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CATEGORY: SAFETY SURVEILLANCE
Market Surveillance
Activities carried out by competent authorities to verify that medical devices on the market comply with applicable regulations. Under EU MDR, member state authorities conduct both proactive and reactive market surveillance.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Market surveillance is the set of activities by competent authorities (and manufacturer post-market systems) to ensure devices on the market remain compliant and safe—distinct from, but related to, manufacturer PMS.
PROCESS / STEPS
- Authorities inspect, sample, and enforce; manufacturers must cooperate and respond to requests.
- Manufacturers run PMS/vigilance to detect issues early and support authority actions.
- Field safety corrective actions and recalls are coordinated under national rules.
- Keep distribution records to support rapid market actions.
EXAMPLES
- An EU competent authority market surveillance inspection may review technical documentation sampling and vigilance files.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Market Surveillance across 27 authorities in real time.
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