supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
p.000222:
p.000222: 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or
...
p.000223: (h) the information regarding certificates referred to in Article 51(5);
p.000223: (i) the summary of safety and performance referred to in Article 29.
p.000223:
p.000223: Article 53
p.000223:
p.000223: Voluntary change of notified body
p.000223:
p.000223: 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with
p.000223: another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the
p.000223: change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body
p.000223: and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
p.000223: (a) the date on which the certificates issued by the outgoing notified body become invalid;
p.000223: (b) the date until which the identification number of the outgoing notified body may be indicated in the
p.000223: information supplied by the manufacturer, including any promotional material;
p.000223: (c) the transfer of documents, including confidentiality aspects and property rights;
p.000223: (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to
p.000223: the incoming notified body;
p.000223: (e) the last serial number or lot number for which the outgoing notified body is responsible.
p.000223: 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date
p.000223: on which they become invalid.
p.000223:
p.000223: Article 54
p.000223:
p.000223: Derogation from the conformity assessment procedures
p.000223:
p.000223: 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified
p.000223: request, the placing on the market or putting into service, within the territory of the Member State concerned, of a
p.000223: specific device for which the procedures referred to in that Article have not been carried out but use
p.000223: of which is in the interest of public health or patient safety or health.
p.000223:
p.000224: L 117/224 EN
p.000224: Official Journal of the European Union
p.000224: 5.5.2017
p.000224:
p.000224: 2. The Member State shall inform the Commission and the other Member States of any decision to
p.000224: authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such
p.000224: authorisation is granted for use other than for a single patient.
p.000224:
p.000224: 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating
p.000224: to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of
p.000224: time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the
p.000224: territory of the Union and set the conditions under which the device may be placed on the market or
p.000224: put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to
p.000224: in Article 107(3).
p.000224:
p.000224: On duly justified imperative grounds of urgency relating to the health and safety of humans, the
p.000224: Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in
...
p.000225: well-being of the subjects participating in such performance studies are protected and prevail over all other interests
p.000225: and the data generated are scientifically valid, reliable and robust.
p.000225:
p.000225: Performance studies, including performance studies that use left-over samples, shall be conducted in
p.000225: accordance with applicable law on data protection.
p.000225:
p.000225:
p.000225: Article 58
p.000225:
p.000225: Additional requirements for certain performance studies
p.000225:
p.000225: 1. Any performance study:
p.000225: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study;
p.000225: (b) that is an interventional clinical performance study as defined in point (46) of Article 2; or
p.000225:
p.000226: L 117/226 EN
p.000226: Official Journal of the European Union
p.000226: 5.5.2017
p.000226:
p.000226: (c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the
p.000226: studies,
p.000226:
p.000226: shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised,
p.000226: conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.
p.000226:
p.000226: 2. Performance studies involving companion diagnostics shall be subject to the same
p.000226: requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving
p.000226: companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority.
p.000226:
p.000226: 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by
p.000226: an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by
p.000226: ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application
p.000226: for auth orisation of a performance study. At least one lay person shall participate in the ethical review.
p.000226:
p.000226: 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a
p.000226: natural or legal person is established in the Union as its legal representative. Such legal representative shall be
p.000226: responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation. Any
p.000226: communication with that legal representative shall be deemed to be a communication with the sponsor.
p.000226:
p.000226: Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their
p.000226: territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor
p.000226: establishes at least a contact person on their territory in respect of that performance study who shall
p.000226: be the addressee for all communications with the sponsor provided for in this Regulation.
p.000226:
...
p.000240: (g) when relevant, to contribute to the post-market surveillance of other devices; and
p.000240: (h) to detect and report trends in accordance with Article 83. The technical documentation shall be updated
p.000240: accordingly.
p.000240: 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is
p.000240: identified, the manufacturer shall implement the appropriate measures and inform the competent authorities
p.000240: concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety
p.000240: corrective action is implemented, it shall be reported in accordance with Article 82.
p.000240:
p.000240:
p.000240: Article 79
p.000240:
p.000240: Post-market surveillance plan
p.000240:
p.000240: The post-market surveillance system referred to in Article 78 shall be based on a post-market
p.000240: surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market
p.000240: surveillance plan shall be part of the technical documentation specified in Annex II.
p.000240:
p.000240:
p.000240: Article 80
p.000240:
p.000240: Post-market surveillance report
p.000240:
p.000240: Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the
p.000240: results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market
p.000240: surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective
p.000240: actions taken. The report shall be updated when necessary and made available to the notified body and
p.000240: the competent authority upon request.
p.000240:
p.000240: 5.5.2017 EN
p.000240: Official Journal of the European Union
p.000241: L 117/241
p.000241:
p.000241: Article 81
p.000241:
p.000241: Periodic safety update report
p.000241:
p.000241: 1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each
p.000241: device and where relevant for each category or group of devices summarising the results and conclusions of the analyses
p.000241: of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article
p.000241: 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime
p.000241: of the device concerned, that PSUR shall set out:
p.000241: (a) the conclusions of the benefit-risk determination;
p.000241: (b) the main findings of the PMPF; and
p.000241: (c) the volume of sales of the device and an estimate of the size and other characteristics of the population using
p.000241: the device and, where practicable, the usage frequency of the device.
p.000241: Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the
p.000241: technical documentation as specified in Annexes II and III.
p.000241:
p.000241: 2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87
p.000241: to the notified body involved in the conformity assessment of such devices in accordance with Article
p.000241: 48. The notified body shall review the report and add its evaluation to that electronic system with details of any
...
p.000241: state of health the report shall be provided immediately after the manufacturer has established or as soon as it
p.000241: suspects a causal relationship between the device and the serious incident but not later than 10 days
p.000241: after the date on which the manufacturer becomes aware of the serious incident.
p.000241:
p.000242: L 117/242 EN
p.000242: Official Journal of the European Union
p.000242: 5.5.2017
p.000242:
p.000242: 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is
p.000242: incomplete followed up by a complete report.
p.000242:
p.000242: 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about
p.000242: whether the incident is reportable, it shall nevertheless submit a report within the timeframe required
p.000242: in accordance with paragraphs 2 to 5.
p.000242:
p.000242: 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action
p.000242: immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in
p.000242: point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
p.000242:
p.000242: 9. For similar serious incidents that occur with the same device or device type and for which the root cause has
p.000242: been identified or a field safety corrective action implemented or where the incidents are common and well documented,
p.000242: the manufacturer may provide periodic summary reports instead of individual serious incident reports, on
p.000242: condition that the coordinating competent authority referred to in Article 84(9), in consultation with the
p.000242: competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the
p.000242: manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent
p.000242: authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary
p.000242: reports following agreement with that competent authority.
p.000242:
p.000242: 10. The Member States shall take appropriate measures such as organising targeted information
p.000242: campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent
p.000242: authorities suspected serious incidents referred to in point (a) of paragraph 1.
p.000242:
p.000242: The competent authorities shall record centrally at national level reports they receive from healthcare
p.000242: professionals, users and patients.
p.000242:
p.000242: 11. Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to
p.000242: in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to
p.000242: ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
p.000242:
p.000242: Where the manufacturer of the device concerned considers that the incident is a serious incident, it
p.000242: shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent
p.000242: authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action
p.000242: in accordance with Article 84.
p.000242:
p.000242: Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be
p.000242: treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to
p.000242: Article 83, it shall provide an explanatory statement. If the competent authority does not agree with the
p.000242: conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with
p.000242: paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance
p.000242: with Article 84.
p.000242:
p.000242:
p.000242: Article 83
p.000242:
p.000242: Trend reporting
p.000242:
p.000242: 1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically
p.000242: significant increase in the frequency or severity of incidents that are not serious incidents that could have a
p.000242: significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may
p.000242: lead to unacceptable risks to the health or safety of patients, users or other persons or of any
p.000242: significant increase in expected erroneous results established in comparison to the stated performance of the
p.000242: device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and
p.000242: product information.
p.000242:
p.000242: The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology
p.000242: used for determining any statistically significant increase in the frequency or severity of such events
p.000242: or change in performance, as well as the observation period, in the post-market surveillance plan referred to in
p.000242: Article 79.
p.000242:
p.000242: 5.5.2017 EN
p.000242: Official Journal of the European Union
p.000243: L 117/243
p.000243:
p.000243: 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and
p.000243: require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to
p.000243: ensure the protection of public health and patient safety. Each competent authority shall inform the
p.000243: Commission, the other competent authorities and the notified body that issued the certificate, of the
p.000243: results of such assessment and of the adoption of such measures.
p.000243:
p.000243:
p.000243:
p.000243: Article 84
p.000243:
p.000243: Analysis of serious incidents and field safety corrective actions
p.000243:
p.000243: 1. Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall,
p.000243: without delay, perform the necessary investigations in relation to the serious incident and the devices concerned.
p.000243: This shall include risk assessment of the incident and field safety corrective action taking into account the criteria
p.000243: as referred to in paragraph 3 of this Article as appropriate.
p.000243:
p.000243: The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned
p.000243: during the investigations referred to in the first subparagraph and shall not perform any investigation
p.000243: which involves altering the device or a sample of the batch concerned in a way which may affect any
p.000243: subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
p.000243:
p.000243: 2. Member States shall take the necessary steps to ensure that any information regarding a serious incident that
p.000243: has occurred within their territory, or a field safety corrective action that has been or is to be
p.000243: undertaken within their territory, and that is brought to their knowledge in accordance with Article 82 is evaluated
p.000243: centrally at national level by their competent authority, if possible together with the manufacturer, and, where
p.000243: relevant, the notified body concerned.
p.000243:
p.000243: 3. In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks
p.000243: arising from the reported serious incident and evaluate any field safety corrective actions, taking into account the
p.000243: protection of public health and criteria such as causality, detectability and probability of recurrence of the problem,
p.000243: frequency of use of the device, probability of occurrence of direct or indirect harm, the severity of that harm, the
p.000243: clinical benefit of the device, intended and potential users, and the population affected. The competent
p.000243: authority shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the
p.000243: manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the
p.000243: principle of inherent safety contained in Annex I.
p.000243:
p.000243: Upon request by the national competent authority, manufacturers shall provide for all documents necessary for the risk
p.000243: assessment.
p.000243:
p.000243: 4. The competent authority shall monitor the manufacturer's investigation of a serious incident. Where
p.000243: necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent
p.000243: investigation.
p.000243:
p.000243: 5. The manufacturer shall provide a final report to the competent authority setting out its findings from the
p.000243: investi gation by means of the electronic system referred to in Article 87. The report shall set out
p.000243: conclusions and where relevant indicate corrective actions to be taken.
p.000243:
p.000243: 6. In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority
p.000243: referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member
p.000243: State that authorised the medicinal products or the EMA was consulted by the notified body in accordance
p.000243: with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent
p.000243: authority or the EMA, as appropriate.
p.000243:
p.000243: 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating
p.000243: competent authority shall, through the electronic system referred to in Article 87, inform without delay
p.000243: the other competent authorities of the corrective action taken or envisaged by the manufacturer or
p.000243: required of it to minimise the risk of recurrence of the serious incident, including information on the
p.000243: underlying serious incidents and the outcome of its assessment.
p.000243:
p.000244: L 117/244 EN
p.000244: Official Journal of the European Union
p.000244: 5.5.2017
p.000244:
p.000244: 8. The manufacturer shall ensure that information about the field safety corrective action taken is
p.000244: brought without delay to the attention of users of the device in question by means of a field safety notice. The field
p.000244: safety notice shall be edited in an official Union language or languages determined by the Member State in which the
p.000244: field safety corrective action is taken. Except in cases of urgency, the content of the draft field
p.000244: safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph
p.000244: 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of
p.000244: the individual Member State, the content of the field safety notice shall be consistent in all Member States.
p.000244:
p.000244: The field safety notice shall allow the correct identification of the device or devices involved, in particular by
p.000244: including the relevant UDIs, and the correct identification, in particular by including the SRN, if
p.000244: already issued, of the manufacturer that has undertaken the field safety corrective action. The field
p.000244: safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for
p.000244: the field safety corrective action with reference to the device malfunction and associated risks for patients,
p.000244: users or other persons and shall clearly indicate all the actions to be taken by users.
p.000244:
p.000244: The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which
p.000244: that notice shall be accessible to the public.
p.000244:
p.000244: 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments
p.000244: referred to in paragraph 3 in the following cases:
p.000244:
p.000244: (a) where there is concern regarding a particular serious incident or cluster of serious incidents
p.000244: relating to the same device or type of device of the same manufacturer in more than one Member State;
p.000244:
p.000244: (b) where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one
p.000244: Member State is in question.
p.000244: That coordinated procedure shall cover the following:
p.000244: — designation of a coordinating competent authority on a case by case basis, when required;
p.000244:
p.000244: — defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent
p.000244: authority and the involvement of other competent authorities.
p.000244:
p.000244: Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be
p.000244: the competent authority of the Member State in which the manufacturer has its registered place of business.
p.000244:
p.000244: The coordinating competent authority shall, through the electronic system referred to in Article 87,
p.000244: inform the manufacturer, the other competent authorities and the Commission that it has assumed the role
p.000244: of coordinating authority.
p.000244:
p.000244: 10. The designation of a coordinating competent authority shall not affect the rights of the other
p.000244: competent authorities to perform their own assessment and to adopt measures in accordance with this
p.000244: Regulation in order to ensure the protection of public health and patient safety. The coordinating
p.000244: competent authority and the Commission shall be kept informed of the outcome of any such assessment and the
p.000244: adoption of any such measures.
p.000244:
p.000244: 11. The Commission shall provide administrative support to the coordinating competent
p.000244: authority in the accomplishment of its tasks under this Chapter.
p.000244:
p.000244:
p.000244: Article 85
p.000244:
p.000244: Analysis of vigilance data
p.000244:
p.000244: The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor
p.000244: the data available in the electronic system referred to in Article 87, in order to identify trends, patterns or signals
p.000244: in the data that may reveal new risks or safety concerns.
p.000244:
p.000244: Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely
p.000244: changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating
p.000244: competent authority shall inform the manufacturer, or where applicable the authorised representative, which
p.000244: shall then take the necessary corrective actions.
p.000244:
p.000244: 5.5.2017 EN
p.000244: Official Journal of the European Union
p.000245: L 117/245
p.000245:
p.000245: Article 86
p.000245:
p.000245: Implementing acts
p.000245:
p.000245: The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the
p.000245: detailed arrangements and procedural aspects necessary for the implementation of Articles 80 to 85 and 87
p.000245: as regards the following:
p.000245: (a) the typology of serious incidents and field safety corrective actions in relation to specific devices,
p.000245: or categories or groups of devices;
p.000245: (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and
p.000245: the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers
p.000245: as referred to in Articles 80, 81, 82, 83 and 84 respectively;
p.000245: (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting
p.000245: of suspected serious incidents by healthcare professionals, users and patients;
p.000245: (d) timelines for the reporting of field safety corrective actions, and for the provision by
p.000245: manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be
p.000245: reported as referred to in Article 82;
p.000245: (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 84;
p.000245: (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process,
p.000245: including tasks and responsibilities of the coordinating competent authority and involvement of other competent
p.000245: authorities in this process.
p.000245:
p.000245: The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure
p.000245: referred to in Article 107(3).
p.000245:
p.000245:
p.000245: Article 87
p.000245:
p.000245: Electronic system on vigilance and post-market surveillance
p.000245:
p.000245: 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to
p.000245: collate and process the following information:
p.000245: (a) reports by manufacturers on serious incidents and field safety corrective actions referred to in
p.000245: Article 82(1) and Article 84(5);
p.000245: (b) the periodic summary reports by manufacturers referred to in Article 82(9);
p.000245: (c) the reports by manufacturers on trends referred to in Article 83;
p.000245: (d) the PSURs referred to in Article 81;
p.000245: (e) the field safety notices by manufacturers referred to in Article 84(8);
p.000245: (f) the information to be exchanged between the competent authorities of the Member States and between
p.000245: them and the Commission in accordance with Article 84(7) and (9).
p.000245: That electronic system shall include relevant links to the UDI database.
p.000245:
p.000245: 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic
p.000245: system to the competent authorities of the Member States and to the Commission. The notified bodies shall also
p.000245: have access to that information to the extent that it relates to devices for which they issued a certificate in
p.000245: accordance with Article 49.
p.000245:
p.000245: 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to
p.000245: the electronic system referred to in paragraph 1.
p.000245:
p.000245: 4. On the basis of arrangements between the Commission and competent authorities of third countries or internat
p.000245: ional organisations, the Commission may grant those competent authorities or international organisations access to the
p.000245: electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity
p.000245: and make provision for confidentiality and data protection equivalent to those applicable in the Union.
p.000245:
p.000246: L 117/246 EN
p.000246: Official Journal of the European Union
p.000246: 5.5.2017
p.000246:
p.000246: 5. The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted,
p.000246: upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the
p.000246: Member State in which the incident occurred.
p.000246:
p.000246: 6. The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt
p.000246: via the electronic system referred to in paragraph 1 of this Article to the competent authorities of
p.000246: the Member States in which the incidents occurred.
p.000246:
p.000246: 7. The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall
p.000246: be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the
p.000246: competent authorities of the following Member States:
p.000246: (a) the Member State in which the field safety corrective action is being or is to be undertaken;
p.000246: (b) the Member State in which the manufacturer has its registered place of business.
p.000246: 8. The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via
p.000246: the electronic system referred to in paragraph 1 of this Article to the competent authority of:
p.000246:
p.000246: (a) the Member State or Member States participating in the coordination procedure in accordance with
p.000246: Article 84(9) and which have agreed on the periodic summary report;
p.000246: (b) the Member State in which the manufacturer has its registered place of business.
p.000246: 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon
p.000246: receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued
p.000246: the certificate for the device in question in accordance with Article 51.
p.000246:
p.000246: Section 3
p.000246: Market sur veillance
p.000246:
p.000246: Article 88
p.000246:
p.000246: Market surveillance activities
p.000246:
p.000246: 1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of
p.000246: devices including, where appropriate, a review of documentation and physical or laboratory checks on the
p.000246: basis of adequate samples. The competent authorities shall, in particular, take account of established
p.000246: principles regarding risk assessment and risk management, vigilance data and complaints.
p.000246:
p.000246: 2. The competent authorities shall draw up annual surveillance activity plans and allocate a
p.000246: sufficient number of material and competent human resources in order to carry out those activities taking into
p.000246: account the European market surveillance programme developed by the MDCG pursuant to Article 99 and local
p.000246: circumstances.
p.000246:
p.000246: 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
p.000246: (a) may require economic operators to, inter alia, make available the documentation and information necessary for
p.000246: the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of
p.000246: devices or access to devices free of charge; and
p.000246: (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators,
p.000246: as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
p.000246:
p.000246: 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and
p.000246: make it accessible to other competent authorities by means of the electronic system referred to in Article 95.
p.000246:
p.000246: 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that
p.000246: present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the
p.000246: protection of public health.
p.000246:
p.000246: 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority
p.000246: shall draw up a report on the findings of the inspection that concern compliance with the legal and technical
p.000246: requirements applicable under this Regulation. The report shall set out any corrective actions needed.
p.000246:
p.000246: 5.5.2017 EN
p.000246: Official Journal of the European Union
p.000247: L 117/247
p.000247:
p.000247: 7. The competent authority which carried out the inspection shall communicate the content of the report referred
p.000247: to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting
p.000247: the final report, the competent authority shall give that economic operator the opportunity to submit comments. That
p.000247: final inspection report shall be entered in the electronic system provided for in Article 95.
p.000247:
p.000247: 8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews
p.000247: and assessments shall be carried out at least every four years and the results thereof shall be
p.000247: communicated to the other Member States and the Commission. Each Member State shall make a summary of the results
p.000247: accessible to the public by means of the electronic system referred to in Article 95.
p.000247:
p.000247: 9. The competent authorities of the Member States shall coordinate their market surveillance
p.000247: activities, cooperate with each other and share with each other and with the Commission the results thereof, to
p.000247: provide for a harmonised and high level of market surveillance in all Member States.
p.000247:
p.000247: Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint
p.000247: market surveillance activities and specialisation.
p.000247:
p.000247: 10. Where more than one authority in a Member State is responsible for market surveillance and
p.000247: external border controls, those authorities shall cooperate with each other, by sharing information relevant to their
p.000247: role and functions.
p.000247:
p.000247: 11. Where appropriate, the competent authorities of the Member States shall cooperate with the
p.000247: competent authorities of third countries with a view to exchanging information and technical support and
p.000247: promoting activities relating to market surveillance.
p.000247:
p.000247:
p.000247: Article 89
p.000247:
p.000247: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
p.000247:
p.000247: Where the competent authorities of a Member State, based on data obtained by vigilance or market
p.000247: surveillance activities or on other information, have reason to believe that a device:
p.000247:
p.000247: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or to other
p.000247: aspects of the protection of public health; or
p.000247: (b) otherwise does not comply with the requirements laid down in this Regulation,
p.000247:
p.000247: they shall carry out an evaluation of the device concerned covering all requirements laid down in this
p.000247: Regulation relating to the risk presented by the device or to any other non-compliance of the device.
p.000247: The relevant economic operators shall cooperate with the competent authorities.
p.000247:
p.000247:
p.000247: Article 90
p.000247:
...
p.000249: assess the national measures taken. The Commission may decide, by means of implementing acts, whether the national
p.000249: measures are justified or not. In the absence of a Commission decision within six months of their
p.000249: notification, the national measures shall be considered to be justified. Those implementing acts shall be adopted in
p.000249: accordance with the examination procedure referred to in Article 107(3).
p.000249:
p.000249: 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making
p.000249: available on the market or putting into service of a device, specific category or group of devices should be
p.000249: prohibited, restricted or made subject to particular requirements or that such device or category or group of
p.000249: devices should be withdrawn from the market or recalled in all Member States in order to protect the health and
p.000249: safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing
p.000249: acts) to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance
p.000249: with the examination procedure referred to in Article 107(3).
p.000249:
p.000249:
p.000249: Article 94
p.000249:
p.000249: Good administrative practice
p.000249:
p.000249: 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state
p.000249: the exact grounds on which it is based. Where such a measure is addressed to a specific economic
p.000249: operator, the competent authority shall notify without delay the economic operator concerned of that measure, and
p.000249: shall at the same time inform that economic operator of the remedies available under the law or the
p.000249: administrative practice of the Member State concerned and of the time limits to which such remedies are subject.
p.000249: Where the measure is of general ap plicability, it shall be appropriately published.
p.000249:
p.000250: L 117/250 EN
p.000250: Official Journal of the European Union
p.000250: 5.5.2017
p.000250:
p.000250: 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human health
p.000250: or safety, the economic operator concerned shall be given the opportunity to make submissions to the
p.000250: competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
p.000250:
p.000250: Where action has been taken without the economic operator having had the opportunity to make submissions
p.000250: as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible
p.000250: and the action taken shall be reviewed promptly thereafter.
p.000250:
p.000250: 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that
p.000250: it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation.
p.000250:
p.000250: 4. Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified
p.000250: body has been involved in the conformity assessment, the competent authorities shall by means of the electronic
p.000250: system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body
p.000250: of the measure taken.
p.000250:
p.000250: Article 95
p.000250:
p.000250: Electronic system on market surveillance
p.000250:
p.000250: 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to
p.000250: collate and process the following information:
p.000250: (a) summaries of the results of the surveillance activities referred to in Article 88(4);
p.000250: (b) the final inspection report as referred to in Article 88(7);
p.000250: (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article
p.000250: 90(2),
p.000250: (4) and (6);
p.000250: (d) information in relation to non-compliance of products as referred to in Article 92(2);
p.000250: (e) information in relation to the preventive health protection measures referred to in Article 93(2);
p.000250: (f) summaries of the results of the reviews and assessments of the market surveillance activities of the Member
p.000250: States referred to in Article 88(8).
p.000250: 2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the
p.000250: electronic system to all competent authorities concerned and, where applicable, to the notified body that
p.000250: issued a certificate in accordance with Article 51 for the device concerned and be accessible to the Member States
p.000250: and to the Commission.
p.000250:
p.000250: 3. Information exchanged between Member States shall not be made public where to do so might impair
p.000250: market surveillance activities and co-operation between Member States.
p.000250:
p.000250: CHAPTER VIII
p.000250: COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
p.000250:
p.000250: Article 96
p.000250:
p.000250: Competent authorities
p.000250:
p.000250: The Member States shall designate the competent authority or authorities responsible for the
p.000250: implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and
p.000250: knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States
p.000250: shall communicate the names and contact details of the competent authorities to the Commission which shall publish
p.000250: a list of competent authorities.
p.000250:
p.000250: Article 97
p.000250:
p.000250: Cooperation
p.000250:
p.000250: 1. The competent authorities of the Member States shall cooperate with each other and with the Commission. The
p.000250: Commission shall provide for the organisation of exchanges of information necessary to enable this
p.000250: Regulation to be applied uniformly.
p.000250:
p.000250: 5.5.2017 EN
p.000250: Official Journal of the European Union
p.000251: L 117/251
p.000251:
p.000251: 2. Member States shall with the support of the Commission participate, where appropriate, in initiatives developed
p.000251: at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical
p.000251: devices.
p.000251:
p.000251: Article 98
p.000251:
p.000251: Medical Device Coordination Group
p.000251:
p.000251: The Medical Device Coordination Group (MDCG) established in accordance with the conditions and
p.000251: detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support
p.000251: of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this
p.000251: Regulation as well as those under Regulation (EU) 2017/745.
p.000251:
p.000251: Article 99
p.000251:
p.000251: Tasks of the MDCG
p.000251:
...
p.000253: and databanks for specific types of devices setting common principles to collect comparable information. Such registers
p.000253: and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices.
p.000253:
p.000253: CHAPTER IX
p.000253: CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
p.000253:
p.000253: Article 102
p.000253:
p.000253: Confidentiality
p.000253:
p.000253: 1. Unless otherwise provided for in this Regulation and without prejudice to existing national
p.000253: provisions and practices in the Member States on confidentiality, all parties involved in the application of this
p.000253: Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to
p.000253: protect the following:
p.000253: (a) personal data in accordance with Article 103;
p.000253: (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual
p.000253: property rights unless disclosure is in the public interest;
p.000253: (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or
p.000253: audits.
p.000253:
p.000254: L 117/254 EN
p.000254: Official Journal of the European Union
p.000254: 5.5.2017
p.000254:
p.000254: 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities
p.000254: and between competent authorities and the Commission shall not be disclosed without the prior agreement
p.000254: of the originating authority.
p.000254:
p.000254: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States
p.000254: and notified bodies with regard to exchange of information and the dissemination of warnings, nor the
p.000254: obligations of the persons concerned to provide information under criminal law.
p.000254:
p.000254: 4. The Commission and Member States may exchange confidential information with regulatory authorities
p.000254: of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
p.000254:
p.000254: Article 103
p.000254:
p.000254: Data protection
p.000254:
p.000254: 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member
p.000254: States pursuant to this Regulation.
p.000254:
p.000254: 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the
p.000254: Commission pursuant to this Regulation.
p.000254:
p.000254: Article 104
p.000254:
p.000254: Levying of fees
p.000254:
p.000254: 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities
p.000254: set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of
p.000254: cost-recovery principles.
p.000254:
p.000254: 2. Member States shall inform the Commission and the other Member States at least three months
p.000254: before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly
p.000254: available on request.
p.000254:
p.000254: Article 105
p.000254:
...
p.000270: of specimen) that may affect the performance of the device;
p.000270:
p.000270: (ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and
p.000270: the consumables used with it, if any. This information shall cover, where appropriate:
p.000270:
p.000270: (i) infection or microbial hazards, such as consumables contaminated with potentially infectious
p.000270: substances of human origin;
p.000270:
p.000270: (ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of
p.000270: radiation);
p.000270: (iii) physical hazards such as explosion.
p.000270:
p.000270: (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of
p.000270: its registered place of business at which he can be contacted and its location be established, together
p.000270: with a telephone number and/or fax number and/or website address to obtain technical assistance;
p.000270:
p.000270: 5.5.2017 EN
p.000270: Official Journal of the European Union
p.000271: L 117/271
p.000271:
p.000271: (ae) date of issue of the instructions for use or, if they have been revised, date of issue and
p.000271: identifier of the latest revision of the instructions for use, with a clear indication of the introduced
p.000271: modifications;
p.000271:
p.000271: (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to
p.000271: the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
p.000271:
p.000271: (ag) where device kits include individual reagents and articles that may be made available as separate devices,
p.000271: each of these devices shall comply with the instructions for use requirements contained in this Section and with the
p.000271: requirements of this Regulation;
p.000271:
p.000271: (ah) for devices that incorporate electronic programmable systems, including software, or software that
p.000271: are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT
p.000271: security measures, including protection against unauthorised access, necessary to run the software as
p.000271: intended.
p.000271:
p.000271: 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the
p.000271: following principles:
p.000271:
p.000271: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection
p.000271: and/or preparation and information on how to run the test and interpret the results;
p.000271:
p.000271: (b) specific particulars may be omitted provided that the other information supplied by the manufacturer
p.000271: is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
p.000271:
p.000271: (c) the device's intended purpose shall provide sufficient information to enable the user to understand
p.000271: the medical context and to allow the intended user to make a correct interpretation of the results;
p.000271: (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
...
p.000287: status shall be fully documented. Such documentation shall include information about ownership and the legal
p.000287: or natural persons exercising control over the notified body.
p.000287:
p.000287: 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that
p.000287: organisation as well as its organisational structure and governance, and the relationship with the notified
p.000287: body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both
p.000287: the notified body and the organisation to which it belongs.
p.000287:
p.000287: 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country
p.000287: or is owned by another legal entity, the activities and responsibilities of those entities, as well as
p.000287: their legal and operational relationships with the notified body, shall be clearly defined and documented.
p.000287: Personnel of those entities performing conformity assessment activities under this Regulation shall be
p.000287: subject to the applicable requirements of this Regulation.
p.000287:
p.000287: 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified
p.000287: body shall be such that they ensure that there is confidence in the performance by the notified body and in the
p.000287: results of the conformity assessment activities it conducts.
p.000287:
p.000287: 1.1.5. The notified body shall clearly document its organisational structure and the functions,
p.000287: responsibilities and authority of its top-level management and of other personnel who may have an influence upon the
p.000287: performance by the notified body upon the results of its conformity assessment activities.
p.000287:
p.000287: 1.1.6. The notified body shall identify the persons in top-level management that have overall authority
p.000287: and responsi bility for each of the following:
p.000287:
p.000287: (a) provision of adequate resources for conformity assessment activities;
p.000287:
p.000287: (b) development of procedures and policies for the operation of the notified body;
p.000287:
p.000287: (c) supervision of implementation of the procedures, policies and quality management systems of the
p.000287: notified body;
p.000287:
p.000287: (d) supervision of the notified body's finances;
p.000287:
p.000287: (e) activities and decisions taken by the notified body, including contractual agreements;
p.000287:
p.000287: (f) delegation of authority to personnel and/or committees, where necessary, for the performance of
p.000287: defined activities;
p.000287:
p.000287: (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with
p.000287: other competent authorities, the Commission and other notified bodies.
p.000287:
p.000287: 1.2. Independence and impartiality
p.000287:
p.000287: 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation
p.000287: to which it performs conformity assessment activities. The notified body shall also be independent of any
p.000287: other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does
p.000287: not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
p.000287:
p.000288: L 117/288 EN
p.000288: Official Journal of the European Union
p.000288: 5.5.2017
p.000288:
p.000288: 1.2.2. The notified body shall be organised and operated so as to safeguard the independence,
p.000288: objectivity and impartiality of its activities. The notified body shall document and implement a structure
p.000288: and procedures for safeguarding impartiality and for promoting and applying the principles of
p.000288: impartiality throughout its organisation, personnel and assessment activities. Such procedures shall
p.000288: provide for the identification, investi gation and resolution of any case in which a conflict of interest may
p.000288: arise including involvement in consultancy services in the field of devices prior to taking up employment with the
p.000288: notified body. The investigation, outcome and its resolution shall be documented.
p.000288:
...
p.000288: marketing or maintenance of the devices or processes under assessment; and
p.000288:
p.000288: (e) be linked to any organisation which itself provides consultancy services as referred to in the point (d). Such
p.000288: restriction shall not preclude general training activities that are not client specific and that relate to regulation
p.000288: of devices s or to related standards.
p.000288:
p.000288: 1.2.4. Involvement in consultancy services in the field of devices prior to taking up employment with a notified body
p.000288: shall be fully documented at the time of employment, and potential conflicts of interests shall be monitored and
p.000288: resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided
p.000288: consultancy services in the field of devices to that specific client prior to taking up employment with a notified
p.000288: body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the
p.000288: same group for a period of three years.
p.000288:
p.000288: 1.2.5. The impartiality of notified bodies, of their top-level management and of the assessment personnel
p.000288: shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a
p.000288: notified body and subcontractors involved in assessment activities shall not depend on the results of the
p.000288: assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management.
p.000288:
p.000288: 1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conflict of
p.000288: interests shall be ensured and documented between, on the one hand, the authority responsible for notified bodies
p.000288: and/or the competent authority and, on the other hand, the notified body.
p.000288:
p.000288: 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or
p.000288: subcontractors or of any associated body, including the activities of its owners do not affect its
p.000288: independence, impartiality or the objectivity of its conformity assessment activities.
p.000288:
p.000288: 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and
p.000288: conditions, taking into account the interests of small and medium-sized enterprises as defined in
p.000288: Recommendation 2003/361/EC in relation to fees.
p.000288:
p.000288: 1.2.9. The requirements laid down in this Section shall in no way preclude exchanges of technical
p.000288: information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
p.000288:
p.000288: 5.5.2017 EN
p.000288: Official Journal of the European Union
p.000289: L 117/289
p.000289:
p.000289: 1.3. Confidentiality
p.000289:
p.000289: 1.3.1. The notified body shall have documented procedures in place ensuring that its
p.000289: personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect
p.000289: the confidentiality of the information which comes into its possession during the performance of the conformity
p.000289: assessment activities, except when disclosure is required by law.
p.000289:
p.000289: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
p.000289: under this Regulation or any provision of national law giving effect to it, except in relation to the authorities
...
p.000293: activities have been appropriately carried out.
p.000293:
p.000293: 3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be
p.000293: employed by the notified body itself and shall not be external experts or be subcontracted. Those
p.000293: personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following:
p.000293: — devices legislation and relevant guidance documents;
p.000293: — device conformity assessments relevant to this Regulation;
p.000293: — the types of qualifications, experience and expertise relevant to device conformity assessment;
p.000293:
p.000293: — a broad base of knowledge of device technologies, including sufficient experience of the conformity
p.000293: assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
p.000293: — the notified body's quality system, related procedures and the required qualifications for personnel involved;
p.000293:
p.000293: — the ability to draw up records and reports demonstrating that the conformity assessment activities have been
p.000293: appropriately carried out.
p.000293:
p.000293: 3.3. Documentation of qualification, training and authorisation of personnel
p.000293:
p.000293: 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each
p.000293: member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria
p.000293: referred to in Section 3.2. Where, in exceptional circumstances, the fulfilment of the qualification criteria set out
p.000293: in Section
p.000293: 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the
p.000293: authorisation of those members of personnel to carry out specific conformity assessment activities.
p.000293:
p.000293: 3.3.2. For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain
p.000293: up to date:
p.000293:
p.000293: — a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment
p.000293: activities;
p.000293:
p.000293: — records attesting to the required knowledge and experience for the conformity assessment activity for which they
p.000293: are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the
p.000293: assessment personnel and records of the conformity assessment activities carried out by each of them.
p.000293:
p.000293: 3.4. Subcontractors and external experts
p.000293:
p.000293: 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined
p.000293: component parts of a conformity assessment activity.
p.000293:
p.000293: The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be
p.000293: permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts
p.000293: working on behalf of the notified body. The notified body in question shall retain full responsibility for being able
p.000293: to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific
p.000293: tasks, for making a decision based on a subcontractor's assessment and for the work conducted by
p.000293: subcontractors and experts on its behalf.
p.000293: The following activities may not be subcontracted by notified bodies:
...
p.000299:
p.000299: — the performance studies,
p.000299:
p.000299: — post-market surveillance and post-market performance follow up,
p.000299:
p.000299: — validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability
p.000299: and conclusions data from equivalent and similar devices,
p.000299:
p.000299: — the performance evaluation report,
p.000299:
p.000299: — justifications in relation to non-performance of performance studies or PMPF.
p.000299:
p.000299: In relation to data from performance studies included within the performance evaluation, the notified
p.000299: body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of
p.000299: the approved performance study plan.
p.000299:
p.000299: The notified body shall ensure that the performance evaluation adequately addresses the relevant safety
p.000299: and performance requirements provided for in Annex I, that it is appropriately aligned with the risk
p.000299: management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected
p.000299: in the information provided relating to the device.
p.000299:
p.000299:
p.000299: 4.5.5. Specific Procedures
p.000299:
p.000299: The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to
p.000299: in Section 5 of Annex IX, for which they are designated.
p.000299:
p.000299: In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil
p.000299: the requirements of this Regulation in relation to consultation of the EMA or a medicinal products
p.000299: competent authority during its assessment of such types of device.
p.000299:
p.000300: L 117/300 EN
p.000300: Official Journal of the European Union
p.000300: 5.5.2017
p.000300:
p.000300: 4.6. Reporting
p.000300:
p.000300: The notified body shall:
p.000300:
p.000300: — ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are
p.000300: clear and demonstrate compliance with the requirements of this Regulation and can represent objective
p.000300: evidence of such compliance to persons that are not themselves involved in the assessment, for example
p.000300: personnel in designating authorities,
p.000300:
p.000300: — ensure that records that are sufficient to provide a discernible audit trail are available for quality management
p.000300: system audits,
p.000300:
p.000300: — clearly document the conclusions of its assessment of performance evaluation in a performance
p.000300: evaluation assessment report,
p.000300:
p.000300: — for each specific project, provide a detailed report which shall be based on a standard format
p.000300: containing a minimum set of elements determined by the MDCG.
p.000300: The report of the notified body shall:
p.000300:
p.000300: — clearly document the outcome of its assessment and draw clear conclusions from the verification of
p.000300: the manufacturer's conformity with the requirements of this Regulation,
p.000300:
p.000300: — make a recommendation for a final review and for a final decision to be taken by the notified
p.000300: body; this recommendation shall be signed off by the member of personnel responsible in the notified body,
p.000300: — be provided to the manufacturer in question.
p.000300:
p.000300: 4.7. Final review
p.000300:
...
p.000306:
p.000306: — a description of the procedures in place to keep up to date the post-market surveillance system and, where
p.000306: applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on
p.000306: vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures,
p.000306:
p.000306: — documentation on the performance evaluation plan, and
p.000306:
p.000306: — a description of the procedures in place to keep up to date the performance evaluation plan, taking
p.000306: into account the state of the art.
p.000306:
p.000306: 2.2. Implementation of the quality management system shall ensure compliance with this Regulation.
p.000306: All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be
p.000306: documented in a systematic and orderly manner in the form of a quality manual and written policies and
p.000306: procedures, such as quality programmes, quality plans and quality records.
p.000306:
p.000306: 5.5.2017 EN
p.000306: Official Journal of the European Union
p.000307: L 117/307
p.000307:
p.000307: Moreover, the documentation to be submitted for the assessment of the quality management system shall
p.000307: include an adequate description of, in particular:
p.000307:
p.000307: (a) the manufacturer's quality objectives;
p.000307:
p.000307: (b) the organisation of the business and in particular:
p.000307:
p.000307: — the organisational structures with the assignment of staff responsibilities in relation to
p.000307: critical procedures, the responsibilities of the managerial staff and their organisational authority,
p.000307:
p.000307: — the methods of monitoring whether the operation of the quality management system is efficient and in particular the
p.000307: ability of that system to achieve the desired design and device quality, including control of devices which fail to
p.000307: conform,
p.000307:
p.000307: — where the design, manufacture, and/or final verification and testing of the devices, or parts of any
p.000307: of those processes, is carried out by another party, the methods of monitoring the efficient operation of
p.000307: the quality management system and in particular the type and extent of control applied to the other
p.000307: party,
p.000307:
p.000307: — where the manufacturer does not have a registered place of business in a Member State, the draft
p.000307: mandate for the designation of an authorised representative and a letter of intention from the authorised
p.000307: representative to accept the mandate;
p.000307:
p.000307: (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the
p.000307: devices, and the corresponding documentation as well as the data and records arising from those
p.000307: procedures and techniques. Those procedures and techniques shall specifically cover:
p.000307:
p.000307: — the strategy for regulatory compliance, including processes for identification of relevant
p.000307: legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with,
p.000307: conformity assessment procedures,
p.000307:
p.000307: — identification of applicable general safety and performance requirements and solutions to fulfil those
...
p.000312: by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified
p.000312: body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide
p.000312: it with a supplement to the EU technical documentation assessment certificate.
p.000312:
p.000312:
p.000312: 5.2. Assessment of the technical documentation of companion diagnostics
p.000312:
p.000312: (a) The manufacturer of a companion diagnostic shall lodge with the notified body an application for
p.000312: the assessment of the technical documentation. The notified body shall assess that application in
p.000312: accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex.
p.000312:
p.000312: (b) The application shall enable the characteristics and performance of the device to be understood, and shall
p.000312: enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to
p.000312: the suitability of the device in relation to the medicinal product concerned.
p.000312:
p.000312: (c) The notified body shall, before issuing an EU technical documentation assessment certificate for the
p.000312: companion diagnostic and on the basis of the draft summary of safety and performance and the draft
p.000312: instructions for use, seek a scientific opinion from one of the competent authorities designated by the
p.000312: Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this
p.000312: Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this
p.000312: point, regarding the suitability of the device in relation to the medicinal product concerned. Where the
p.000312: medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No
p.000312: 726/2004 of the European Parliament and of the Council (1), the notified body shall seek the opinion of the EMA. If the
p.000312: medicinal product concerned is already authorised, or if an application for its authorisation has been submitted,
p.000312: the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the
p.000312: authorisation.
p.000312:
p.000312: (d) The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of
p.000312: all the necessary documentation. This 60-day period may be extended once for a further 60 days on
p.000312: justified grounds. The opinion and any possible update shall be included in the documentation of the notified body
p.000312: concerning the device.
p.000312:
p.000312: (e) The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its
p.000312: decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU
p.000312: technical documentation assessment certificate shall be delivered in accordance with point (e) of Section
p.000312: 5.1.
p.000312:
p.000312: (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community
p.000312: procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a
p.000312: European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
p.000312:
p.000312: 5.5.2017 EN
p.000312: Official Journal of the European Union
p.000313: L 117/313
p.000313:
p.000313: (f) Before changes affecting the performance and/or the intended use and/or the suitability of the
p.000313: device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of
p.000313: the changes. The notified body shall assess the planned changes and decide whether the planned changes
p.000313: require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a
p.000313: supplement to the EU technical documentation assessment certificate. In the latter case, the notified body
p.000313: shall assess the changes and seek the opinion of the medicinal products authority consulted. The medicinal products
p.000313: authority consulted shall give its opinion within 30 days of receipt of the all the necessary
p.000313: documentation regarding the changes. A supplement to the EU technical documentation assessment
p.000313: certificate shall be issued in accordance with point (f) of Section 5.1.
p.000313:
p.000313: CHAPTER III
p.000313: ADMINISTRATIVE PROVISIONS
p.000313:
p.000313: 6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
p.000313: it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been
p.000313: placed on the market, keep at the disposal of the competent authorities:
p.000313: — the EU declaration of conformity,
p.000313: — the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and
p.000313: records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
p.000313: — information on the changes referred to in Section 2.4.,
p.000313: — the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
p.000313: — the decisions and reports from the notified body as referred to in this Annex.
p.000313:
p.000313: 7. Each Member State shall require that the documentation referred to in Section 6 is kept at
p.000313: the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its
p.000313: authorised represen tative, established within its territory goes bankrupt or ceases its business activity
p.000313: prior to the end of that period.
p.000313:
p.000314: L 117/314 EN
p.000314: Official Journal of the European Union
p.000314: 5.5.2017
...
p.000315: consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down
p.000315: in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
p.000315:
p.000315: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000315:
p.000315: The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article
p.000315: 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the
p.000315: documentation of the notified body concerning the device. The notified body shall give due consideration
p.000315: to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views
p.000315: expressed by the experts consulted in accordance with Article 48(6), when making its decision. The notified body
p.000315: shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable;
p.000315:
p.000315: (k) for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the
p.000315: draft instructions for use, of one of the competent authorities designated by the Member States in
p.000315: accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the
p.000315: medicinal products authority consulted’ depending on which has been consulted under this point) on the
p.000315: suitability of the device in relation to the medicinal product concerned. Where the medicinal product
p.000315: falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the
p.000315: EMA. If the medicinal product concerned is already authorised, or if an application for its
p.000315: authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the
p.000315: EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its
p.000315: opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a
p.000315: further 60 days on justified grounds. The opinion of the medicinal products authority consulted and any
p.000315: possible update shall be included in the documentation of the notified body concerning the device. The notified body
p.000315: shall give due consideration to the opinion expressed by the medicinal products authority consulted when
p.000315: making its decision. It shall convey its final decision to the medicinal products authority consulted; and
p.000315:
p.000315: (l) draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific
p.000315: opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D
p.000315: devices or covered by the third indent of Section 2.
p.000315:
p.000316: L 117/316 EN
p.000316: Official Journal of the European Union
p.000316: 5.5.2017
p.000316:
p.000316: 4. Certificate
p.000316:
p.000316: If the type conforms to this Regulation, the notified body shall issue an EU type-examination
p.000316: certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of
p.000316: the type examination assessment, the conditions of certificate's validity and the data needed for identification of
p.000316: the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of
p.000316: the documentation shall be annexed to the certificate and a copy kept by the notified body.
p.000316:
p.000316: 5. Changes to the type
p.000316:
p.000316: 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of
p.000316: any planned change to the approved type or of its intended purpose and conditions of use.
p.000316:
p.000316: 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use
p.000316: shall require further approval from the notified body which issued the EU type-examination certificate where such
p.000316: changes may affect conformity with the general safety and performance requirements or with the conditions prescribed
p.000316: for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision
p.000316: and provide him with a supplement to the EU type-examination report. The approval of any change to the approved
p.000316: type shall take the form of a supplement to the EU type-examination certificate.
p.000316:
p.000316: 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations
p.000316: of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment.
p.000316:
p.000316: 5.4. Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with
p.000316: other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the
p.000316: notified body shall consult the EU reference laboratory that was involved in the initial consultation,
p.000316: in order to confirm that compliance with the CS, when available, or with other solutions chosen by the
p.000316: manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
p.000316:
p.000316: The EU reference laboratory shall provide a scientific opinion within 60 days.
p.000316:
p.000316: 5.5. Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU
p.000316: type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the
p.000316: medicinal products competent authority that was involved in the initial consultation or the EMA. The
p.000316: medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid
p.000316: documentation regarding the changes. The approval of any change to the approved type shall take the form of a
p.000316: supplement to the initial EU type-examination certificate.
p.000316:
p.000316: 6. Administrative provisions
p.000316:
p.000316: The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its
p.000316: authorised representative shall, for a period ending no sooner than 10 years, after the last device has been placed on
p.000316: the market, keep at the disposal of the competent authorities:
p.000316: — the documentation referred to in the second indent of Section 2,
p.000316: — information on the changes referred to in Section 5,
p.000316: — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section
p.000316: 7 of Annex IX shall apply.
p.000316:
p.000316: 5.5.2017 EN
p.000316: Official Journal of the European Union
p.000317: L 117/317
p.000317:
p.000317: ANNEX XI
p.000317:
p.000317: CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
p.000317:
p.000317: 1. The manufacturer shall ensure that the quality management system approved for the manufacture of
p.000317: the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and
p.000317: shall be subject to the surveillance referred to in Section 4.
p.000317:
p.000317: 2. When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU
p.000317: declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the
...
p.000328:
p.000328: 1. Application form
p.000328:
p.000328: The application form shall be duly filled in, containing the following information:
p.000328:
p.000328: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact
p.000328: details of its contact person or legal representative in accordance with Article 58(4) established in the Union;
p.000328:
p.000328: 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer
p.000328: of the device intended for performance evaluation and, if applicable, of its authorised representative;
p.000328:
p.000328: 1.3. title of the performance study;
p.000328:
p.000328: 1.4. single identification number in accordance with Article 66(1);
p.000328:
p.000328: 1.5. status of the performance study, such as. the first submission, resubmission, significant amendment;
p.000328:
p.000328: 1.6. details and/ or reference to the performance study plan, such as including details of the
p.000328: design phase of the performance study;
p.000328:
p.000328: 1.7. if the application is a resubmission with regard to a device for which an application has been already
p.000328: submitted, the date or dates and reference number or numbers of the earlier application or in the case
p.000328: of significant amendment, reference to the original application. The sponsor shall identify all of the
p.000328: changes from the previous application together with a rationale for those changes, in particular, whether any
p.000328: changes have been made to address conclusions of previous competent authority or ethics committee reviews;
p.000328:
p.000328: 1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with
p.000328: Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
p.000328:
p.000328: 1.9. identification of the Member States and third countries in which the clinical performance study
p.000328: is to be conducted as part of a multicentre or multinational study at the time of application;
p.000328:
p.000328: 1.10. brief description of the device for performance study, its classification and other information necessary for
p.000328: the identification of the device and device type;
p.000328:
p.000328: 1.11. summary of the performance study plan;
p.000328:
p.000328: 1.12. if applicable, information regarding a comparator device, its classification and other information
p.000328: necessary for the identification of the comparator device;
p.000328:
p.000328: 1.13. evidence from the sponsor that the clinical investigator and the investigational site are capable
p.000328: of conducting the clinical performance study in accordance with the performance study plan;
p.000328:
p.000328: 1.14. details of the anticipated start date and duration of the performance study;
p.000328:
p.000328: 1.15. details to identify the notified body, if already involved at the stage of application for the performance
p.000328: study;
p.000328:
p.000328: 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is
p.000328: assessing or has assessed the application;
p.000328:
p.000328: 5.5.2017 EN
p.000328: Official Journal of the European Union
p.000329: L 117/329
p.000329:
p.000329: 1.17. the statement referred to in Section 4.1.
p.000329:
p.000329: 2. Investigator's brochure
p.000329:
p.000329: The investigator's brochure (IB) shall contain the information on the device for performance study that
p.000329: is relevant for the study and available at the time of application. Any updates to the IB or other
p.000329: relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.
p.000329: The IB shall be clearly identified and contain in particular the following information:
p.000329:
p.000329: 2.1. Identification and description of the device, including information on the intended purpose, the
p.000329: risk classifi cation and applicable classification rule pursuant to Annex VIII, design and manufacturing
p.000329: of the device and reference to previous and similar generations of the device.
p.000329:
p.000329: 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use,
p.000329: including storage and handling requirements, as well as, to the extent that such information is available, information
p.000329: to be placed the label, and instructions for use to be provided with the device when placed on the
p.000329: market. In addition, information relating to any relevant training required.
p.000329:
p.000329: 2.3. Analytical performance.
p.000329:
...
p.000329: opinions shall be submitted as soon as available.
p.000329:
p.000329: 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article
p.000329: 65 and the corresponding national law.
p.000329:
p.000330: L 117/330 EN
p.000330: Official Journal of the European Union
p.000330: 5.5.2017
p.000330:
p.000330: 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the
p.000330: informed consent document.
p.000330:
p.000330: 4.5 Description of the arrangements to comply with the applicable rules on the protection and
p.000330: confidentiality of personal data, in particular:
p.000330:
p.000330: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure,
p.000330: dissemination, alteration or loss of information and personal data processed;
p.000330:
p.000330: — a description of measures that will be implemented to ensure confidentiality of records and personal data of
p.000330: subjects;
p.000330:
p.000330: — a description of measures that will be implemented in case of a data security breach in order to mitigate the
p.000330: possible adverse effects.
p.000330:
p.000330: 4.6. Full details of the available technical documentation, for example detailed risk analysis/management
p.000330: documen tation or specific test reports shall be submitted to the competent authority reviewing an
p.000330: application upon request.
p.000330:
p.000330: CHAPTER II
p.000330: OTHER OBLIGATIONS OF THE SPONSOR
p.000330:
p.000330: 1. The sponsor shall undertake to keep available for the competent national authorities any
p.000330: documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the
p.000330: sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance
p.000330: study, that obligation may be fulfilled by that person on behalf of the sponsor.
p.000330:
p.000330: 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event
p.000330: as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
p.000330:
p.000330: 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10
p.000330: years after the clinical performance study with the device in question has ended, or, in the event that the device is
p.000330: subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
p.000330:
p.000330: Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the
p.000330: competent authorities for the period indicated in the first subparagraph in case the sponsor, or his
p.000330: contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
p.000330:
p.000330: 4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure
p.000330: that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000226: (f) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative has given informed consent, in accordance with Article 59;
p.000226:
p.000226: (g) the subject or, where the subject is not able to give informed consent, his or her legally designated
p.000226: representative, has been provided with the contact details of an entity where further information can be received in
p.000226: case of need;
p.000226:
p.000226: (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data
p.000226: concerning him or her in accordance with Directive 95/46/EC are safeguarded;
p.000226:
p.000226: (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable
p.000226: risk as possible for the subjects, and both the risk threshold and the degree of distress are
p.000226: specifically defined in the performance study plan and constantly monitored;
p.000226:
p.000226: (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or,
p.000226: where appropriate, any other person entitled by national law to provide the relevant patient care under performance
p.000226: study conditions;
p.000226:
p.000226: 5.5.2017 EN
p.000226: Official Journal of the European Union
p.000227: L 117/227
p.000227:
p.000227: (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his
p.000227: or her legally designated representatives, to participate in the performance study;
p.000227:
p.000227: (l) where appropriate, biological safety testing reflecting the latest scientific knowledge or any other
p.000227: test deemed necessary in the light of the device's intended purpose has been conducted;
p.000227:
p.000227: (m) in the case of clinical performance studies, the analytical performance has been demonstrated, taking into
p.000227: considera tion the state of the art;
p.000227:
p.000227: (n) in the case of interventional clinical performance studies, the analytical performance and scientific validity
p.000227: has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics,
p.000227: the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
p.000227:
p.000227: (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of
p.000227: the art as well as provisions in the field of occupational safety and accident prevention;
p.000227:
p.000227: (p) the requirements of Annex XIV are fulfilled.
p.000227:
p.000227: 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated
p.000227: representative, may, without any resulting detriment and without having to provide any justification, withdraw from the
p.000227: performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the
...
p.000232: Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is
p.000232: valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State
p.000232: concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45
p.000232: days of the validation date of the application referred to in paragraph 5. The Member State may extend this
p.000232: period by a further 20 days for the purpose of consulting with experts.
p.000232:
p.000232: 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of
p.000232: technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV.
p.000232:
p.000232: 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex
p.000232: XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent
p.000232: interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination
p.000232: procedure referred to in Article 107(3).
p.000232:
p.000232:
p.000232: Article 67
p.000232:
p.000232: Assessment by Member States
p.000232:
p.000232: 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not
p.000232: have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons
p.000232: financing the performance study, as well as free of any other undue influence.
p.000232:
p.000232: 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who
p.000232: collectively have the necessary qualifications and experience.
p.000232:
p.000232: 5.5.2017 EN
p.000232: Official Journal of the European Union
p.000233: L 117/233
p.000233:
p.000233: 3. Member States shall assess whether the performance study is designed in such a way that potential remaining
p.000233: risks to subjects or third persons, after risk minimization, are justified, when weighed against the
p.000233: clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards,
p.000233: examine in particular:
p.000233: (a) the demonstration of compliance of the device(s) for performance study with the applicable general
p.000233: safety and performance requirements, apart from the aspects covered by the performance study, and whether,
p.000233: with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This
p.000233: includes, in case of performance studies, the evaluation of the analytical performance, and in case of
p.000233: interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and
p.000233: scientific validity, taking into consideration the state of the art;
p.000233:
p.000233: (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000182: of other diagnostic options and technologies, whereas the final clinical outcome for the patient is
p.000182: dependent on further diagnostic and/or therapeutic options which could be available.
p.000182:
p.000182: 5.5.2017 EN
p.000182: Official Journal of the European Union
p.000183: L 117/183
p.000183:
p.000183: (65) Where specific devices have no analytical or clinical performance or specific performance requirements are
p.000183: not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions
p.000183: relating to such requirements.
p.000183:
p.000183:
p.000183: (66) The rules on performance studies should be in line with well-established international guidance in this field,
p.000183: such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of
p.000183: medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the
p.000183: Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies
p.000183: conducted outside the Union in accordance with international guidelines to be accepted within the Union.
p.000183: In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of
p.000183: Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
p.000183:
p.000183:
p.000183: (67) It should be left to the Member State where a performance study is to be conducted to determine the
p.000183: appropriate authority to be involved in the assessment of the application to conduct a performance study and to
p.000183: organise the involvement of ethics committees within the timelines for the authorisation of that performance study as
p.000183: set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that
p.000183: context, Member States should ensure the involvement of laypersons, in particular patients or patients'
p.000183: organisations. They should also ensure that the necessary expertise is available.
p.000183:
p.000183:
p.000183: (68) An electronic system should be set up at Union level to ensure that every interventional
p.000183: clinical performance study and other performance study involving risks for the subjects of the studies is
p.000183: recorded and reported in a publicly accessible database. To protect the right to protection of personal data,
p.000183: recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data
p.000183: of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with
p.000183: the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable
...
Orphaned Trigger Words
p.000182: purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of
p.000182: the performance claimed by the manufacturer and the compliance of the device by the EU reference
p.000182: laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment
p.000182: reports. The consultation of expert panels in relation to the performance evaluation should lead to a
p.000182: harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance
p.000182: aspects and developing CS on categories of devices that have undergone that consultation process.
p.000182:
p.000182: (54) To enhance patient safety and to take due account of technological progress, the current classification system
p.000182: for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the
p.000182: corresponding conformity assessment procedures should be accordingly adapted.
p.000182:
p.000182: (55) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in
p.000182: four risk classes and to establish a set of robust risk-based classification rules, in line with international
p.000182: practice.
p.000182:
p.000182: (56) The conformity assessment procedure for class A devices should be carried out, as a general rule, under the
p.000182: sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C
p.000182: and class D devices, an appropriate level of involvement of a notified body should be compulsory.
p.000182:
p.000182: (57) The conformity assessment procedures for devices should be further strengthened and streamlined
p.000182: whilst the requirements for notified bodies as regards the performance of their assessments should be
p.000182: clearly specified to ensure a level playing field.
p.000182:
p.000182: (58) It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in
p.000182: order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the
p.000182: market or recalled, and on any certificate on its conformity.
p.000182:
p.000182: (59) It is necessary to clarify the requirements regarding batch release verification for the highest risk devices.
p.000182:
p.000182: (60) EU reference laboratories should be enabled to verify by laboratory testing the performance
p.000182: claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when
p.000182: such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance
p.000182: that is at least equivalent.
p.000182:
p.000182: (61) To ensure a high level of safety and performance, demonstration of compliance with the general
p.000182: safety and performance requirements laid down in this Regulation should be based on clinical evidence. It
p.000182: is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on
p.000182: scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured
p.000182: and transparent process, generating reliable and robust data, sourcing and assessment of available scientific
p.000182: information and data generated in performance studies should be based on a performance evaluation plan.
p.000182:
p.000182: (62) As a general rule, clinical evidence should be sourced from performance studies that have been carried out
p.000182: under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or
p.000182: legal person to be the sponsor taking responsibility for the performance study.
p.000182:
p.000182: (63) It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such
p.000182: updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer.
p.000182: Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety
p.000182: and performance through a continuous process of performance evaluation.
p.000182:
p.000182: (64) It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is
...
p.000247: external border controls, those authorities shall cooperate with each other, by sharing information relevant to their
p.000247: role and functions.
p.000247:
p.000247: 11. Where appropriate, the competent authorities of the Member States shall cooperate with the
p.000247: competent authorities of third countries with a view to exchanging information and technical support and
p.000247: promoting activities relating to market surveillance.
p.000247:
p.000247:
p.000247: Article 89
p.000247:
p.000247: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
p.000247:
p.000247: Where the competent authorities of a Member State, based on data obtained by vigilance or market
p.000247: surveillance activities or on other information, have reason to believe that a device:
p.000247:
p.000247: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or to other
p.000247: aspects of the protection of public health; or
p.000247: (b) otherwise does not comply with the requirements laid down in this Regulation,
p.000247:
p.000247: they shall carry out an evaluation of the device concerned covering all requirements laid down in this
p.000247: Regulation relating to the risk presented by the device or to any other non-compliance of the device.
p.000247: The relevant economic operators shall cooperate with the competent authorities.
p.000247:
p.000247:
p.000247: Article 90
p.000247:
p.000247: Procedure for dealing with devices presenting an unacceptable risk to health and safety
p.000247:
p.000247: 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities find that
p.000247: the device presents an unacceptable risk to the health or safety of patients, users or other persons,
p.000247: or to other aspects of the protection of public health, they shall without delay require the manufacturer of
p.000247: the devices concerned, its authorised representative and all other relevant economic operators to take all
p.000247: appropriate and duly justified corrective action to bring the device into compliance with the requirements of
p.000247: this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature
p.000247: of the risk, to restrict the making available of the device on the market, to subject the making available of the
p.000247: device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period
p.000247: that is clearly defined and communicated to the relevant economic operator.
p.000247:
p.000247: 2. The competent authorities shall, without delay, notify the Commission, the other Member States
p.000247: and, where a certificate has been issued in accordance with Article 51 for the device concerned, the notified body
p.000247: that issued that certificate, of the results of the evaluation and of the actions which they have required the economic
p.000247: operators to take, by means of the electronic system referred to in Article 95.
p.000247:
p.000248: L 117/248 EN
...
p.000262: by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons
p.000262: involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to
p.000262: those contaminants and residues and to the duration and frequency of exposure.
p.000262:
p.000262: 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably
p.000262: practicable the risks posed by substances or particles, including wear debris, degradation products and
p.000262: processing residues, that may be released from the device. Special attention shall be given to substances
p.000262: which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex
p.000262: VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having
p.000262: endocrine disrupting properties for which there is scientific evidence of probable serious effects to human
p.000262: health and which are identified in accordance with the procedure set out in Article 59 of Regulation
p.000262: (EC) No 1907/2006 of the European Parliament and of the Council (2).
p.000262:
p.000262: 10.4. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the
p.000262: unintentional ingress of substances into the device, taking into account the device and the nature of
p.000262: the environment in which it is intended to be used.
p.000262:
p.000262: 11. Infection and microbial contamination
p.000262:
p.000262: 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or
p.000262: reduce as far as possible the risk of infection to the user or, where applicable, other persons. The design shall:
p.000262:
p.000262: (a) allow easy and safe handling;
p.000262: (b) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use; and, where
p.000262: necessary
p.000262: (c) prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of
p.000262: contamination of the specimen.
p.000262:
p.000262: 11.2. Devices labelled either as sterile or as having a specific microbial state shall be designed,
p.000262: manufactured and packaged to ensure that their sterile condition or microbial state is maintained under the
p.000262: transport and storage conditions specified by the manufacturer until that packaging is opened at the point of use,
p.000262: unless the packaging which maintains their sterile condition or microbial state is damaged.
p.000262:
p.000262: 11.3. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of
p.000262: appropriate, validated methods.
p.000262:
p.000262: 11.4. Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled
p.000262: conditions and facilities.
p.000262:
p.000262: 11.5. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the
p.000262: product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the
p.000262: packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
p.000262:
p.000262: 11.6. The labelling of the device shall distinguish between identical or similar devices placed on the
p.000262: market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are
p.000262: sterile.
p.000262:
p.000262: 12. Devices incorporating materials of biological origin
p.000262:
p.000262: Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the
...
p.000289: assessment activities, except when disclosure is required by law.
p.000289:
p.000289: 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks
p.000289: under this Regulation or any provision of national law giving effect to it, except in relation to the authorities
p.000289: responsible for notified bodies, competent authorities for devices in the Member States or the Commission.
p.000289: Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the
p.000289: requirement of this Section.
p.000289:
p.000289: 1.4. Liability
p.000289:
p.000289: 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment
p.000289: activities, unless liability is assumed by the Member State in question in accordance with national law
p.000289: or that Member State is directly responsible for their conformity assessment.
p.000289:
p.000289: 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic
p.000289: scope of activities of the notified body and be commensurate with the risk profile of the devices
p.000289: certified by the notified body. The liability insurance shall cover cases where the notified body may be
p.000289: obliged to withdraw, restrict or suspend certificates.
p.000289:
p.000289: 1.5. Financial requirements
p.000289:
p.000289: The notified body shall have at its disposal the financial resources required to conduct its conformity assessment
p.000289: activities within its scope of designation and related business operations. It shall document and provide evidence of
p.000289: its financial capacity and its long-term economic viability, taking into account, where relevant, any
p.000289: specific circumstances during an initial start-up phase.
p.000289:
p.000289: 1.6. Participation in coordination activities
p.000289:
p.000289: 1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of any relevant
p.000289: stan dardisation activities and in the activities of the notified body coordination group referred to in
p.000289: Article 49 of Regulation (EU) 2017/745 and that its assessment and decision-making personnel are informed
p.000289: of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
p.000289:
p.000289: 1.6.2. The notified body shall take into consideration guidance and best practice documents.
p.000289:
p.000289: 2. QUALITY MANAGEMENT REQUIREMENTS
p.000289:
p.000289: 2.1. The notified body shall establish, document, implement, maintain and operate a quality management system that
p.000289: is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting
p.000289: and demonstrating the consistent fulfilment of the requirements of this Regulation.
p.000289:
p.000289: 2.2. The quality management system of the notified body shall address at least the following:
p.000289: (a) management system structure and documentation, including policies and objectives for its activities;
p.000289: (b) policies for assignment of activities and responsibilities to personnel;
p.000289: (c) assessment and decision-making processes in accordance with the tasks, responsibilities and role of
p.000289: the notified body's personnel and top-level management;
p.000289: (d) the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
...
p.000310: tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant
p.000310: requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to
p.000310: the device or request the manufacturer to carry out such tests.
p.000310:
p.000310:
p.000310: 4.4. The notified body shall review the clinical evidence presented by the manufacturer in the
p.000310: performance evaluation report and the related performance evaluation that was conducted. The notified body
p.000310: shall use employed device reviewers with sufficient clinical expertise and including external clinical
p.000310: experts with direct and current experience relating to the clinical application of the device in question
p.000310: for the purposes of that review.
p.000310:
p.000310:
p.000310: 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data
p.000310: from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such
p.000310: data, taking into account factors such as new indications and innovation. The notified body shall
p.000310: clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the
p.000310: data for demonstrating conformity.
p.000310:
p.000310:
p.000310: 4.6. The notified body shall verify that the clinical evidence and the performance evaluation are adequate and
p.000310: shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety
p.000310: and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk deter
p.000310: mination, the risk management, the instructions for use, the user training and the manufacturer's post-market
p.000310: surveillance plan, and include a review of the need for, and the adequacy of, the PMPF plan proposed,
p.000310: where applicable.
p.000310:
p.000310:
p.000310: 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the
p.000310: performance evaluation and the benefit-risk determination, and whether specific milestones need to be
p.000310: defined to allow the notified body to review updates to the clinical evidence that result from post-market
p.000310: surveillance and PMPF data.
p.000310:
p.000310:
p.000310: 4.8. The notified body shall clearly document the outcome of its assessment in the performance
p.000310: evaluation assessment report.
p.000310:
p.000310:
p.000310: 4.9. Before issuing an EU technical documentation assessment certificate, the notified body shall
p.000310: request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance
p.000310: claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions
p.000310: chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The
p.000310: verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5).
p.000310:
p.000310:
p.000310: In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation,
p.000310: consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure
p.000310: laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
...
p.000329:
p.000329: 2.1. Identification and description of the device, including information on the intended purpose, the
p.000329: risk classifi cation and applicable classification rule pursuant to Annex VIII, design and manufacturing
p.000329: of the device and reference to previous and similar generations of the device.
p.000329:
p.000329: 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use,
p.000329: including storage and handling requirements, as well as, to the extent that such information is available, information
p.000329: to be placed the label, and instructions for use to be provided with the device when placed on the
p.000329: market. In addition, information relating to any relevant training required.
p.000329:
p.000329: 2.3. Analytical performance.
p.000329:
p.000329: 2.4. Existing clinical data, in particular:
p.000329:
p.000329: — from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from
p.000329: relevant professional associations relating to the safety, performance, clinical benefits to patients,
p.000329: design characteristics, scientific validity, clinical performance and intended purpose of the device and/or
p.000329: of equivalent or similar devices;
p.000329:
p.000329: — other relevant clinical data available relating to the safety, scientific validity, clinical
p.000329: performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including
p.000329: details of their similarities and differences with the device in question.
p.000329:
p.000329: 2.5. Summary of the benefit-risk analysis and the risk management, including information regarding
p.000329: known or foreseeable risks and warnings.
p.000329:
p.000329: 2.6. In the case of devices that include tissues, cells and substances of human, animal or microbial origins
p.000329: detailed information on the tissues, cells and substances, and on the compliance with the relevant
p.000329: general safety and performance requirements and the specific risk management in relation to those tissues, cells and
p.000329: substances.
p.000329:
p.000329: 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements set out in
p.000329: Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for
p.000329: fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or
p.000329: have only been partly fulfilled or are lacking.
p.000329:
p.000329: 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of
p.000329: the performance study and in particular information on any deviation from normal clinical practice.
p.000329:
p.000329: 3. Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
p.000329:
p.000329: 4. Other information
p.000329:
p.000329: 4.1. A signed statement by the natural or legal person responsible for the manufacture of the device for
p.000329: performance study that the device in question conforms to the general safety and performance requirements
p.000329: laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| education | education |
| elderly | Elderly |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| illness | Physically Disabled |
| immuno-compromised | immuno-compromised |
| impairment | Cognitive Impairment |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| military | Soldier |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| sexually transmitted | sexually transmitted disases |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| usage | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
| home | ['property'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| influence | ['substance', 'usage'] |
| liberty | ['restricted'] |
| property | ['home'] |
| restricted | ['liberty'] |
| substance | ['influence', 'usage'] |
| usage | ['influence', 'substance'] |
Trigger Words
capacity
consent
developing
ethics
harm
justice
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input