The Significance of the EU AI Act for Medical Devices

Written By Create Regularity Affairs Consultancy

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The EU AI Act applies a comprehensive risk-based approach to regulating digital medical products. By aligning and interacting with existing regulations like the EU MDR/IVDR and GDPR, the Act impacts AI across healthcare, focusing on patient safety, AI system efficacy, data governance, and ethical use.

The EU AI Act applies a comprehensive risk-based approach to regulating digital medical products. By aligning and interacting with existing regulations like the EU MDR/IVDR and GDPR, the Act impacts AI across healthcare, focusing on patient safety, AI system efficacy, data governance, and ethical use.

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