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CATÉGORIE: CLASSIFICATION
Règle de classification
Les critères réglementaires utilisés pour déterminer la classe de risque d'un dispositif médical. L'Annexe VIII de l'EU MDR contient 22 règles de classification.
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
Classification rules (e.g., EU MDR Annex VIII, IMDRF principles, national rule sets) determine device risk class and therefore pathway, clinical evidence, and audit intensity.
PROCESS / STEPS
- Identify all applicable rules; apply the strictest relevant class when multiple rules apply.
- Document borderline analysis and intended purpose carefully—classification follows claims and use.
- Reassess after design or indication changes.
- Align class with QMS, labeling, and economic operator duties.
EXAMPLES
- A software that provides diagnostic information may jump classes versus software that only stores data.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Règle de classification across 27 authorities in real time.
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