Frameworks and principles
Assurance and testing
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…
Official policy proposals and consultations
Guidance on the AI auditing framework: draft guidance and consultation
Applications of artificial intelligence (AI) increasingly permeate many aspects of our lives. We understand the distinct benefits that AI can…
Regulation and official guidance
Code of practice: automated vehicle trialling
This Code is primarily intended to be used by organisations or individuals planning to trial or pilot automated vehicle technologies…
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…
Regulation and official guidance
A buyer’s guide to AI in health and care
The exciting promise of artificial intelligence (AI) to transform areas of health and care is becoming a reality. Prospective vendors…
Frameworks and principles
Evidence standards framework (ESF) for digital health technologies
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework…
Frameworks and principles
Deliverable 1: principles for the evaluation of artificial intelligence or machine learning-enabled medical devices to assure safety, effectiveness and ethicality
As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…
Frameworks and principles
Deliverable 2: principles to support the development and deployment of artificial intelligence or machine learning-enabled medical devices across jurisdictions
As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…
