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Erik Vollebregt
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint…
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Erik Vollebregt
So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date…
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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…
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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…
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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,…
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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…
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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…
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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…
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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…