In Vitro Diagnostic Medical Equipment Overview

The new regulatory requirement for placing In Vitro Diagnostic equipment on the market is the In Vitro Diagnostic Regulation (IVDR) 2017/746 which came into force on 26 May 2017. It will replace the IVD directive (IVDD) 98/79/EC with the transition time ending on 26 May 2022.

Download our new Fact Sheet regarding the IVD requirements.