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类别: DOCUMENTATION
临床评价报告(CER)
EU MDR要求的文件，呈现医疗器械的临床评价，包括临床数据分析、残余风险识别和获益-风险结论。必须在器械整个生命周期内更新。
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
A Clinical Evaluation Report (CER) documents the clinical evaluation process and conclusions supporting device safety and performance under EU MDR.
PROCESS / STEPS
- Define clinical claims and data requirements.
- Collect literature, investigations, and experience data.
- Appraise and analyze; conclude benefit-risk.
- Update CER with PMCF/PMS inputs on schedule.
EXAMPLES
- Class III and implantable devices face the highest expectations for CER depth and currency.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 临床评价报告(CER) across 27 authorities in real time.
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