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…
Research and analysis item
The Bank of England and the Financial Conduct Authority launched the Artificial Intelligence Public-Private Forum (AIPPF) on 12 October 2020.
Artificial intelligence is everywhere and affects everyone – from deciding what content people see on their social media feeds to…
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
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
Regulation and official guidance
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
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices B
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices A
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Project to update CTA 2107 clarifying existing language. To include: – Clarifying the use of the term “validation”; – Relocating…
Artificial Intelligence (AI) is quickly becoming a pervasive tool in the health care industry. This standard identifies the core requirements…
The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the…
