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 […]
Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring. The European database of medical devices, Eudamed, is showing its potential to strengthen market surv…
Netherlands-based medical devices legal specialist Erik Vollebregt speaks to Ashley Yeo about how the European database of medical devices is faring.The European database of medical devices,Eudamed, is showing its potential to strengthen market survei…