The new EU medical devices regulations were published today in the Official Journal of the EU. The regulations were adopted by the European Parliament on 5 April 2017.

The official texts of the two regulations are now available at the following links:

The date of entry into force of the two regulations is set on 25 May 2017. However, a transitional period of three years will allow manufacturers to adapt to the requirements of the MDR, which will become fully applicable on 26 May 2020. The IVDR is subject to a transitional period of five years, and will apply fully as of 26 May 2022.