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CATEGORY: SAFETY SURVEILLANCE
Vigilance
The systematic process of monitoring and reporting adverse events and field safety corrective actions for medical devices after they reach the market. Under EU MDR, manufacturers must report serious incidents to competent authorities.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to Vigilance across 27 authorities in real time.
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