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MDR hit by COVID-19 delay

THE European Commission’s proposal to postpone the implementation of the Medical Devices Regulation (MDR) 2017/745 by 12 months has been adopted by the European Parliament.

The urgent step was brought in on April 17, 2020, in direct response to the exceptional circumstances associated with the COVID-19 global pandemic.

The proposal now has to be approved by European member states and published in the Official Journal of the European Union (OJEU) before it comes into force.

This is expected to be completed by May 26 at the latest. Once in force, the new Date of Application (DoA) for the MDR will be 26 May 2021.

However, there are no plans to delay the DoA of the In Vitro Diagnostics Regulation (IVDR).

Read more here.

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