Regulatory Requirements for Medical Devices Based on Artificial Intelligence

Abstract Artificial intelligence is rapidly transforming healthcare, yet in Europe, there are no standardized regulations for AI-based medical devices under the Medical Device Regulation. This gap necessitates independent compliance verification by medical device manufacturers. This paper addresses the regulatory void by proposing a comprehensive training concept. It equips manufacturers with essential artificial intelligence knowledge and outlines current market introduction challenges. Through pre-tests and training sessions, the concept's efficacy will be assessed and refined. In summary, this work offers insights into AI's transformative potential and regulatory hurdles in healthcare, paving the way for improved standards and practices.