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UK AI in life sciences and digital health: tracker of legislation, regulatory guidance, medical devices (SaMD/AIaMD), government initiatives and consultations

Practice notes
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This Practice Note tracks key legislative and regulatory developments, government initiatives and strategies, and consultations relating to the use of artificial intelligence (AI) in life sciences and digital health in the UK.

The rapid acceleration of AI within life sciences and digital health is spotlighting its power to transform research, fuel innovation and enhance patient care, whilst at the same time presenting intricate regulatory challenges.

Across the UK, AI cuts across multiple established legal and regulatory frameworks, with the Medical Devices Regulations 2002 (MDR 2002), SI 2002/618 (as amended) being a central point of intersection.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is advancing a suite of reforms to the UK medical device framework, with notable consequences for AI and digital health—particularly for Software as a Medical Device (SaMD), AI as a Medical Device (AIaMD) and cybersecurity expectations. See News Analyses:

  • Life Sciences UK—key developments in 2025 and horizon scanning for 2026—AI and digital health
  • UK medical devices regulatory reform—where are we now and what’s next for 2025?
  • A closer look at MHRA’s proposals on future regulation of medical devices in the UK
  • UK lays out roadmap for regulation of software and AI as medical devices...
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Web page updated on 22/05/2026

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