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Erik Vollebregt
As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will…
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Erik Vollebregt
Some time ago I promised you a follow up on the 20 June Council meeting, but I also mentioned that it could wait for a while at the time because the outcome…
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Erik Vollebregt
The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is…
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Erik Vollebregt
In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…
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Erik Vollebregt
Now that my firm Axon Lawyers has a YouTube channel, why not use it more? I was recently invited as speaker to the DIA Meeting on Personalized Medicines and Companion Diagnostics in Washington DC…
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Erik Vollebregt
Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly…
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Erik Vollebregt
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary…
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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…