Healthcare AI 2025

FRANCE Law and Practice Contributed by: Liliana Eskenazi, Julie Ernewein and Pauline Lecrenais, Fréget Glaser et Associés

In parallel, the PLD, or Product Liability Directive, aims to modernise the EU liability regime to better address the risks associated with AI systems and connected products. Existing French rules on medical liability remain applicable for the time being, and their inter - action with evolving EU provisions is discussed in 4. Liability and Risk in Healthcare AI . 2.3 Approval and Certification Processes AI systems used for medical purposes must comply with both the EU AI Act and the MDR/IVDR. Under Article 6 of the AI Act, such AI-based medical devices are considered to be high risk, particularly when clas - sified as Class IIa or higher under the MDR/IVDR, trig - gering stringent conformity assessment requirements. Legal and Reimbursement Framework CE Marking To be marketed in the EU, AI-based digital medical devices must first obtain CE marking. This certification confirms that the device meets European regulatory requirements for safety and performance. To obtain CE marking, the manufacturer must compile techni - cal documentation providing evidence to demonstrate the quality and safety of the device. The MDR/IVDR require detailed descriptions of software architecture, data processing, and risk management. The AI Act adds documentation requirements focused on trans - parency and accountability, including risk assess - ments, data governance, and performance testing of high-risk medical AI systems. In France, the ANSM evaluates the benefits and risks associated, in particular, with the use of medical devices. • Clinical evaluation by HAS/CNEDiMTS: after CE marking, the device is assessed by CNEDiMTS within HAS to determine eligibility for reimburse - ment (LATM/LPPR inclusion). • Early access and accelerated pathways: France offers accelerated access options for innova - tive digital medical devices, such as the PECAN scheme (for temporary funding of devices pre - sumed to be innovative) and other pathways to facilitate prompt use of AI tools with strong clinical potential.

• Reimbursement pathway: after HAS approval, the Economic Committee for Health Products (CEPS) sets reimbursement tariffs for individually pre - scribed devices. • Data protection: AI systems processing personal health data must also comply with the GDPR. The ANS issues conformity certificates related to interoperability and cybersecurity requirements. Coordination of AI Act and MDR/IVDR Conformity Procedures According to the MDCG’s June 2025 guidance, devel - opers must comply with conformity procedures under both the AI Act and the MDR/IVDR. Where obligations overlap, the guidance provides coordination rules to avoid duplication. Manufacturers of AI systems used for medical purposes are expected to integrate test - ing, reporting processes, and documentation required under the AI Act into the technical documenta - tion already prepared for MDR/IVDR compliance. In France, notified bodies designated under the MDR/ IVDR and the ANSM oversee regulatory processes. 2.4 Software as a Medical Device (SaMD) Software with a medical purpose is included within the scope of the MDR. SaMD refers to a software appli - cation having a diagnostic, therapeutic, preventive, monitoring or disease management purpose. This includes in particular treatment planning tools, medi - cal imaging algorithms, intelligent remote monitoring platforms. The MDR introduced a specific rule (“Rule 11”) for software, classifying software based on its potential impact on the patient’s health. According to the AI Act, continuous-learning algo - rithms must be developed in such a way as to eliminate or reduce, as far as is possible, the risk of potentially biased outputs influencing input for future opera - tions and to ensure that any such feedback loops are duly addressed with appropriate mitigation measures (Article 15 of the AI Act). Per the MDCG’s June 2025 guidance, the post-market monitoring system is key to ensuring continued performance and compliance.

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