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KATEGORIE: SAFETY SURVEILLANCE
Vigilanz
Der systematische Prozess der Überwachung und Meldung von unerwünschten Ereignissen und Sicherheitskorrekturmaßnahmen für Medizinprodukte nach der Markteinführung.
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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