French judges clarify the notion of medical devices

The Paris Court of Appeal has just issued a landmark decision concerning the notion of medical devices, in the context of a five-year dispute between two French companies. Such decisions are rare, even in the other European countries which use the same EU legal definition for medical devices (e.g. Spain and United Kingdom - which has a similar definition despite the country is no longer being an EU member state).

Overturning the first decision in this matter, the Paris Court stated that a product is a medical device if it has a medical purpose and that it is its manufacturer who decides whether or not there is a medical purpose. Similar positions have already been taken by the German and Italian courts. Therefore, a distributor should not be challenged if it sells a product which could be considered prima facie as a medical device, but which is not presented as such.

The Court also considers that a product may have - and may be marketed with - a dual use, e.g. aesthetic and medical, as long as it carries the CE mark for its medical use.

The final point of interest in the Paris Court's decision is that it formally relies on some general regulatory statements issued by the French Health Care Products Agency to reach its conclusion. This demonstrates once again the strength of such regulatory publications, even though they are not mandatory from a strict legal standpoint.