The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start the trilogue have been published for the medical devices regulation proposal and for the IVD regulation proposal. Only part of the picture Unfortunately […]
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all other member states, the Netherlands had to play their part in executing the Joint Immediate Action Plan. Also, they have some ideas of […]
I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that started a train of thought on how these cases might influence the medical devices industry, especially because I have already mentioned that these […]
Yet another post! Apologies, I am very productive these days. A lot is happening and I am just trying to keep track because the moment is NOW if we don’t want to get stuck with medical devices regulation in the EU that will not achieve its objectives, hurt innovation and last but not least, make […]
I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in significant detail. Since I am only a lawyer, I am very happy with the clinical picture with respect to this proposal from someone […]
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary view. I have poked fun at the process before with the ostrich picture but having read the proposal I am feeling more cynical […]