ANNEX III

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 to 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.

(a)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.
(b)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 riskmanagement 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.

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

Article 92

Electronic system on vigilance and on post-market surveillance

1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:

(a)the reports by manufacturers on serious incidents and field safety
corrective actions referred to in Article 87(1) and Article 89(5);
(b)the periodic summary reports by manufacturers referred to in
Article 87(9);
(c)the reports by manufacturers on trends referred to in Article 88;
(d)the PSURs referred to in Article 86;
(e)the field safety notices by manufacturers referred to in Article 89(8);
(f)the information to be exchanged between the competent authoritiesof 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.

2. 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.

3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1.

4. 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.

5. 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.

6. 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.

7. 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:

(a)the Member States in which the field safety corrective action is
being or is to be undertaken;
(b)the Member State in which the manufacturer has its registered place of business.

8. 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:

(a)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;
(b)the Member State in which the manufacturer has its registered place of business.

9. 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.

MDR – Article 85 – Post-market surveillance report

Article 85

Post-market surveillance report

Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.

MDR – Article 84 – Post-market surveillance plan

Article 84

Post-market surveillance plan

The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices other than custom-made devices, the post- market surveillance plan shall be part of the technical documentation specified in Annex II.

MDR – Article 83 – Post-market surveillance system of the manufacturer

Article 83

Post-market surveillance system of the manufacturer

1. 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).

2. 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.

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

(a)to update the benefit-risk determination and to improve the risk
management as referred to in Chapter I of Annex I;
(b)to update the design and manufacturing information, the
instructions for use and the labelling;
(c)to update the clinical evaluation;
(d)to update the summary of safety and clinical performance referred to in Article 32;
(e)for the identification of needs for preventive, corrective or field
safety corrective action;
(f)for the identification of options to improve the usability,
performance and safety of the device;
(g)when relevant, to contribute to the post-market surveillance of other devices; and
(h)to detect and report trends in accordance with Article 88.

The technical documentation shall be updated accordingly.

4. 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.