The EU Medical Devices Regulation (MDR) has been postponed

To ensure that the medtech industry and all stakeholders focus their efforts on the fight against the COVID-19 outbreak and the associated public health crisis, the European Commission issued a proposal, dated 3 April 2020 (COM/2020/144 final), to defer the application of certain provisions of the Medical Devices Regulation (EU) 2017/745 (MDR).

The Commission proposal followed a fast-track legislative procedure. Following the Commission proposal, the European Parliament adopted its position of 17 April 2020, the decision of the Council of the European Union was issued on 22 April 2020 and, on 24 April 2020, the Publications Office of the European Union published a Regulation (EU) 2020/561 of 23 April 2020 amending the MDR as regards the dates of application of certain of its provisions.

Regulation (EU) 2020/561 impacts a number of obligations incumbent on manufacturers, authorised representatives, importers and distributors under the MDR. Notably, the new Regulation postpones the MDR application date to 26 May 2021.

However, some MDR provisions are set to apply from 24 April 2020, including Article 59 of the MDR (Derogation from the conformity assessment procedures).

The Reading Grid linked below clarifies the new MDR timelines and outlines the main changes brought by Regulation (EU) 2020/561.