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CATÉGORIE: CLASSIFICATION
Dispositif médical de Classe III
La catégorie de risque la plus élevée aux États-Unis, nécessitant une approbation PMA. Exemples : stimulateurs cardiaques, valves cardiaques et stents à élution.
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 III is the highest US risk class—usually PMA—covering life-supporting/implantable or high-risk devices.
PROCESS / STEPS
- Confirm Class III status early in development.
- Plan clinical evidence and manufacturing controls.
- Execute PMA strategy and post-approval commitments.
EXAMPLES
- Pacemakers and many high-risk implants are Class III.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Dispositif médical de Classe III across 27 authorities in real time.
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