Proposal to Delay EU MDR Implementation Brings Manufacturers Some Good News
Caroline Freeman, Senior Consultant, Quality & Compliance Services, IQVIA
With less than 2 months to go to the date of application of the EU Medical Devices Regulation 2017/745 (MDR), set for May 26, 2020, the Commission finally announced on March 25, 20201 that work is ongoing to postpone this by one year. The announcement was quickly followed by the publication of the Commission proposal text on April 3, 20202, and this was followed within three working days by the Council’s own document establishing the mandate for negotiating with the European Parliament, and also, incidentally, making a much-needed technical correction to the original Commission proposal3. Political agreement from the European Parliament (EP) was reached in a vote in plenary session by an overwhelming majority of EP members, on April 16, 2020. The EP dealt with the proposal as an urgent procedure and made no additional changes to the Council’s text. (more…)