[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 defined by the manufacturer and the classification criteria of the MDR or IVDR-whether the product qualifies as a medical device. If so, all relevant regulations of the AIA apply in addition to those of the MDR/IVDR.Both the MDR/IVDR and the AIA assign products to different risk classes based on their respective risk potential, defining specific requirements accordingly. However, the classification criteria and implications differ between the regulatory frameworks. As a result, even medical devices in the lower MDR/IVDR risk category with involvement of a notified body are considered high-risk products under the AIA. It is therefore crucial to differentiate precisely between the respective regulations.The harmonization of regulatory requirements remains a challenge, particularly because classification under the AIA and MDR/IVDR is based on different criteria despite some similar terminology. Open questions persist, especially regarding lowest-risk medical devices and self-learning AI systems. Further development of regulatory guidelines is necessary to ensure the safe and efficient integration of innovative AI applications into healthcare. The German Federal Ministry of Health (BMG) and the Federal Institute for Drugs and Medical Devices (BfArM) are actively working at both national and European levels to develop pragmatic solutions.