The EU Council has released a draft of their position on the proposed MDR and IVDR. On 5 October 2015, the Ministers of the EU countries agreed on the General Approach of the position.
The Council, Parliament, and Commission will negotiate the various proposals into the first half of 2016. The Council’s General Approach will serve as a basis for these discussions. While the process remains in the Council First Reading, the parties are steadily progressing towards the compromise necessary to advance to the Second Reading.