While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]
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 […]
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 […]
Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for rapporteur Liese’s amendments for the IVD regulation proposal to also be published. And here they are. Basically this proposal is not jerking the wheel in the other direction as the Roth-Behrendt proposal does, but is […]
With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go. As a starting point, […]
Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to the market and presentations of my partner Carine van den Brink about marketing, advertising and online sales of IVDs and me about software […]
Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with very interesting external speakers. The seminar is free and you are welcome to attend with as many colleagues as you like (just make […]