类别: REGULATORY PATHWAYS

公告机构

由欧盟成员国指定的评估医疗器械是否符合EU MDR要求的机构。公告机构负责技术文件审查、质量体系审核并颁发CE证书。

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

EU NANDO ↗

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