In the wake of its exit from the European Union, the United Kingdom is working to update regulations applicable to medical devices that use software based on artificial intelligence (AI).
The UK’s Medicines and Healthcare products Regulatory Agency detailed its plans in a recently released Guidance, “Software and AI as a Medical Device Change Programme.” The Guidance maps out 11 different “work packages” that would implement changes across the entire medical device lifecycle, from initial product qualification to post-market surveillance.
The Guidance work packages also address issues specific to AI-enabled medical devices, including cybersecurity issues, mobile health and applications, alternative approval routes for innovative technologies, and the interpretability of AI data.
