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

Article 92 – Electronic system on vigilance and on post-market surveillance

The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
the reports by manufacturers on serious incidents and field safety corrective actions referred to in
Article 87(1)
⁠
and
Article 89(5)
⁠
;
the periodic summary reports by manufacturers referred to in
Article 87(9)
⁠
;
the reports by manufacturers on trends referred to in
Article 88
⁠
;
the PSURs referred to in
Article 86
⁠
;
the field safety notices by manufacturers referred to in
Article 89(8)
⁠
;
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with
Article 89(7) and (9)
⁠
.
That electronic system shall include relevant links to the UDI database.
The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission. The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with
Article 53
⁠
.
The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1.
On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.
The reports on serious incidents referred to in point
(a) of Article 87(1)
⁠
shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred.
The trend reports referred to in
Article 88(1)
⁠
shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member State in which the incidents occurred.
The reports on field safety corrective actions referred to in point
(b) of Article 87(1)
⁠
shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:
the Member States in which the field safety corrective action is being or is to be undertaken;
the Member State in which the manufacturer has its registered place of business.
The periodic summary reports referred to in
Article 87(9)
⁠
shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
the Member State or Member States participating in the coordination procedure in accordance with
Article 89(9)
⁠
and which have agreed on the periodic summary report;
the Member State in which the manufacturer has its registered place of business.
The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with
Article 56
⁠
.
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