Today, the Official Journal of the European Union has published the Regulation (EU) 2020/561 of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices (“MDR”), as regards the dates of application of certain of its provisions (here).
The European Parliament and the Council have finally adopted the proposal to postpone by one year the date of application of the MDR from 26 May 2021. 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. In particular, the amendment allows national competent authorities to authorise the placing on the market or putting into service for the period from 24 April 2020 to 25 May 2021 of medical devices for which the conformity assessment procedures have not been carried out (non-CE certified medical devices) but the use of which is in the interest of public health or patient safety.
Consequently, the present amendment also postpones the date of repeal of the Directive 90/385/EEC on active implantable medical devices and the Directive 93/42/EEC on medical devices by one year. However, this Regulation will not have impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance)