Europe – Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in principle in the MDCG meeting of 28 May 2021. In addition to setting the priorities, the Plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market…