The UK government has released its response to the Regulatory Horizons Council’s report on AI as a Medical Device. The government accepted most recommendations, including (1) providing long-term funding for the MHRA, (2) strengthening regulatory capacity, (3) using a ‘legislatively light’ framework, (4) ensuring manufacturers mitigate risks such as AI bias; and (5) innovative mechanisms for accelerated access, with post-market evidence generation and collaboration among stakeholders. The government accepted in principle further recommendations such as (1) requiring manufacturers to ensure safety in local deployments and (2) maintaining a ‘plan B’ for device withdrawal. None of the recommendations were outright rejected, but some have limitations in their current implementation.
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