The latest edition of EPHJ featured a round table dedicated to the impact of AI on health and medical devices. This round table was organised by the EPHJ teams in partnership with Inartis. For this special report, DeviceMed magazine sought the opinion of a legal expert in artificial intelligence in healthcare. Here, Mr Luysterborg (Deloitte) describes the implications of the new European AI law for medical devices and the main and the main difficulties it raises for manufacturers.