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Global Certification Technical Update

March 2020

March 2020 Updates

European Commission

European Commission Proposes One-Year Delay For Medical Devices Regulation

Mar 26, 2020

The European Commission has announced that they are working on a proposal to delay enforcement of the EU Medical Device Regulation by one year. They intend to submit the proposal early April and call on the European Parliament and the Council of Ministers to adopt it quickly, as the deadline for entry into force is at the end of May.

The EU’s Medical Devices Regulation (MDR) is due to take effect from May 26, 2020, while the In-Vitro Diagnostic Devices Regulation (IVDR) will take effect from May 26, 2020. Nothing will change until this proposal has been accepted by the European Parliament and European Council.

As a reason for this delay the European Commission said “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.”



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