The new In Vitro Diagnostics Regulation (IVDR)
The In Vitro Diagnostics Regulation (IVDR) is the new regulatory framework which will affect all in vitro diagnostic medical devices on the European market.
The IVDR (Regulation (EU) 2017/746) replaces the current EU Directive on in vitro diagnostic devices (IVDD 98/79/EC) and will apply on 26 May 2022. There is no way to automatically transfer old IVDD classified devices over to the new IVDR, all IVDs must be transitioned to the new regulations’ requirements.
What does this In Vitro Diagnostics Regulation (IVDR) mean for manufacturers and for the users of medical devices? Learn what you need to know about IVDR and its consequences.