On May 22, 2025, France BioLead requested that the ANSM issue an opinion on the non-classification of equipment used in the manufacture of autologous cell therapies as medical devices.
The ANSM issued a favorable opinion and accepted France BioLead's argument on June 16, 2025. This was based on the fact that equipment for manufacturing autologous cell therapies is subject to good manufacturing practice regulations. This equipment is not used directly on patients and does not perform an autonomous medical function.
In practical terms, this means that companies developing all or part of equipment for manufacturing autologous cell therapies in France do not need to submit a medical device classification dossier. The assessment of the qualitative adequacy of the equipment is therefore the responsibility of the manufacturing site, in accordance with good manufacturing practices.
