The coronavirus (Covid-19) crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. However, none of this could reasonably have been anticipated at the time 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 has adopted a proposal to postpone by one year the date of application of the MDR to allow Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.
Regarding the proposal, Stella Kyriakides, Commissioner for Health and Food Safety, stated that: "Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided."
Turkish Medicines and Medical Devices Agency stated in its announcement made on 17 April 2020, that the EU Commission's postponement proposal amending the date of entry of MDR as 26 May 2021, is approved by EU Parliament during the general sitting dated 17 April 2020.
Originally Published 20 April, 2020
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.