market surveillance


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…


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

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…


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,…


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…


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

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…


Eudamed enters into full force

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…

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