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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 4 (Art 35 - 50) – Notified bodies

Article 40 – Nomination of experts for joint assessment of applications for notification

The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of medical devices to participate in the activities referred to in
Articles 39
⁠
and
48
⁠
.
The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in
Article 57
⁠
.

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