The European Union In Vitro Diagnostic Medical Devices Regulation (IVDR)
As we approach the end of the IVDR transition period, after May 26, 2022, all new in vitro diagnostic devices and Class A non-sterile IVD devices will need to be IVDR compliant in order to be marketed in the European Union. This means that all manufacturers of CE-marked IVD devices will be affected by the […]
