AI in medical devices and complex liability challenges

The issue of compensability for damages resulting from the use of smart medical devices is still open. European Regulation N. 745 of 2017, on medical devices and the liability of their manufacturers, was recently amended by Regulation N. 607 of 2023, concerning any software “specifically intended by the manufacturer to be used for one or more of the medical purposes”.The AI Act, which affects the use of AI-powered medical software, and the Directive on Liability for Defective Products, have also recently intervened, while the Directive on Damage Caused by Artificial Intelligence is still in progress. These disciplines do not offer a new model of liability, nor even an adequate mechanism for covering damages, especially not traceable to mere insurance mechanisms. So there is still a need to prevent damages from remaining anonymous and not compensated; the problem of the compensability of such damages also remains open, and therefore it is up to the interpreter to find the solution.