Contributor Page
Axon Lawyers
 
Email  |  Articles
Contact Details
Tel: +31 31 886506500
Fax: +31 31 886506555
Piet Heinkade 183
1019 HC
Amsterdam
Netherlands
By Erik Vollebregt
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 21 December and as expected, the EU Court followed its Advocate General.
By Erik Vollebregt
A recently published decision of the European Patent Office’s (EPO) Board of Appeal about European patents and clinical trials provides for interesting reading and for some important pointers about how to deal with clinical trials for medicinal products but also for medical devices as to not destroy novelty of a patentable invention with invalidity as result.
By Erik Vollebregt
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 in the Netherlands.
By Erik Vollebregt
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.
By Erik Vollebregt
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 United States and cases about interpretation of the Product Liability Directive have been few, they do shape the scope of no fault liability in the EU of manufacturers of medical devices for their products.
By Erik Vollebregt
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 currently attending in Indianapolis.
By Erik Vollebregt
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 in the EU regulating the internet sales of medical devices.
By Erik Vollebregt
Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011.
By Erik Vollebregt
On 23 September 2011 the draft of the e-labelling regulation that I wrote about earlier was discussed in the comitiology committee for the Medical Devices Directive.
By Erik Vollebregt
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 to many people close to developments in EU legislation, EU guidance and standards.
By Erik Vollebregt
If the clinical trial is to produce results in the form of data that the manufacturer of the investigational device wants to use to complete its technical file with a view to CE marking the device, it is critical for the manufacturer to own or at least have unfettered use of the data produced.
By Erik Vollebregt
Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of Justice.