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  • Lloyd Price

MHRA policy paper on the 'Impact of AI on the regulation of medical products'





Exec Summary:


The MHRA is aware of the positive impact AI can have on healthcare and is committed to regulating AI in medical devices effectively. They will balance promoting innovation with ensuring public safety.


They are working with other organisations to develop best practices for AI in medicine and will use AI responsibly to improve healthcare.


The UK will regulate AI-based medical products with a balanced approach that considers their specific complexities. By working with international organizations like the IMDRF, the US FDA and Health Canada, they aim to ensure the safe and responsible use of AI in medicine, keeping the UK at the leading edge of global best practices.


The MHRA recognises the importance of using the latest evidence for critical decisions and plan to responsibly explore how AI can be used to benefit public health while promoting innovation in healthcare.


This aligns with their five core principles, suggesting they will prioritise safety while embracing new technologies.


We are developing an MHRA data strategy which will include a theme on safely and responsibly applying advanced analytics and AI within the business. Within this, there is a deliverable on exploring the role of Large Language Models (LLM) and Generative AI across the business including the capabilities we will require across tech, people and partnerships.


The Medicines and Healthcare products Regulatory Agency (MHRA)


The Medicines and Healthcare products Regulatory Agency (MHRA) is the independent regulator of medicines, medical devices and blood components for transfusion in the UK. We operate in a statutory framework set by HM Government.


Our responsibilities are to;


  • ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)


  • secure safe supply chains for medicines, medical devices and blood components


  • promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines


  • educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use


  • enable innovation and research and development that is beneficial to public health


  • collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health.


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