Medical device CE marking

Publication of IVDR


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

The Regulation may be found in our library

IVDR 2017/746/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU


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 five years for in vitro medical devices.