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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
Two weeks ago I made a prediction on some worst case scenarios that could come out of ENVI today. That turned out to be pretty accurate given what I know at this…
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Erik Vollebregt
So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date…
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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
While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to…
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Erik Vollebregt
As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones,…
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Erik Vollebregt
Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for rapporteur Liese’s amendments for the IVD regulation proposal to also be published….
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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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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…