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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 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

Article 25 – Identification within the supply chain

Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
Economic operators shall be able to identify the following to the competent authority, for the period referred to in
Article 10(8)
⁠
:
any economic operator to whom they have directly supplied a device;
any economic operator who has directly supplied them with a device;
any health institution or healthcare professional to which they have directly supplied a device.

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