Case C‑329/16

Syndicat national de l’industrie des technologies médicales (Snitem) and Philips France

v

Premier ministre and Ministre des Affaires sociales et de la Santé

(Request for a preliminary ruling from the Conseil d’État (France))

(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)

Summary — Judgment of the Court (Fourth Chamber), 7 December 2017

1. Approximation of laws—Medical devices—Directive 93/42—Scope—Product marketed for non-medical use—Not included

   (Council Directive 93/42, as amended by Directive 2007/47, Art. 1(2)(a))

2. Approximation of laws—Medical devices—Directive 93/42—Scope—Drug prescription assistance software—Included

   (Council Directive 93/42, as amended by Directive 2007/47, Arts 1(1) and 2(a))

1.  See the text of the decision.

   (see paras 24-26)

2.  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.

   Consequently, and to the extent that such software constitutes a medical device, it must, pursuant to Article 17(1) of that directive, compulsorily bear the CE marking of conformity when it is placed on the market. Once the marking has been obtained, the product, having regard to that function, may be placed on the market and circulate freely in the European Union without having to undergo any additional procedure, such as a new certification (see, to that effect, judgment of 19 November 2009, Nordiska Dental, C‑288/08, EU:C:2009:718, paragraph 21).

   In respect of medical software comprising both modules that meet the definition of the term ‘medical device’ and others that do not meet it and that are not accessories within the meaning of Article 1(2)(b) of Directive 93/42, only the former fall within the scope of the directive and must be marked CE.

   As a result, the manufacturer of such software is required to identify which of the modules constitute medical devices, so that the CE marking can be affixed to those modules only.

   (see paras 35, 36, 38, 39, operative part)