CELEX: 62016CA0329
Language: en
Date: 2017-12-07 00:00:00
Title: Case C-329/16: 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 (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)

12.2.2018   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 52/7
            
         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))
   (2018/C 052/09)
   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.
   
      (1)  OJ C 296, 16.8.2016.