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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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More on 3D printing (and biofabrication)

On 16 July I had the honor to give a lecture about Legal and Regulatory Aspects of 3D Printing (and biofabricaton) in the Focus on Life Sciences Summerschool program of University Medical…
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Glimpse of IFT 2014

From 21 – 24 June, the yearly conference of the International Food Technologists (IFT) took place in New Orleans, Louisiana. During this conference, over 16.000 food science and technology professionals discussed the…
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In the mean time: a Staff Working Document

It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going…
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Mobile medical apps update from the HIMSS

On Thursday 8 May I presented about EU regulation of mobile medical apps at the HIMSS Mobile Medical Apps roadshow in Berlin. The European Commisison’s Green Paper on mHealth has been hotly anticipated…
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Annual Conference on European Food Law

Early this week the Academy of European Law’s Annual Conference on Food Law took place on 5 and 6 May in Trier and offered a unique opportunity to receive an analysis of…
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Health claim on water drowns – Decision of the General Court in case T-17/12

Recently, the General Court has decided a dispute concerning a health claim on water, explaining the concept of a disease risk reduction claim as defined by art. 14 (1) of the Health…
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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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