To prevent shortages or delays in getting key medical devices on the market, Parliament will vote to postpone the application of the Medical Devices Regulation.
On Friday, Parliament will vote by urgent procedure on the recent Commission proposal to postpone the date of application of the Medical Devices Regulation by one year until 26 May 2021. This would address the need to make more vitally important medical devices available across the EU and allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.
European legislation ensures that medical devices are safe to use and facilitates patients’ access to devices on the European market.
In 2017, two new regulations on medical devices and in vitro diagnostic medical devices were adopted to improve patient safety and increase transparency on medical devices across the EU. The new regulation for medical devices was supposed to be fully applicable on 26 May 2020. 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.
Vote: Friday, 17 April
Procedure: Ordinary legislative procedure - urgent procedu