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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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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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IVDR and MDR implementation seminar

If you are in the neighbourhood of Amsterdam this Wednesday 18 April, consider dropping by for our IVDR and MDR implementation seminar because there are still some seats left. IVDR is mentioned…
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Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an IVDR seminar

You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on…
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An unsurprising case of software qualification with an interesting twist

The unsurprising software qualification case that I wrote about earlier turns out to still have a little twist in the judgment that the European Court of Justice (CJEU) recently rendered in that…
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Happy New Medical Devices Year!

Happy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely. May your management be convinced that making and selling medical devices is actually core business…
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A wave of MDR and IVDR rollout coming our way

With the clock for the countdown to the end of transitional periods for the MDR and IVDR ticking away, everyone is of course very interested what the competent authorities are doing regarding…
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MDR and IVDR workshop at Advamed on 4 December

At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with…
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