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:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR)
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 2017. The IVDR is subject to a transitional period of five years, and will apply fully as of 26 May 2022.