Current systems4 min read

CE-marked systems in Europe

In Europe, AI medical devices carry the CE mark of the Medical Devices Regulation, with AI-specific rules via the European AI Act.

In the European Union, AI systems used for breast imaging are medical devices and must carry a CE mark under the Medical Devices Regulation (MDR). The MDR requires manufacturers to demonstrate safety and clinical benefit before a device reaches patients.

The EU goes further. The AI Act, rolled out progressively through the 2020s, adds a specific layer for “high-risk” medical AI — data governance, transparency, human oversight, robustness and post-market surveillance. This makes Europe one of the most regulated health-AI markets in the world.

European requirements

  • CE marking under the MDR
  • Clinical evaluation of safety and performance
  • Compliance with the AI Act's “high-risk” requirements
  • Post-market surveillance after launch

In brief

CE marking is mandatory for AI devices in the EU.
Europe's AI Act adds strict rules for high-risk medical AI.
Post-market surveillance continues after launch.

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