Regulatory Guidance on Software and AI as Medical Devices

“The MHRA has released guidance on Software and Artificial Intelligence (AI) as Medical Devices, outlining the regulatory framework, classification, and safety requirements for these technologies in healthcare.

Key Highlights:

• Regulatory Framework: Classification of Software as a Medical Device (SaMD) and In Vitro Diagnostics (IVD) under UK regulations.
• Change Program & Roadmap: Launched on October 17, 2022, to drive regulatory updates throughout the SaMD lifecycle.
• Post-Market & Vigilance: Guidance for manufacturers on reporting adverse incidents and field safety corrective actions.
• AI Regulation & Research:
• MHRA & Brunel University: Studying adaptive AI algorithms in medical devices.
• Wellcome Trust Project: 3-year initiative to regulate and evaluate digital mental health technology.
• Global Collaboration: MHRA works with international regulators, academia, and UK health organizations to advance AI and software regulation.
• This guidance ensures SaMD and AI-powered healthcare solutions are safe, effective, and compliant with UK regulations.
  

Region: European union
Source: https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device#full-publication-update-history