Advocate General Endorses MEDDEV Guidance on Classification of Software Programmes as Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona issued his opinion in Case C-329/16¹, the first case in which the Court of Justice of the European Union (CJEU) has been asked to consider the classification of software in the context of medical devices legislation. The issue to be addressed by the Court is whether a particular software programme, intended to be used by doctors to support prescribing decisions, falls within the definition of a medical device as provided by Directive 93/42/EEC (the Medical Devices Directive²). This Advisory considers the opinion of the Advocate General and the implications for digital health developers.

Background

The subject of the case is a software programme manufactured by Philips France. The programme, Intellispace Critical Care and Anesthesia (ICCA), is intended for use by doctors in anaesthesia and intensive care services to provide information with regards to possible contraindications, interactions with other medicines and excessive dosing, and therefore to support prescribing decisions. The ICCA has been CE marked as a medical device, confirming that it meets the essential requirements of the Medical Devices Directive and may be placed on the market throughout the EU.

The dispute in Case C-329/16 arose from the fact that French law³requires that software programmes designed to assist medical prescriptions should be subject to a national certification system. Philips France claimed that, by imposing a further requirement in addition to the conformity procedure laid down in the Medical Devices Directive, the French Government infringed Article 4(1) of the Directive, under which Member States must not restrict the placing on the market and putting into service of devices bearing a CE mark. The national certification system therefore amounts to a restriction on import of the device, contrary to EU law.

A question was, therefore, referred to the European Court from the French Conseil d'Etat for a preliminary ruling on whether the type of software in this case constitutes a medical device within the meaning of the Medical Devices Directive, in circumstances where the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing, but does not itself act in or on the human body.

Software as a medical device

Directive 2007/47/EC⁴amended the definition of a medical device at Article 1 of the Medical Devices Directive to include an express reference to software that is intended by the manufacturer to have one of the designated medical purposes. The 6^th recital to Directive 2007/47/EC confirms: "General purpose software used in a medical environment is not a medical device".

This general principle that, in order to fall within the definition of a medical device, a product must be intended for a medical purpose has been confirmed by the European Court in relation to other types of products; for example, in the Brain Products decision⁵, the Court stated that a system for recording human brain activity was a medical device only when it was intended for medical use. However, the assessment is by no means straightforward when applied to software because, unlike general medical devices, it may not be immediately apparent whether the software is intended for a medical purpose, when it does not act directly on the human body to restore, correct or modify bodily functions.

European guidance has been developed to assist developers in determining whether software should be categorised as a medical device or whether it simply performs a general purpose within the context of the healthcare setting. Although not a legal text, the MEDDEV guidelines, prepared in collaboration with national authorities, industry, and the national accredited bodies, are considered to provide a valid systematic interpretation of the applicable legal framework.

Findings of the Court

In Case C-329/16, the French Government argued that the ICCA software does not satisfy the definition of a medical device within the meaning of Article 1(2)(a) of the Medical Devices Directive and could not therefore be marketed in France without the authorisation of the French authorities (the Haute Autorité Santé). They asserted that the ICCA's function of assisting the prescription process does not fall within the definition in the Directive, as the software itself does not make prescription decisions; they claimed its functions are purely administrative. Further, the French Government considered that, while some of the functionalities of the ICCA may have a medical purpose, these were not the modalities referred for consideration by the referring court. The fact that certain modalities might have a medical function does not mean that the whole programme should be classified as a medical device, as other aspects of the programme have purely administrative functions that do not create or modify data.

The Advocate General disagreed with the French Government's assessment, and found that ICCA should be classified as a medical device. The Advocate General's analysis of the device endorses the guidance set out in the MEDDEV as applicable to software,⁶ and from national competent authorities, such as the MHRA.⁷In particular, the Advocate General found the following factors to be important:

• The ICCA software carries a CE marking and, therefore, benefits from the presumption of conformity with the Medical Devices Directive; in order to succeed in its case, the French Government is required to overturn that presumption, which it has failed to do.
• The ICCA is not a programme of general use that is used in a healthcare setting; it goes beyond simple storage of data and modifies and interprets such data to calculate certain information that is useful for healthcare professionals to make proper prescribing decisions. As such, the ICCA has a therapeutic and diagnostic purpose in line with the definition of medical device. It is not necessary for the software itself to make the prescription decision, but providing support to healthcare professionals in prescribing medicinal products is sufficient to have a medical purpose.
• The fact that the ICCA does not act directly on the interior or the surface of the human body does not prevent its classification as a medical device; a "contribution" to the principal intended action is sufficient.
• The classification of the programme refers to all the functionalities and modules of the ICCA as a whole, and the functionalities cannot be separated and classified individually.
• The Commission MEDDEV guidance and other guidance issued by the competent authorities of the Member States, including the MHRA and the French Medicines Agency (the ANSM), are aligned in their assessment of software, and classify programmes such as ICCA as medical devices.

The Advocate General, therefore, suggested that the CJEU should answer the question referred by the Conseil d'Etat as follows:

"Subject to the national court's assessment of its functionality, prescribing software such as that which is the subject of the present proceedings may be described as a medical device within the meaning of Article 1(2)(a) of Directive 93/42/EC of 14 July 1993 on medical devices in so far as it provides the physician with the information necessary to detect contraindications, interactions between drugs and excessive dosages".

The European Court will now consider this opinion and deliver a judgment in due course. While the Advocate General's opinion is not binding on the Court, it does help to clarify how to apply the existing regulatory criteria to medical software pending the Court's decision.

© 2017 Arnold & Porter Kaye Scholer LLP. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.