Evaluating the Impact of the EU AI Act on Medical Device Regulation.
Evaluating the Impact of the EU AI Act on Medical Device Regulation.
Konstantinos Kalodanis,G. Feretzakis,4 Authors,Dimosthenis Anagnostopoulos
TLDR
Challenges related to compliance, certification processes, and potential conflicts between the AI Act and existing medical device frameworks while providing recommendations for harmonization are explored.
Abstract
Artificial Intelligence (AI) is increasingly incorporated into medical devices, revolutionizing diagnostics, treatment planning, and patient monitoring. To ensure AI's safe and ethical use, the European Commission published the AI Act in 2024, which places stringent obligations on AI systems, especially those classified as high-risk, such as medical devices. This paper evaluates the impact of the EU AI Act on existing regulations such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It explores challenges related to compliance, certification processes, and potential conflicts between the AI Act and existing medical device frameworks while providing recommendations for harmonization.