JavaScript required
We’re sorry, but Coda doesn’t work properly without JavaScript enabled.
Skip to content
Gallery
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
More
Share
Explore
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Article 57 – Electronic system on notified bodies and on certificates of conformity
The Commission, after consulting the MDCG, shall set up and manage an electronic system to collate and process the following information:
the list of subsidiaries referred to in
Article 37(3)
;
the list of experts referred to in
Article 40(2)
;
the information relating to the notification referred to in
Article 42(10)
and the amended notifications referred to in
Article 46(2)
;
the list of notified bodies referred to in
Article 43(2)
;
the summary of the report referred to in
Article 44(12)
;
the notifications for conformity assessments and certificates referred to in
Articles 54(3)
and
55(1)
;
withdrawal or refusals of applications for the certificates as referred to in
Article 53(2)
and Section 4.3 of
Annex VII
;
the information regarding certificates referred to in
Article 56(5)
;
the summary of safety and clinical performance referred to in
Article 32
.
The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, where appropriate to the notified bodies and where provided elsewhere in this regulation or in
Regulation (EU) 2017/746
to the public.
Want to print your doc?
This is not the way.
Try clicking the ⋯ next to your doc name or using a keyboard shortcut (
Ctrl
P
) instead.
