EU: Commission adopts proposal to postpone application of Medical Devices Regulation
The European Commission ('the Commission') announced, on 3 April 2020, that it had adopted the proposal ('the Proposal') to postpone the application of Regulation (EU) 2017/7457 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ('the Medical Devices Regulation'). In particular, the Commission detailed that because of the current exceptional circumstances related to COVID-19 ('Coronavirus') the application of the Medical Devices Regulation shall be postponed by one year, until 26 May 2021. Moreover, the Commission outlined that the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, but that the currently applicable rules will continue to guarantee the protection of public health in the meantime.
Finally, the Commission highlighted that the Proposal needs the full support of the European Parliament and the Council of the EU through an accelerated co-decision procedure.
You can read the press release here.