Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.
The AI Act is now part of the new legislative framework
The AI Act is a new part of the new legislative framework and also applies to medical devices and IVDs.
One of the fundamental tenets is that the medical device and IVD are subject to EU harmonized legislation: the MDR and IVDR are delineated in Annex I of the AI Act.
Risk Categorization Per the European AI Act | Emergo by UL
Risk Categorization Per the European AI Act
Our Emergo by UL experts explain the importance of risk categorization in complying with the European Artificial Intelligence Act and Medical Device Regulation (2017/745 MDR) and In-Vitro Diagnostic Regulation (2017/746 IVDR).
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