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SaMD and AI in the UK

Transforming Healthcare with Technology: The UK's Regulatory Approach to Software and AI in Medical Devices


In the ever-evolving landscape of healthcare, technology has emerged as a formidable ally. Software, including Artificial Intelligence (AI), now plays an indispensable role in health and social care, revolutionizing the way we diagnose, treat, and manage patient data. The United Kingdom has recognized the significance of this transformation and has taken steps to ensure that patients are protected and innovation thrives in this domain.


Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled the "Software SaMD and AI as a Medical Device Change Programme." This initiative seeks to establish clear regulatory requirements for software and AI used in healthcare, ensuring that patients are safeguarded and that the UK becomes a global hub for responsible medical device software innovation. This program builds upon broader medical device regulatory reforms, emphasizing the importance of adapting to the digital era.


The new SaMD and AI program

The Change Programme comprises several work packages, each with its set of objectives and deliverables for the SaMD and AI. Let's explore the key aspects of this transformative initiative:


  • Ensuring Safety and Functionality: The first focus of the Change Programme is to create regulatory requirements that assure the safety and intended functionality of software and AI as medical devices. This is crucial for safeguarding patients and the public, as well as fostering trust in these technologies.

  • Clear Guidelines for Manufacturers: Manufacturers must have a clear understanding of the regulatory landscape. The programme aims to provide them with well-defined guidelines and streamlined processes that specifically cater to software and AI. In addition, it will support manufacturers with tools to demonstrate compliance, possibly through the designation of standards.

  • Market Alignment and Collaboration: To reduce market friction, the Change Programme will collaborate with key partners like the National Institute for Health and Care Excellence (NICE) and NHS England. By aligning domestic requirements and eliminating duplication, the program will provide a unified and streamlined framework for digital health in the UK. This not only benefits healthcare providers but also positions the UK as a global leader in responsible innovation.


International Collaboration

Recognizing the global nature of healthcare technology, the UK will engage with other regulators both bilaterally and through the International Medical Device Regulators Forum (IMDRF). This international cooperation aims to foster convergence and consensus on software and AI products' regulation worldwide.


The Change Programme of SaMD and AI encompasses two primary workstreams, each addressing distinct aspects of medical device software:


1. Software as a Medical Device (SaMD): This stream includes eight work packages focused on making key reforms across the SaMD lifecycle. These reforms are designed to ensure that software medical devices are safe, effective, and adhere to regulatory standards.


2. AI as a Medical Device (AIaMD): The second workstream consists of three work packages that tackle the unique challenges posed by AI in medical devices. AI technology brings a new dimension to medical device software, and these work packages will address the nuances of regulating AI-powered devices.


This forward-thinking approach by the UK government underlines the commitment to harnessing the potential of software and AI in healthcare while prioritizing patient safety and international collaboration. The "Software and AI as a Medical Device Change Programme" is a testament to the UK's dedication to responsible innovation, setting a course for a brighter and more innovative future for medical technology and healthcare.


In a world where technology is redefining healthcare, the UK's efforts to establish clear regulatory frameworks demonstrate a commitment to pioneering a safer, more innovative era for medical device software and AI. The "Software and AI as a Medical Device Change Programme" is a testament to the country's dedication to responsible innovation and the pursuit of a brighter, more technologically advanced future for healthcare.


Find below the guidance, for more help check our UKRP services at https://www.afpharmaservice.com/ukrp-medical-device

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