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KATEGORIE: CLASSIFICATION
Klasse IIa (EU MDR)
Eine Geräteklasse mit mittlerem bis niedrigem Risiko unter der EU MDR. Klasse IIa erfordert die Beteiligung einer Benannten Stelle.
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
Under EU MDR, Class IIa covers medium-risk devices (e.g., many short-term invasive devices). Classification uses Annex VIII rules and drives Notified Body involvement and clinical evidence depth.
PROCESS / STEPS
- Apply MDR classification rules carefully (duration of use, invasiveness, active nature).
- Engage a Notified Body for conformity assessment appropriate to Annex IX/X/XI route.
- Build technical documentation, CER, and PMS/PMCF proportionate to risk.
- Maintain certificates and EUDAMED registration obligations.
EXAMPLES
- Hearing aids, short-term catheters, and many diagnostic devices fall in IIa depending on rules.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Klasse IIa (EU MDR) across 27 authorities in real time.
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