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CATEGORY: CLINICAL
Clinical Evaluation
A systematic and planned process to continuously generate, collect, analyze, and assess clinical data pertaining to a medical device. Under EU MDR, clinical evaluation is required throughout the device lifecycle and must be documented in a Clinical Evaluation Report (CER).
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Clinical Evaluation across 27 authorities in real time.
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