Evaluating the Impact of the EU AI Act on Medical Device Regulation.

Journal: Studies in health technology and informatics
PMID: 40200442

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.

Authors

  • Konstantinos Kalodanis
    Harokopio University of Athens, Kallithea, Greece.
  • Georgios Feretzakis
    School of Science and Technology, Hellenic Open University, Patras, Greece.
  • Panagiotis Rizomiliotis
    Department of Informatics & Telematics, Harokopio University of Athens, Kallithea, Greece.
  • Vassilios S Verykios
    School of Science and Technology, Hellenic Open University, Patras, Greece.
  • Charalampos Papapavlou
    Department of Electrical & Computer Engineering, University of Patras, Patras, Greece.
  • Apostolos Skrekas
    Department of Management Science & Technology, Athens University of Economics & Business, Athens, Greece.
  • Dimosthenis Anagnostopoulos
    Department of Informatics & Telematics, Harokopio University of Athens, Kallithea, Greece.

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