On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software program intended to be used by doctors to support  prescribing decisions falls within the definition of medical device as provided by Directive 93/42/EEC (the Medical Devices Directive).

Definition of a medical device

As we have discussed previously in this blog, there is no general exclusion for software in the definition of medical device provided by the Medical Devices Directive. Software may be regulated as a medical device if it has a medical purpose, meaning that it is capable of appreciably restoring, correcting or modifying physiological functions in human beings. The assessment is by no means straightforward for software as, unlike general medical devices, it is not immediately apparent how these parameters apply to programs. The Commission MEDDEV guidance makes a distinction between software specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, and software for general purposes that is used in a healthcare setting which will not be considered as a medical device.

Opinion of the Advocate General

The software subject of this case, the Intellispace Critical Care and Anesthesia (ICCA) manufactured by Philips France, is designed to assist anesthesia and intensive care services by providing doctors with information to assist their prescribing decisions. It provides information with regards to possible contraindications, interactions with other medicines and excessive dosing. The ICCA has been CE marked as a medical device.

The dispute in this case arose from the fact that French law requires that software designed to assist medical prescriptions should be certified at national level. Philips France claimed that, by imposing a further requirement in addition to the conformity procedure laid down by the Directive, the French Government had set up a restriction on import of the device, contrary to EU law.

The French Government argued that the ICCA does not satisfy the definition of a medical device under the Directive, as its functions are purely administrative and for storage purposes, and could not, therefore, be marketed in France without such certification from the French authorities.

The Advocate General disagreed with the French Government’s assessment, and found that ICCA should be classified as a medical device. The following 3 factors are key to reach this conclusion: (i) the ICCA is not a program for general purposes that is used in a healthcare setting; it goes beyond simple storage of data and modifies and interprets such data providing certain information that is useful for healthcare professionals to make adequate prescribing decisions; (ii) 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; as “contributing” to the principal intended action is sufficient, and; (iii) the Commission’s MEDDEV guidance and other guidance issued by national competent authorities are aligned, and classify programs such as ICCA as medical devices.

Next steps

The European Court will now consider this opinion and deliver a judgment in a few months. This case is the first time that the European Courts have considered software that may be classified as medical devices, and the decision of the Court will likely have an immediate effect on the EU market and how software used in healthcare setting is regulated.

You may find further details on this case in our Advisory.