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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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Article 29 – Registration of devices

Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in
Article 27(2)
⁠
, assign a Basic UDI-DI as defined in Part C of
Annex VI
⁠
to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of
Annex VI
⁠
related to that device.
Before placing on the market a system or procedure pack pursuant to
Article 22(1)
⁠
and (3), that is not a custom- made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of
Annex VI
⁠
related to that system or procedure pack.
For devices that are the subject of a conformity assessment as referred to in
Article 52(3)
⁠
and in the second and third subparagraphs of
Article 52(4)
⁠
, the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of
Annex XII
⁠
and confirm in Eudamed that the information referred to in Section 2.2 of Part A of
Annex VI
⁠
is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of
Annex VI
⁠
related to that device.
Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of
Annex VI
⁠
, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
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