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Unofficial consolidated textConsolidated 2025-01-10English

Regulation (EU) 2017/746

IVDR current consolidated text

English consolidated text dated 2025-01-10, reproduced from EUR-Lex. It is not an authentic Official Journal reproduction. It is recommended to check the original source in case of doubt.

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Contents

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129 provisions

Articles114

CHAPTER I

INTRODUCTORY PROVISIONS

Section 1Scope and definitions
  1. Article 1Subject matter and scope
  2. Article 2Definitions
Section 2Regulatory status of products and counselling
  1. Article 3Regulatory status of products
  2. Article 4Genetic information, counselling and informed consent

CHAPTER II

MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT

  1. Article 5Placing on the market and putting into service
  2. Article 6Distance sales
  3. Article 7Claims
  4. Article 8Use of harmonised standards
  5. Article 9Common specifications
  6. Article 10General obligations of manufacturers
  7. Article 10aObligations in case of interruption or discontinuation of supply of certain devices
  8. Article 11Authorised representative
  9. Article 12Change of authorised representative
  10. Article 13General obligations of importers
  11. Article 14General obligations of distributors
  12. Article 15Person responsible for regulatory compliance
  13. Article 16Cases in which obligations of manufacturers apply to importers, distributors or other persons
  14. Article 17EU declaration of conformity
  15. Article 18CE marking of conformity
  16. Article 19Devices for special purposes
  17. Article 20Parts and components
  18. Article 21Free movement

CHAPTER III

IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

  1. Article 22Identification within the supply chain
  2. Article 23Medical devices nomenclature
  3. Article 24Unique Device Identification system
  4. Article 25UDI database
  5. Article 26Registration of devices
  6. Article 27Electronic system for registration of economic operators
  7. Article 28Registration of manufacturers, authorised representatives and importers
  8. Article 29Summary of safety and performance
  9. Article 30European database on medical devices

CHAPTER IV

NOTIFIED BODIES

  1. Article 31Authorities responsible for notified bodies
  2. Article 32Requirements relating to notified bodies
  3. Article 33Subsidiaries and subcontracting
  4. Article 34Application by conformity assessment bodies for designation
  5. Article 35Assessment of the application
  6. Article 36Nomination of experts for joint assessment of applications for notification
  7. Article 37Language requirements
  8. Article 38Designation and notification procedure
  9. Article 39Identification number and list of notified bodies
  10. Article 40Monitoring and re-assessment of notified bodies
  11. Article 41Review of notified body assessment of technical documentation and performance evaluation documentation
  12. Article 42Changes to designations and notifications
  13. Article 43Challenge to the competence of notified bodies
  14. Article 44Peer review and exchange of experience between authorities responsible for notified bodies
  15. Article 45Coordination of notified bodies
  16. Article 46List of standard fees

CHAPTER V

CLASSIFICATION AND CONFORMITY ASSESSMENT

Section 1Classification
  1. Article 47Classification of devices
Section 2Conformity assessment
  1. Article 48Conformity assessment procedures
  2. Article 49Involvement of notified bodies in conformity assessment procedures
  3. Article 50Mechanism for scrutiny of conformity assessments of class D devices
  4. Article 51Certificates of conformity
  5. Article 52Electronic system on notified bodies and on certificates of conformity
  6. Article 53Voluntary change of notified body
  7. Article 54Derogation from the conformity assessment procedures
  8. Article 55Certificate of free sale

CHAPTER VI

CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

  1. Article 56Performance evaluation and clinical evidence
  2. Article 57General requirements regarding performance studies
  3. Article 58Additional requirements for certain performance studies
  4. Article 59Informed consent
  5. Article 60Performance studies on incapacitated subjects
  6. Article 61Performance studies on minors
  7. Article 62Performance studies on pregnant or breastfeeding women
  8. Article 63Additional national measures
  9. Article 64Performance studies in emergency situations
  10. Article 65Damage compensation
  11. Article 66Application for performance studies
  12. Article 67Assessment by Member States
  13. Article 68Conduct of a performance study
  14. Article 69Electronic system on performance studies
  15. Article 70Performance studies regarding devices bearing the CE marking
  16. Article 71Substantial modifications to performance studies
  17. Article 72Corrective measures to be taken by Member States and information exchange between Member States on performance studies
  18. Article 73Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
  19. Article 74Coordinated assessment procedure for performance studies
  20. Article 75Review of the coordinated assessment procedure
  21. Article 76Recording and reporting of adverse events that occur during performance studies
  22. Article 77Implementing acts

CHAPTER VII

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

Section 1Post-market surveillance
  1. Article 78Post-market surveillance system of the manufacturer
  2. Article 79Post-market surveillance plan
  3. Article 80Post-market surveillance report
  4. Article 81Periodic safety update report
Section 2Vigilance
  1. Article 82Reporting of serious incidents and field safety corrective actions
  2. Article 83Trend reporting
  3. Article 84Analysis of serious incidents and field safety corrective actions
  4. Article 85Analysis of vigilance data
  5. Article 86Implementing acts
  6. Article 87Electronic system on vigilance and post-market surveillance
Section 3Market surveillance
  1. Article 88Market surveillance activities
  2. Article 89Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
  3. Article 90Procedure for dealing with devices presenting an unacceptable risk to health and safety
  4. Article 91Procedure for evaluating national measures at Union level
  5. Article 92Other non-compliance
  6. Article 93Preventive health protection measures
  7. Article 94Good administrative practice
  8. Article 95Electronic system on market surveillance

CHAPTER VIII

COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS

  1. Article 96Competent authorities
  2. Article 97Cooperation
  3. Article 98Medical Device Coordination Group
  4. Article 99Tasks of the MDCG
  5. Article 100The European Union reference laboratories
  6. Article 101Device registers and databanks

CHAPTER IX

CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

  1. Article 102Confidentiality
  2. Article 103Data protection
  3. Article 104Levying of fees
  4. Article 105Funding of activities related to designation and monitoring of notified bodies
  5. Article 106Penalties

CHAPTER X

FINAL PROVISIONS

  1. Article 107Committee procedure
  2. Article 108Exercise of the delegation
  3. Article 109Separate delegated acts for different delegated powers
  4. Article 110Transitional provisions
  5. Article 111Evaluation
  6. Article 112Repeal
  7. Article 113Entry into force and date of application
Annexes15
  1. Annex IGENERAL SAFETY AND PERFORMANCE REQUIREMENTS
  2. Annex IITECHNICAL DOCUMENTATION
  3. Annex IIITECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
  4. Annex IVEU DECLARATION OF CONFORMITY
  5. Annex VCE MARKING OF CONFORMITY
  6. Annex VIINFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
  7. Annex VIIREQUIREMENTS TO BE MET BY NOTIFIED BODIES
  8. Annex VIIICLASSIFICATION RULES
  9. Annex IXCONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
  10. Annex XCONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
  11. Annex XICONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
  12. Annex XIICERTIFICATES ISSUED BY A NOTIFIED BODY
  13. Annex XIIIPERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP
  14. Annex XIVINTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
  15. Annex XVCORRELATION TABLE