IVD

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EU companion diagnostics regulatory developments – the movie

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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Actually, the wings are on fire – ENVI vote result worst of all worlds

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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ENVI IVD Regulation proposal vote postponed as well

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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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…

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Euro update and Don't Lose The SME

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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ENVI's IVD regulation amendments

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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Rapporteur Liese's IVD regulation amendments are out: not so horizontal as expected

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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Hold on to your seat: ENVI's Dagmar Roth-Behrendt report is here

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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Axon Seminar In Vitro Diagnostics Wednesday 12 September 2012

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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