25 mars 2020
SAMMANFATTNING: Europeiska kommissionen arbetar på ett förslag att fördröja implementationsdatumet av Medical Device Regulation med ett år. Det nya datumet kommer i så fall bli i maj 2021. Förslaget väntas läggas fram i början av april och beslut väntas tas under maj månad.
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Cecilia Fällman
Cecilia FällmanProduct Manager Compliance Excellence
Tel: +46 (0)72 717 10 67

Latest information from the European Commission

Live read-out of the College meeting of 25/03/2020…
European Commission announcement 25/03/2020

“With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.”

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