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Episode 26 – IVDR preparation with Andreas Stange
Episode 26 – Prepare for IVDR with Andreas Stange Episode 26 – IVDR preparation with Andreas Stange
We talked a lot about the EU MDR, but we should not forgot that there are also a similar change that is happening to the In-vitro Diagnostic Medical Devices with the EU IVDR 2017/746.
Manufacturers should be ready by May 26, 2022 but this will be really a huge work for them. Before only 20% of the products needed a notified body for placing their products on the market. Now with the IVDR it’S 80%.
So how should they prepare for that? Dr. Andreas Stange from TÜV SÜD will be my…
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