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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 28 – UDI database

The Commission, after consulting the MDCG shall set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of
Annex VI
⁠
.
When designing the UDI database, the Commission shall take into account the general principles set out in Section 5 of Part C of
Annex VI
⁠
. The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.
The core data elements to be provided to the UDI database, referred to in Part B of
Annex VI
⁠
, shall be accessible to the public free of charge.
The technical design of the UDI database shall ensure maximum accessibility to information stored therein, including multi-user access and automatic uploads and downloads of that information. The Commission shall provide for technical and administrative support to manufacturers and other users of the UDI database.

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