The Significance of the EU AI Act for Medical Devices
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.