The entry into force date of the Medical Device Regulation (EU) 2017/745 is to be postponed by one year.
The European Parliament (EP) has adopted the proposal of the European Commission (EC) to postpone the Medical Devices Regelation by one year. This will allow Member States, health institutions and economic operators to prioritise the fight against the COVID-19 pandemic.
If the text is adopted by the Member States the application of Medical Devices Regulation will be postponed until 26 May 2021. Adoption and publication in the Official Journal is expected by 26 May 2020.
N.B. In 2017 the EC published 2 new medical regulations: a medical devices regulation and and in vitro medical devices regulation. Both regulations were supposed to be fully applicable by 26 May 2021. The date of application of the In Vitro Diagnostics Medical Devices Regulation is not affected (!) by the new proposal and becomes applicable from 26 May 2022, as planned.