EU medical device regulations published today – entry into force 25 May 2017

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 2020.  The IVDR is subject to a transitional period of five years, and will apply fully as of 26 May 2022.

This post was originally co-authored by Marco de Morpurgo.