Post-market surveillance (PSUR) and post-market clinical surveillance (PMCF)

The Regulation (EU) 2017/745 of the European Parliament and Council, of April 5th, 2017, concerning medical devices, will come into force from 25/05/2021. The regulation (according to ANNEX III of the TECHNICAL DOCUMENTATION ON POST-MARKETING SURVEILLANCE) requires that post-marketing surveillance be carried out by means of
– PSUR post-market surveillance report
– PMCF Post-Marketing Clinical Monitoring Report

The study proposes, according to the market and the type of device, to issue the mentioned reports as follows:
1. Definition of the list of medical devices and registration of the results;
2. Issuance of PMS post-marketing surveillance plans;
3. Conducting studies and collecting data;
4. Evaluation, according to the number of similar products on the market, of the repercussion of accidents and incidents in the sector (search for the improbability that happens / 10 to the minus 6) and;
5. Issuance of surveillance reports.

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