Companies should act now to prepare for the full implementation of the MDR and IVDR.

On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current regulatory framework for medical devices in the EU. This change will be followed on 26 May 2022 by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Together, the new regulations aim to increase harmonisation across the EU with respect to medical devices and in vitro diagnostic devices and to address weaknesses in the current regimes, with the goal of increasing protection for consumers. While the MDR and IVDR will not be fully active for another 12 to 36 months, respectively, companies should act now to ensure that they have appropriate systems in place to comply.