13 May 2020

Gun + Partners

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The coronavirus (Covid-19) crisis has created extraordinarycircumstances that require substantial additional resources and anincreased availability of vitally important medical devices.However, none of this could reasonably have been anticipated at thetime of adoption of the Medical Device Regulation numbered (EU)2017 /745 ("MDR") to be in the force on 26 May 2020.

In this regard, on 3 April 2020, the European Commission hasadopted aproposalto postpone by one year the dateof application of theMDRto allow Member States, health institutions andeconomic operators to prioritize the fight against the coronaviruspandemic.

Regarding the proposal, Stella Kyriakides, Commissioner forHealth and Food Safety, stated that: "Our priority is tosupport Member States to address the coronavirus crisis and protectpublic health as powerfully as possible by all meansnecessary. Any potential market disruptions regarding theavailability of safe and essential medical devices must and will beavoided."

Turkish Medicines and Medical Devices Agency stated in itsannouncement made on 17 April 2020, that the EU Commission'spostponement proposal amending the date of entry of MDR as 26 May2021, is approved by EU Parliament during the general sitting dated17 April 2020.

Originally Published 20 April, 2020

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Original post:
European Parliament Approved The Proposal For Postponing The Implementation Date Of Medical Device Regulation No (EU) 2017/745 (MDR) - Food, Drugs,...