Recast

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Happy 2025 – more churn for MDR and IVDR!

Erik Vollebregt

Happy new year everyone! I hope you had a good rest over the holidays because 2025 will be interesting. I am planning to revive this blog this year and hope to put new energy in it by making it more periodical with smaller bits of information and shorter analysis. You will still get my unique […]
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Impossible and Incredible And Yet Really Happened

Karin Verzijden What can we learn from the Impossible vs. Incredible case in the Netherlands? At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on […]
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Happy New Year – with all those developments

, Erik Vollebregt The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year…
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The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

, Erik Vollebregt Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the…
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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

, Erik Vollebregt In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…
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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

, Erik Vollebregt Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time…
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EU ENVI Parliamentary Committee resolution re Review : "learn the lessons of this fraud" and an FDA internal report

, Erik Vollebregt The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of…
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The latest on the Recast, Review, Revision of EU medical devices framework

, Erik Vollebregt Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or…
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New EU guidance on medical devices vigilance reporting – more than meets the eye

, 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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Something new at Eucomed's MedTech Forum (also about the Recast)

, Erik Vollebregt Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011. At the end of conference I did learn something…
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FDA draft guidance on mobile medical applications

, Erik Vollebregt On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth…
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