Defining AI Systems in Medical Device Regulations
TÜV SÜD
Impact of Incoming EHDS Regulation on the Healthcare Sector
Simmons & Simmons
Interplay of Medical Devices and AI from a Notified Body Standpoint
BSI
Recent advancements in AI – implications for medical device technology and certification
BSI
A definition of Artificial Intelligence: main capabilities and scientific disciplines
EU Commission
Assessment List for Trustworthy Artificial Intelligence (ALTAI) for self-assessment
EU Commission
European Accessibility Act
EU Commission
MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746
EU Commission
MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act
EU Commission
Artificial Intelligence Stakes a Claim on Medtech
BGE
The Future of AI-Enabled Health: Leading the Way
World Economic Forum
Usability Engineering for Medical Devices using Artificial Intelligence and Machine Learning Technology
Various
Machine Learning AI in Medical Devices
BSI
Total Product Lifecycle Considerations for Generative AI- Enabled Devices
FDA
Assessment Guide for Digital Health Technologies That Use Artificial Intelligence (AI)
AQuAS
The Impact Of Human-AI Interaction On Discrimination
EU Commission
Best Practices Guide for Medical Device Cybersecurity
Health Sciences Authority
The EU AI Act Meets MDR
BSI
The Regulation Of Artificial Intelligence As A Medical Device: Government Response To The Regulatory Horizons Council
Department for Science Innovation and Technology
Guidelines on Prohibited Artificial Intelligence (AI) Practices
EU Commission
Questionnaire “Cybersecurity for Medical Devices – Audit“
IG-NB
Questionnaire “Cybersecurity for Medical Devices – Technical Documentation”
IG-NB
Questionnaire: Artificial Intelligence (AI) in medical devices
Team NB
Guideline for AI-based medical devices and IVD
Johner Institute
Guideline for AI for medical products
Johner Institute
EU AI Act Compliance Checker
Future of Life Institute
Software and artificial intelligence (AI) as a medical device
MHRA
European AI Office
EU Commission
How to trust AI enabled Medical Devices. An overview covering technical and clinical aspects.
TÜV SÜD
Artificial intelligence and Machine Learning in Medical Devices
TÜV SÜD
Global Approach to Software as a Medical Device
FDA
What are examples of Software as a Medical Device?
FDA
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
FDA
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
FDA
Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
FDA
EU AI Act
European Parliament and the Council
AI Airlock: The Regulatory Sandbox for AIaMD
MHRA
Characterization Considerations for Medical Device Software and Software-Specific Risk
IMDRF
Good machine learning practice for medical device development: Guiding principles
IMDRF
South Africa’s Artificial Intelligence Planning
Department of Communications and Digital Technologies
Artificial Intelligence in Africa: Challenges and Opportunities
Use Case Brief: Artificial Intelligence in Health – A Focus on Africa
CIPIT
Artificial Intelligence in Healthcare: Proposals for Policy Development in South Africa
Naidoo et al.
Regulatory Considerations on Artificial Intelligence for Health
World Health Organization
Mapping the Regulatory Landscape of AI in Healthcare in Africa
Townsend et al.
State of AI in Healthcare in Sub-Saharan Africa
Ceimia
Seizing the Opportunity: The Future of AI in Latin America
The Economist Impact
Center of Artificial Intelligence and Health for Latin America and the Caribbean: Document
AI4Caribbean
Advances in the Use of Artificial Intelligence in Latin American Medical Education
Domínguez et al.
Policy and Regulatory Recommendations for Digital Health in Latin America and the Caribbean
Americas Business Dialogue
Regulatory Ecosystem for Artificial Intelligence in the Health Sector
Regulatory Ecosystem Document
Regulatory Mapping on Artificial Intelligence in Latin America
Access Now
The Artificial Intelligence and Data Act (AIDA) – Companion document
Health Canada
Transparency for machine learning-enabled medical devices: Guiding principles
Health Canada
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
Health Canada
Good Machine Learning Practice for Medical Device Development: Guiding Principles
Health Canada
Pre-market guidance for machine learning-enabled medical devices
Health Canada
FDA Digital Health and Artificial Intelligence Glossary – Educational Resource
FDA
Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products (March 2023)
FDA
Good Machine Learning Practice for Medical Device Development: Guiding Principles
FDA
Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan
FDA
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback
FDA
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
FDA
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
FDA
The database is updated weekly. Last updated: 23 June 2025.
Content strategist: Flavio Angei
