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Transition Arrangements For IVDs Under New EU Regulation: How Much Longer Is CE Marking Valid?

Executive Summary

Transitioning to the new EU IVD Regulation is going to require a major overhaul of processes and technical documents for IVD companies and also place heavy demands on EU notified bodies. So how long do those operating in the EU have to comply? And what is required in terms of governance? Some answers below.


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