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KATEGORIE: CLASSIFICATION
Klasse-III-Medizinprodukt
Die höchste Risikokategorie für Medizinprodukte in den USA, die eine PMA-Genehmigung erfordert. Beispiele: Herzschrittmacher, Herzklappen und medikamentenbeschichtete Stents.
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 Klasse-III-Medizinprodukt across 27 authorities in real time.
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