I imagine what I want to write in my case, I write it in the search engine and I get exactly what I wanted. Thank you!
Valentina R., lawyer
EN
(2016/C 296/30)
Language of the case: French
Applicants: Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France
Defendants: Premier ministre and Ministre des Affaires sociales et de la Santé
Must [Council] Directive 93/42/EEC of 14 June 1993 [concerning medical devices (OJ 1993 L 169, p. 1)] be interpreted as meaning that software, the purpose of which is to offer to prescribers practising in towns, a health establishment or a medico-social establishment support for determining a drug prescription, in order to improve the safety of prescription, facilitate the work of the prescriber, encourage conformity of the prescription with national regulatory requirements and reduce the cost of treatment at the same quality, constitutes a medical device within the meaning of that directive, where that software has at least one function that permits the use of data specific to a patient to help his doctor issue his prescription, in particular by detecting contraindications, drug interactions and excessive doses, even though it does not itself act in or on the human body?