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CATÉGORIE: SAFETY SURVEILLANCE

Surveillance du marché

Activités menées par les autorités compétentes pour vérifier la conformité des dispositifs médicaux sur le marché.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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

  1. Authorities inspect, sample, and enforce; manufacturers must cooperate and respond to requests.
  2. Manufacturers run PMS/vigilance to detect issues early and support authority actions.
  3. Field safety corrective actions and recalls are coordinated under national rules.
  4. 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

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