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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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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 revision of...
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Marketing surveillance shaping up pre-Review with Dutch Minister feedback to...
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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In the mean time… joint immediate action plan, unannounced audits and other...
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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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 on in the medical devices...
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EU Court decides TÜV Rheinland / PIP breast implants case
It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants...
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New sort of applicable economic operators regulation: the Market Surveillance...
Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect...
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Managing the 2024 MDR danger zone – and outlines of a potential solution in...
Archer, season 1 episode 3 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...
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The new Blue Guide 2022 – not much new for devices and IVDs, but certainly...
In short After approximately six years after the previous (2016) version of the Blue Guide the 2022 version finally ‘dropped’ on 29 June 2022 in the Official Journal edition C edition of that day. I...
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Verelendung is a process, people!
Over the summer holidays I (and perhaps some other people too) were in burning anticipation about announced measures to be adopted to deal with the MDR slowly moving to a big crunch or other...
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Focus on the authorised representative
Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so much about the...
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