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 [...]
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