EU’s IVDR Plan Demands Team Effort And Flexibility From All Stakeholders
Let’s do this thing! That is essentially the Medical Device Coordination Group’s message to stakeholders when it comes to IVDR implementation. It calls for solutions - even if the system does not start off perfectly.
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The European Commission group responsible for overseeing the implementation of the EU Medical Device Regulation has told the medtech industry to redouble its compliance efforts and ignored industry’s warnings about the current difficulties it is experiencing.
The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.