Abstract
Artificial intelligence (AI) is increasingly embedded in clinical decision-making, yet recent proposals to simplify the European Union (EU) Artificial Intelligence Act (AI Act) have reopened the question of whether AI-enabled medical devices should remain subject to the AI Act’s full high-risk regime. Under 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 contained in the AI Act. This narrative review analyses the Health Innovation Package and related legislative developments under the EU simplification agenda and examines their impact on the relationship between the AI Act and medical device law. It shows that the proposed reform 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 postmarket monitoring. Rather than resolving regulatory overlap, the amendments 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.