A Review of the Artificial Intelligence Act Proposal and the Medical Device Regulation

The Artificial Intelligence Act (AIA) proposal is designed to regulate Artificial Intelligence (AI) systems intended to be placed on the market or put into service in the European Union (EU). The proposal covers different products, including Medical Devices (MD). It is expected that harmonisation will be achieved with the application of obligations and requirements in the AIA, ensuring the protection of human rights and the Union values. Nevertheless, there is a concern that conflicting scenarios may occur once the AIA is passed. This paper reviews the AIA, its possible implications for MDs, and prior work in line with the AIA.