European Union – Medicinal products. Article 1(1) and 1(2)(a) of Council Directive (EEC) 93/42, as amended by Directive (EC) 2007/47, should be interpreted as meaning that software, of which at least one of the functions made it possible to use patient-specific data for the purposes, among other things, of detecting contraindications, drug interactions and excessive doses, was, in respect of that function, a medical device within the meaning of those provisions, even if that software did not act directly in or on the human body. The Court of Justice of the European Union so held in a preliminary ruling in proceedings concerning the legality of certain national legislative provisions regarding the certification obligation for drug prescription assistance software and dispensation assistance software laid down in the French Social Security Code.