Medical Devices Regulation

By: Gabriela Magda…
Created: 23 April 2020 - 02:04
Updated: 23 April 2020 - 02:04

The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone by one year the date of application of the Medical Devices Regulation. This will allow all key players - Member States, health institutions and economic operators to give priority to the fight against the ongoing coronavirus pandemic, forming a key position in the timing of the lifting of confinement measures as Member States return to the road of recovery.

The adopted amendment takes into consideration the need for an increased availability of vitally important medical devices across the EU, and at the same time continues to guarantee patient health and safety until the new legislation becomes applicable.

The adopted amendment therefore postpones the application of the Medical Devices Regulation by one year - until 26 May 2021. The currently applicable rules will continue to guarantee patient health and safety.

https://ec.europa.eu/commission/presscorner/detail/en/ip_20_718