Prescription support software are considered as medical device

by Gabriel Avigdor

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Prescription support software is considered as medical device

On 7 December 2017, the European Court of Justice (‘ECJ’) made an important ruling in the French case SNITEM and Philips vs Premier Ministre des Affaires sociales et de la Santé (Case C-329/16). The Court followed its general advocate advice, who issued a non-binding recommendation on 28 June 2017, and defined for the first time under what conditions should medical software (standalone software) be qualified as a medical device pursuant to Directive 93/42/EEC on medical device.

In this decision, the ECJ considers 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”. Therefore, software of which specific functions do not have a medical purpose, are not medical device and are out of the scope of the Directive.

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CE marking is sufficient

The Court adds that once the software bears CE marking, a national authority cannot request the software developer to proceed to an additional requirement such as another certification, as CE marking is sufficient.

In this French case, a decree contained an obligation to get a specific certification for prescription support software according to art. L. 161-38 of the French Code of Social Security. The French authority maintained its position that such software cannot be considered as medical device and therefore, would require this specific certification. WRONG, says the ECJ who confirmed that the clear intention of Philips to use this software in the context of healthcare, and for medical use, makes the functions of this software a medical device. Certications issued by the “Haute Autorité de Santé” (‘HAS’) were compulsory and now are now anymore. Even more, the decree will certainly be either cancelled or amended after this ruling.

This is an important decision for the medical software industry and for innovation in that sector to place them on the EU market (and also in Switzerland), as ECJ clarifies that although it remains compulsorily to “bear the CE marking of conformity when it is placed on the market. Once the marking has been obtained, the product, having regard to that function, may be placed on the market and circulate freely in the European Union without having to undergo any additional procedure, such as a new certification”.

This EU ruling is a lightening in the process which will benefit the industry by save time and money when putting medical software on the market. This clarification allows companies to avoid engaging costs as compliance as a measure of prevention. Legally speaking, there may be a possibility for companies that are in the process of getting their medical software certified to stop the process, or even claim for reimbursement if the decree is cancelled or modified and becomes illegal as a result of the ECJ ruling. In addition, it is likely that this decision may have an impact in other Member States of the EU, which would also be transposable, not only for prescription support software, but also for other medical software, or mobile medical Apps.

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Scope of this decision

What is the scope of this decision?

Firstly, this decision applies clearly to prescription support software, but not only. The the ECJ provided criteria that are broad enough for applying to other medical software if the objective pursues a specifically medical objective. This ruling may be applicable by analogy to all medical software with a medical objective, even with no interaction in or on the human body. It is however necessary to proceed to a specific analysis on a case by case basis for each functionality of the medical software or the mobile medical App.

Secondly, this decision also applies to hospitals developing medical software, as these institutions can be software developers even with no commercialisation, as though they are responsible for first placing on the market. It is therefore necessary for hospitals developing medical software or Apps to assess whether it requires complying with the EU medical device Directive.

From a geographic point of view, even if the decision comes from a European authority, it applies to Switzerland, with automatic recognition of CE marking thank to the international convention on mutual recognition in relation to conformity assessment dated 2002 with EU.

Finally, the fact that this ruling is based on the Directive 93/42/EEC will remain valid with its replacement by the EU Regulation 2017/745 on medical device that is going to replace as of 26 May 2020.

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In deeper details – Background of the dispute

The dispute arose in relation to “Intellispace Critical Care and Anesthesia” (“ICCA”) software developed by Philips, as this company focuses now into the software and IT projects in relation to the healthcare sector. The functions of the prescription support software makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses.

The dispute opposed the national syndicate of medical technological industries (SNITEM in French) and Philips on one hand, against the French Minister of Social and Health Affairs on the other hand. Based on a local decree which imposes prescription support software companies to get a specific certification, the French authority argued that: (a) Philips’ software was not a medical device, (b) requires getting the additional specific certification for prescription support software, and therefore (c) cannot freely put into the market its software on the sole basis of the CE marking.

On the other hand, Philips argued that, its software is a medical device and “the requirement to adapt software to technical standards constitutes a measure having equivalent effect to quantitative restrictions on imports which, overlapping with the certification obligation for medical devices laid down in Directive 93/42, which is applicable to software, does not meet the requirements of necessity and proportionality”.

In other words, Philips claimed that CE marking was sufficient. Philips won the case on this question.

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Challenges of this case and first precedent

The central question of this case is not the certification itself, but the question to know if ICCA software is be considered as a medical device or not in accordance with Directive 93/42/EEC on medical device. This question may appear somehow unoriginal. It is not. If a software is considered as a medical device, regardless of how it is classified, will need to comply with the EU medical device Directive requirements. In the German case Brain Products GmbH vs BioSemi VOF, the ECJ only provided an indirect reference to the criteria for software as a medical device (‘SaaMD’) qualification.  In that case, the ECJ mentioned that fitness Apps would probably not meet the definition of medical device, while software monitoring humain brain activity would.

The Philips case also refers to the MEDDEV 2.1/6 (Commission Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices) as explained by the advocate general in its recommendations dated 28 June 2017.

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CONDITIONS AND EXAMPLES

ECJ reminds that it is not sufficient to use the software in a medical context; it is also necessary that the intended purpose, defined by the manufacturer, is specifically medical. Therefore, two cumulative conditions are necessary to consider a health-related software as a medical device, which are relating respectively to the objective pursued and the action resulting therefrom.

  1. Objective pursued: 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;
  2. Action resulting therefrom: ECJ interprets the Directive 93/42/EEC and considers that “although that 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”.

Interesting to notice that, according to the ECJ’s argumentation, the second condition is not decisive. On the contrary, requiring that the action resulting from the device shall produce an effect or works directly in or on the body would mean that software with no effect on the body would not be subject to the Directive, which would be contrary to the intent of the EU legislature.

In the case of prescription support software, the European Court of Justice states (§25) that functions of such 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 an 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 Directive 93/42”.

SaaMD or not? Examples:

The ECJ provides examples of prescription support software that may or may not be used as a medical device:

  • SaaMD: 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;
  • Not a SaaMD: software for general purposes, when used in a healthcare setting, is not a medical device;
  • Not a SaaMD: software intended to indicate the contraindications mentioned by the manufacturer of that drug in its instructions for use;
  • Not a SaaMD: 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.

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OUTCOME OF THIS RULING

After this ruling, there are at least three main take aways:

  • First, medical device regulation applies to functionalities of medical software where two cumulative conditions are met (medical purpose pursued by the manufacturer and the action pursued therefrom), with a focus on the first condition;
  • Second, such regulation only applies to functions of the software which are coded in a way to produce such effect, but do not apply to the source code in its entirety, even if the software has no effect in or on the human body;
  • Third, where the software, for that particular section of the source code, bears CE marking, it benefits from freedom of circulation of goods within the EU [and therefore in Switzerland as well] and can be placed on the market without any further certification or requirement.

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What other consequences for software as a medical device?

When a software is qualified as a medical device, the manufacturer will have to assess its classification based on the degree of risk for the human body (classes from I to III) and will have to comply with its duties to declare Class I software to the regulation authority (national authorities in the EU and Swissmedic in Switzerland). For classes IIa, IIb and class III software, obligations are stricter.

Depending on the conditions that are applicable, there is a materiovigilance requirement (pre-market approval and then post-market surveillance/vigilance) by the manufacturer, as well as product security, quality control and quality assurance management, as well as other standards (such as ISO). For products coming from the EU, once they bear the CE marking, they benefit from the freedom of circulation in Switzerland and vice versa without any pre-market approval.

All standards that apply to medical devices, depending on the degree of risk, but also obligations, restrictions and potential sanctions of the authorities, will mutatis mutandis apply to software as a medical device. This is necessary to guarantee free circulation within the EU of safe and secure products for consumers or patient health.

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