← 所有术语
类别: CLINICAL
临床证据
通过医疗器械临床使用产生的安全性和性能数据，包括来自临床调查、已发表文献和上市后监管的数据。EU MDR要求比之前MDD更高标准的临床证据。
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
Track regulatory signals related to 临床证据 across 27 authorities in real time.
START FREE →