Post-market surveillance

Under the EU MDR and IVDR, PMS is a planned, proactive system, not a complaint inbox. Its results feed risk management, clinical or performance evaluation, labeling and CAPA, and they are summarized in the PMSR or PSUR.

‘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;

EU MDR, Article 2(60)

‘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;

IVDR, Article 2(63)

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.

21 CFR, 822.3

systematic process to collect and analyse experience gained from medical devices that have been placed on the market

ISO 13485:2016, clause 3.14