[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.
basic information
For more details, please download the PDF or feel free to contact us.
Price range
Delivery Time
Applications/Examples of results
For more details, please download the PDF or feel free to contact us.
catalog（1）
Download All Catalogs
Recommended products
Distributors
TÜV SÜD is one of the world's largest third-party testing and certification organizations headquartered in Germany, providing certification, inspection, testing, and evaluation services across a wide range of fields. The company's Japanese subsidiary, TÜV SÜD Japan, was established in 1993 to respond to the growing demand for quality and safety testing and certification in the Japanese market under TÜV SÜD's business framework. It offers various testing, certification, auditing, management system certification, and training services in a wide range of fields, including electrical and electronic equipment, healthcare and medical devices, industrial equipment, IT and AV equipment, 5G-related devices, food, automotive, railways, energy and plant equipment, chemicals and processes, and cosmetics.