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CATÉGORIE: CLASSIFICATION
Dispositif médical de Classe II
Dispositifs médicaux à risque modéré nécessitant généralement une clearance 510(k) aux États-Unis. La plupart des dispositifs médicaux appartiennent à cette catégorie.
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
Class II devices present moderate risk and typically need 510(k) in the US (with exemptions). Classification drives testing, clinical expectations, and postmarket burden.
PROCESS / STEPS
- Confirm product code and class.
- Select pathway (often 510(k)).
- Plan performance testing and labeling.
- Maintain QMS and postmarket reporting.
EXAMPLES
- Many infusion pumps and monitoring accessories are Class II.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Dispositif médical de Classe II across 27 authorities in real time.
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