Medical prescription support software when the purpose defined by the manufacturers is specifically medical, must be described as "medical devices” under the terms of the appropriate directive (93/42/CEE), even if they do not directly interact with the human body. When it covers CE marking, their marketing in EU territory cannot be obstructed or banned by obligations pertaining to national certification.
This is the substance of the decision made by the European Court of Justice on Thursday 7 December (C‑329/16), in response to a referral on these points introduced by the French Council of State. The Court was requested to give into opinion on an appeal by the Syndicat national de l’industrie médicale (SNITEM) and by one of its members, Philips France, the manufacture of a medical prescription support software, against French regulation that subjects this kind of software to certified requirements even though they possess the CE marking, which is obstructing their free marketing in France in violation of the directive. The French court made a request to the Court because it was not sure whether this software could be described as medical devices under the terms of the directive.
Following the conclusions of the Advocate General on this case (see EUROPE 11818), the Court indicates that when this medical prescription support software is matched with the patients' own data and the medicines that the doctor intends to prescribe (allowing the latter to prevent any side-effects, drug interactions or excessive dosages during the prevention, control or treatment of diseases), they have, for this reason, a purpose and a specifically medical use.
It is therefore appropriate to describe them as "medical devices" under the terms of the directive even if they do not have a direct impact on the human body.
The Court therefore concludes that in this case, the Philips software is a medical device and must therefore have the CE marking of compliance when it is on the market. It can therefore be put on the market for this use and circulated freely within the EU without requiring additional certification. (Original version in French by Francesco Gariazzo)