Will it be really difficult for IVD manufacturers? [IVDR 2017/746]

Medical Device made Easy Podcast · Mar 30, 2021

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We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but…