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Benannte Stelle
Eine von einem EU-Mitgliedstaat benannte Organisation zur Bewertung der Konformität von Medizinprodukten mit der EU MDR. Benannte Stellen führen technische Dokumentationsprüfungen und QMS-Audits durch.
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
Notified Bodies assess conformity of most Class IIa+ devices (and certain Class I variants) under EU MDR/IVDR. They do not replace the manufacturer’s legal responsibility for the device.
PROCESS / STEPS
- Select an NB designated for your device codes and technologies (NANDO database).
- Apply for conformity assessment under the correct annex route.
- Submit technical documentation and host QMS audits.
- Close nonconformities; receive CE certificate with scope and conditions.
- Maintain surveillance audits and certificate renewals.
EXAMPLES
- Implantable devices and many software devices require NB review under MDR.
RELATED GUIDES & TOOLS
SOURCES
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