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The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone by one year the date of application of the Medical Devices Regulation.
This will allow the 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 the Member States return to the road of recovery.
The adopted amendment takes into consideration the need for an increased availability of vitally important medical devices across the EU, and at the same time continues to guarantee patient health and safety until the new legislation becomes applicable.
The coronavirus crisis increases the demand for certain vital medical devices. It is therefore important to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices that could be caused by the limited capacity of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.
The adopted amendment, therefore, postpones the application of the Medical Devices Regulation by one year – until 26 May 2021. The currently applicable rules will continue to guarantee patient health and safety.
In order to ensure an effective regulatory framework for medical devices, the present amendment also postpones the date of the repeal of the Directive on active implantable medical devices and the Directive on medical devices by one year.
The present adoption will not have an impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
Based on information from the European Commission website.