Erik Vollebregt
Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of them that watched the vote on the Parliament’s streaming servi…
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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for…