What has been pro­posed by the Euro­pean Com­mis­sion and con­firmed by the Euro­pean Par­lia­ment has been signed off by the Euro­pean Council. 

As a con­se­quence, the delay of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) has now offi­cial­ly been con­firmed. The amend­ing reg­u­la­tion, which delays the start date by one year, was pub­lished in the Offi­cial Jour­nal of the EU on 24 April. The new date of appli­ca­tion thus will be May 26, 2021.

Source: Euro­pean Commission

For fur­ther infor­ma­tion on the MDR delay, we rec­om­mend the fol­low­ing con­tent on our website