Jun 19, 2020
German Notified Body TÜV SÜD has obtained designation to issue CE Mark certificates under the European In-vitro Diagnostic Medical Devices Regulation (IVDR).
There are now four Notified Bodies designated to the IVDR ahead of the Regulation’s May 2022 date of application, according to the NANDO database:
- BSI Assurance UK Ltd. (UK)
- BSI Group The Netherlands B.V. (The Netherlands)
- DEKRA Certification GmbH (Germany)
- TÜV SÜD Product Service GmbH Zertifizierstellen (Germany)
Given that the percentage of IVD devices anticipated to require CE Marking from Notified Bodies will increase from less than 10% currently to more than 80% under the IVDR, TÜV SÜD’s designation should come as welcome news—so long as significantly more Notified Bodies follow suit to support manufacturers’ IVDR compliance.
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
- Whitepaper: Understanding Europe’s IVDR 2017/746
Author
- Stewart Eisenhart