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CATEGORY: DOCUMENTATION
Clinical Evaluation Report (CER)
A document required by EU MDR that presents the clinical evaluation of a medical device, including analysis of clinical data, identification of residual risks, and the benefit-risk conclusion. Must be updated throughout the device lifecycle.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Clinical Evaluation Report (CER) across 27 authorities in real time.
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