The fact that a software is not acting by itself within or upon the human body does not mean it cannot be classified as a medical device, explained the Advocate General Manuel Campos Sanchéz-Bordona in his conclusions delivered on Wednesday 28 June (C-329/16).
The Philips France company markets medical prescription assistance software used in the anaesthetics and resuscitation domain. This helps use a patient’s own data to assist a doctor establish their prescription by detecting side effects, drug interaction and excessive dosage.
The medical technology industry’s union, the Syndicat national de l’industrie des technologies médicales (SNITEM), which represents medical device sector companies in France, including Philips France, believes this kind of software should not be subject to current certification requirements in France, even though the software carries the EC trademark. According to the SNITEM, this software should be regarded as “medical devices” under the terms of directive 93/42 prohibiting member states from preventing or restricting the marketing of medical devices bearing EU markings.
Questioned by the French Council of State, the Advocate General points out that the software in question appears to contain its own medical functions given that it facilitates therapeutic tasks and disease control carried out under anaesthetics or during intensive care, which allows for the collection, analysis and processing of data for these patients. Once the doctor introduces the patient’s data into the software, this helps the doctor locate an appropriate treatment whilst avoiding problems that could result from an unsuitable treatment.
Mr Campos Sanchéz-Bordona therefore concludes that in an instrumental way, the software carries out the objective of preventing, controlling, treating and relieving a disease and it should therefore be classified as a medical device. According to the latter, the fact that the software in question does, by itself, act within or upon the human body does not contradict its classification as a medical device in so far as under the terms of the directive, the software in question contributes to a corrective action on the human body, namely, action involving the use of medicines. (Original version in French by Mathieu Bion)