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Rapporteur Liese's IVD regulation amendments are out: not so horizontal as expected

17 Apr 2013, Erik Vollebregt Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for  rapporteur Liese’s amendments for the IVD regulation proposal to also be published….

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A medical device is medical – but what does that mean?

26 Nov 2012, Erik Vollebregt Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it…