European Commission Certifies First Notified Body Under EU IVDR

The European Commission designated Germany-based Dekra Certification as the first notified body for product certification under the EU’s In Vitro Diagnostic Regulation, which becomes effective in May 2022.

Dekra was also designated as a notified body under the EU Medical Devices Regulation, which becomes effective in May 2020.

The commission said it expects to have 20 notified bodies in place for both the MDR and the IVDR by the end of 2019, but the industry has been skeptical that it will reach that number.