Position: Classifying GenAI Under the European Union’s Medical Device Regulation

Abstract

The rapid growth of Generative Artificial Intelligence (GenAI) in healthcare has introduced novel systems and processes that require careful classification under the European Union's Medical Device Regulation (MDR). The diversity of these applications raises important questions about their regulatory categorization. Proper classification of GenAI systems is essential, as it determines the level of regulatory oversight, impacting both patient safety and the pace of healthcare innovation. This paper addresses the critical issue of whether GenAI-tools should be classified as a medical device under the MDR, focusing on Rule 11. By exploring various use cases, we provide a detailed analysis of the regulatory implications, offering insights for developers, healthcare providers and regulators on navigating this emerging field.