Category - ivds

medicaldeviceslegal

The IVD regulation proposal in a nutshell

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, […]

medicaldeviceslegal

What to expect in the new EU in vitro diagnostics regulation?

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 […]

medicaldeviceslegal

In Vitro Diagnostics seminar at Axon Lawyers on 12 September

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 […]