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类别: CLINICAL
临床评价
系统性和计划性地持续产生、收集、分析和评估医疗器械临床数据的过程。根据EU MDR，需要在器械整个生命周期内进行临床评价，并记录在临床评价报告（CER）中。
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 evaluation continuously appraises clinical data to support safety and performance claims—central under EU MDR and reflected in CER documentation.
PROCESS / STEPS
- Define clinical questions from intended purpose and risks.
- Identify clinical data (investigations, literature, experience).
- Appraise and analyze; update CER and risk/benefit conclusions.
- Feed PMCF and PMS when residual questions remain.
EXAMPLES
- CER updates after significant design or indication changes.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 临床评价 across 27 authorities in real time.
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