The Regulation of Artificial Intelligence as a Medical Device: Government Response

The UK government has responded to the Regulatory Horizons Council’s recommendations on regulating Artificial Intelligence as a Medical Device (AIaMD).

The Medicines and Healthcare products Regulatory Agency (MHRA) is expanding its regulatory capacity for AIaMD, focusing on both pre-market and post-market phases. This includes targeted training and new guidance documents to help manufacturers comply with regulations.

The regulatory framework aims to be “”legislatively light,”” relying on standards and guidance while addressing AI-specific challenges. Manufacturers must provide evidence of risk evaluation and mitigation, particularly for concerns like generalizability and AI bias.

The MHRA is also strengthening post-market surveillance to ensure patient safety. New legislation will take effect in June, improving oversight and regulatory processes for AI-driven medical devices.

The UK is positioning itself as a global leader in AIaMD regulation. It actively participates in international forums such as the International Medical Device Regulators Forum and collaborates with regulatory bodies like the FDA and Health Canada.

Patient and public involvement is a key priority for the MHRA. The agency is committed to clear communication and accessible guidance to build trust in the AIaMD regulatory system.

Source:https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council

Region: Europe