# Software and AI as a Medical Device Change Programme

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/728f1aa4-c889-47c7-9e8a-c42a23dac7d8
Type: Guidance
Published: September 15, 2021
Updated: June 14, 2023

> The MHRA (UK Medicines and Healthcare products Regulatory Agency) has introduced a new work programme designed to modernize the regulatory framework for software and artificial intelligence (AI) in health and social care. Since many of these digital applications qualify as medical devices, the MHRA is focused on ensuring safety standards are fit for the digital age while positioning the UK as a leader in responsible innovation. Rather than detailing a specific company violation, this document outlines a multi-agency collaboration between the MHRA, NICE, CQC, and the HRA. These organizations have established the online AI and Digital Regulations Service to help developers navigate the legal and evaluation pathways required for compliance. The primary issue addressed is the complexity of existing regulations, which can delay the adoption of beneficial technologies. Developers are required to follow these updated pathways to ensure their products meet best practice principles. This initiative aims to provide transparency and centralize guidance, ultimately ensuring that patients and healthcare professionals can safely access effective technological advances sooner under a reformed UK medical device regulatory environment.

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## Content

Software and AI play an increasingly prominent role in health systems, having a wide set of applications across health and social care. Many of these applications will be regulated as medical devices. It is increasingly important then that medical device regulation be fit for purpose, to ensure patients, public, and healthcare professionals are empowered with the best medical technology available. This work programme will deliver bold change to provide a regulatory framework that provides a high degree of protection for patients and public, but also make sure that the UK is the home of responsible innovation for medical device software. Partnerships The online AI and Digital Regulations Service helps digital health innovators and adopters of these technologies to navigate the regulatory system. This service is a multi-agency collaboration between the National Institute for Health and Care Excellence, the Care Quality Commission, the Health Research Authority and the Medicines and Healthcare products Regulatory Agency. By collating information from all four organisations in one place, the site provides guidance and signposting for the development and adoption of new technologies and makes information more accessible to a broader audience. The online service maps out the regulatory and evaluation pathway, to help developers progress their technology in line with legal requirements and best practice principles. This will enable health practitioners, patients and the public to benefit from effective technological advances sooner.

## Attachments

- [Software and AI as a Medical Device Change Programme roadmap](/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme-roadmap)