Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the European Parliament and the Council.

In the context of the COVID-19 pandemic Member States, health institutions and economic operators redeployed financial and other resources to address the unprecedented challenges of the crisis. By doing so, they delayed the implementation of the In Vitro Diagnostic Medical Devices Regulation of 2017, which introduced certain requirements for medical devices and a stronger role for so-called conformity assessment bodies. To prevent disruption of supply of essential healthcare products as a result of these delays, the Commission proposed in October a progressive roll-out of the Regulation of 2017. The adoption of this proposal by the co-legislators will keep the supply of these essential healthcare products flowing.