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Unofficial consolidated textConsolidated 2026-01-01English

Regulation (EU) 2017/745

MDR current consolidated text

English consolidated text dated 2026-01-01, 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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141 provisions

Articles124

CHAPTER I

SCOPE AND DEFINITIONS

  1. Article 1Subject matter and scope
  2. Article 2Definitions
  3. Article 3Amendment of certain definitions
  4. Article 4Regulatory status of products

CHAPTER II

MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, 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 17Single-use devices and their reprocessing
  15. Article 18Implant card and information to be supplied to the patient with an implanted device
  16. Article 19EU declaration of conformity
  17. Article 20CE marking of conformity
  18. Article 21Devices for special purposes
  19. Article 22Systems and procedure packs
  20. Article 23Parts and components
  21. Article 24Free 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 25Identification within the supply chain
  2. Article 26Medical devices nomenclature
  3. Article 27Unique Device Identification system
  4. Article 28UDI database
  5. Article 29Registration of devices
  6. Article 30Electronic system for registration of economic operators
  7. Article 31Registration of manufacturers, authorised representatives and importers
  8. Article 32Summary of safety and clinical performance
  9. Article 33European database on medical devices
  10. Article 34Functionality of Eudamed

CHAPTER IV

NOTIFIED BODIES

  1. Article 35Authorities responsible for notified bodies
  2. Article 36Requirements relating to notified bodies
  3. Article 37Subsidiaries and subcontracting
  4. Article 38Application by conformity assessment bodies for designation
  5. Article 39Assessment of the application
  6. Article 40Nomination of experts for joint assessment of applications for notification
  7. Article 41Language requirements
  8. Article 42Designation and notification procedure
  9. Article 43Identification number and list of notified bodies
  10. Article 44Monitoring and re-assessment of notified bodies
  11. Article 45Review of notified body assessment of technical documentation and clinical evaluation documentation
  12. Article 46Changes to designations and notifications
  13. Article 47Challenge to the competence of notified bodies
  14. Article 48Peer review and exchange of experience between authorities responsible for notified bodies
  15. Article 49Coordination of notified bodies
  16. Article 50List of standard fees

CHAPTER V

CLASSIFICATION AND CONFORMITY ASSESSMENT

SECTION 1Classification
  1. Article 51Classification of devices
SECTION 2Conformity assessment
  1. Article 52Conformity assessment procedures
  2. Article 53Involvement of notified bodies in conformity assessment procedures
  3. Article 54Clinical evaluation consultation procedure for certain class III and class IIb devices
  4. Article 55Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
  5. Article 56Certificates of conformity
  6. Article 57Electronic system on notified bodies and on certificates of conformity
  7. Article 58Voluntary change of notified body
  8. Article 59Derogation from the conformity assessment procedures
  9. Article 60Certificate of free sale

CHAPTER VI

CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

  1. Article 61Clinical evaluation
  2. Article 62General requirements regarding clinical investigations conducted to demonstrate conformity of devices
  3. Article 63Informed consent
  4. Article 64Clinical investigations on incapacitated subjects
  5. Article 65Clinical investigations on minors
  6. Article 66Clinical investigations on pregnant or breastfeeding women
  7. Article 67Additional national measures
  8. Article 68Clinical investigations in emergency situations
  9. Article 69Damage compensation
  10. Article 70Application for clinical investigations
  11. Article 71Assessment by Member States
  12. Article 72Conduct of a clinical investigation
  13. Article 73Electronic system on clinical investigations
  14. Article 74Clinical investigations regarding devices bearing the CE marking
  15. Article 75Substantial modifications to clinical investigations
  16. Article 76Corrective measures to be taken by Member States and information exchange between Member States
  17. Article 77Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
  18. Article 78Coordinated assessment procedure for clinical investigations
  19. Article 79Review of coordinated assessment procedure
  20. Article 80Recording and reporting of adverse events that occur during clinical investigations
  21. Article 81Implementing acts
  22. Article 82Requirements regarding other clinical investigations

CHAPTER VII

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

SECTION 1Post-market surveillance
  1. Article 83Post-market surveillance system of the manufacturer
  2. Article 84Post-market surveillance plan
  3. Article 85Post-market surveillance report
  4. Article 86Periodic safety update report
SECTION 2Vigilance
  1. Article 87Reporting of serious incidents and field safety corrective actions
  2. Article 88Trend reporting
  3. Article 89Analysis of serious incidents and field safety corrective actions
  4. Article 90Analysis of vigilance data
  5. Article 91Implementing acts
  6. Article 92Electronic system on vigilance and on post-market surveillance
SECTION 3Market surveillance
  1. Article 93Market surveillance activities
  2. Article 94Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
  3. Article 95Procedure for dealing with devices presenting an unacceptable risk to health and safety
  4. Article 96Procedure for evaluating national measures at Union level
  5. Article 97Other non-compliance
  6. Article 98Preventive health protection measures
  7. Article 99Good administrative practice
  8. Article 100Electronic system on market surveillance

CHAPTER VIII

COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS

  1. Article 101Competent authorities
  2. Article 102Cooperation
  3. Article 103Medical Device Coordination Group
  4. Article 104Support by the Commission
  5. Article 105Tasks of the MDCG
  6. Article 106Provision of scientific, technical and clinical opinions and advice
  7. Article 107Conflict of interests
  8. Article 108Device registers and databanks

CHAPTER IX

CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

  1. Article 109Confidentiality
  2. Article 110Data protection
  3. Article 111Levying of fees
  4. Article 112Funding of activities related to designation and monitoring of notified bodies
  5. Article 113Penalties

CHAPTER X

FINAL PROVISIONS

  1. Article 114Committee procedure
  2. Article 115Exercise of the delegation
  3. Article 116Separate delegated acts for different delegated powers
  4. Article 117Amendment to Directive 2001/83/EC
  5. Article 118Amendment to Regulation (EC) No 178/2002
  6. Article 119Amendment to Regulation (EC) No 1223/2009
  7. Article 120Transitional provisions
  8. Article 121Evaluation
  9. Article 122Repeal
  10. Article 123Entry into force and date of application
Annexes17
  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 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, 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 PRODUCT CONFORMITY VERIFICATION
  12. Annex XIICERTIFICATES ISSUED BY A NOTIFIED BODY
  13. Annex XIIIPROCEDURE FOR CUSTOM-MADE DEVICES
  14. Annex XIVCLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
  15. Annex XVCLINICAL INVESTIGATIONS
  16. Annex XVILIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
  17. Annex XVIICORRELATION TABLE