AI Act meets MDR: What the Digital Omnibus Means for AI-Enabled Medical Devices
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Life Sciences Coffee… AI Act meets MDR: What the Digital Omnibus Means for AI-Enabled Medical Devices AI is becoming a standard feature of medical devices, and the EU rules that govern it are still moving. With the Digital Omnibus on AI, manufacturers have gained time: the AI Act's high-risk requirements for AI in medical devices and IVDs will not apply until 2 August 2028. The requirements themselves remain, and…
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