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Article

"S" is for scope: does that include to 'enhance'?

The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its…
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Article

Food information all over the place

Food information services by Google Recently, Google added nutritional information into its search functionality relating to more than 1,000 food items ranking from fruits to vegetables and from meats to complete meals….
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Article

More on mHealth and e-labeling

Further to my recent post about e-labeling and my appeal to take more account of the specific mHealth market needs I had a discussion with another devices expert who suggested that the majority of medical…
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Article

E-labeling in the EU – some practical experience and: Save the apps market!

The e-labeling regulation has entered into full force a couple of months ago (1 March 2013), and I thought it would be a nice idea to share some of my experience with the new…
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Article

Autumn College on EU Food law

On 5 and 6 September 2013, the Autumn College on EU Food Law will take place in Brussels. This event offers a unique opportunity to receive a profound insight and practical understanding…
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Article

Karin Verzijden

Karin is a Dutch attorney-at-law who co-founded the boutique life sciences law firm Axon Lawyers in Amsterdam. Her interest in food legislation stems from a combination of professional involvement and a personal…
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Article

Sofie van der Meulen

Sofie is a lawyer working @ the boutique life sciences law firm Axon Lawyers in Amsterdam. Sofie has gained broad experience in advice and litigation in the field of administrative law. @…
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Article

In the mean time… joint immediate action plan, unannounced audits and other things over the summer

While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint…
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Article

ENVI IVD Regulation proposal vote postponed as well

So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date…
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