Latest MDCG Preparedness Plan Totally Ignores COVID-19 And Indicates No MDR Delay
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.
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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.
The European Commission has reiterated that the MDR deadline of 26 May will go ahead despite the COVID-19 crisis, further hampering notified body resources and audit freedoms. It has put its foot on the accelerator by issuing seven new documents.
Medtech Insight is tracking the IVD companies manufacturing tests for SARS-CoV-2, the coronavirus that causes COVID-19.