The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.
There is growing consternation about the lack of readiness of some structures vital to the implementation of the IVD Regulation (IVDR) and particularly to the regulation of the highest risk class D IVDs.
These missing cornerstones to IVDR implementation, including the European Reference Laboratories (EURLs), have been highlighted in the European Commission’s just...
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