In April 2021, the European Commission proposed the Artificial Intelligence Act, which is now debated in the EU parliament. The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR). In its current version, the AI Act only regulates AI medical devices that are subject to the MDR. Other health-related AI applications fall outside the scope of the AI Act. However, also the MDR is not fully adapted to the risks posed by AI. While
both the AI Act and the MDR are risk-based, the comparison below shows the differences in assessment criteria. For AI medical devices, the AI Act provides improvements for fundamental rights but also needs some specifications to fill the gaps left by the MDR.

Cite as: Hannah van Kolfschooten & Janneke van Oirschot, ‘The EU Medical Devices Regulation and the EU AI Act: A Short Comparison’ (Health Action International, March 2023)