[Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR].

Abstract

The use of artificial intelligence (AI) in healthcare offers great potential but also presents regulatory challenges. The EU Artificial Intelligence Act (AIA), the Medical Device Regulation (MDR), and the Regulation on in vitro diagnostic medical devices (IVDR) establish the framework for the safe and ethical use of AI-based medical devices in Europe.When assessing the regulatory classification of AI software or products with AI components, it must be determined-based on the intended purpose def