Private Health Journal

Glossary · Regulation

Post-Market Surveillance

PMS · post-market monitoring

Post-Market Surveillance

Regulatory

Systematic collection and review of a device's real-world performance after it is placed on the market.

For learning systems this is where degradation is caught; a model that passed validation can fail quietly in a new population.

Context

SourceRegulation (EU) 2017/745 (MDR), Art. 83–86