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 […]
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7. It is clear that the EU is upping its game on vigilance with the ongoing criticism on the CE system for medical devices, […]
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all […]