As announced, the IMDRF is on the case for software, which shows how important this subject is becoming in the medical devices field. I notice this everyday in my medical devices practice, as more and more medical devices software work comes in. That is great for me, as I grew up around software engineers in […]
The EU member states have so far been the dark horse in the discussions surrounding the revision of the EU medical devices directives, keeping their cards close to their chest and not getting involved in the largely fact free politics surrounding the ENVI rapporteurs’ drafts for the medical devices and IVD regulations. Council of Employment, […]
These days I am more and more involved in medical devices software matters: interesting questions about modularisation, whether or not EHRs are medical devices in Europe and negotiation of systems integration agreements within the systems integration clause of the EU medical devices directive, just to mention a few. But so far I have not really […]
Weinig advocaten weten meer van IT of maker er intensiever gebruik van dan Erik Vollebregt. De life sciences advocaat uit Amsterdam kreeg een prijs voor de wijze waarop zijn kantoor social media inzet. meer lezen …
Axon IP UpdatePresentations can be downloaded by clicking on the titles:Unitary Patent and SPS’s; relevant case law by Karin Verzijden and Annemieke Kooy, Axon LawyersIncorporating the unitary Patent in your business strategy by Robbert-Jan, EPCPatent…
While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]
Wednesday 12 June IP UpdateAxon organizes a seminar addressing recent developments in IP relevant to the life sciences sector.Program and invitation …
The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll share my impression of it with you. I have grouped what I heard by subjects so it’s easier to […]
As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a lot – and no less complex. I won’t repeat all the procedural proposals that are both in the medical devices […]
ENVI’s amendments, following those of IMCO have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. […]