In vitro diagnostics

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The genetic testing amendment in the IVDR

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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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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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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The fog of war following a tsunami of amendments

That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we…

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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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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…

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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…

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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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