Final text MDR /IVDR for voting

27 Feb 2017

On 22 February 2017 the final texts of the new EU Medical Device and In-Vitro Diagnostics Regulations have been released by the EU Council and is scheduled for voting to adopt the legislation on 7 March 2017, followed by a vote in the European Parliament in April.

If passed, the regulations could be formally published by May 2017, and enter into force in either May or June. Given that timetable, the new rules established under the MDR would apply in 2020 and the IVDR regulations would apply in 2022.