Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

CDx requirements under IVDR – Challenges for clinical

34% of the devices on the market are CE marked under IVDR. 66% of devices remain uncertified under the IVD Regulation or discontinued.

3. Not all guidance on ‘how to’ meet requirements is available

The Organisation for Professionals in Regulatory Affairs

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Potentially.. A train crash waiting to happen.. (we will have to see what happens over the next few months)

The Organisation for Professionals in Regulatory Affairs

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