Guidance

Software and AI as a Medical Device Change Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 16 September 2021
• Last updated: 14 June 2023 — See all updates

Documents

Software and AI as a Medical Device Change Programme - Roadmap

HTML

Details

Software (and AI in particular) plays 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.

For example, 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.

Published 16 September 2021
Last updated 14 June 2023 + show all updates

1. 14 June 2023

   Partnerships section updated.

2. 17 October 2022

   Added - 'Software and AI as a Medical Device Change Programme - Roadmap'

3. 16 September 2021

   First published.