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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 43 – Identification number and list of notified bodies

The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with
Article 42(11)
⁠
. It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.
The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in
Article 57
⁠
. The Commission shall ensure that the list is kept up to date.

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