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▶ 주제: EU AIA and its inter play with the EU MDR/IVDR
▶ 일시: 2025년 03월 20일 CST 9시 (한국시간: 03월 20일 23시)
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.
EU AIA and its interplay with the EU MDR/IVDR | Emergo by UL
EU AIA and its interplay with the EU MDR/IVDR
Understand how the EU Artificial Intelligence Act (EU AIA) is set to redefine the regulatory environment for AI-driven medical devices and IVDs.
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