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

 
• By Amanda Maxwell

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.

The majority of IVD companies marketing their products in the EU have a complex and costly transition to make to ensure that their products are in compliance with the future In Vitro Diagnostics Regulation.

Although the regulation has yet to be adopted – likely in late 2016/early 2017 – the texts have been posted in their near-final version, and the IVD sector is aware...

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