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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)
ECLI:EU:UNKNOWN:62016CA0329
62016CA0329
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12.2.2018
Official Journal of the European Union
C 52/7
(Case C-329/16) (<a id="ntc1-C_2018052EN.01000701-E0001" href="#ntr1-C_2018052EN.01000701-E0001"> (<span class="super note-tag">1</span>)</a>)
((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
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.
(<a id="ntr1-C_2018052EN.01000701-E0001" href="#ntc1-C_2018052EN.01000701-E0001">(<span class="super">1</span>)</a> <a href="./../../../../legal-content/EN/AUTO/?uri=OJ:C:2016:296:TOC">OJ C 296, 16.8.2016</a>.)
* * *
(*1) Language of the case: French.