Frameworks and principles
Healthcare and medicine
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…
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ISO 13482:2014
BS EN ISO 13482:2014
Robots and robotic devices. Safety requirements for personal care robots
What is this standard about? It supplies the latest guidelines and specifications to ensure the safe design and use of…
ISO/TS 22287:2019
PD ISO/TS 22287:2019
Health informatics. Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)
What is ISO/TS 22287 – Terminology services in healthcare about? The use of terminology service helps in understanding and sharing…
PAS 277:2015 from BSI
Health and wellness apps. Quality criteria across the life cycle. Code of practice
What is PAS 277 – Health and wellness apps – Code of practise with quality standards for all stages of…
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
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…
Strategies and roadmaps
Medical technology strategy
Building on the broader Life Sciences Vision, this high-level document reviews the current UK medtech landscape and identifies and prioritises…
Regulation and official guidance
