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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 55 – Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices

A notified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to
Article 54(1)
⁠
. Such notification shall take place through the electronic system referred to in
Article 57
⁠
and shall include the summary of safety and clinical performance pursuant to
Article 32
⁠
, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of
Annex I
⁠
, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of
Annex IX
⁠
or Section 6 of
Annex X
⁠
, as applicable. In the case of divergent views between the notified body and the expert panels, a full justifi? cation shall also be included.
A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with
Article 44
⁠
,
45
⁠
,
46
⁠
,
47
⁠
or
94
⁠
and, where deemed necessary, take appropriate measures in accordance with
Articles 95
⁠
and
97
⁠
.
The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.

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