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Call For Simplification Of Standardization Processes As Full Application Of EU Regs Nears

 
• By Amanda Maxwell

It is now just over a year before the full application of the new EU Medical Devices Regulation. But there are delays in the standards that underpin it. Will any be referenced in time? What can the Commission do to speed up the process?

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At this point, it is unclear if any harmonized standards will be referenced in the Official Journal of the EU (OJEU) by the May 26, 2020, date of application of the Medical Devices Regulation (EU 2017/745).

That is the concern of COCIR, the EU industry association for medical imaging, radiotherapy, health ICT and electromedical product manufacturers.

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