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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Annexes

Annex 3 – Technical documentation on post-market surveillance

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with

Articles 83⁠

86⁠

shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

1.1

The post-market surveillance plan drawn up in accordance with

Article 84⁠

The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in

Article 83⁠

The post-market surveillance plan shall address the collection and utilization of available information, in particular:

information concerning serious incidents, including information from PSURs, and field safety corrective actions;

records referring to non-serious incidents and data on any undesirable side-effects;

information from trend reporting;

relevant specialist or technical literature, databases and/or registers;

information, including feedbacks and complaints, provided by users, distributors and importers; and

publicly available information about similar medical devices.

The post-market surveillance plan shall cover at least:

a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;

effective and appropriate methods and processes to assess the collected data;

suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of

Annex I⁠

;

effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;

methods and protocols to manage the events subject to the trend report as provided for in

Article 88⁠

, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;

methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;

reference to procedures to fulfil the manufacturers obligations laid down in

Articles 83⁠

84⁠

and

86⁠

;

systematic procedures to identify and initiate appropriate measures including corrective actions;

effective tools to trace and identify devices for which corrective actions might be necessary; and

a PMCF plan as referred to in Part B of

Annex XIV⁠

, or a justification as to why a PMCF is not applicable.

1.2

The PSUR referred to in

Article 86⁠

and the post-market surveillance report referred to in

Article 85⁠

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