MEDDEV

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With Little Movement on Device Regs, EU States Turn to Joint Action Plan

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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Axon Seminar Medical Software & Apps 16 October 2013

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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EU court decides another borderline case regarding "pharmacological effect"

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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Everything you always wanted to know about stand alone software, but were afraid to ask

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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New EU guidance on medical devices vigilance reporting – more than meets the eye

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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New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

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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Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

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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EU court to clarify medical device / drug borderline and the status of MEDDEV documents

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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New European Commission guidelines for clinical investigations

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…

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