News - April 28, 2020

The Medical Devices Regulation officially postponed by one year

On 3 April, the European Commission adopted a proposal to postpone by one year the application of the Medical Devices Regulation (MDR). Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April. The amending Regulation 2020/561 (attached) has been published in the Official Journal on 24 April and has entered into force on its date of publication.

The adoption of this proposal means that the date of application of the MDR will become 26 May 2021 instead of 26 May 2020. This also means that the Medical Devices Directives will be repealed one year later on the new date of application of the MDR.