BSI Transitions

BSI Transitions

In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR)

Red Overlay
ivdr banner
ivdr banner
Red Overlay

In Vitro Diagnostic Regulation IVDR

BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR. The expertise of our IVD team means we are able to review devices covering over 80 NBOG codes. Our IVD specialists are product experts in their respective fields and have undergone rigorous regulatory training.






Key resources to help your transition to the IVDR