As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a lot – and no less complex.
I won’t repeat all the procedural proposals that are both in the medical devices regulation proposal and the IVD regulation proposal (like UDI); please see the medical devices regulation proposal and my discussion of that proposal in that respect. I have tried to group them [...]
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