If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]
If you’re active in the medical devices industry in Europe you will no doubt have come across EU data protection regulation. It applies to all personal data (including data concerning health) relating to EU citizens that your company processes. As you may know, the EU is presently revising the current directive and has a proposal […]
The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]
Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the relevant documents is here and a good summary by MedTech Europe (Eucomed and EDMA) is here. Then there is the convenient overview and […]
Thursday 31 January Novel Foods & Health Claims SeminarAxon organizes a seminar addressing Novel Foods & Health ClaimsProgram and invitation …
Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it concerns a direct interpretation of the definition of medical device in the EU Medical Devices Directive (MDD), which is why I have already […]
Axon Seminar Medical DevicesPresentations can be downloaded by clicking on the titles:Recast of the Medical Device Directives by Sabine Hoekstra-Van den Bosch, Philips HealthcareChanging EU regulations; a dynamic environment by Luc Sterkman, QServePro…
I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain the current changes in EU medical devices law to the US audience and to each other. Apart from the ever charming and authoritative Ms […]
Milan, Italy (October 31, 2012) – The Alliance of European Life Sciences Law Firms is pleased to announce that the law firm Italy Legal Focus has joined its ranks as its Italian member. Read more