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The MDR – where are we now?

There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a…
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Enforcement measures regarding borderline products

As observed in an earlier post, the boundaries between food products and medicinal products are sometimes blurred. However, the qualification of a product as either one or the other may have huge…
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Organic certification of mirco-algae

Micro-algae enjoy an increased interest, for instance as an alternative source of protein. Manufacturers of this type of algae experience that there is a high demand for organicly grown micro-algae. For quite a long time, it was not clear what standards are applicable to the organic production of micro-algae. Recently, new EU legislation was published, which clarifies those conditions. However, practical issues remain unresolved. Together with the Dutch micro-algae manufacturer Nutress,

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Autumn College on EU Food Law

This year is the 4th edition of a 2-days seminar on two particular topics of EU Food Law, notably health claims and food information. Karin created this event, together with Lexxion, in…
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Software MEDDEV ‘updated’

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious…
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Life Sciences @ Work Venture Challenge interviewt Carine van den Brink

Carine van den Brink, vanaf het begin juryvoorzitter kijkt terug op 15 Venture Challenge edities en geeft advies voor toekomstig Venture Challenge teams.

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Brexit: what are the consequences for nutraceuticals?

Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned….
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The final text of the IVDR: first impressions

The IVDR text that the Council, Commission and Parliament reached agreement on is finally public (since 15 June). I’ve had the time to read it now. I am not going to draft…
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Medical devices and the #Brexit

Wow, while I was still working on wrapping my head around the hundreds of pages of final texts of the MDR and IVDR, the Brexit happened. Speaking of surprises – this was…
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