Medicines and Healthcare products Regulatory Agency Archives - AI Standards Hub

Medicines and Healthcare products Regulatory Agency

Strategies and roadmaps

Impact of AI on the regulation of medical products

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Topic:

Adoption and commercialisation Good practice in development and use

Domain:

Healthcare and medicine - Medical devices

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This document summarises the MHRA’s strategic approach to AI regulation following the UK Government request for an update from regulators…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 15 Jan 2025

Strategies and roadmaps

Roadmap towards the future regulatory framework for medical devices

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Domain:

Healthcare and medicine - Medical devices

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“This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 29 Feb 2024

Frameworks and principles

Predetermined change control plans for machine learning-enabled medical devices: Guiding principles

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Topic:

Risk management Safety

Domain:

Healthcare and medicine

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In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…

Organisation: Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance on GxP data integrity

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Domain:

Healthcare and medicine

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The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Software and artificial intelligence (AI) as a medical device

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Topic:

Domain:

Healthcare and medicine - Medical devices

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Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance: medical device stand-alone software including apps

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Topic:

Good practice for development and use Safety

Domain:

Healthcare and medicine - Medical devices

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Information on when software applications are considered to be a medical device and how they are regulated. This content is…

Last Updated: 12 Oct 2022

Strategies and roadmaps

Software and AI as a medical device change programme

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Topic:

Assurance and testing Safety

Domain:

Healthcare and medicine - Medical devices

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The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical…

Last Updated: 19 Dec 2022

Official policy proposals and consultations

Consultation on the future regulation of medical devices in the United Kingdom

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Topic:

Assurance and testing Explainability and transparency Safety

Domain:

Healthcare and medicine - Medical devices

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Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory…

Last Updated: 15 Dec 2022

Frameworks and principles

Good machine learning practice for medical device development: guiding principles

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Topic:

Accuracy and performance Data Ethical considerations Good practice for development and use Safety System quality

Domain:

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)…

Last Updated: 19 Dec 2022