First Advocate General Opinion On The Classification Of Software Programs As Medical Devices

Author:Ms Jacqueline Mulryne and Silvia Valverde
Profession:Arnold & Porter Kaye Scholer LLP

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...

To continue reading