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European Commission's Device Standardization Request Imminent

 
• By Amanda Maxwell

After a failed attempt last year, the formal standardization request from the European Commission to the European standards bodies will shortly kickstart essential standards work to support compliance with the Medical Device Regulation.

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The European Commission is nearly at the point of adopting and issuing a standardization request to the EU standards bodies in the context of the new Medical Device Regulation (MDR), which now fully applies on 26 May 2021.

The purpose of the request will be to invite the standards bodies, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), to revise and update current medical device standards and to draft new standards to enable manufacturers to

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