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(UPDATE) EU Standards: Potential Hiatus As Priorities, Deadlines And Timeframes Take Shape

 
• By Amanda Maxwell

The European Commission’s long overdue MDR/IVDR standards request document – still a draft – gives the European standards bodies just over a week from today to respond. But CEN/Cenelec says it cannot reply yet. So what is the problem?

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The European Commission has, at last, set out the terms of its request for standards to assist manufacturers comply with the new EU Medical Device and IVD Regulations to the European standards bodies, CEN and Cenelec.

The terms of the request are set out in a draft Commission Implementing Decision.The document says that the next step is for the standards committees to respond to the commission on this draft request – by 25 July – before the request is finalized and becomes official

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