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類別: CLINICAL
臨床證據
透過醫療器材臨床使用產生的安全性和性能數據，包括來自臨床調查、已發表文獻和上市後監管的數據。EU MDR要求比之前MDD更高標準的臨床證據。
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
Clinical evidence is the clinical data and evaluation results that support conformity with safety and performance requirements (EU MDR) or reasonable assurance of safety and effectiveness (FDA). It underpins CER, submissions, and SSCP.
PROCESS / STEPS
- Define clinical claims and equivalent devices carefully.
- Appraise literature, investigations, and PMCF/RWE systematically.
- Analyze benefit-risk with residual risks and uncertainties.
- Update evidence continuously via PMS.
EXAMPLES
- A well-known Class IIa device may rely heavily on literature equivalence; novel implants usually need device-specific investigations.
RELATED GUIDES & TOOLS
SOURCES
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