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