Newsalert Pharma - Commission postpones application of the Medical Devices Regulation


On April 3, 2020, the European Commission adopted a “Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions” 2020/0060 (COD).
The Proposal aims at deferring the application of most provisions of the Medical Devices Regulation (Regulation 745/2017/EU - MDR) by one year (until May 26, 2021), in order to avoid the potential impact of the implementation of the new regulatory framework on Member States’ need for an increased availability of vitally important medical devices across the EU whilst fighting the coronavirus pandemic.