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…
Medicines and Healthcare products Regulatory Agency
Regulation and official guidance
Guidance on GxP data integrity
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…
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…
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
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…
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…
Frameworks and principles
Good machine learning practice for medical device development: guiding principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)…
