Category: Medical Technology

The document discusses the intersection of medical device regulations and the EU AI Act, highlighting how both sets of regulations will apply to medical devices that include AI systems. It outlines the responsibilities of manufacturers, the classification of devices as high-risk, and the compliance requirements necessary for market access in the EU.

The EU AI Act, which came into force on August 1, 2024, is set to significantly impact the MedTech sector by imposing stringent regulations on medical devices that utilize AI. As organizations prepare for compliance by 2026, they must pay particular attention to “high-risk systems” that could affect patient health and safety.