Find a Notified Body for IVDR Certification

When do you need an IVDR Notified Body?

Under IVDR 2017/746, most in vitro diagnostic medical devices require third-party conformity assessment by a Notified Body. Only Class A non-sterile devices can self-declare without NB involvement. All Class B, C and D devices — which cover the vast majority of IVDs — require a designated NB.

IVDR Notified Body capacity is extremely limited. Per the EC's 20th NB Survey (published 2 July 2026, data as of 28 February 2026), only 19 NBs are designated under IVDR — versus 52 designated under MDR — and many have restricted scope or long queues. Early engagement with a suitable NB is critical for any IVDR compliance timeline.

IVDR device classes and NB requirements

Device Class	NB Involvement	Key Assessment
Class A non-sterile	No NB — self-declaration	—
Class A sterile	NB for sterility aspects only	Annex XI
Class B	Yes	Annex IX or XI
Class C	Yes — technical documentation + QMS audit	Annex IX + X
Class D	Yes — strictest scrutiny, EU reference laboratory	Annex IX + batch verification
Companion diagnostics	Yes + medicinal product authority coordination	Annex IX

Why finding an IVDR Notified Body is difficult

Very few NBs are currently designated under IVDR, and designation scopes vary significantly. Some NBs only cover specific IVD categories. Cold outreach to NBs for IVDR often results in long response times, scope mismatches, or no response at all.

Finding an NB that covers your specific IVD category, has current capacity, and is accepting new clients requires insight that is not easily available from EUDAMED alone.

How ECP matching works

Describe your IVD — classification, intended purpose, intended users, performance data status, and IVDR transition timeline. ECP routes your request to Notified Bodies with matching scope and available capacity. You receive NB responses directly with scope confirmation, indicative timelines and next steps.