Find a Notified Body for IVDR Certification
In-vitro diagnostic devices above Class A (self-testing/sterile aside) need conformity assessment from a Notified Body designated under IVDR 2017/746. Filter this directory by IVDR designation and country, or describe your device and reach several matching bodies at once.
Which IVD risk classes need a Notified Body under IVDR?
| Risk class | NB involvement |
|---|---|
| Class A, non-sterile | Not required — self-declaration |
| Class A, sterile | Required for the sterility aspect only |
| Class B | Required — technical documentation assessment (sampling basis) |
| Class C | Required — technical documentation assessment |
| Class D | Required — full technical documentation assessment plus batch verification and EU reference laboratory involvement where designated |
Why capacity is especially tight for IVDR
IVDR pulled a much larger share of the IVD market into mandatory third-party assessment than the directive it replaced, while the pool of IVDR-designated Notified Bodies grew far more slowly. Designated scope is coded by IVD categories in EUDAMED, so two IVDR-designated bodies can still cover completely different test types — matching a specific device to open capacity takes real research.
Frequently asked questions
- Do all IVDs need an IVDR Notified Body?
- No. Class A devices (non-sterile) can self-declare. Class A sterile, all of Class B, C, and D in-vitro diagnostics need Notified Body involvement — a much bigger share of the market than under the old IVD Directive, where roughly 80% of devices were self-certified.
- Why is IVDR Notified Body capacity even tighter than MDR?
- IVDR designation only ramped up meaningfully from 2022 onward, well behind MDR — far fewer bodies are currently designated for IVDR than for MDR, while a much larger share of IVDs now require third-party assessment than before. Waitlists and narrow designated scopes are common.
- What do I need before contacting an IVDR Notified Body?
- Device risk class (A/B/C/D) under IVDR Annex VIII rules, intended purpose, and the state of your performance evaluation documentation. Precise classification matters more here than under MDR since the class boundaries directly gate which conformity route applies.
- How does this directory help?
- Filter Notified Bodies by IVDR designation and country directly — every listing shows real contact details, no account required. Describe your device once and reach several matching bodies at once instead of researching each in EUDAMED individually.