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EU mHealth regulatory requirements and update: why the NO in innovation?

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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Guest post: Organisational models and corporate criminal liability under Italian law

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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EU Eudamed database for medical devices: La Sagrada Familia or Chartes cathedral?

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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Axon seminar Intellectual Property Licensing Update

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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Netherlands medical devices compliance update

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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IMDRF Software as Medical Device definition document completes

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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New proposal for Novel Foods Regulation

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…
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COOL update

 As announced in the post of October 30, 2013, the European Commission was expected to table a report concerning mandatory country of origin labelling (COOL) for meat used as an ingredient. In December…
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Just as good as a daily glass of milk

Introduction Recently, Advocate General Wathelet rendered his conclusion in a case regarding the claim “Just as good as the daily glass of milk” used for a dairy product consisting of fruit curd….
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