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GLOSSARYEU

Post-Market Surveillance

Activities a manufacturer performs with other economic operators to set up and maintain a systematic procedure. The procedure proactively collects and reviews experience from devices on the market, so that any need for immediate corrective or preventive action is identified.

Where it is written
Regulation (EU) 2017/745, Article 2(60)
Also called
PMS

Avoid This Mistake

The definition covers activities performed in cooperation with other economic operators, so post-market surveillance is wider than the manufacturer's own data collection.

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