← Alle Begriffe
KATEGORIE: CLASSIFICATION
Klasse-I-Medizinprodukt
Die niedrigste Risikokategorie für Medizinprodukte. In den USA sind die meisten Klasse-I-Produkte von der 510(k)-Pflicht befreit.
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 I devices are lowest risk. Many US Class I devices are 510(k)-exempt; EU Class I may be self-declared except sterile/measuring/reusable surgical variants needing NB involvement.
PROCESS / STEPS
- Confirm classification and exemptions.
- Implement proportionate QMS and labeling.
- Register/list as required (US establishment registration/device listing).
- Monitor postmarket complaints even for low-risk devices.
EXAMPLES
- Elastic bandages and many manual instruments are typical Class I examples (check current product codes).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Klasse-I-Medizinprodukt across 27 authorities in real time.
START FREE →