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Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

20 Jun 2022, Erik Vollebregt

We live in interesting times for medical devices in the Union – some have said we are headed for a cliff edge at the end of the grace period. I would personally prefer to say that we are in the danger zone, which would be a zone of danger (Archer pun on Top Gun), but […]

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In the mean time: a Staff Working Document

23 Jun 2014, Erik Vollebregt It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going…

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In the mean time… joint immediate action plan, unannounced audits and other things over the summer

25 Jul 2013, Erik Vollebregt While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint…

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Axon Seminar Medical Devices Wednesday 14 November 2012

14 Nov 2012, Erik Vollebregt The seminar addresses the changes in the new medical devices regulation compared to current legislation. Speakers and their presentations: Sabine Hoekstra-Van den Bosch, Philips Healthcare Recast of Medical Device Directives Luc Sterkman,…

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Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

23 Apr 2012, Erik Vollebregt Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…

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The latest on the Recast, Review, Revision of EU medical devices framework

27 Mar 2012, 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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Eudamed enters into full force

28 Apr 2011, Erik Vollebregt The European Database on Medical Devices (Eudamed) is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of…