Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China.

Abstract

In the last decade, advanced AI methods were applied to radiology, providing tools for clinical practice. Regulations across countries are a relevant topic, considering that AI tools must be regarded as medical devices. We describe the regulatory scenarios in the EU, USA, and China. For the EU, we considered the 2017 Medical Device Regulation, including AI tools as "active" medical devices, the 2018 General Data Protection Regulation, protecting data privacy, and the risk-based approach by the 2