[Information] Application of the EU AI Act to the Medical Device Industry

A thorough explanation of the application of AI laws to medical devices! What obligations are imposed on manufacturers and users?

This document is a white paper that examines the EU AI Act, a comprehensive legal framework regarding AI, from the perspective of its application to the medical device industry. It explains important aspects such as the impact of the EU AI Act on the medical device industry, prohibited uses of AI, risk-based classification, and obligations for transparency. In addition to discussing the relationship between the EU AI Act and the European Medical Device Regulation (EU MDR) and ensuring compliance, it also introduces the concept of a regulatory sandbox. 【Contents】 ■ Introduction ■ Important aspects of the EU AI Act concerning medical devices ■ Inconsistencies between the EU AI Act and EU MDR requirements ■ Ensuring compliance with the EU AI Act and EU MDR ■ Regulatory sandbox ■ Conclusion *For more details, please download the PDF or feel free to contact us.

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