Frameworks and principles
Medical devices
Strategies and roadmaps
Impact of AI on the regulation of medical products
This document summarises the MHRA’s strategic approach to AI regulation following the UK Government request for an update from regulators…
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices B
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices A
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Regulation and official guidance
Software and artificial intelligence (AI) as a medical device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…
Regulation and official guidance
Guidance: medical device stand-alone software including apps
Information on when software applications are considered to be a medical device and how they are regulated. Open Government Licence…
Regulation and official guidance
Digital technology assessment criteria (DTAC)
The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital…
Strategies and roadmaps
Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan
The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action…
Strategies and roadmaps
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…
Official policy proposals and consultations
Consultation on the future regulation of medical devices in the United Kingdom
Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory…
Regulation and official guidance
A guide to good practice for digital and data-driven health technologies
This guide is designed to support innovators in understanding what the NHS is looking for when it buys digital and…
