Judgment of the Court (Fourth Chamber) of 7 December 2017 (request for a preliminary ruling from the Conseil d’État — France) — Syndicat national de l’industrie des technologies médicales (Snitem), Philips France v Premier ministre, Ministre des Affaires sociales et de la Santé

(Case C-329/16) ¹

(Reference for a preliminary ruling — Medical devices — Directive 93/42/EEC — Scope — ‘Medical device’ — CE marking — National legislation making drug prescription assistance software subject to a certification procedure laid down by a national authority)

Language of the case: French

Referring court

Conseil d’État

Parties to the main proceedings

Applicants: Syndicat national de l’industrie des technologies médicales (Snitem), Philips France

Defendants: Premier ministre, Ministre des Affaires sociales et de la Santé

Operative part of the judgment

Article 1(1) and Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as meaning that software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not act directly in or on the human body.

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¹ OJ C 296, 16.8.2016.