Your search for ‘Axon Lawyers’ returned 19 results

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.

Cultured meat has been an increasingly hot topic since the first "clean meat" hamburger was introduced in London in 2013.

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.

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.

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.

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.

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.

Probiotics are known as "beneficial bacteria" that can be found in, amongst others, dairy products and food supplements.

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.

Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011.

Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette.

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.

Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products ...

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.

The organic sector has developed from a niche market to one of the most dynamic sectors of EU agriculture.

The FDA knows just how vital it is to ensure the safety of our nation's food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation.

Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear.