Compliance
Notified Body
TL;DR
An EU-designated conformity-assessment organisation that audits manufacturers and dossiers under MDR/IVDR before CE Marking can be applied.
Notified Bodies (NBs) are designated by Member State authorities under Regulation (EU) 2017/745 / 2017/746 and listed in NANDO. For Class IIa and above (MDR) and Class B and above (IVDR) the NB reviews technical documentation, audits the QMS, may sample-test devices, and issues the CE certificate. Annual surveillance audits and unannounced audits are part of the regime.
NB capacity has been the chronic bottleneck of MDR/IVDR; engaging an NB early in the project is now standard practice.
Regulatory anchors
- Regulation (EU) 2017/745 Annex VII
- NANDO database
Related terms
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