On 12 July 2018, the French Administrative Supreme Court (Conseil d’Etat) partially annulled Decree No. 2014-1359 insofar as it establishes a general certification obligation for medical prescription assistance software by the High Health Authority (HAS) regardless of its functionalities (Decision n. 387156). The decision follows a December 2017 preliminary ruling of the CJEU in response to a request from the French Administrative Supreme Court in the context of an action lodged against the decree by the French medical devices trade association (Snitem) and prescription assistance software manufacturer Philips France. In that judgment, the CJEU confirmed that software that uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive (93/42/EEC), and restated that EU member states cannot impose additional procedures, such as a new certification, to allow the marketing of CE-marked medical devices in their territories (see our previous update, CJEU’s first ruling on the classification of software as a medical device: a predictable scenario with a possible cliff-hanger?).
In line with this ruling, the French Administrative Supreme Court quashed Articles 1, 3 and 2 of the decree insofar as it makes the certification of medical prescription software mandatory for those of their functionalities that allow the use of patient-specific data for medical purposes (that is, the purposes mentioned in Article 1(2) of the Medical Devices Directive), as well as for modules which are accessories to these functionalities within the meaning of the same provisions. It considered that such obligation is not justified in light of Article 8 of the Medical Devices Directive, which provides for a safeguard clause, or Article 14b, relating to specific health surveillance measures, and that Article L.161-38 II of the French Social Security Code therefore does not comply with the objectives of Article 4 of the Medical Devices Directive. Accordingly, the French Administrative Supreme Court ruled that the provisions of the contested decree are, to that extent, devoid of any legal basis. It also refused the Ministry of Health’s request to limit the effects of the annulment in time, and the annulment therefore takes effect as of the date of the ruling (12 July 2018).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2018 Issue (Thomson Reuters).