類別: REGULATORY PATHWAYS

公告機構

由歐盟成員國指定的評估醫療器材是否符合EU MDR要求的機構。公告機構負責技術文件審查、品質體系審核並頒發CE證書。

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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