The amendment document relating to the dates of application of the new medical device regulation MDR (EU) 2017/745, decided by the European parliament on 17 April 2020, has finally been published and is in force. It follows the proposal of the European Commission with some minor corrections, such as considering the Corrigendum from 25 November 2019, in which a shift was already granted for certain class I devices, for which the conformity assessment procedure requires the involvement of a notified body in future.

As a result, the dates relating to the end of the transition period from the MDD to the MDR originally fixed on 26 May 2020 have been shifted to 26 May 2021. The other deadlines and implementation dates remain unchanged.