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
Share
Explore
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance

Article 100 – Electronic system on market surveillance

The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
summaries of the results of the surveillance activities referred to in
Article 93(4)
⁠
;
the final inspection report referred to in
Article 93(7)
⁠
;
information in relation to devices presenting an unacceptable risk to health and safety as referred to in
Article 95(2), (4) and (6)
⁠
;
information in relation to non-compliance of products as referred to in
Article 97(2)
⁠
;
information in relation to the preventive health protection measures referred to in
Article 98(2)
⁠
;
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in
Article 93(8)
⁠
.
The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with
Article 56
⁠
for the device concerned and be accessible to the Member States and to the Commission.
Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.
Want to print your doc?
This is not the way.
Try clicking the ⋯ next to your doc name or using a keyboard shortcut (
CtrlP
) instead.