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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 medical...
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ISO 14155:2011 is here: revised standards for medical devices clinical trials
ISO 14155, who in medical devices is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the 2009...
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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...
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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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Critical analysis of the European Society of Cardiologists’ report on medical...
Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European Society of...
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Outlines of the medical devices Recast become more fixed with Council...
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 industry, the project...
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Some important practical points for ISO 14155 compliant clinical trial...
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 my thoughts on these. This...
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Some important practical points for ISO 14155 compliant clinical trial...
In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to mind and if so, I will...
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Hold on to your seat: ENVI’s Dagmar Roth-Behrendt report is here
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary view. I have poked fun...
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Guest blog: no enhanced patient safety resulting from rapporteur...
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 significant...
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The moment is NOW! And medicinal product trials requirements feedback in...
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 get stuck with medical devices...
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Netherlands medical devices compliance update
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like...
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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 the trilogue have been published...
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