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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

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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Economist, why so pessimistic about open source medical devices software?

I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by…
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EU court AG concludes in borderline case – "intended use by nature"?

The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The…
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EU ENVI Parliamentary Committee resolution re Review : "learn the lessons of this fraud" and an FDA internal report

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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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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Axon Seminar Cell-based Therapies Wednesday 18 April 2012

The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
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Article

Axon Seminar Cell-based Therapies Wednesday 18 April 2012

The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
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Article

Everything you always wanted to know about stand alone software, but were afraid to ask

I hope you won’t mind me imposing on you with some more self promotion – it’s for your own good as this is about saving you money, both in the short run…
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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…
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