European
Compliance Platform
European
Compliance Platform
19 Notified Bodies hold a designation under IVDR 2017/746 (NANDO, 12 October 2026), against 52 under MDR. With so few bodies, capacity for Class B, C and D devices is tight: shortlist early and confirm each body’s IVDR codes.
| NB number | Notified Body | Country | MDR | IVDR |
|---|---|---|---|---|
| 0050 | National Standards Authority of Ireland (NSAI) | Ireland | ✓ | ✓ |
| 0051 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. | Italy | ✓ | ✓ |
| 0123 | TÜV SÜD Product Service GmbH | Germany | ✓ | ✓ |
| 0124 | DEKRA Certification GmbH | Germany | ✓ | ✓ |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany | ✓ | ✓ |
| 0318 | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Spain | ✓ | ✓ |
| 0344 | DEKRA Certification B.V. | Netherlands | ✓ | ✓ |
| 0373 | ISTITUTO SUPERIORE DI SANITA' | Italy | ✓ | ✓ |
| 0459 | GMED SAS | France | ✓ | ✓ |
| 0483 | mdc medical device certification GmbH | Germany | ✓ | ✓ |
| 0537 | Eurofins Electric & Electronics Finland Oy | Finland | ✓ | ✓ |
| 0598 | SGS FIMKO OY | Finland | ✓ | ✓ |
| 1434 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Poland | ✓ | ✓ |
| 1639 | SGS Belgium NV | Belgium | ✓ | ✓ |
| 2265 | 3EC International a.s. | Slovakia | ✓ | ✓ |
| 2460 | DNV Product Assurance AS | Norway | ✓ | ✓ |
| 2797 | BSI Group The Netherlands B.V. | Netherlands | ✓ | ✓ |
| 2962 | QMD Services GmbH | Austria | ✓ | ✓ |
| 3018 | Kiwa Sertio Oy | Finland | – | ✓ |
Source: NANDO, European Commission, 12 October 2026. Designations change: open NANDO for each body’s current scope, conditions and notification documents.
Found Notified Bodies that fit?
Describe your device once and send one request to several Notified Bodies, free. You choose the bodies; we email you when they reply.
Send my request free →Under IVDR, Class B, C and D devices need a Notified Body, and so do sterile Class A devices (for the sterility aspects only). For Class D devices the body also involves an EU reference laboratory where one is designated, and companion diagnostics require a consultation with a medicines authority.
19 in NANDO on 12 October 2026. 18 of them are also designated under MDR.
Only if it also holds an IVDR designation. MDR and IVDR designations are separate, and each covers specific codes.
Open the body in NANDO, select Regulation (EU) 2017/746 and compare its IVDR codes with your device. Then ask the body in writing whether it accepts new applications for that device type.