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Commission's Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour

 
• By Amanda Maxwell

A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with the new regulations when they apply in 2020 and 2022. So, what is happening?

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The European Commission has given the European standards body, CEN/CENELEC, a draft list of standards that it is considering including in a standardization request that will feature some 230 standards intended to be harmonized against the Medical Device Regulation (MDR), and 50 standards against the IVD Regulation (IVDR).

These Regulations have already entered into force and fully apply on May 26, 2020 and 2022, respectively. Despite this, it...

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