Annex III of the MDR is cited less often than Annex II, but it is just as mandatory. It does not deal with manufacturing: it defines the technical documentation on post-market surveillance (PMS) that the manufacturer draws up in accordance with Articles 83 to 86. This documentation must be presented in a clear, organised, readily searchable and unambiguous manner.
Annex II and Annex III: two complementary sets of documentation
Annex II describes the device as it is placed on the market: description, information supplied by the manufacturer, design and manufacturing, general safety and performance requirements, risk management, verification and validation. Manufacturing information (processes and their validation, continuous monitoring, final product testing, manufacturing sites, suppliers and sub-contractors) belongs to its Section 3.
Annex III organises what happens after placing on the market: how the manufacturer collects and uses field data, and what it concludes from them. PMS conclusions feed into the update of the benefit-risk analysis, risk management and clinical evaluation documented under Annex II.
The content of Annex III
Annex III has two parts.
Section 1.1 — The post-market surveillance plan (Article 84). The manufacturer demonstrates in it that it complies with the obligation in Article 83. The plan addresses the collection and use of available information, in particular: serious incidents (including information from PSURs) and field safety corrective actions; non-serious incidents and undesirable side-effects; trend reporting; relevant literature, databases and registers; feedback and complaints from users, distributors and importers; publicly available information about similar devices.
It covers at least: a proactive and systematic process for collecting this information; methods for assessing the data; indicators and threshold values for the continuous reassessment of the benefit-risk analysis and risk management; methods for investigating complaints and analysing field experience; methods for managing events subject to trend reporting (Article 88); arrangements for communicating with competent authorities, notified bodies, economic operators and users; procedures for identifying and initiating appropriate measures, including corrective actions; tools for tracing the devices concerned; and the PMCF plan (Annex XIV, Part B) or a justification of why it is not applicable.
Section 1.2 — The PSUR or the post-market surveillance report. The PMS report (Article 85) concerns class I devices and is updated when necessary. The periodic safety update report (PSUR, Article 86) concerns classes IIa, IIb and III: it is updated at least annually for classes IIb and III, and at least every two years for class IIa.
Consistency with the ISO 13485 QMS
This is a point notified bodies check systematically: consistency between the PMS plan and the processes actually in place in the QMS, in particular feedback, complaint handling, reporting to authorities, analysis of data and corrective action (clauses 8.2.1, 8.2.2, 8.2.3, 8.4 and 8.5.2 of ISO 13485:2016).
The technical documentation must also be kept up to date (Article 10(4)). A PMS plan that is no longer applied, indicators that are never reassessed or a PSUR that does not reflect field data are frequent nonconformities, as is a manufacturing process changed without updating Section 3 of Annex II.
Regulatory source: Annexes II and III and Articles 83 to 86 of Regulation (EU) 2017/745 — EUR-Lex