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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 5 (Art. 51 – 60) Classification and conformity assessment

Article 58 – Voluntary change of notified body

In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
the date on which the certificates issued by the outgoing notified body become invalid;
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;
the transfer of documents, including confidentiality aspects and property rights;
the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;
the last serial number or lot number for which the outgoing notified body is responsible.
The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
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