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類別: DOCUMENTATION
臨床評價報告(CER)
EU MDR要求的文件，呈現醫療器材的臨床評價，包括臨床數據分析、殘餘風險識別和獲益-風險結論。必須在器材整個生命週期內更新。
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 臨床評價報告(CER) across 27 authorities in real time.
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