UDI

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Current and mostly future UDI developments in the EU

I gave a presentation on current and future developments in UDI at the RAPS 2014 conference in Austin last week, sitting on a panel on global developments in UDI with presentations on…

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In the mean time: a Staff Working Document

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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EU Eudamed database for medical devices: La Sagrada Familia or Chartes cathedral?

I had the pleasure of presenting at the Informa Conference on the Medical Devices Directives and the Revision¬†in Brussels today. An nice conference with a good overview of what is coming our…

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What's cooking at IMDRF? UDI and software, among other things

After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of…

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"P" is for Post Market Surveillance – start your engines now

I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was…

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Axon Seminar Medical Devices Wednesday 14 November 2012

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

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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