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October 2017

The Court of Justice of the European Union ("CJEU") has ruled on various occasions on the scope of the definition of 'medical device' under the Medical Devices Directive (Directive 93/42/EEC). However, Case C-329/16 Syndicat national de I'industrie de technologies médicales (SNITEM) and Philips France v Premier Minister and Ministre de Affairs sociales et de la Santé is the first time that the CJEU has been asked to rule directly on standalone software as medical devices.

On 28 June 2017, Advocate General Campos Sánchez-Bordona delivered his Opinionⁱin the case, finding that a prescription support software that provides healthcare professionals with information particular to a patient regarding contraindications, drug interactions and dosage limits can be a 'medical device' under the Medical Devices Directive.

In this article, we examine the Advocate General's Opinion and the potential implications it might have for digital health in the European Union.

The Dispute

Philips France ("Philips") produces and markets a prescription support tool called IntelliSpace Critical Care   Anaesthesia ("ICCA"), which provides physicians with certain information to allow them to prescribe drugs, particularly potential contraindications, interactions with other drugs and dose limits

ICCA is CE marked as a medical device under the Medical Devices Directive. A CE mark on a medical device is a notice from the manufacturer to the public confirming the product meets the 'essential requirements' of the Medical Device Directiveⁱⁱ. A medical device bearing a CE mark can, in general terms, be imported into, marketed and sold in any country in the European Union without restriction.

The dispute concerns a provision of the French Decree n°2014-1359 (dated 14 November 2014) that requires certain prescription support software to have a national certification in addition to a CE mark. Philips and SNITEM (the French medical technology industry body) each applied to the Conseil d'Étatⁱⁱⁱ for the relevant elements of Decree n°2014-1359 to be cancelled on the basis that it unlawfully hindered the free movement of goods within the EU. The Conseil d'État subsequently referred the following question to the CJEU for a preliminary ruling:

"Must [the Medical Devices Directive] 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?"

Written submissions were made by SNITEM, the French and Italian Governments and the European Commission during the course of the proceedings before the CJEU.

The Advocate General's Opinion

The Advocate General recommended that the CJEU respond to the Conseil d'État's question by confirming a prescription support software can be a medical device within the meaning of Article 1(2)(a) of the Medical Device Directive (which defines 'medical device')^iv, if it provides the physician information allowing them to detect contraindications, interactions between drugs and excessive dosages. However, the Advocate General did not go as far as considering whether ICCA had the relevant features – that was a matter for the Conseil d'État to determine.

The following factors were material to the Advocate General's Opinion:

• Fixation of a CE mark to a medical device is a notice from the manufacturer that the product conforms to the ‘essential requirements’ of the Medical Device Directive. CE marked medical devices therefore benefited from a presumption of free movement, so Member States of the European Union cannot prevent the marketing or commercialisation of such products unless justified on the basis that they adversely affect the health or safety of the user. The CE marked ICCA software benefited from this presumption and the French Government failed to rebut that presumption.

• Contrary to the French Government's submissions, ICCA was likely to be a 'medical device' as defined in Article 1(2)(a) of the Medical Devices Directive:

• ICCA provided information to anaesthetists that they needed prior to and during surgery. It also helped the medical prescription for healthcare professionals working in critical care, intensive care and continuing care units, enabling them to adopt medical decisions. In both cases, the software allowed physicians to calculate doses of prescription drugs, possible contraindications or the duration of the treatment. In light of those functions, it was difficult to argue (as the French Government did) that was not "software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes"; and

• To be a medical device, the manufacturer must intend the product to have a 'medical purpose' i.e. fall within one of the four indents of the definition of 'medical device' in Article 1(2)(a) of the Medical Devices Directive (see footnote iv). The medical purpose requirement of the definition was met by ICCA. The software allowed physicians to prescribe medicines more safely and minimise the risk of an incorrect prescription. Consequently the software achieved the medical purpose of "…prevention, monitoring, treatment or alleviation of disease".

• Although not legally binding, MEDDEV 2.1/6 allows interpretation of the legal framework that applies to standalone software as medical devices. This guidance, developed by the European Commission in collaboration with the Competent Authorities of the Member States, the health industry and medical device industry bodies and other stakeholders, reflects the interpretation of the EU medical device legislation in practice. According to the MEDDEV 2.1/6, "[s]oftware which is intended to create or modify medical information might be qualified as a medical device".

• Guidance from other national Competent Authorities such as the UK's Medicines and Healthcare products Agency ("MHRA") support the view that ICCA would be a medical device.

France

France's Haute Autorité de Santé ("HAS") and Agence Nationale de Sécurité du Médicament et des Produits de Santé ("ANSM") do not consider prescription support tools as being medical devices yet^v. As seen, they remain differently regulated in France. However, ANSM would assess the medical purpose of a product on a case-by-case basis. Specific guidelines were issued by HAS in September 2016.^vi

United Kingdom

The Advocate General's Opinion is aligned with the approach taken by the MHRA. As the Advocate General notes, the MHRA has issued guidance on standalone software as a medical device ("MHRA Guidance"). The guidance is an interactive series of flowcharts and information that is designed to assist the user in deciding whether a software product could be a medical device in the UK.

According to the MHRA Guidance, some decision support software "may not be considered to be a medical device if it exists only to provide reference information to enable a healthcare professional to make a clinical decision, as they ultimately rely on their own knowledge. However, if the software/app performs a calculation or interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device."

Specific examples of decision support software that according to the MHRA are most likely to be medical devices include:

• software that it is intended to influence the actual treatment - dose, size of implant, time of treatment etc.; and
• software that results in a diagnosis or prognosis.

The assessment will inevitably be fact-driven and will depend on the manufacturer's intended use for the product.

Comment

The Advocate General's Opinion is unsurprising and it is likely that the CJEU's judgment in due course will be along the same lines.

Software is becoming increasingly important in the provision of healthcare, with increased use in decision support software and telemedicine. Faced with these rapid advancements, Member States may introduce additional measures to protect patients in the absence of reforms to the legislation at EU level. Although the new Medical Device Regulation (which applies from May 2020) introduces new classification rules for software (Rule 11), the definition of 'medical device' remains largely aligned with its predecessor, the Medical Devices Directive.

With the incorporation of automated reasoning, decision support software may increasingly be considered as medical devices. However, this also raises a question of where the boundary of liability between the healthcare professional and the medical device manufacturer lies. .

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

ⁱThe Advocate General's Opinion can be accessed here. At the time of writing, the Opinion is available in Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, Italian, Greek, Hungarian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian and Spanish.

ⁱⁱCE marking is also a requirement under Directive 98/79/EC concerning in vitro medical devices and Directive 93/42/EEC concerning active implantable medical devices.

ⁱⁱⁱThe Conseil d'État is the French highest administrative court. It is the competent jurisdiction to hear and decide against a decree or a ministerial order. This court also plays an advisory role before the enactment of decrees.

^iv Article 1(2)(a) of the Medical Device Directive defines "medical device" as:

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

^v http://ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/Logiciels-et-applications-mobiles-en-sante/(offset)/1

"L’ANSM est l’autorité compétente en matière de DM et de DMDIV sur le territoire français. La Direction des dispositifs médicaux de diagnostics et des plateaux techniques (DMDPT) prend en charge ces produits. Elle assure :

• la surveillance du marché
• l’interprétation réglementaire (qualification/classification)
• la vigilance des DM, DM DIV et autres produits entrant dans son champ de compétence
• Elle est amenée à traiter des signalements relatifs aux logiciels d’aide à la prescription (LAP) et aux logiciels d’aide à la dispensation (LAD) qui ne sont toutefois pas considérés comme des dispositifs médicaux. "

^vi"Référentiel de certification des logiciels d’aide à la prescription version 2 – septembre 2016: https://www.has-sante.fr/portail/upload/docs/application/pdf/2016-09/referentiel_lapv22092016.pdf

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