Opinion from the Advocate General regarding classification of software as medical devices

For many companies digitalisation is one of the greatest challenges of this century. But as if that weren’t enough, companies must also grapple with a legal framework whose rules are not always adapted to the new digital age. A recent opinion from the Advocate General may, however, provide guidance on the question of when software may be considered a medical device.

On 28 June 2017, the Advocate General presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France. The question concerned the laws governing the classification of software medical devices. The background was that Philips France had launched software that was developed to provide support to healthcare professionals in prescribing medicinal products. The software was called Intel-lispace Critical Care and Anesthesia (ICCA). ICCA is to be used within intensive care and anaesthesia to support physicians in determining which drug to prescribe, by detecting contraindications, drug interactions and overdosage after patient information has been entered into the software.

From previous judgements by the Court of Justice of the European Union (CJEU) it has been established that it is not sufficient for a product to be used in a medical context for it to be considered a medical device, as defined in Directive 93/42. To be a medical device, it is also necessary that the intended purpose, defined by the manufacturer, is specifically medical (see Judgment of the Court (Third Chamber), 22 November 2012 Brain Products GmbH v BioSemi VOF and Others).

In order to establish whether a product is intended for medical use, the court has further stated that it is appropriate to take account of all relevant factors in the case to assess the use for which the product is intended by the manufacturer and the methods and place of its use (see Judgement of the Court (Tenth Chamber), 4 March 2015, in Case C‑547/13). Thus, the fact that the product is intended to treat a medical state and that such treatment must be carried out in a medical centre and under the supervision of a practitioner are indications capable of establishing that the product is intended for medical use. Furthermore, the fact that a product bears a CE mark certifying the conformity of a medical device with the provisions of Directive 93/42 constitutes another factor among others to be taken into consideration in that regard.

In the present case, the software was CE-marked, whereas it is presumed to be a medical device. It is therefore up to the counterparty, in the present case the French government, to rebut the assumption. The French government has stated that the software does not meet the requirements of the term ‘medical device’, as set out in Article 1(2)(a) of Directive 93/42, as the software is not intended for diagnosis or treatment and that it is not used for investigation, replacement or modification of the anatomy or of a physiological process or control of conception. Furthermore, the Article 1(2)(a) of Directive 93/42 states after amendment that software for general purposes when used in a healthcare setting is not a medical device. Additionally, the European Commission has also published a guidance document regarding the qualification of independent software that is used in health care, MEDDEV 2.1/6. According to the guidelines, software is not a medical device if used for “simple search”. However, “simple search” does not include software that provides inter-pretative search results, e.g. to identify medical findings in health records.

The Advocate General has now concluded that as ICCA analyses the information entered, and the analyses are then used to assist physicians in prescribing the drugs, ICCA is used for diagnostic and/or therapeutic purposes. Furthermore, as the software provides physicians with certain information to prevent faulty prescription, the aims of the software are to monitor, treat or alleviate a disease. Moreover, ICCA aims to detect contradictions, drug interactions and overdosage, whereas it is not only administrative in nature and does not just store and archive information. It is thus a medical device according to the Advocate General.

Conclusion
In conclusion, the Advocate General stated that the software itself need not act on the human body to be a medical device. The determining factor is that the software has a function that is not only of an administrative nature, that it has diagnostic and therapeutic purposes and is aimed at prevention, monitoring, treatment or alleviation of disease.

The opinion of the Advocate General is not binding for the CJEU. However, it is often of great assistance to the court and cited in the ruling. It is now up to the CJEU to decide if ICCA is a medical device in accordance with the opinion of the Advocate General. We will, of course, monitor the outcome of the case.