The Commission proposed a one-year delay for the Medical Device Regulation (MDR) transition deadline. The delay was decided to relieve pressure on industry and allow them to focus fully on urgent priorities related to the coronavirus crisis. This should allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.
The coronavirus crisis has created extraordinary circumstances that require major additional resources and an increased availability of vitally important medical devices. Those circumstances have a significant impact on various areas covered by the Medical Devices Regulation. It is therefore very likely that Member States, health institutions, economic operators and other relevant parties would not have been in a position to ensure its proper implementation and application from the stipulated date of application on 26 May 2020. The medtech industry admitted that they were struggling to meet these new rules while also getting protective gear to help health care systems during the coronavirus outbreak. Citing those pressures, the medtech industry has asked for the deadline to be delayed six months after the coronavirus pandemic is declared over.
The proposed MDR transition deadline is May 26, 2020.
To safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the Directive on active implantable medical devices and the Directive on medical devices by one year.
This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
In addition, the proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.
The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.