Well, the 26 February workshop is behind us. The expectations were high, but I think in the end the workshop turned out to be the dud I expected; some people I spoke with rather called it a theatrical sizzle or a dud with some drama. A nice factual and chronological overview can be found in […]
I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was a very good conference with some of the best EU experts sharing their knowledge. There were also some easter eggs of information. The […]
Wednesday 20 March Corporate Law SeminarAxon organizes a seminar addressing recent developments in Dutch Corporate Law relevant to the life sciences sector.Program and invitation …
With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like ”fireworks” that make this workshop sound like it will be an ‘epic battle‘, or how about a ‘clash of the titans’? I wouldn’t want to go […]
The DIA Euromeeting is quickly becoming a more an more interesting event for the medical devices community, as the DIA has been working on getting a full devices theme in place for the duration of the conference. The program that they have this year is comprehensive and features high profile and quality speakers (and me too) […]
Sweden is a lovely and industrious country that takes engineering very seriously; the small Scandinavian country that we know from its boxy but good cars also builds its own fighter jets (pretty good ones actually) and is determined to put its mark on the regulation of standalone software under EU medical devices law. The Swedish competent […]
Axon Seminar Novel Foods & Health ClaimsPresentations can be downloaded by clicking on the titles:Future of Food by Roger van Hoesel, Food Valley and StartLifeLegal & regulatory aspects of Novel Foods & Health Claims by Karin Verzijden, Ax…
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo calls them in an interesting analysis of the IVD regulation proposal: the MAID (manufacturer, authorized representative, importer, and distributor). Both the IVD and medical […]
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo calls them in an interesting analysis of the IVD regulation proposal: the MAID (manufacturer, authorized representative, importer, and distributor). Both the IVD and medical […]
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]