The UK government accepted all 44 recommendations on regulating artificial intelligence in healthcare on 6 October 2026. The decision does not change the law or replace the rules already in force.

The Medicines and Healthcare products Regulatory Agency (MHRA) will begin work on modernising rules for AI-enabled medical devices. For patients, healthcare providers and developers, the next test is how quickly safeguards and guidance take shape.

First draft guidance is due by December

The MHRA plans to publish draft guidance by December 2026 on managing changes to AI-enabled medical devices. It is intended to set boundaries for permitted updates, including to adaptive AI products, while preserving each device’s intended purpose.

The government’s first priority is to modernise rules for software and AI-enabled medical devices. That includes clarifying which products count as medical devices and how they should be classified by risk and intended use.

A broader roadmap is due in 2027

The accepted recommendations also point to monitoring safety and performance throughout a device’s lifecycle, rather than relying mainly on assessment before it reaches the market. They include clearer information for patients, defined responsibilities across the health system and attention to whether technologies work for different population groups.

  • Draft guidance on changes to AI-enabled medical devices: due by December 2026.
  • Full implementation roadmap, including roles, responsibilities and timelines: due by Spring 2027.
  • Progress updates: annual.

Until the government makes regulatory changes, accepting the recommendations remains a commitment to act, not a change to the rules clinicians and developers must follow.

The recommendations set a direction for reform. Patients and developers are still waiting for the detailed guidance and changes that would put it into practice.