Oct 30, 2019

UK Notified Body BSI has obtained designation to issue CE Mark certificates under the European In-vitro Diagnostic Medical Devices Regulation (IVDR), the second such organization to do so.

BSI Assurance UK Ltd is now listed in the European Commission’s NANDO database of Notified Bodies designated to the IVDR, along with Germany’s DEKRA.

As mentioned in our previous coverage of DEKRA’s IVDR designation, the first CE Marking certifications for IVDs under the new Regulation may not be issued until mid- to late 2020 based on certification process timeframes.

Emergo by UL consultants in Europe will provide further updates on IVDR as well as Medical Devices Regulation (MDR) Notified Body designation issues as we learn them.

Additional European IVDR and Notified Body resources from Emergo by UL: