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Axon Seminar Functional & Medical Foods 24 September 2014

This seminar focussed on the food information and nutrition and health claims regulations. Speakers and their presentations: Bernd Mussler, DSM Marketing ingredients supported by EU Health claims Karin Verzijden & Sofie van…
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Movement in the Commission – medical devices policy back to DG Enterprise

Last week we finally had some new interesting developments (sorry for the boring silence on this blog but there was really nothing to report): the new Commission has completed and we are…
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FDA draft guidance on mobile medical applications

If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…
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Consequences of the EU Ker-Optika case for eHealth services

In a previous post I have analysed the consequences of the European Court of Justice’s Ker-Optika judgment for e-commerce in physical medical devices.

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New EU Commission guidance on medical devices borderline products and classification

Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual…
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Axon Seminar on Corporate Law

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Axon seminar Functional & Medical Foods

On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods. Where? Next door to our office in Pakhuis de Zwijger. Functional foods The Institute of…
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Updates, patches, add-ons, plugins & the Blue Guide

Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the…
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Where are we with the MDR and IVDR after the Greek Presidency?

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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