CATEGORY: REGULATORY PATHWAYS

Notified Body

An organization designated by an EU member state to assess conformity of medical devices with EU MDR requirements. Notified Bodies conduct technical documentation reviews, quality system audits, and issue CE certificates.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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

EU NANDO ↗

Track regulatory signals related to Notified Body across 27 authorities in real time.

START FREE →