High-Risk Without Safeguards? The EU AI Act and the Deregulation of Medical AI

Artificial intelligence (AI) is increasingly embedded in clinical decision-making, yet recent reforms to the European Union (EU) Artificial Intelligence Act (AI Act) risk creating a category of high-risk medical AI systems without corresponding safeguards. In the current framework, AI-enabled medical devices are regulated through a combination of sectoral medical device legislation, the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), and additional AI-specific safeguards in the AI Act. Recent EU “simplification” initiatives, including the Digital Omnibus and the Health Innovation Package, propose to remove these safeguards. This narrative review analyses recent EU legislative developments and their impact on the relationship between the AI Act and medical device law. It shows that the proposed reforms would retain the high-risk classification of AI-enabled medical devices while removing most associated AI Act obligations. In effect, this decouples risk classification from the safeguards that give it regulatory meaning, including requirements on data governance, risk management, human oversight, and post-market monitoring. Rather than resolving regulatory overlap, the reforms shift the centre of gravity back to product-focused medical device law without ensuring equivalent AI-specific safeguards. These changes may narrow attention to fundamental rights, weaken oversight in clinical use, and increase legal uncertainty regarding accountability and responsibility. In a domain where AI systems directly shape clinical decisions and patient outcomes, these changes risk undermining the conditions for safe, equitable, and accountable deployment of medical AI.