EU AI Act Compliance for Medical Devices: What US Healthcare Companies Must Know in 2026
The EU AI Act classifies medical device AI as high-risk by default. For US vendors selling into European markets, that means new data governance mandates, mandatory bias testing, and fines up to 6% of global revenue for non-compliance. If your organization manufactures or distributes AI-enabled medical devices in any EU member state, you are already subject to the most sweeping AI regulation in history. The ...

