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Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
There are some changes to some Class I devices. But at the time of this episode, there is still 1 vote remaining before acceptance of the Corrigendum.
Following the release of Corrigendum 2 of the Medical Device Regulation MDR 2017/745 and IVDR 2017/746, there is a significative change related to Medical Device class I that is up classified.
In this first part of this podcast episode, I have invited Erik Vollebregt to clarify the situation and help us understand the consequences of this corrigendum.
If you are a class I manufacturer, you need to look at that as there will be a lot of…
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