InleidingEr komt meer en meer software op de markt die in een klinische setting wordt gebruikt. Tot voor kort vond met medische software in klinische setting vooral op PACS-systemen, op netwerken lees meer …
The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The other two are C-109/12 Lycocentre and C-308/11 Chemische Fabrik Kreussler, with respect to the latter see also here. The other two are more […]
Reparatie medische apparatuurNu ziekenhuisbudgetten meer en meer onder druk komen te staan, merk ik in mijn praktijk dat ziekenhuizen meer uitwijken naar andere partijen dan de OEM voor reparaties die na verloop van de garantietijd moeten plaatsvinden…
Implanting Quality and rooting out riskFirst it was burst breast implants and then disintegrating hipimplants. After making headlines around the world, finger-pointing ensued, with both regulatory authorities and manufacturers coming under read more …
The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of the Review of the medical devices directives, still scheduled for the end of Q2 2012 as far as I know. At its meeting […]
Presentations can be downloaded by clicking on the titles:ATMPs by Eliane Schutte, SignifixLatest developments in biotech patents by Carine van den Brink, AxonCell-based therapies legal & regulatory by Alex Denoon, Lawford Davies Denoon and Erik V…
Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to safeguard the credibility of the EU medical devices vigilance system (which are conveniently summarised in his speech of 9 Febuary 2012): the Dutch […]
I hope you won’t mind me imposing on you with some more self promotion – it’s for your own good as this is about saving you money, both in the short run (if you register before 16 April you pay more than 50% less) and in the long term (well, you know what legal and/or […]
Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or revision of the EU medical devices directives, however you want to call it in the mean time. I believe the term ‘revision’ is […]
I hope you won’t mind me doing a little bit of marketing for the non-devices activities of my firm. Axon Lawyers organises a seminar on cell-based therapies on 18 April in Amsterdam, which will be very interesting for companies thinking about or already underway with such products in the EU as it will be specifically […]