Can we fix / improve the MDR and the IVDR?

Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to me: people that say that the MDR or IVDR is ‘new’. In a way of course they are if you look at things on a cosmic timescale, but in objective terms the MDR or IVDR cannot be seen as new anymore – more as renewing because of the constant stream of MDCG (and to a less extent Commission) guidance to fill in the many gaps and the ma [...] « Read the rest of this article on medicaldeviceslegal »