IVDR (In Vitro Diagnostic Regulation)

HARTMANN is already preparing for the implementation of the new EU regulation on In Vitro Diagnostics Medical Device Regulation (2022: IVDR)

IVDR-ready in 2022

Starting from May 26, 2022, new in vitro diagnostic devices and in vitro diagnostic devices without a valid IVDD certificate will have to comply with the requirements regulated in the IVDR. This will include a new classification system with risk classes A to D.

Get in touch if you are looking for IVDR ready products and we’ll help you find the solutions you need.