Application of MDR postponed
On Friday 17 April, the European Parliament has decided to postpone the EU Regulation on Medical Devices (better known as MDR – Medical Devices Regulation) by one year. More precisely, it concerns the postponement of the date of application of this regulation. This decision is motivated by the coronavirus crisis – the press release reports: “This decision will allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic”. Friday’s proposal therefore postpones the application of the Regulation by one year – until 26 May 2021.
However, the proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
In order to safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the Directive on active implantable medical devices and the Directive on medical devices by one year.
The European Commission’s proposal for a regulation to postpone MDR was published on April 3, 2020. It was adopted by the European Council on April 7, 2020 in a resolution for negotiations in the European Parliament. The proposal has now been adopted without changes by the parliament.
However, the decision of the European Parliament merely postpones the start of MDR by one year. Since only the start of the MDR application (DoA – Date of Application) is now being postponed by one year, but not the transition and sales period, the MDR transition period will be shortened from 4 to 3 years. The end date of the transitional period remains May 26, 2024.
Existing problems regarding the implementation of the system remain; experts hope that the EU Commission will quickly provide the necessary framework for the successful and timely implementation of MDR.