AI in Medical Devices: German Authorities Publish Guidance Roadmap (heise.de)

• Joint roadmap from German regulators for AI in medical devices.
• Provides guidance on legal compliance for developers and operators.
• Provisional status due to fast-evolving technology and upcoming EU AI Act.

"The German Federal Network Agency, the Federal Commissioner for Data Protection, and the state of Hesse have jointly published a guidance roadmap for regulating artificial intelligence (AI) in medical devices. The document aims to provide orientation for manufacturers, users, and testing bodies on how to develop and operate AI-powered medical devices in a legally compliant manner. Due to rapid technological development and the ongoing European AI Act legislative process, the roadmap is considered provisional and likely requires early adaptation. It addresses data protection, transparency, safety, and liability, and aims to strengthen Germany as an innovation hub for AI in medical technology."