Council of the European Union and European Parliament 5 April 2017, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

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European Union · · · Cited by 962 · 05-04-2017

CHAPTER I. INTRODUCTORY PROVISIONS
Section 1. Scope and definitions
Article 1. Subject matter and scope
Article 2. Definitions
Section 2. Regulatory status of products and counselling
Article 3. Regulatory status of products
Article 4. Genetic 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
Article 5. Placing on the market and putting into service
Article 6. Distance sales
Article 7. Claims
Article 8. Use of harmonised standards
Article 9. Common specifications
Article 10. General obligations of manufacturers
Article 11. Authorised representative
Article 12. Change of authorised representative
Article 13. General obligations of importers
Article 14. General obligations of distributors
Article 15. Person responsible for regulatory compliance
Article 16. Cases in which obligations of manufacturers apply to importers, distributors or other persons
Article 17. EU declaration of conformity
Article 18. CE marking of conformity
Article 19. Devices for special purposes
Article 20. Parts and components
Article 21. Free 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
Article 22. Identification within the supply chain
Article 23. Medical devices nomenclature
Article 24. Unique Device Identification system
Article 25. UDI database
Article 26. Registration of devices
Article 27. Electronic system for registration of economic operators
Article 28. Registration of manufacturers, authorised representatives and importers
Article 29. Summary of safety and performance
Article 30. European database on medical devices
CHAPTER IV. NOTIFIED BODIES
Article 31. Authorities responsible for notified bodies
Article 32. Requirements relating to notified bodies
Article 33. Subsidiaries and subcontracting
Article 34. Application by conformity assessment bodies for designation
Article 35. Assessment of the application
Article 36. Nomination of experts for joint assessment of applications for notification
Article 37. Language requirements
Article 38. Designation and notification procedure
Article 39. Identification number and list of notified bodies
Article 40. Monitoring and re-assessment of notified bodies
Article 41. Review of notified body assessment of technical documentation and performance evaluation documentation
Article 42. Changes to designations and notifications
Article 43. Challenge to the competence of notified bodies
Article 44. Peer review and exchange of experience between authorities responsible for notified bodies
Article 45. Coordination of notified bodies
Article 46. List of standard fees
CHAPTER V. CLASSIFICATION AND CONFORMITY ASSESSMENT
Section 1. Classification
Article 47. Classification of devices
Section 2. Conformity assessment
Article 48. Conformity assessment procedures
Article 49. Involvement of notified bodies in conformity assessment procedures
Article 50. Mechanism for scrutiny of conformity assessments of class D devices
Article 51. Certificates of conformity
Article 52. Electronic system on notified bodies and on certificates of conformity
Article 53. Voluntary change of notified body
Article 54. Derogation from the conformity assessment procedures
Article 55. Certificate of free sale
CHAPTER VI. CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
Article 56. Performance evaluation and clinical evidence
Article 57. General requirements regarding performance studies
Article 58. Additional requirements for certain performance studies
Article 59. Informed consent
Article 60. Performance studies on incapacitated subjects
Article 61. Performance studies on minors
Article 62. Performance studies on pregnant or breastfeeding women
Article 63. Additional national measures
Article 64. Performance studies in emergency situations
Article 65. Damage compensation
Article 66. Application for performance studies
Article 67. Assessment by Member States
Article 68. Conduct of a performance study
Article 69. Electronic system on performance studies
Article 70. Performance studies regarding devices bearing the CE marking
Article 71. Substantial modifications to performance studies
Article 72. Corrective measures to be taken by Member States and information exchange between Member States on performance studies
Article 73. Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
Article 74. Coordinated assessment procedure for performance studies
Article 75. Review of the coordinated assessment procedure
Article 76. Recording and reporting of adverse events that occur during performance studies
Article 77. Implementing acts
CHAPTER VII. POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
Section 1. Post-market surveillance
Article 78. Post-market surveillance system of the manufacturer
Article 79. Post-market surveillance plan
Article 80. Post-market surveillance report
Article 81. Periodic safety update report
Section 2. Vigilance
Article 82. Reporting of serious incidents and field safety corrective actions
Article 83. Trend reporting
Article 84. Analysis of serious incidents and field safety corrective actions
Article 85. Analysis of vigilance data
Article 86. Implementing acts
Article 87. Electronic system on vigilance and post-market surveillance
Section 3. Market surveillance
Article 88. Market surveillance activities
Article 89. Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 90. Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 91. Procedure for evaluating national measures at Union level
Article 92. Other non-compliance
Article 93. Preventive health protection measures
Article 94. Good administrative practice
Article 95. Electronic system on market surveillance
CHAPTER VIII. COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
Article 96. Competent authorities
Article 97. Cooperation
Article 98. Medical Device Coordination Group
Article 99. Tasks of the MDCG
Article 100. The European Union reference laboratories
Article 101. Device registers and databanks
CHAPTER IX. CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 102. Confidentiality
Article 103. Data protection
Article 104. Levying of fees
Article 105. Funding of activities related to designation and monitoring of notified bodies
Article 106. Penalties
CHAPTER X. FINAL PROVISIONS
Article 107. Committee procedure
Article 108. Exercise of the delegation
Article 109. Separate delegated acts for different delegated powers
Article 110. Transitional provisions
Article 111. Evaluation
Article 112. Repeal
Article 113. Entry into force and date of application
ANNEXES. ANNEX I

5.5.2017

Official Journal of the European Union

L 117/176

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 April 2017

on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on

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