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EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”

 
• By Eliza Slawther

A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?

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• Source: Shutterstock

EU notified body association, TEAM-NB, has drafted a position paper, proposing a series of specific, uniform timeframes for notified bodies when implementing Medical Device Coordination Group (MDCG) guidance into their quality management systems in the context of the EU’s Medical Device and IVD Regulations.

The aim is to create harmonized processes within notified bodies that will lead to greater predictability when it comes to the roll-out of activities linked to new guidance and additional...

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