EU member states show some of their cards on medical devices revision

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…


What's cooking at IMDRF? UDI and software, among other things

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…


The IVD regulation proposal in a nutshell

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…


What to expect in the new EU in vitro diagnostics regulation?

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…


New EU guidance on medical devices vigilance reporting – more than meets the eye

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….


New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

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…

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