ENVI's IVD regulation amendments

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,…


ENVI's amendments

ENVI’s amendments, following those of IMCO ┬áhave been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…


The fog of war following a tsunami of amendments

That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we…

Navigate through our knowledgebase