The EU AI Act, Regulation (EU) 2024/1689, is the European Union's horizontal law on artificial intelligence. It takes a risk-based approach, banning a small set of unacceptable practices, imposing detailed obligations on high-risk systems, and setting transparency rules for limited-risk systems. Healthcare is heavily affected because AI systems that are medical devices, or safety components of medical devices, requiring notified body assessment under the MDR or IVDR are generally classified as high risk. Such systems must meet requirements on risk management, data governance, technical documentation, transparency, human oversight, and accuracy and robustness. The AI Act applies alongside the MDR and IVDR rather than replacing them, so manufacturers of AI-enabled medical devices must satisfy both regimes. Its obligations phase in over a multi-year timeline following entry into force in 2024.
What is the EU AI Act in healthcare?
The EU AI Act, Regulation (EU) 2024/1689, is the EU's risk-based law on artificial intelligence; many medical AI systems are classified as high risk.
Are medical AI devices high risk under the AI Act?
Generally yes. AI systems that are medical devices or their safety components and require notified body assessment under the MDR or IVDR are classified as high-risk under the AI Act.
Does the AI Act replace the MDR?
No. The AI Act applies in addition to the MDR and IVDR. Manufacturers of AI-enabled medical devices must comply with both frameworks.
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