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类别: SAFETY SURVEILLANCE
不良事件
与医疗器械使用相关的任何不良临床事件，无论是否由器械引起。制造商必须在规定时间内向监管机构报告某些不良事件。
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
An adverse event is an undesirable clinical occurrence associated with device use—whether or not device-caused. Reportability depends on jurisdiction and seriousness.
PROCESS / STEPS
- Capture event details, device identifiers, and patient outcomes.
- Assess seriousness, causality, and reportability clocks.
- File MDR/vigilance reports as required; update risk files.
- Trend similar events for signals and CAPA.
EXAMPLES
- Malfunction without injury may still be reportable if recurrence could cause serious injury.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 不良事件 across 27 authorities in real time.
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