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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
After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of…
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Erik Vollebregt
With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or…
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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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Erik Vollebregt
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….
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Erik Vollebregt
The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…