European Commission Certifies Second Notified Body Under EU IVDR

The European Commission has named BSI Assurance UK as the second notified body designated under the EU’s In Vitro Diagnostic Regulation (IVDR).

Germany-based Dekra Certification as the first notified body designated under the IVDR, which becomes effective in May 2022.

The commission said it expects to have 20 notified bodies in place for the MDR and the IVDR by the end of 2019.