Artificial Intelligence and Medical Devices - Compliance with the AI Act

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The AI Act, which came into force on August 1, 2024, focuses on regulating AI systems and general-purpose AI models, particularly impacting the healthcare sector. AI systems are extensively used in healthcare for various purposes such as diagnosing diseases, clinical decision support, analyzing health data, and optimizing medical therapy.

Stakeholders in the healthcare sector are urged to ensure compliance with the AI Act by assessing its applicability, conducting gap analyses, and working closely with notified bodies. The Act categorizes AI systems based on risk levels, with high-risk AI systems, commonly found in medical devices, subject to stringent obligations.

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