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类别: SAFETY SURVEILLANCE
上市后监管(PMS)
医疗器械上市后系统性收集、分析和解读数据。根据EU MDR，制造商必须实施与器械风险等级相称的主动PMS体系。
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
Post-market surveillance systematically collects and analyzes real-world device experience after launch. Under EU MDR it must be proactive and proportionate to risk class.
PROCESS / STEPS
- Write a PMS plan linked to residual risks and clinical questions.
- Collect complaints, literature, registries, and regulatory signals.
- Analyze trends; feed CAPA, risk file, and clinical evaluation.
- Produce PSUR/PMS reports on the required cadence.
EXAMPLES
- Class III implants typically need denser PMCF/PMS than Class I devices.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 上市后监管(PMS) across 27 authorities in real time.
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