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CATÉGORIE: SAFETY SURVEILLANCE
Vigilance
Le processus systématique de surveillance et de signalement des événements indésirables et des actions correctives de sécurité pour les dispositifs médicaux après leur mise 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
Vigilance is post-market incident reporting and field safety systems—EU MDR serious incidents/FSCA, FDA MDR, and equivalent national schemes.
PROCESS / STEPS
- Define intake, triage, and reportability criteria in the QMS.
- Investigate root cause and related devices/lots.
- Report within statutory clocks to authorities/NBs.
- Decide FSCA/recall communications and effectiveness checks.
EXAMPLES
- A serious incident in the EU may require reporting to the competent authority and NB under MDR timelines.
RELATED GUIDES & TOOLS
SOURCES
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