Complete List of Notified Bodies Under the IVDR
AUTHOR
Catherine | Associate Director Marketing
Under the IVDR, Regulation (EU) 2017/746, manufacturers of class A in vitro diagnostic devices, other than devices for performance studies, declare conformity themselves. If those devices are placed on the market in sterile condition, a notified body assesses the sterile aspects (Article 48(10)). Devices for performance studies follow Articles 57 to 77 (Article 48(11)). All other classes need a notified body designated under the IVDR. This page lists all notified bodies designated under the IVDR, from the EU's own database.
What do notified bodies do under the IVDR?
Notified bodies take part in the conformity assessment set out in Article 48 and Annexes IX to XI of the IVDR. The class of a device determines the procedure. The IVDR has four classes, A to D, and seven classification rules in Annex VIII. The Medical Device Coordination Group explains them in MDCG 2020-16 rev.5 (September 2026).
All Notified Bodies Designated Under the IVDR
As of , NANDO lists 19 notified bodies under the IVDR. Source: NANDO, Single Market Compliance Space.
| NB number | Notified body | Country | First notified in NANDO |
|---|---|---|---|
| 0050 | National Standards Authority of Ireland (NSAI) | Ireland | 18 Feb 2023 |
| 0051 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. | Italy | 22 Apr 2025 |
| 0123 | TÜV SÜD Product Service GmbH | Germany | 17 Jun 2020 |
| 0124 | DEKRA Certification GmbH | Germany | 10 Oct 2019 |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany | 27 Nov 2020 |
| 0318 | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Spain | 19 Feb 2025 |
| 0344 | DEKRA Certification B.V. | Netherlands | 16 Jun 2021 |
| 0373 | ISTITUTO SUPERIORE DI SANITA' | Italy | 11 Sep 2024 |
| 0459 | GMED SAS | France | 19 Aug 2021 |
| 0483 | mdc medical device certification GmbH | Germany | 16 Feb 2023 |
| 0537 | Eurofins Electric & Electronics Finland Oy | Finland | 16 Sep 2023 |
| 0598 | SGS FIMKO OY | Finland | 21 Oct 2025 |
| 1434 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Poland | 17 Jul 2025 |
| 1639 | SGS Belgium NV | Belgium | 23 Apr 2025 |
| 2265 | 3EC International a.s. | Slovakia | 30 Apr 2022 |
| 2460 | DNV Product Assurance AS | Norway | 01 May 2025 |
| 2797 | BSI Group The Netherlands B.V. | Netherlands | 24 Dec 2019 |
| 2962 | QMD Services GmbH | Austria | 23 Dec 2022 |
| 3018 | Kiwa Sertio Oy | Finland | 31 Oct 2023 |
"First notified in NANDO" is the approval date of the first version of the body's IVDR notification in NANDO. Names are shown as NANDO records them.
A designation covers specific device types and conformity assessment procedures, and it can end, be restricted or be suspended. Before you approach a notified body, check its entry in NANDO. An MDR designation does not replace a designation under the IVDR.
Transition Deadlines Under the IVDR
Regulation (EU) 2024/1860 extended the transition periods in Article 110 of the IVDR:
| Devices | May be placed on the market or put into service until | Application to a notified body by | Written agreement by | Article |
|---|---|---|---|---|
| Devices with a certificate under Directive 98/79/EC | 31 December 2027 | 26 May 2025 | 26 September 2025 | 110(3a) |
| Class D (see note) | 31 December 2027 | 26 May 2025 | 26 September 2025 | 110(3b)(a) |
| Class C (see note) | 31 December 2028 | 26 May 2026 | 26 September 2026 | 110(3b)(b) |
| Class B; class A placed on the market in sterile condition (see note) | 31 December 2029 | 26 May 2027 | 26 September 2027 | 110(3b)(c) |
Note: these rows apply only to legacy devices for which Directive 98/79/EC did not require a notified body and a declaration of conformity was drawn up before 26 May 2022 (Article 110(3b)). New devices have no such transition period.
In all cases the manufacturer must have had a quality management system under Article 10(8) in place by 26 May 2025, and the conditions of Article 110(3c) apply, including no significant changes in design and intended purpose.
The Commission's December 2025 proposal to simplify the MDR and IVDR (procedure 2025/0404(COD)) had not been adopted by the date above.
Sources
- NANDO: notified bodies under Regulation (EU) 2017/746
- Regulation (EU) 2017/746 (IVDR), consolidated version of 10 January 2025
- Regulation (EU) 2024/1860
See also the list of notified bodies under the MDR.
General information, not legal advice. Legal status as of 9 November 2026.
Catherine | Associate Director Marketing
Climedo
Passionate about creating innovative event and content marketing formats to make the benefits of digital health solutions more tangible. Enjoys fine art, photography, foreign languages and all things digital.
