KATEGORIE: CLASSIFICATION

Klasse-II-Medizinprodukt

Medizinprodukte mit mittlerem Risiko, die in den USA typischerweise eine 510(k)-Zulassung erfordern. Die meisten Medizinprodukte fallen in diese Kategorie.

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

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