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Regulation2026-10-06

The UK government accepted all 44 recommendations from the National Commission on AI in healthcare. It will modernise the regulatory framework for AI-enabled medical devices. The MHRA will lead reforms to clarify device classification and intended purpose. A new approach will balance pre-market and post-market assurance. The government will prioritise equitable access for underserved populations. It will work with regulators, the NHS, industry and academia to implement changes. The £10 billion NHS digital investment will support these efforts. The goal is to enable safe, trusted and scalable AI adoption in healthcare.

What changed

UK Medical Devices Regulations 2002 were not fit for AI-enabled products.

What it unlocks

A proportionate, lifecycle-based regulatory framework for AI in healthcare.

  • 44 recommendations accepted
  • £10 billion over three years for NHS digital transformation

Sources

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