Find an MDR or IVDR Notified Body (2026)

Current EU Notified Body snapshot

The European Commission's 20th Notified Body survey, published on 2 July 2026 with a data cutoff of 28 February 2026, reported 53 active respondents: 52 designated under MDR and 19 designated under IVDR. Some bodies held both designations, so the two regulation counts must not be added together.

Which device classes need a Notified Body?

Use the two official systems for different checks

Build a shortlist that is actually valid

1. Confirm the product is a medical device or IVD and document its MDR/IVDR classification.
2. Map the device to the applicable MDR or IVDR designation codes; class alone is not enough.
3. Filter NANDO by the correct Regulation and inspect the full scope and conditions for each candidate.
4. Check current certificate information in EUDAMED where relevant, but use NANDO for designation scope.
5. Ask each candidate in writing whether it is accepting the exact device type, what evidence it needs, and its current contracting and assessment lead times.

Does Class I require a Notified Body?

Standard Class I non-sterile, non-measuring devices do not require a Notified Body under MDR 2017/745 — the manufacturer self-declares conformity by issuing a Declaration of Conformity and affixing the CE mark. However, Class I devices with a sterile state or a measuring function require NB involvement limited to those specific aspects only (Annex IX Chapter I or Annex XI Part A). Class I reusable surgical instruments are also subject to NB involvement for the aspects covered by Annex XI Part A.

Which Notified Bodies cover Class III medical devices under MDR?

Do not use a static brand list for Class III selection. A four-digit number belongs to a specific legal entity, and familiar groups may operate different bodies or numbers in the EU and UK. Filter NANDO for Regulation (EU) 2017/745, then confirm the codes and conditions that cover the device's technology and intended purpose. Contact the legal entity shown in NANDO for current capacity.

Which Notified Bodies cover IVDR Class D devices?

Use NANDO's Regulation (EU) 2017/746 scope records rather than a static name list. Confirm the relevant IVR codes and any conditions on the notification. Class D assessments can also involve an EU reference laboratory under the IVDR procedures where applicable, so ask the shortlisted NB how that step affects evidence, samples and lead time.

How do I find a Notified Body that is accepting new applications?

NANDO is the authoritative live source for designation and scope. EUDAMED's Notified Bodies & Certificates module is the public source for certificate information registered by NBs and became mandatory on 28 May 2026. Neither system provides dependable live capacity data, so obtain written confirmation from the NB that it is accepting the exact device type and ask for separate estimates for contracting and conformity assessment.

What is the difference between MDR and IVDR Notified Bodies?

MDR 2017/745 and IVDR 2017/746 have separate designation processes. An MDR designation does not confer IVDR scope, and a class label alone does not define the notification scope. If a portfolio contains both medical devices and IVDs, verify each Regulation and every applicable designation code separately in NANDO.

Sources checked 20 August 2026: European Commission 20th Notified Body survey announcement, NANDO, and EUDAMED Notified Bodies & Certificates module. Survey counts are dated snapshots; NANDO remains the live designation source.