EU AIA and its interplay with the EU MDR/IVDR

The European Union issued the Artificial Intelligence Act (AIA), published as Regulation (EU) 2024/1689 in the Official Journal of the European Union on July 12, 2024. The regulation places additional requirements on manufacturers of AI-enabled devices. Medical device manufacturers need to understand the compliance requirements for AI-enabled devices, particularly how they intersect with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The AIA introduces a new framework focusing on risk classification of AI systems and changes in conformity assessment procedures for medical device software that employs AI technology.

In this webinar, our presenter will help attendees understand the key decision points they might face when determining the regulatory pathway for AI-driven medical devices. They will examine how the AIA overlaps with MDR/IVDR requirements. Additionally, our presenter will discuss the additional requirements for high-risk AI systems and share practical strategies to equip manufacturers for future regulatory submissions in this evolving landscape.

About the presenter

Sade Sobande, lead quality and regulatory affairs consultant

Sade Sobande is an RAC-Devices accredited regulatory affairs professional with over 14 years of experience in the medical device industry. Sobande has a BEng in Chemical Engineering from the University of Manchester, U.K., and an MSc in Biochemical Engineering from University College, London, U.K. 

Sobande is passionate about regulatory strategy and submissions and supporting customers in getting their products to market in the safest and most efficient manner. She specializes in regulatory strategy and submissions for medical device software. Her expertise includes international regulatory compliance for class I-III CE marked devices; class II-IV MDLs for Health Canada; compilation of FDA 510(k)s; regulatory submissions/registrations in MENA and APAC territories.