IVDR Notified Body
Submit one structured request with your IVD device class, intended purpose and current documentation status — the scope can be matched with Notified Bodies designated under IVDR 2017/746 with the right scope and available capacity.
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. As of 2024, only a small number of NBs are designated under IVDR, and many have restricted scope or long queues. Early engagement with a suitable NB is critical for any IVDR compliance timeline.
| 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 |
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.
Describe your IVD — classification, intended purpose, intended users, performance data status, and IVDR transition timeline. A prepared request can be sent to Notified Bodies with matching scope and available capacity. You receive NB responses directly with scope confirmation, indicative timelines and next steps.
Send the product details and we will suggest the next practical compliance step.