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类别: SAFETY SURVEILLANCE
警戒
医疗器械上市后系统性监控和报告不良事件及现场安全纠正措施的过程。根据EU MDR，制造商必须向主管部门报告严重事件。
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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