EU MDR

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 83 – Post-market surveillance system of the manufacturer

For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system referred to in

Article 10(9)⁠

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

Data gathered by the manufacturer’s post-market surveillance system shall in particular be used:

to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of

Annex I⁠

;

to update the design and manufacturing information, the instructions for use and the labelling;

to update the clinical evaluation;

to update the summary of safety and clinical performance referred to in

Article 32⁠

;

for the identification of needs for preventive, corrective or field safety corrective action;

for the identification of options to improve the usability, performance and safety of the device;

when relevant, to contribute to the post-market surveillance of other devices; and

to detect and report trends in accordance with

Article 88⁠

. The technical documentation shall be updated accordingly.

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with

Article 87⁠

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