Category - amendments


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, but still a lot – and no less complex. I won’t repeat all the procedural proposals that are both in the medical devices […]


ENVI’s amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. […]


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 are currently in with the medical devices and IVD regulation proposals and the amendments proposed. Tsunami of amendments The period for tabling amendments […]