Find a Notified Body by Device Class

Select your device class

Use the filter below to narrow the table to Notified Bodies designated for your device class. Note that Class I non-sterile, non-measuring devices do not require a Notified Body — manufacturers self-declare conformity under MDR. Class I devices with a sterile state, measuring function, or reusable surgical instrument status require NB involvement only for those specific aspects.

* NB scope and device counts sourced from EUDAMED and NANDO, June 2025. Designation scope does not guarantee current capacity — contact each NB for availability.

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?

Under MDR 2017/745, Notified Bodies designated for Class III include TÜV Rheinland (0197), BSI Group (0086), TÜV SÜD (0123), SGS Belgium (1639), DNV (0085), NSAI (0050), GMED (0459), LRQA (0062), and IMQ (0051). Capacity for Class III is severely constrained across all designated NBs — most maintain waitlists and several have temporarily closed to new Class III applications. Manufacturers of Class III devices should initiate NB contact as early as possible in the development lifecycle, ideally at the design input stage.

Which Notified Bodies cover IVDR Class D devices?

IVDR Class D devices — the highest-risk in vitro diagnostics, including blood grouping reagents, companion diagnostics for cancer therapy and HIV confirmatory assays — can only be assessed by a very limited number of NBs: TÜV Rheinland (0197), BSI Group (0086), TÜV SÜD (0123), and SGS Belgium (1639). All four have significant backlogs and require manufacturers to engage them well before the IVDR application deadline. The EU Scientific Laboratories must also be consulted for certain Class D devices, adding further lead time.

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

The official sources are the EUDAMED Notified Body register and the NANDO (New Approach Notified and Designated Organisations) database maintained by the European Commission. Both show designation scope, but neither shows current capacity or whether a given NB is accepting new clients. The only way to determine availability is to contact each NB directly — a process that is time-consuming and often results in no response or lengthy delays. Submitting a structured request through ECP routes your application to NBs that have indicated current availability and whose designation scope matches your specific device class and type, significantly reducing search time.

What is the difference between MDR and IVDR Notified Bodies?

MDR 2017/745 and IVDR 2017/746 are distinct regulations with separate designation processes. A Notified Body must apply for and be granted designation under each regulation independently — being designated under MDR does not automatically confer IVDR designation. Several NBs in the table above hold designation under both regulations, but others cover only MDR. IVDR designation requires specific expertise in laboratory diagnostics, quality management of IVD production processes, and clinical performance evaluation — competencies that not all MDR-designated NBs have sought to develop. If your product portfolio includes both medical devices and IVDs, verify that your chosen NB holds designation under both regulations and for your specific device classes.