Gap Analysis on Regulatory Frameworks for AI-embedded Medical Devices

The widespread adoption of artificial intelligence (AI) across various industries poses significant challenges to regulating AI technologies. In the healthcare sector, medical devices are classified by varying risk levels and typically undergo stringent certification processes. However, integrating AI into medical devices complicates establishing a harmonized regulatory and certification framework. This complexity is mainly due to the differing regulatory environments across countries. Given the ubiquity of AI in healthcare, the regulation and certification of AI-embedded medical devices should encompass not only technical functionalities but also ethical considerations. Developing a globally harmonized framework focused on verifiable ethical principles for regulating and certifying AI-embedded medical devices is imperative, particularly considering the profound impact that AI integration can have on patient care. This paper analyzes the discrepancies in regulatory frameworks for AI in medical devices within the European Union and the United States - emphasizing the challenges of aligning existing medical device regulations with the EU AI Act, particularly in addressing ethical principles in the certification process.