Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time

 
• By Amanda Maxwell

Preparing all items needed to support the implementation of the EU’s Medical Device and IVD Regulations in time is going to be impossible. Competent authority expert Thomas W Møller explains how work on a third of implementation tasks still remains to be started.

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As controversial as this may sound, it will be impossible to produce guidance on all aspects of the implementation of the Medical Device Regulation by 26 May 2021.

However, “those overseeing implementation need to continue to work together to prioritize what is needed and to manage the roadmap...

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