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Erik Vollebregt
Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of…
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Erik Vollebregt
In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to…
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Erik Vollebregt
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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Erik Vollebregt
In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share…
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Erik Vollebregt
On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth…
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Erik Vollebregt
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. This post extrapolates the reasoning of the European Court…
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Erik Vollebregt
And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the Combined…
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Erik Vollebregt
On 8 June the European Commission published a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities. Up to now, e-labelling was problematic and regulated in a fragmented way….
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Erik Vollebregt
As I have written before on this blog, medical devices are spectacularly unregulated by medical devices specific EU legislation when it comes to advertising and marketing. That does not mean however that…