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
“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 for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
Research and analysis item
Recent advancements in AI – implications for medical device technology and certification
Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why…
Research and analysis item
The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
Research and analysis item
Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
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. This content is…
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…
