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CATEGORY: CLINICAL
Clinical Evidence
The safety and performance data generated through clinical use of a medical device, including data from clinical investigations, published literature, and post-market surveillance. EU MDR requires a higher standard of clinical evidence than the previous MDD.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Clinical evidence is the clinical data and evaluation results that support conformity with safety and performance requirements (EU MDR) or reasonable assurance of safety and effectiveness (FDA). It underpins CER, submissions, and SSCP.
PROCESS / STEPS
- Define clinical claims and equivalent devices carefully.
- Appraise literature, investigations, and PMCF/RWE systematically.
- Analyze benefit-risk with residual risks and uncertainties.
- Update evidence continuously via PMS.
EXAMPLES
- A well-known Class IIa device may rely heavily on literature equivalence; novel implants usually need device-specific investigations.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Clinical Evidence across 27 authorities in real time.
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