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類別: SAFETY SURVEILLANCE
警戒
醫療器材上市後系統性監控和報告不良事件及現場安全糾正措施的過程。根據EU MDR，製造商必須向主管部門報告嚴重事件。
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
Track regulatory signals related to 警戒 across 27 authorities in real time.
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