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Erik Vollebregt
Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical…
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Karin Verzijden
Dutch slaughterhouse Van Hattem suffering severe blow This week the Trade and Industry Appeals Tribunal, (in Dutch: College van Beroep voor het bedrijfsleven) rendered its judgment (interim injunction) in the lawsuit that…
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Erik Vollebregt
mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s…
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Erik Vollebregt
No one is an island, and neither is my firm. We have the honor to cooperate with the excellent Italian law firm Italy Legal Focus in the Alliance of European Life Sciences…
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Erik Vollebregt
I had the pleasure of presenting at the Informa Conference on the Medical Devices Directives and the Revision in Brussels today. An nice conference with a good overview of what is coming our…
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Erik Vollebregt
The life sciences sector is a moving and shaking place when it comes to IP and IP licensing. Licenses are the proverbial fabric of the industry. For that reason my firm thought…
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Erik Vollebregt
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all…
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Erik Vollebregt
In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…
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Karin Verzijden
Introduction Novel Foods (NF) are all foods that were not used for human consumption to a significant degree within the EU prior to 1997. One of the most well known examples is…