As recently reported, on April 3, 2020 the EU Commission proposed the postponement of the application date of the Medical Devices Regulation by one year, i.e. until May 26, 2021. The proposed amendment is intended to facilitate an increased availability of vitally important medical devices across the EU. As expected, the European Parliament and the Council approved the proposal on 17 and 23 April 2020, respectively.
The concerns of the market participants regarding increased requirements for the certification of medical devices will therefore be deferred for the time being.
This will not, however, have any impact on the date of application of the In-vitro Diagnostics Regulation, (EU) 2017/746, which becomes applicable as of May 26, 2022.
Text of the Regulation (EU) 2020/561