,
Karin Verzijden
On the 6th May 2013, the European Commission adopted a proposal for a draft regulation on official controls and other official activities performed which aims to strengthen the enforcement of health and…
,
Erik Vollebregt
Here’s some EU legislative procedure fun: do you know the joke about the European Parliament committee that was going to compromise to have an unproblematic vote? – It didn’t! Well, that was…
,
Erik Vollebregt
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,…
,
Erik Vollebregt
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…
,
Erik Vollebregt
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…
,
Carine van den Brink
This seminar discussed the Unitary Patent, the Supplementary Protection Certificate (SPC’s) and the significance of patents. Speakers and their presentations: Karin Verzijden & Annemieke Kooy, Axon Lawyers Unitary Patent System and SPC’s…
,
Erik Vollebregt
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…
,
Erik Vollebregt
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…
,
Erik Vollebregt
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,…