The European Court of Justice (ECJ) has just made its decision in the case C329/16 SNITEM & Philips France vs. Health Minister, and endorsed the conclusions of the Advocate General.
The ECJ holds that a prescription support software (LAP) constitutes a medical device within the meaning of Directive 93/42 when one of the functionalities of this software allows the exploitation of data specific to a patient in particular to detect contraindications, drug interactions and excessive doses, even if such software does not act directly in or on the human body. However, the ECJ adds that it is only this functionality that constitutes a medical device (§ 40).
The solution is significant, because if the Directive provides, since 2007, that a software “is a medical device when specifically intended by the manufacturer to be used in one or several (…) medical purposes”, no decision from the ECJ had ever determined, so far, the conditions under which software could be qualified as a medical device.
Beyond the case before the Conseil d’Etat (see below), the decision of the ECJ to intervene is of prime importance for the LAP’s manufacturers and publishers.
Philips France (Philips) manufactures and commercializes the prescription support software called “Intellispace Critical Care and Anesthesia” (ICCA). This software provides physicians with information required for appropriately prescribing medicines, notably concerning contraindications, drugs interactions and excessive doses. ICCA has obtained CE mark, which evidences conformity of such software to the requirements provided by the Directive.
SNITEM and Philips have launched two actions before the Conseil d’Etat asking for the withdrawal of French Decree No. 2014-1359 of 14 November 2014 relating to the obligation to obtain a certification for all prescription support software and dispensation support software. Claimants have put forward that the certification requirement does not comply with European law since the Decree requires that some software, including those which have already obtained CE mark (such as ICCA), provide a certification issued by French authority.
The preliminary question submitted by the Conseil d’Etat
Upon receiving this request, the Conseil d’Etat first questioned of whether software such as ICCA is medical device within the meaning of the Directive. In fact, arguments subjected to it first require the Conseil d’Etat to distinguish between software that is not qualified as medical device and software that is and for which only applicants’ argument is likely to be upheld.
The preliminary question submitted by the Conseil d’Etat to the ECJ is as follows:
“Must [Council] Directive 93/42/EEC of 14 June 1993 [concerning medical devices] 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?”
It is from this preliminary question that the ECJ was seized on June 13, 2016.
Reasoning of the ECJ
Based on the interpretation of the Directive and the relevant case law of the ECJ to this issue (in particular Brain Products and Oliver Medical), as well as on the MEDDEVs, the ECJ, unlike the solution defended by the French Government, responds to the Conseil d’Etat that a software is qualified as medical device when it “provides the physician with information that allows him to detect contraindications, drug interactions and excessive doses”.
The qualification criteria provided by the Directive and the MEDDEVs
In reaching this conclusion, and in summary, the ECJ first recalls that it is expressly stated in Article 1 (2) of Directive 93/42 that software constitutes a medical device when it satisfies both conditions of any such software, relating respectively to (i) the purpose pursued and (ii) the effect achieved.
Concerning the criteria relating to the purpose pursued by the software
According to the ECJ, the European legislator expressly provided that software itself is a medical device when it is specifically intended by the manufacturer to be used in one or several of the medical purposes contained in the definition of a medical device, a software with a general use used in a medical environment not being a medical device. Thus, as reminded by the ECJ, in order for software to fall within the scope of Directive 93/42, it is not enough for it to be used in a medical context, but it is necessary that their destination, defined by their manufacturer, being specifically medical (Decision dated 22 November 2012, Brain Products, C-219/11, EU: C: 2012:742, points 16 and 17).
In contrast, the ECJ specifies that software that “cross-checks the data specific to a patient with the drugs that the physician plans to prescribe and is thus able to provide, in an automated way, an analysis to detect, in particular, any contraindications, drug interactions and excessive doses, is used for the purpose of prevention, control, treatment or mitigation of disease and therefore pursues a purpose specifically medical” (§ 25).
However, as the Advocate General has pointed out (which has not been disputed on this point), ICCA provides assistance with medical prescription in anesthesia departments and intensive care units. In the first case, as soon as the patient is admitted, the software integrates both the information prior to an operation and those available in the systems to which the software is connected; it analyzes and processes this data to provide the anesthetist with the information he needs during the operation. For intensive care, reanimation or constant care units, the program is capable of managing the many unique patient characteristics required for medical decision making. In both cases, ICCA includes an engine that allows physicians and health professionals to calculate prescription of drugs, possible allergies or duration of treatment.
As the Attorney General stated in its conclusions, the collection, the analysis and the processing of patient’s data—operations at which ICCA helps healthcare professionals detect contraindications, interactions between drugs and excessive doses – remove this computer tool from those which have only a purely administrative character (argument advanced by the French Government). He added: “From the patient’s collected data (which may come from other systems or devices this patient is connected to) and with the help of its computational engines, the software automatically converts this data in useful information for the health professional while suggesting the appropriate doses of the drug (…)” this functionality allowing “the exploitation of data specific to a patient to help his physician to establish his prescription”.
Therefore, in view of the aforementioned functions of ICCA, the ECJ follows the conclusions of the Advocate General who had noted that ICCA was an instrumental means at the service of health professionals, which it facilitates the therapeutic and control tasks of patients under anesthesia or intensive care.
Concerning the condition relating to the effect achieved
The Conseil d’Etat wondered whether software that does not act by itself in or on the human body can be a medical device within the meaning of Directive 93/42.
Unsurprisingly, the ECJ recalls in its decision that Recital 6 of Directive 2007/47 suggests that the purpose of the use of the software counts, and not the way in which the effect it is able to produce on or in the human body.
For the reasons given above, the ECJ responded to the question raised by the Conseil d’Etat as follows: “The answer to the preliminary question must be that Article 1 (1) and Article 1 (2) (a) of Directive 93/42 must be interpreted in that a software with one of the functionalities enables the use of data specific to a patient, in particular for detecting contraindications, drug interactions and excessive doses, is, for this functionality, a medical device, within the meaning of these provisions, even if such software does not act directly in or on the human body” (§39).
The ECJ finally duly recalls the consequences of this qualification.
The ECJ thus specifies, in direct connection with the context of the preliminary question submitted to it, that when software is qualified as a medical device, it must compulsorily be CE marked when it is placed on the market. Once this marking has been obtained, this product, with regard to this functionality, can be placed on the market and move freely within the Union without having to undergo any other additional procedure, such as a new certification (ECJ, Decision dated 19 November 2009, Nordiska Dental, C 288/08, EU: C: 2009: 718, item 21).
However, only functionalities that meet the definition of a medical device fall within the scope of the Directive and must be CE marked. It is therefore the responsibility of the manufacturer to identify the limits and interfaces of the different modules which, in the case of modules subject to Directive 93/42, must be clearly identified by the manufacturer and based on the use to be made of the product, in accordance with the guidelines in this area (§ 37). As a result, the manufacturer of such prescription assistance software is required to identify which of the modules constitute medical devices, so that the CE marking can be affixed to these modules alone.
The consequence for the validity of the certification scheme imposed by the Public Health Code is not neutral. It will be up to the Conseil d’Etat to decide on the opposability of this procedure for LAPs containing a functionality that qualifies such software as a medical device.
Beyond the specific case and the future of the 2014 Decree, the Court’s interpretation of the Directive has immediate and major consequences for the industrials concerned, since the marketing in each Member State of software that must be qualified as medical device is subject to very strict and binding requirements.
The decision in this case, based on the provisions of Directive 93/42/CE, is of interest with the aim of the application of the new Regulation No. 2017/745, which has retained – by further detailing – the dual category of software for medical purposes on the one hand and software with a general use used in a medical environment. If, unlike the former, the latter are not medical devices, the medical functionalities carried by the software will remain key in the determination of the medical purpose pursued, and therefore of the medical device qualification.