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Happy Holidays, and an exciting and innovative New Year to you – and a correction

You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at…
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The EU Council Debate on medical devices regulations: wheelbarrow of frogs

Well, we had the Council meeting last Tuesday on among other things Health, in which the medical devices regulation proposal was debated at quite a length. Where are we now and where are…
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EU Council to meet on Tuesday on MDR and IVDR proposals

This Tuesday morning 10 December the EU Council will meet to discuss the dossier of medical devices and IVDs revision for the last time during the Lithuanian Presidency, from 10:00 to 12:00….
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Dutch interim injunction with high impact

On November 15, 2013, the District Court Gelderland rendered its judgment in the lawsuit (interim injunction) that was filed by Nutricia against healthcare insurer VGZ and five other insurers. The court ruled…
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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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Prošek vs. Prosecco – cheers!

Italy vs. Croatia What’s in a name? With Croatia’s accession to the European Union as of 1 July 2013 the beloved Croatian wine called Prošek is not allowed to be marketed under…
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Scientific substantiation of health claims – what's cooking?

EFSA opinions Lately, we have seen a number of positive EFSA opinions for various health claims. What do these claims relate to? Who are the applicants for such claims? What type of…
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The unfinished internal market for medical devices

The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what…
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The Role of Razzies in EU Food Law

Golden Raspberries One day before the distribution of the Academy Awards for excellence of cinematic achievements, the ceremony of Golden Raspberries or “Razzies” takes place. Razzies are awarded in recognition of the…
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