Following a reference for a preliminary ruling, the ECJ has handed down their judgment on the interpretation of Directive 93/42/EEC (as amended) ("the Directive") in the Snitem case (C 329/16). The impact of their decision may have wide ranging implications for the E-health industry and those involved in the creation of software and applications that are designed to run alongside pharmaceuticals and medical devices.
In France, drug prescription assistance software (e.g. identifying contraindications) was subject to a notification procedure laid down in the Social Security Code. This procedure was directed at software that had a role in offering assistance in the prescription or dispensing of medicines. Syndicat national de l’industrie des technologies médicales ("Snitem") and Philips France brought an action asserting that this notification procedure constituted a measure having equivalent effect to quantitative restrictions ("MEQR"), as a number of the software applications were already classed as a medical device and thus were required to bear the CE marking. This additional notification procedure was hindering the free trade of goods bearing the CE marking which was in direct conflict with the Directive.
What was the reference?
The following question was referred to the European Court of Justice ("the ECJ"):
"Must Directive [93/42] be interpreted as meaning that software, the purpose of which is to offer to prescribers practising in towns, a health establishment or a medico-social establishment support for determining a drug prescription, in order to improve the safety of prescription, facilitate the work of the prescriber, encourage conformity of the prescription with national regulatory requirements and reduce the cost of treatment at the same quality, constitutes a medical device within the meaning of that directive, where that software has at least one function that permits the use of data specific to a patient to help his doctor issue his prescription, in particular by detecting contraindications, drug interactions and excessive doses, even though it does not itself act in or on the human body?"
Essentially, the ECJ has taken this to mean whether Article 1(1) and Article 1(2)(a) of the Directive 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 (emphasis added).
The question hinged on the interpretation of these articles and whether they could be read together or whether they should be read separately. In order to reach their judgment, the ECJ looked at the purpose behind the articles and what they were intended to achieve.
What was 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."
Essentially, this means that the purpose of the software must be looked at under Article 1 (2) (a) of the Directive meaning that the software is for the prevention, monitoring, treatment or alleviation of a disease, and therefore pursues a specifically medical objective. It is irrelevant whether or not the software acts within the human body and it is irrelevant that it was never intended to do so.
What are the implications of this ruling?
From a national perspective, drug prescription software should be classed as a medical device and have the CE marking affixed. This means that the medical device will not have to undergo a second notification procedure under the French Social Security Code. However, as this judgment is binding all over Europe, it is likely to have an impact on software developers who may previously have thought themselves outside the scope of the Directive, because the software was not acting within the human body. For any already on the market without the CE marking, it is likely that they would have to be withdrawn until the CE marking is affixed.
What is the impact of this judgment on the new medical devices regulation (Regulation (EU) 2017/745) ("the Regulation")
As one might anticipate for a newer piece of legislation, "software" is treated differently in the definition of a "medical device" than it is in the older Directive. In the latter there is specific provision "including the software intended by its manufacturer to be used for diagnostic and/ or therapeutic purposes….", that is to say, not including "treatment or alleviation". Although this addition was intended to expand the definition of what might be a "medical device", its inclusion might be considered by some to have narrowed the application of the Directive. This judgement has made it clear that that is not the case.
The judgement makes it clear that if a device has one of the "medical purposes" listed, that it will be a medical device.
The Regulation includes a specific mention of stand-alone software in recital 19, which also makes the same point as the ECJ decision:
"It is necessary to clarify that software in its own right, when 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, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device". (emphasis added)
It may be that the ECJ had regard to the Regulation when they considered the question referred. The Court provided greater clarity in respect of software than is perhaps the case under the currently applicable Directive, but which matches the clarity provided more explicitly in the Regulation.
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