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Erik Vollebregt
Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Regulators using the joint plan will stay…
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Erik Vollebregt
This seminar addressed how to develop compliant medical software and how to prepare for increased scrutiny by the authorities. Speakers and their presentations: Robert Houtenbos, mHealth consultant How to design medical software…
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Erik Vollebregt
Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar. The judgment immediately brought one of my favorite Yogi Berra quotes to mind: “You’ve got…
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Erik Vollebregt
I hope you won’t mind me imposing on you with some more self promotion – it’s for your own good as this is about saving you money, both in the short run…
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Erik Vollebregt
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….
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Erik Vollebregt
The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…
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Erik Vollebregt
Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am…
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Erik Vollebregt
Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of…
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Erik Vollebregt
Just before the holidays the Commission has issued guidelines on an issue that suffers a lot from the lack of harmonisation in the EU: clinical investigation for medical devices. Now that the…