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MDR application may be halted for 1 year. European Commission announces proposal to help the fight against COVID-19.

March 25, 2020

Today’s live read-out by the European Commission spokesperson Stefan De Keersmaecker announced a proposal to delay the application of the new MDR.  “The European Commission is working on a proposal to postpone the entry into force of the new Medical Devices Regulation for 1 year. We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis”.

Earlier this week, Medtech Europe has issued a press release calling for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems. The industry is working relentlessly to provide personal protective equipment (PPEs), diagnostics, respiratory devices and other critical medical equipment to patients, healthcare workers, and hospitals on the COVID-19 frontline.”

The date of application of the MDR was set to be 25 May 2020.

 

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