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EU MDR
Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
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Annexes
Annex 1 – General safety and performance requirements
Annex 2 – Technical documentation
Annex 3 – Technical documentation on post-market surveillance
Annex 4 – EU declaration of conformity
Annex 5 – CE marking of conformity
Annex 6 – Information 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
Annex 7 – Requirements to be met by notified bodies
Annex 8 – Classification rules
Annex 9 – Conformity assessment based on a quality management system and assessment of the technical documentation
Annex 10 – Conformity assessment based on type examination
Annex 11 – Conformity assessment based on product conformity verification
Annex 12 – Certificates issued by a notified body
Annex 13 – Procedure for custom-made devices
Annex 14 – Clinical evaluation and post-market clinical follow-up
Annex 15 – Clinical investigations
Annex 16 – List of groups of products without an intended medical purpose referred to in Article 1(2)
Annex 17 – Correlation table
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Annexes
