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The European Parliament voted to suspend the implementation of the MDR by one year.
The decision to delay took into account the challenges of the coronavirus pandemic and the need for increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable.

 

On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the MDR for one year, in light of the COVID-19 crisis. The MDR had been due to become fully active on 26 May 2020.

 

 

Proposal Accepted

 

On 3 April 2020, the European Commission published the proposal, “Regulation of the European Parliament and of the Council: amending Regulation (EU) 2107/745 on medical devices as regards the dates of application of certain of its provisions”.
This document proposes a delay to the date of application of certain provisions of the MDR by one year. European Commission agrees to postpone it on the 17th of April.

 

 

EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect on May 26, 2021.

EU IVDR is still scheduled to go into force on May 26, 2022.

The pressure to postpone implementation of MDR has been mounting as countries around the world reel from the impact of COVID-19. The coronavirus pandemic and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, and economic operators. 

Comments (1)

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This is a great news! To be honest, especially for us. We submitted per MDD and the entire process prolonged a bit and we were afraid if we will make it until the May. But, this extension is a relief.