EU Medical Device Regulation (MDR)

• Many AI systems used for diagnosis or treatment are classified as medical devices
• Under MDR, these tools must obtain CE marking by demonstrating safety and performance
• AI software typically undergoes conformity assessment as Class IIa or IIb medical devices
• Requirements include risk management, quality assurance, and post-market surveillance
• Developers must test for issues like false positives/negatives and algorithmic biases

EU Artificial Intelligence Act (AIA)

• Major new regulation specifically for AI, applying in phases over the next few years
• Introduces a risk-based classification system for AI applications
• Most healthcare AI systems will be categorized as "high-risk AI" under this Act
• High-risk AI systems face strict obligations:
  • Implementing robust risk management processes
  • Ensuring high-quality training datasets to avoid bias
  • Maintaining transparency and human oversight
  • Registering the AI in an EU database

Coordination Between Regulations

• Medical AI tools will need to comply with both MDR and the AI Act
• Efforts are underway to harmonize these frameworks to avoid duplicate processes
• Germany will enforce these EU rules nationally through designated oversight bodies