In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which 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. The CJEU’s decision was a response to a request for a preliminary ruling from the French Administrative Supreme Court (Conseil d’Etat) raised in the context of an action lodged by the French medical devices trade association (Snitem) and Philips France – a manufacturer of CE marked prescription assistance software for anaesthetists and doctors in critical care – seeking annulment of French regulations imposing a specific certification for prescription assistance software.
The merits of the Court’s first ruling on the classification of software as a medical device consist primarily in its official confirmation of existing EU guidance on the classification of standalone software, which is expected to remain relevant under the new Medical Devices Regulation. However, rather intriguingly, the French Administrative Supreme Court failed to ask – the legally more interesting question – whether national certification requirements for specific purposes such as the management of public health funding could be compatible with the Medical Devices Directive, a point that was thus only marginally addressed by the Court. It therefore remains to be seen if the Court’s confirmation of the medical device status of prescription software with the characteristics of the software manufactured by Philips will be sufficient for the Conseil d’Etat to annul the French certification requirements for prescription assistance software insofar such software has been CE marked as a medical device in the EU.
In our article “The CJEU’s First Ruling On The Classification Of Software As A Medical Device: A Predictable Scenario With A Possible Cliff-hanger?“, which was recently published in the European Pharmaceutical Law Review (Volume 2, Issue 1), we comment on the possible implications of this – at first sight – unsurprising ruling and consider whether the CJEU’s judgment leaves room for a national epilogue.
To read the full case note please click here.