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Erik Vollebregt
With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like “fireworks” that make…
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Erik Vollebregt
The DIA Euromeeting is quickly becoming a more an more interesting event for the medical devices community, as the DIA has been working on getting a full devices theme in place for…
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Erik Vollebregt
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…
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Erik Vollebregt
The seminar addresses the changes in the new medical devices regulation compared to current legislation. Speakers and their presentations: Sabine Hoekstra-Van den Bosch, Philips Healthcare Recast of Medical Device Directives Luc Sterkman,…
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Erik Vollebregt
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…
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Erik Vollebregt
“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday…
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Erik Vollebregt
Dear readers, while I am working on the promised blog posts on parts of the new regulation proposal for medical devices, I would like to let you know about the two and…
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Erik Vollebregt
Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices,…
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Erik Vollebregt
Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to…