[1] Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.
A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in.
The Medical Device Regulation (EU) 2017/745 (MDR) provides in §2 the following definition of post-market surveillance: ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;Further requirements on PMS are given in §83 of the MDR; §84 details PMS Plan requirements and references Section 1.1 of Annex III of the MDR; §85 details the PMS report, while §86 describes the contents of the Periodic Safety Update Report (PSUR).
Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (IVDR).
[3][4][5] The MDCG Guideline 2023-3 "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides further clarification on the topic.