How Notified Bodies And Manufacturers Are Attempting To Navigate Uncertainty Under The IVDR
There are still several missing key elements needed for the implementation of the EU’s IVD Regulation. Three key experts focused on how to move forward, particularly with the highest risk, class D, IVDs.
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In the EU, the amending regulation to the MDR is not creating as many waves as the amending regulation to the IVDR did. The reasons are many. But this is good news for the medtech industry, as is a general uptick in purposeful communication.
Too many perceived factors are being used by IVD manufacturers to unnecessarily delay progressing their applications under the IVD Regulation with potentially serious consequences. Three well-known medtech regulatory experts explain why manufacturers must act now.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.