When it comes to medical devices, you have to accept a certain distance
At the start of 2020, the highest French courts have already ruled twice on the use of the term "medical device".
In the past, the legal characterization of a medical device for products which did not come into contact with the patient has been difficult. This is particularly the case with software. That characterization is important, however, in particular because it conditions the placing on the market of the product or the tax system applicable to it.
We therefore need to review the criteria used by judges to qualify equipment as a medical device.
The current definition of a medical device in French legislation is given by article L.5211-1 of the French Public Health Code of Law. Originally this definition resulted from the transposition of the Directive 93/42/EEC of 14 June 1993 related to medical devices. With one nuance, however, which has proved important in practice. In the French texts, the reference to a principal intended action "in or on the human body" provided for by the directive had disappeared.
Furthermore, litigation has focused a great deal on this difference between the qualification of a medical device as such in European Union law and French law. The importance of this indication merited its retention in the definition of a medical device resulting from Regulation 2017/745/EU dated 5 April 2017 relating to medical devices.
In view of this difficulty in characterization linked to contact with the human body, the Court of Justice of the European Union, to which a preliminary question by the French courts had been referred, had ruled in a ruling dated 7 December 2017 (C-329/16). It had identified two criteria for characterizing a medical device as such: the intended purpose and the action produced.
Two rulings, delivered in February 2020 by the French courts, apply these concepts in order to classify a medical device as such. One is a ruling by the State Council (10 February 2020, no. 421576) and a ruling of the Administrative Court of Appeal of Versailles (25 February 2020, no. 17VE01933). We shall analyse their application of the concepts of intended purpose (I) and action produced (II).
I. Criterion # 1 of the medical device: the intended purpose
The primary distinction between a medical device and a “common” product operating in a medical environment is its purpose. A medical device must be intended by the manufacturer to be used for medical purposes, an exhaustive list of which is set out by article R.5211-1 of the French Public Health Code of Law:
diagnosis, prevention, control, treatment or alleviation of a disease;
diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability;
the study, replacement or modification of the anatomy or of a physiological process;
control of the design.
Application to medical device hardware
In this way, an activimeter is intended for a medical purpose, when it measures the level of radioactivity during the preparation of doses of radioisotopes intended to be administered to a patient. Indeed, according to the State Council, in a ruling dated 10 February 2020 (recitals 2 and 6), the product is intended for the purpose of diagnosis, prevention, control, treatment or alleviation of a disease.
Application to medical device software
The question of qualification then arises in terms of software systems because of their specific nature and when they do not act by themselves "in or on the human body"
In its ruling of 7 December 2017, the Court of Justice of the European Union (CJEU) offers practitioners a clear explanation of the situations for which software must be classified as a medical device. While laying down a principle of the existence of two cumulative criteria necessary for the qualification of a medical device (the intended purpose and the action produced), the CJEU also defines an exception to this principle by focusing only on the medical purpose of the device.It specifies that the software in question can be classified as a medical device simply by taking into account its purpose. It will therefore be useless to consider the action produced "in or on the human body"
Indeed, the CJEU holds that to refuse the qualification of a medical device to a software system, that does not act, by nature, on the human body, would be contrary to the intent of the European legislator.
In considering the purpose of the medical device, the CJEU relies on the distinction already present in the 2007 directive (no. 2007/47/EC, recital 6) which amended the 1993 directive, and included in European Regulation 2017/745 of 5 April 2017 (recital 19) between:
on the one hand, medical device software: "(...)specifically intended by the manufacturer for one or more of the medical purposes referred to in the definition of the concept of medical device";
on the other hand, software systems that do not constitute medical devices "(...) intended for general purposes, even when used in a healthcare environment, or (...) intended for uses relating to lifestyle or well-being"
In its ruling of 25 February 2020, the qualification of software for the compression, storage and transmission of medical images had been brought before the Administrative Court of Versailles. To exclude the qualification of medical device, the ruling characterizes the intended purpose and considers that software which does not allow the display of medical images, does not perform any action on medical images, and therefore does not participate "actively" in the diagnosis (the Versailles Administrative Court of Appeal (CAA), February 25, 2020, §4-5, no. 17VE01933).
This is how to apply the solution identified by the CJEU which excludes from the medical device sector software, used in a medical context, whose sole purpose is to archive, collect and/or transmit data.
Case law gives us other examples of these principles both in the aforementioned ruling of 7 December 2017 of the CJEU (which had ruled on various features of a software package) and in decisions of the French courts:
medical prescription assistance software constitutes a medical device (CE, 12 July 2018, recital 5, no. 387156). Indeed, it allows the exploitation of patient-specific data for the purposes, in particular, of detecting contraindications, medicinal interactions and excessive dosages. It therefore falls within the purpose of diagnosis and treatment of an illness, that is to say a "purely medical purpose";
patient data storage software is not a medical device (CJEU, 7 December 2017, §26, C-329/16);
software whose function is limited to indicating to the doctor the name of the drug and its generics, without taking into account the data specific to the patient, is not a medical device (CJEU, 7 December 2017, §26, C-329/16);
software used to report the contraindications mentioned by the manufacturer of a drug in its instructions for use is not a medical device (CJEU, 7 December 2017, §26, C-329/16).
II. Criterion #2 for qualifying a medical device as such: the action produced
The second distinction between a “common” product and a medical device is based on the action produced by the latter.
The medical device must act on the patient without resorting to pharmacological, immunological or metabolic means. It is this condition that poses difficulties when the device does not come into contact with the patient's body. This is why, in 2017, the CJEU clarified that it is not necessary for such a device “to act directly in and on the body” of the patient (§28). In this way, software, acting indirectly on the patient's illness, can be classified as a medical device.
In the dispute which gave rise to the aforementioned ruling of the State Council of 10 February 2020, precisely this criterion of the action produced was debated. The Administrative Court of Appeal of Marseille (18 Apr 2018 no. 17MA01271) considered that equipment used only for the preparation of a medicine without acting directly on the patient did not constitute a medical device.
The State Council (CE, 10 February 2020, recital 3, no. 421576), for its part, illustrates the condition of the action produced by taking the example of hardware used in the preparation of pharmaceutical solutions. If the solution is not subsequently administered to a patient, the equipment cannot, for lack of direct action, be classified as a medical device.
On the other hand, a system which measures the dose of a radio-pharmaceutical product in the automatic preparation of a liquid solution, and which thus makes it possible to avoid any dangerous effect at the time of its administration to the patient, constitutes a medical device. In this case, the device has an immediate effect on the patient's body since the precision of the measurements carried out can have significant consequences on the patient's health and safety.
In summary, to classify a product as a medical device, it must:
be intended for medical purposes as provided for in article R.5211-1 of the French Public Health Code of Law;
act directly or indirectly on the body of an individual patient.