Artificial Intelligence in healthcare is already a reality. Healthcare providers have embedded the technology into their workflows and decision-making processes improving patient outcomes and access, supporting healthcare professionals, and bringing benefits to society at large. At the same time, future innovation in AI-enabled technology promises further advancements to assist European health systems in responding to the major challenges they face.

Medical devices are regulated under the European Medical Device Regulations (MDR & IVDR). The MDR applies since May 2021 and ensures the safety and clinical performance of medical devices. The scope of the Regulation also includes medical device software, including those who embed AI, that supports prevention, diagnosis, treatment and the monitoring and management of health and quality of life.

The proposal for the Artificial Intelligence Act was published in spring 2021. The horizontal regulation would introduce additional requirements for AI-enabled medical devices put on the European market.

The proposed Act leaves many uncertainties for manufacturers, healthcare professionals, and patients, especially in respect of its interplay with the sectoral MDR & IVDR. This event aims to clarify how horizontal and sectorial legislation will interact to ensure that high-quality, safe, and performing AI-based healthcare products can be placed on the European market.

This event is organized within the framework of the French Presidency of the Council of the European Union *

*This event is not organized by the French government. However, the organizer has been authorized by the French government to use the official logo of the French Presidency of the Council of the European Union