Medical device CE marking

Designated Notified Bodies for MDR and IVDR


At the moment there are 7 notified bodies designated to perform audits according the MDR. These notified bodies are: BSI-UK, BSI-NL, DARE!!, DEKRA Certification, IMQ and TÜV Rheinland, TÜV-SUD.

Under the IVDR, there are now 2 notified bodies designated. These notified bodies are: BSI-UK, DEKRA Certification.

We recommend staying in close contact with your Notified Body concerning their designation for the MDR and/or IVDR.