Dec 22, 2020
TÜV Rheinland is now the fifth Notified Body (NB) listed in the NANDO database as designated under the EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR). The German organization was likewise the fifth NB to be designated under MDR. The current list of IVDR-designated NBs is now as follows:
- BSI Assurance UK Ltd. (UK)
- BSI Group The Netherlands B.V. (The Netherlands)
- DEKRA Certification GmbH (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
- TÜV Rheinland LGA Products GmbH (Germany)
Association of Notified Bodies warns of insufficient readiness for IVDR implementation
A position paper issued in November by Team-NB, the European association of Notified Bodies dealing with medical devices, raises concerns about the viability of the current IVDR implementation date of May 2022. The low number of IVDR-designated Notified Bodies is one of the chief problems cited in the paper, especially given the expectation that UK-based BSI Assurance will lose its IVDR designation in the case of a no-deal Brexit. Team-NB states that it will only support a 2022 target if two conditions are met by the end of 2020, one of which is the designation under IVDR of at least half of the 22 existing Notified Bodies.
An overview released by the European Commission (EC) and updated as of December 7 shows that there have been 16 applications for IVDR designation, one of which was subsequently withdrawn. As some of these applications are still in the early stages, it appears unlikely that six more Notified Bodies will be listed for IVDR by Team-NB’s end-of-year deadline. Emergo by UL will continue to provide details on both Brexit and IVDR planning as they become available.
Learn more about European IVD regulatory requirements at Emergo by UL:
- European CE Mark consulting for IVD device manufacturers
- European Authorized Representative in-country representation
- Usability engineering (UE) support for the EU IVDR transition
- Whitepaper: Understanding Europe’s IVDR 2017/746
- Webinar: Human factors engineering for IVD products under IVDR
Author
- Timothy Herr