December 5, 2024

UK: MHRA trials five AI technologies as part of pilot scheme to change regulatory approach

In this article:

MHRA’s AI Airlock Pilot Launched: The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the AI Airlock, a pilot scheme to refine regulations for AI-powered medical devices, ensuring faster and safer access for patients.
Focus on Transformative Technologies: Five innovative devices targeting cancer, chronic respiratory diseases, and radiology diagnostics were selected to explore their potential to revolutionize patient care.
Regulatory Sandbox Approach: The AI Airlock acts as a controlled “sandbox” where manufacturers can test methods for collecting evidence to demonstrate safety and efficacy under MHRA supervision.
Adapting to AI Challenges: The initiative addresses unique challenges posed by AI medical devices, including their evolving nature as they learn, aiming to establish robust regulatory pathways.
Benefits for NHS and Patients: By creating a tailored framework, the pilot aims to streamline market entry for transformative AI technologies, accelerating access for NHS patients.

Contact Expert Request Form