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Conference bonanza: let's meet at RAPS or Advamed

This is not a substantive post, just a note to say that I am visiting the RAPS Regulatory Convergence conference in Austin next week and then the Advamed MedTech conference in Chicago…
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More movement – new rapporteur for MDR, same for IVDR

Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP…
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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FDA draft guidance on mobile medical applications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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