According to the official EU press-release from 03/04/2020 European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.
As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.
Today’s proposal, therefore, postpones, for exceptional reasons in the current context, the application of the Regulation by one year – until 26 May 2021.
Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.
In addition, the proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.
The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.