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EU court rules on no-fault liability for medical services with medical devices

The judgment in the Centre hospitalier universitaire de Besançon v Thomas Dutrueux, Caisse primaire d’assurance maladie du Jura case that I wrote about earlier has been handed down by the EU Court on…
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Developments and outlook re anti-kickback and corruption in the Dutch devices sector

Although no significant things happened in business compliance developments on a EU level for some time since Eucomed asked itself about guidance for sponsorship of conferences, things are very much in flux…
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More on mobile medical apps, and on clinical decision support systems

I have been running around a lot lately doing presentations on conferences about medical devices and software, so I though it would be useful to give you a round-up on that subject….
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Developments in EU product liability for medical devices – or not

Now here is an important case for the medical devices industry. Although product liability litigation has not (yet) evolved into the type of bet the company litigation it can be in the…
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Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am…
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More on internet sales of medical devices

With the Ker-Optika judgment that I wrote about before in relation to internet sales of medical devices and online sale of eHealth services the European Court (ECJ) set boundaries for national legislation…
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Something new at Eucomed's MedTech Forum (also about the Recast)

Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011. At the end of conference I did learn something…
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Regulating Medical Software and nothing new on the Recast

Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak…
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EU regulation of e-labelling of medical devices to apply as of 1 March 2013

On 23 September 2011 the draft of the e-labelling regulation that I wrote about earlier was discussed in the comitology committee for the Medical Devices Directive. I received the text of the…
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