Case C-329/16 - Snitem and Philips France
On 7 December 2017, the Court of Justice of the European Union (CJEU) ruled that to the extent software constitutes a medical device and bears the CE marking of conformity, it may be placed on the market and circulate freely in the European Union and may not be made subject to additional national certification requirements. This decision, which will certainly be of interest to businesses active in the field of digital health and of course the producers of medical devices, also recapitulates the two conditions which software must meet in order to be considered a medical device.
Background
France adopted legislation that requires certain prescription-support software to obtain national certification (attesting to compliance with rules of good practice), even if the software already bears the CE marking.
Philips France (‘Philips’), which manufactures and markets the drug prescription assistance software Intellispace Critical Care and Anesthesia (ICCA), and the Syndicat national de l’industrie des technologies médicales (Snitem), the representative body for businesses active in the medical devices sector in France, brought proceedings before the Council of State seeking to have the legislation in question set aside.
The claimants argued that since the ICCA software bears the CE marking, attesting to the fact that it has undergone an assessment of its conformity with the requirements of the Medical Devices Directive (93/42), it should not be subject to an additional national certification procedure.
In particular, the claimants contended that the national certification procedure constitutes a measure having an equivalent effect to a quantitative restriction on imports. In imposing an additional requirement for the certification of medical devices, on top of those provided for by the Medical Devices Directive, the legislation breaches Article 4(1) of the directive, pursuant to which Member States must not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking.
The Council of State was uncertain whether software such as ICCA should be considered a medical device within the meaning of Article 1(2)(a) of Directive 93/42 and thus sought an interpretation of the French legislation from the Court of Justice.
The Judgment
The Court of Justice first noted that software constitutes a medical device for purposes of the Medical Devices Directive where it satisfies the two cumulative conditions which must be met by a medical device, relating to the objective pursued and the action resulting therefrom.
The objective pursued
Software is deemed a medical device per se when it is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device. Thus, software intended for general purposes is not considered a medical device when used in a healthcare setting (para. 24).
The Court noted that the claimant's software cross-references patient-specific data with the drugs that the doctor is considering prescribing and is thus able to provide the doctor, in an automated manner, with an analysis intended to detect, in particular, possible contraindications, drug interactions and excessive dosages. The Court found that the software is thus used “for the purpose of prevention, monitoring, treatment or alleviation of a disease”, and hence pursues a specifically medical objective, making it a medical device within the meaning of Article 1(2)(a) of Directive 93/42.
The Court clarified, however, that this would not be the case for software that, while intended for use in a medical context, has the sole purpose of archiving, collecting or transmitting data, such as:
- patient medical-data storage software;
- software whose function is limited to indicating to the attending physician the name of the generic drug associated with the one the doctor intends to prescribe; and
- software intended to indicate the contraindications mentioned by the manufacturer of the drug in its instructions for use (paras. 25 and 26).
The action resulting from the objective pursued
Secondly, as regards the condition relating to the action resulting from the objective pursued, the Council of State asked whether software which does not function automatically in or on the human body can be considered a medical device within the meaning of Article 1(2)(a) of Directive 93/42.
In that respect, the Court noted that although the provision in question states that the main action of a medical device ‘in or on the human body’ cannot be obtained exclusively by pharmacological or immunological means, or by metabolism, it does not require that the device itself act directly in or on the human body (para. 28).
The Court thus emphasized the fact that the European legislature intended to focus, when determining whether software should be classified as a medical device, on the purpose of its use and not the manner in which the effect it is capable of producing on or in the human body is likely to materialise (para. 29).
Thus, in order to be classified as a medical device, it is irrelevant if software acts directly or indirectly on the human body; what matters is that it fulfils one or more of the medical purposes set out in the definition of a medical device.
Moreover, the Court added that this interpretation has been confirmed by the Commission Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices, whose objective is to promote a uniform application of the provisions of the Medical Devices Directive throughout the European Union. It should be recalled that the guidelines indicate that software constitutes a medical device (i) where it is specifically intended by the manufacturer to be used for one of the purposes set out in Article 1(2)(a) of Directive 93/42 and (ii) where it is intended to create or modify medical information, in particular by means of calculation, quantification or comparison of recorded data against certain references, in order to provide information about a particular patient. The guidelines furthermore state that “if the software does not perform an action on data, or performs an action limited to storage, archival, communication, “simple search” or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device.”
Having answered the question of whether software can be considered a medical device, the Court then turned to the issue of certification.
The national certification procedure
The Court noted that to the extent software constitutes a medical device, it must bear the CE marking of conformity when it is placed on the market. Once the CE marking has been obtained, the product, having regard to that particular function, may be placed on the market and circulate freely in the European Union. It may not be made subject to additional national certification requirements (para 35).
