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CATÉGORIE: CLINICAL
Preuves cliniques
Les données de sécurité et de performance générées par l'utilisation clinique d'un dispositif médical.
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
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
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