Advocate General Opinion on Software Medical Devices
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices.
The AG’s opinion is not binding on the CJEU, but it provides useful guidance on the application of the EU medical devices Directive 93/42/EEC (the MDD) to software programs. Importantly, it confirms the position set out in the Commission’s MEDDEV 2.1/6 guidance that software which merely stores and archives data is not a medical device; the software must perform an action on data (i.e., it must interpret and/or change the data).
EU national courts use the preliminary ruling procedure if they are in doubt about the interpretation or validity of an EU law. In such cases, they may ask the CJEU for advice. The Advocate Generals provide the CJEU with public and impartial opinions to assist the Court in its decision making. The Advocate Generals’ opinions are advisory and non-binding, but they are nonetheless influential. In the majority of cases the CJEU follows the Advocate General.
Philips France (Philips) manufactures and places on the EU market a software program called Intellispace Critical Care and Anesthesia (ICCA), which is used by physicians to provide information necessary for the proper administration of medicines for the purposes of resuscitation and anaesthesia. The software highlights possible contraindications, interactions with other medicines and excessive dosing. Philips classified the ICCA as a medical device under the MDD and the product bears a CE mark confirming that the software complies with the applicable requirements of the MDD.
Under French law, software programs intended to support medical prescriptions are subject to national certification requirements. The French Government’s position is that the ICCA must comply with this national certification requirement. Further, it does not consider the ICCA to be a medical device within the meaning of Article 1(2)(a) of the MDD because the function of assisting with prescriptions does not fall under any of the defined purposes within the definition of a medical device.
Philips claimed that the national certification requirement should not apply as it amounted to a restriction on import, contrary to EU law, and that the French Government was in breach of Article 4(1) of the MDD, which provides that Member States must not restrict the placing on the market or the putting into service of medical devices bearing the CE mark within their territory.
The French Conseil d’État referred to the CJEU a request for a preliminary ruling on the question of whether software equivalent to the ICCA satisfies the definition of a medical device under the MDD.
The AG opinion suggests that Philips had correctly classified the ICCA as a medical device. It highlights that since the ICCA bears a CE mark and is freely marketed in 17 EU Member States, it benefits from a presumption of conformity with the MDD. It was a matter for the French Government to rebut this presumption, and it had failed to do so.
In reaching his conclusion, the AG highlighted a number of points, including:
- In order to qualify as a medical device, software must have a function beyond collection and archiving of data (i.e., it must have more than a purely administrative function). Rather, it must modify or interpret the data. The ICCA software includes an engine that allows healthcare professionals to calculate the prescription of medications and the duration of treatments. In light of such functions, the AG considers it difficult to maintain that the ICCA does not have a diagnostic or therapeutic purpose within the scope of the definition of a medical device. The ICCA is not a software program that is limited to administrative functions, but rather software that helps determine the proper prescription for the patient. It is therefore a medical device as it has the aim of “preventing, controlling, treating or alleviating a disease”.
- The fact that the ICCA does not act by itself in or on the human body does not preclude it from classification as a medical device. Contributing to the principal action of correcting the human body through the taking of medicinal products is sufficient.
The above conclusion endorses the position set out in the Commission MEDDEV 2.1/6 guidance on qualification and classification of standalone software, which states:
“…if the software does not perform an action on data, or performs an action limited to storage, archival, communication, ‘simple search’ or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device.”