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CATÉGORIE: REGULATORY PATHWAYS
Organisme notifié
Un organisme désigné par un État membre de l'UE pour évaluer la conformité des dispositifs médicaux aux exigences de l'EU MDR. Les organismes notifiés effectuent des examens de documentation technique et délivrent des certificats CE.
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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