EU-MDR Final Draft Published

The European Council released the final text of the Medical Device Regulation (MDR) and scheduled the vote for March 7, 2017. If passed, the MDR will go to the European Parliament in April.

If both bodies approve, the Official Journal could publish the MDR in May 2017, and it would enter into force in either May or June. Because there is a three-year transition period for the MDR, it would apply in 2020.

You may download the final text, 566 pages, from http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf