On 7 December 2017, the Court of Justice of the European Union (CJEU) ruled that to the extent software constitutes a medical device and bears the CE marking of conformity, it may be placed on the market and circulate freely in the European Union and may not be made subject to additional national certification requirements. This decision, which will certainly be of interest to businesses active in the field of digital health and of course the producers of medical devices, also recapitulates the two conditions which software must meet in order to be considered a medical device.