Frameworks and principles
Medical devices
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…
ISO/IEC CD 8663
Information technology – Brain-computer Interfaces – Vocabulary
This document specifies the terms and definitions commonly used in the field of Brain-computer Interface (BCI), including basic concepts and…
Artificial Intelligence (AI) is quickly becoming a pervasive tool in the health care industry. This standard identifies the core requirements…
IEEE 2802-2022
Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the…
BS 34971/AAMI CR 34971
Application of ISO 14971 to machine learning in artificial intelligence. Guide
What is BS AAMI 34971 – Application of ISO 14971 to machine learning in artificial intelligence – Guide about? Artificial…
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
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…
Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
Research and analysis item
Recent advancements in AI – implications for medical device technology and certification
Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why…
Research and analysis item
The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
Research and analysis item
Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
