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First notified body EU MDR designated!

BSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation –…
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MDR and IVDR in 2019: up or out, sink or swim

Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of…
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Ceci n’est pas une période de transition and first reaction to the Implant Files

As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become…
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How do we get cellular ag products to the market?

“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in…
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Does EC40, a chlorhexidin lacquer to prevent tooth decay, qualify as a medicinal product or not?

The Dutch Minister of Healthcare decided that EC40, a lacquer containing chlorhexidin used for the purpose of preventing tooth decay, should be regarded as both a medicinal product by presentation as well…
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The Netherlands ∙ Proposed Solutions to Tackle Expensive Medicines in The Netherlands: A Critical Review

If you have an interest in Life Sciences, I am glad to draw your attention to my Report in the latest edition of the European Pharmaceutical Law Review (EPLR). As many of…
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The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteria

Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms…
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Take # 1 on Harvard’s Clean Meat Regulatory Roundtable (9-10 August 2018)

Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013. The technology involves using cell culturing techniques to multiply a small amount of…
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Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you…
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