MDR & IVDR Notified Body List (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.

List of MDR and IVDR Notified Bodies

All bodies with an active notification under Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR) in NANDO on 12 October 2026: 52 designated under MDR, 19 under IVDR, 53 in total. Sorted by NB number. A tick means the body is designated under that regulation; the device codes it may assess differ from body to body.

Source: NANDO, European Commission, 12 October 2026. Designations change: open NANDO for each body’s current scope, conditions and notification documents.

Match Notified Bodies to my device →

Which device classes need a Notified Body?

Device class	Notified Body involvement	What to verify
MDR Class I	Generally no NB for a standard non-sterile, non-measuring, non-reusable-surgical device	Confirm the classification and conformity-assessment route
MDR Class Is / Im / Ir	Required, limited to sterility, metrology or reusable-surgical-instrument aspects	The NB's MDR codes and the limited assessment scope
MDR Class IIa / IIb / III	Required	Applicable MDR codes, technologies, conditions and exclusions in NANDO
IVDR Class A	Generally self-declared; Class A sterile requires limited NB involvement	Classification rule and sterility scope
IVDR Class B / C / D	Required	Applicable IVDR codes and any Class D EU reference-laboratory procedure

Use the two official systems for different checks

Official source	Use it for	Do not infer
NANDO	Current designation, four-digit NB number, legislation, detailed scope, conditions and notification documents	Current capacity, lead time or willingness to accept the application
EUDAMED NB & Certificates	Public certificate information registered by NBs; this module became mandatory on 28 May 2026	That an NB is designated for every code needed by a new device

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?

The list above shows which bodies hold an MDR designation, not which device codes each one covers. 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?

The list above shows which bodies hold an IVDR designation; use NANDO’s Regulation (EU) 2017/746 scope records to see which codes each one covers. 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.

Related guides

• MDR Conformity Assessment Routes by Device Class
• How Much Does CE Marking Cost for a Medical Device?
• Notified Body Availability 2026
• How to Select a Notified Body for CE Marking (2026)