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Klinischer Bewertungsbericht (CER)
Ein durch die EU MDR vorgeschriebenes Dokument mit der klinischen Bewertung eines Medizinprodukts.
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 Klinischer Bewertungsbericht (CER) across 27 authorities in real time.
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