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類別: SAFETY SURVEILLANCE
上市後監管(PMS)
醫療器材上市後系統性收集、分析和解讀數據。根據EU MDR，製造商必須實施與器材風險等級相稱的主動PMS體系。
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 上市後監管(PMS) across 27 authorities in real time.
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