Medical device CE marking

Publication of MDR


The European Commission has officially published the medical device Regulation (MDR) on the 5th of May, 2017.

The Regulation may be found in our library

MDR 2017/745/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC


The official timing for transition start 20 days after the new law is published in the Official Journal. Publication was on May 5th 2017, which means an official transition starting date on May 25th 2017. The Regulation will be fully applicable in three years for medical devices.