Clinical evaluation

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Compromise texts for EU Council EPSCO meeting public

The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start…

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The devices have landed – and some promotion

So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR….

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The moment is NOW! And medicinal product trials requirements feedback in medical devices clinical requirements

Yet another post! Apologies, I am very productive these days. A lot is happening and I am just trying to keep track because the moment is NOW if we don’t want to…

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Guest blog: no enhanced patient safety resulting from rapporteur Roth-Behrendt's proposal

I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in…

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New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…

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Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share…

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Outlines of the medical devices Recast become more fixed with Council conclusions

Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…

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Outsourced clinical investigation: legal aspects

Last Wednesday 13 April I spoke at Informa’s 6th Annual Clinical Evaluations and Investigations for Medical Devices conference about legal aspects of outsourced clinical investigation in the medical devices industry. Proceeding from showing…

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New European Commission guidelines for clinical investigations

Just before the holidays the Commission has issued guidelines on an issue that suffers a lot from the lack of harmonisation in  the EU: clinical investigation for medical devices. Now that the…

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