№ lp_1_2_61423
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This document outlines guidelines for AI-based medical devices, focusing on regulatory requirements to ensure compliance and patient safety in AI health solutions.
Year:
2020
Region / city:
Geneva
Topic:
AI-based medical devices
Document type:
Technical paper
Organization / institution:
International Telecommunication Union (ITU)
Author:
Luis Oala, Christian Johner, Pradeep Balachandran
Target audience:
AI solution developers/manufacturers
Period of validity:
Draft document
Approval date:
April 2020
Date of changes:
April 2020
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Organization:
International Telecommunication Union (ITU), Telecommunication Standardization Sector (ITU-T)
Focus Group:
ITU-T Focus Group on AI for Health (FG-AI4H)
Study Period:
2017–2020
Document Code:
FG-AI4H-J-039
Deliverable:
DEL2.2
Version:
0.2.0
Draft Date:
20-09-2020
Meeting:
E-meeting, 30 September – 2 October 2020
Source:
Editors
Editors:
Luis Oala; Christian Johner; Pradeep Balachandran
Contributors:
Alixandro Werneck Leite; Andrew Murchison; Anle Lin; Juliet Rumball-Smith; Pat Baird; Peter G. Goldschmidt; Shan Xu; Sven Piechottka; Zack Hornberger
Purpose:
Discussion
Type of Document:
Technical paper / Draft deliverable
Keywords:
Regulatory Checklist; Software-as-a-Medical Device; AI based Medical Devices
Scope:
Good machine learning practice guidelines for AI-based health solutions
Regulatory References:
IMDRF; FDA
Lifecycle Coverage:
Pre-market and post-market requirements for AI-based medical devices
Year:
2020
Region / City:
Rochester, MN
Topic:
Cybersecurity of medical and research devices
Document type:
Vendor packet
Organization / Institution:
Mayo Clinic
Author:
Mayo Clinic
Target audience:
Vendors, healthcare technology management teams
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / City:
Global
Topic:
Internet of Things, IoT Device Testing
Document Type:
Industry Specification
Organization / Institution:
GSMA
Author:
GSMA
Target Audience:
Mobile Network Operators, IoT Service Providers, IoT Device Makers, IoT Device Application Developers, Communication Module Vendors, Radio Baseband Chipset Vendors
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Description:
Industry specification document outlining test cases for IoT device compliance with GSMA IoT Device Connection Efficiency Guidelines, focusing on device behavior and network resource management.
Note:
Year
Document type:
Worksheet
Year:
2025
Region / city:
Global
Topic:
Internet of Things (IoT)
Document Type:
Industry Specification
Organization / Institution:
GSM Association
Author:
GSM Association
Target audience:
Mobile Network Operators, IoT Device Manufacturers, IoT Device Application Developers
Period of validity:
Ongoing
Approval date:
May 2025
Date of changes:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
COVID-19 treatment, lateral flow device tests
Document Type:
Service Specification
Organization / Institution:
NHS England
Author:
NHS England
Target Audience:
Pharmacy contractors, healthcare professionals
Period of Validity:
Ongoing, from 6 November 2023
Date of Approval:
May 2025
Date of Changes:
01 May 2025
Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
HDA Standard Pharmaceutical (Rx-only) Product and Medical Device Information Short Form Instructions
Note:
Year
Theme:
Pharmaceutical products, Medical devices
Document type:
Instructions, Form
Organization / Institution:
HDA
Target audience:
Distributors, Manufacturers, Supply chain professionals
Year:
XXXX
Region / City:
XXX
Theme:
Post-market Surveillance
Document Type:
Report
Organization:
XXX
Author:
XXX
Target Audience:
Regulatory Authorities, Healthcare Professionals
Period of Validity:
[start date] - [end date]
Approval Date:
YYYY-MM-DD
Revision Date:
YYYY-MM-DD
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
Year:
2020
Region / city:
Not specified
Theme:
Defense, Technology Development
Document Type:
Statement of Objectives
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Defense contractors, technology developers
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Note:
Year
Subject:
Contraception, Medical Procedure
Document Type:
Patient Information and Consent Form
Target Audience:
Patients, Healthcare Providers
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
Year:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021
Note:
Year
Topic:
Wastewater Regulation
Document Type:
Form
Year:
2026
Region / City:
Global
Topic:
Regulatory Compliance, Certification
Document Type:
Notification Form
Organization / Institution:
SGS
Author:
SGS
Target Audience:
Clients holding SGS certification
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Contextual Description:
A form for notifying SGS of any changes or regulatory actions affecting the validity or scope of certification for medical devices.
Year:
2021
Region / City:
West and Central Africa
Topic:
Electricity, Governance, Institutional Strengthening, Africa
Document Type:
Report
Organization:
European Union, African Union Commission
Author:
Dr. Dimitris Papastefanakis, Dr. William Gboney, Dr. George Kyriakarakos, Mr. Jian Bani
Target Audience:
Policy makers, energy sector professionals
Period of Validity:
2021-2040
Approval Date:
August 31, 2021
Date of Revisions:
N/A
Note:
Year