FRANCE Trends and Developments Contributed by: Mathilde Merckx, Xavier Lebrasseur, Juliette Migeon and Diane Courtier, Alchimie Avocats
tion or the use to which it could reasonably be expected. While this regime covers all healthcare and “bor- derline” products (eg, drugs, medical devices, food supplements and cosmetics) it remains too narrow to apply automatically to any AI system as such. The Upcoming Reform on Products Liability and Concomitant Abandonment of Harmonised AI-Liability Framework In light of the new challenges raised by the con- tinuous and increasing evolution of new technol- ogies, the European Commission announced in April 2021 its ambition to “promote a European approach to artificial intelligence” by proposing a new legislation aimed at: • reducing the risks associated with AI sys- tems; and • adjusting liability rules in case of risk materi- alisation and damage occurrence. While the first of these texts reached the end of the legislative process (Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June, 2024 laying down harmo- nised rules on artificial intelligence, the “AI Act”), the AI Liability Directive proposal, published on 28 September 2022, was withdrawn in Febru- ary 2025 due to the absence of a “foreseeable agreement.” The European Commission stated that it would reassess whether to introduce a revised proposal or pursue a different approach. In parallel, two months earlier, the new Euro- pean Products Liability Directive (Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Direc- tive 85/374/EEC), which provisions will have to
be transposed by member states in their national legislation before 9 December, 2026, entered into force. The new products liability Directive has been established to revise the applicable products liability framework “in light of developments related to new technologies, including artificial intelligence (AI), new circular economy business models and new global supply chains, which have led to inconsistencies and legal uncertain- ty, in particular as regards the meaning of the term ‘product’.” The simultaneous entry into force of the New Directive and the (temporary?) abandonment of the AI-liability Directive may not be coincidental. It could indicate that the EU has chosen to apply general liability frameworks to AI-related dam- ages instead of developing a specific regime. Among the most notable updates from the New Directive are: • the revised definition of “product” which now explicitly includes “digital manufacturing files, raw materials and software” (Article 4 (1) of the New directive); • the introduction of the idea of post-market changes, such as learning algorithms or updates, to assess defectiveness: “in assess- ing the defectiveness of a product, all circum- stances shall be taken into account, including (…) the effect on the product of any ability to continue to learn or acquire new features after it is placed on the market or put into service” (Directive 2024/2853, Article 7). This latest addition echoes the definition of AI systems under the AI Act, which describes them in Article 3 (1) as “a machine-based system that is designed to operate with varying levels of
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