What makes medical AI in France distinctive
AI in French healthcare operates in one of the most complex regulatory environments in Europe: the European MDR regulation on medical devices, ANSM supervision, HDS certification for hosting, CNIL rules on health data, and now the EU AI Act. Each regulatory layer is independent and cumulative: MDR compliance does not exempt an organisation from its obligations under the AI Act.
Software as a medical device (SaMD) and CE marking
AI software qualifies as a medical device (Software as a Medical Device, SaMD) when it is intended to be used for medical purposes: diagnosis, prediction, monitoring, treatment or alleviation of a disease. SaMD qualification triggers the application of the MDR 2017/745 regulation, which requires CE marking, risk management procedures, complete technical documentation and, depending on the class of the device, the involvement of a notified body.
The main difficulty for AI systems is the management of algorithmic updates: a substantial modification of the model may require a conformity reassessment. The MDCG (Medical Device Coordination Group) has published specific guidance on AI software that clarifies this point.
Health data and HDS hosting
Any AI solution that requires the hosting of personal health data must use a certified HDS host (Hébergeur de Données de Santé). The list of certified hosts is published by the ANS (Agence du Numérique en Santé). This requirement applies to data hosted in France, and it can create constraints for international cloud solutions that do not hold HDS certification.
