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Commission To Submit Yet Another European Standards Request – In Early 2021

 
• By Amanda Maxwell

Despite having its latest standards request formally rejected, the European Commission is determined to press ahead with proposals for new medtech standards under the new Medical Device Regulation – although the transition time is running out.

Plan C

The European Commission’s "State of Play of Joint Implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR," which was updated in July 2020, talks of submitting a new standards request to European standards bodies CEN and CENELEC in the first quarter of 2021.

Standards are a fundamental cornerstone of the new Medical Device Regulation (MDR). While European harmonized standards are voluntary, they represent one of the most well recognized ways for manufacturers to demonstrate compliance with the relevant requirements of the MDR

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