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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…
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Carine van den Brink
Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…
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Erik Vollebregt
Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar. The judgment immediately brought one of my favorite Yogi Berra quotes to mind: “You’ve got…
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Erik Vollebregt
Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with…
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Erik Vollebregt
While everybody is starting up again after the summer and had 26 September as first major horizon date in their head (the date on which the Commission has said it will publish…
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Erik Vollebregt
In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…