The long-awaited sentence by the Court of Justice on the Snitem - Syndicat national de l'industrie des technologies médicales (C.329/16) case concerning the criteria for qualifying a software as a medical device, was published on 7 December 2017. The ruling - which currently broadens the scope of Dir 93/427/CEE and will widen that of Reg 2017/745 - will strongly impact on the market of medical softwares and apps.
The French association Sniterm (medical technology company), acknowledging the existence in French law of a specific law on medical software, have raised a procedural question to have precise indications about the scope of application of Dir 93/42/CEE (and therefore avoid legislative overlaps). More specifically they asked the court of first instance and then the Court of Justice to evaluate whether the software that is characterized by "a feature that allows the use of a patient’s personal data in order to assist the doctor in the preparation of the prescription, particularly by detecting contraindications, interactions with other medicines and excessive dosages" should or should not be considered a medical device, taking into account in particular that it is not used in or on the human body.
In essence, the Court was asked to establish whether, for the classification of a software as a medical device, the software itself must be intended by the manufacturer to be necessarily used on humans.
The decision of the Court
Taking into account the conclusions already taken by the Advocate General M. Campos Sanchez-Bordona on June 28, 2017, the Court of Justice has taken a broad interpretation of the discipline. Firstly, the Judges of the Court have acknowledged that in order for the software to fall within the scope of Directive 93/42, it is not sufficient that it is used in a medical context. The manufacturer has to have intended the software to be used for a direct and specific medical purpose (judgment of 22 November 2012, Brain Products, C-219/11, EU: C: 2012: 742, points 16 and 17).
Secondly, the Judge of the Court questions whether, in the event that such a medical purpose exists, the software can fall within the notion of medical device, regardless of how it is used (if in or on the human body" or even without any direct contact with the human body). On this point, the Judges of the Court, while acknowledging that the art. 1 lett a) refers to a "use on humans", have recalled Recital 6 of Dir 2007/47 where it is stated that "a software is in itself a medical device when it is specifically intended by the manufacturer to be used for one, or several medical purposes outlined in the definition of medical device. Hence, based on this assumption, they stated that the software can be considered a medical device even without use on humans.
More precisely, according to the Judges of the Court "the EU legislator intended to focus, in order to qualify a software as a medical device, on the purpose of its use and not on how it can produce an effect on or in the human body ". It follows that "for the purposes of qualification of a medical device, the fact that a software acts or does not act directly on the human body, is not relevant, being instead essential that the purpose indicated by the manufacturer is one of those provided for the definition of device itself.
This judgement looks set to have a major impact on the market of software and apps: the application of the sentence implies that the softwares and the apps that support a medical diagnosis - having a medical use - must be CE marked as medical devices, becoming class IIa medical devices by Reg. EU 2017/745.