The EUCJ was required by the French Conseil d’État to assess whether this software shall be classified as a medical device under the Directive 93/42 (Directive). According to the EUCJ, software constitutes a medical device for the purposes of the Directive where it satisfies the two cumulative conditions – which must be met by any device of that nature – relating to (i) the objective pursued and (ii) the action resulting therefrom.
As regards, first, the objective pursued, Article 1(2)(a) of the Directive provides that a medical device must be intended by the manufacturer for use in humans for the purposes, in particular, of the diagnosis, prevention, monitoring, treatment or alleviation of a disease, and the diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.
In the present case, software that cross-references patient-specific data with the drugs that the doctor is contemplating prescribing, and is thus able to provide the doctor, in an automated manner, with analysis intended to detect, in particular, possible contraindications, drug interactions and excessive dosages, is used for the purpose of prevention, monitoring, treatment or alleviation of a disease, and therefore pursues a specifically medical objective, making it a medical device within the meaning of Article 1(2)(a) of the Directive.
That is not the case, however, for software that, while intended for use in a medical context, has the sole purpose of archiving, collecting and transmitting data, like patient medical data storage software, the function of which is limited to indicating to the doctor providing treatment the name of the generic drug associated with the one he plans to prescribe, or software intended to indicate the contraindications mentioned by the manufacturer of that drug in its instructions for use.
This interpretation is confirmed by the European Commission Guidelines on the qualification and classification of stand-alone software used in healthcare set out in the Meddev 2.1/6, whose objective is to promote a uniform application of the provisions of the Directive within the European Union. These guidelines indicate that software constitutes a medical device where it is specifically intended by the manufacturer to be used for one of the purposes set out in Article 1(2)(a) of the Directive and where it is intended to create or modify medical information, in particular by means of calculation, quantification or comparison of the recorded data against certain references, in order to provide information about a particular patient. Those guidelines further state that software that does not perform an action on data or performs an action limited to storage, archiving, lossless compression or, finally, simple search, that is to say, in the latter case, software that functions as a digital library and makes it possible to find information from metadata, without modifying or interpreting it, should not be considered a medical device.
Action on the Human Body
Secondly, as regards the condition relating to the action resulting from the objective pursued, the national court asks whether software which does not function automatically in or on the human body can be a medical device within the meaning of Article 1(2)(a) of the Directive.
In that respect, it should be noted that, although this provision provides that the main action of the medical device ‘in or on the human body’ cannot be obtained exclusively by pharmacological or immunological means, or by metabolism, it does not require such a device to act directly in or on the human body. Thus, it does not matter, in order to be classified as a medical device, whether software acts directly or indirectly on the human body, the essential point being that its purpose is specifically one of those referred to in the definition of medical device (that shall be specifically medical, as clarified by the judgment of 22 November, 2012, Brain Products, C-219/11).
Modules with Different Functions
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 the Directive), only the former fall within the scope of the Directive and must be marked CE.
In that regard, the European Commission’s guidelines (Meddev) confirm in essence that, where software is composed of modules which satisfy the definition of the concept of ‘medical device’ and others not, only the former must bear the CE marking; the others are not subject to the provisions of the Directive. Those guidelines state that it is the responsibility of the manufacturer to identify the limits and interfaces of the different modules which, in the case of modules subject to the Directive, must be clearly identified by the manufacturer and based on the use which will be made of the product.
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.
This ruling helps to clarify whether certain borderline software shall be classified as a medical device.
On one hand, the EUCJ actually confirm the criteria set out in the European Commission’s guidelines on the qualification and classification of stand-alone software used in healthcare (Meddev 2.1/6) and also in the manual on borderline classification in the community regulatory framework of medical devices (1.17 of September 2015), that provides for some useful examples of classification.
These documents point out that not all stand-alone software used within healthcare can be qualified as a medical device, since they have to meet certain conditions. In particular, these guidelines stress the circumstance that devices that are limited to storing and/or communicating data and/or performing simple searches shall not be qualified as medical devices (e.g., app for viewing the anatomy of the human body or app for communication between patient and caregivers while giving birth). Conversely, when the software processes and elaborates the data for the purposes of the diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or handicap, that shall be regarded as a medical device.
On the other hand, the clarification that software does not need to act directly in or on the human body to be classified as a medical device could have the effect of widening the numbers of apps/software that fall within the scope of the medical devices legislation (for instance, apps that support healthcare professionals in diagnosis or software designated for targeted stimulation of cognitive functions by using interactive games and exercises).