Library | Regulatory

Position Paper - Team NB - Medical Device Lifetime

Research Document - Artificial Intelligence in Healthcare – Applications, risks, and ethical and societal impacts

White Paper - MedTech EU - Clinical Evidence Requirements under the EU Diagnostics Regulation (IVDR)

Report - Cybersecurity of Artificial Intelligence in the AI Act

Website - General Data Protection Regulation (GDPR) Compliance Guidelines

Implementing Decision - Commission Implementing Decision (EU) 2021/1182 on the harmonised standards for medical devices of Regulation (EU) 2017/745 (MDR)

Implementing Decision - Commission Implementing Decision - (EU) 2021/1195 on the harmonised standards for in vitro diagnostic medical devices of Regulation (EU) 2017/746 (IVDR)

Implementing Decision - Commission Implementing Decision - (EU) 2022/757 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices

Implementing Decision - Commission Implementing Decision (EU) 2022/6 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems

Position Paper - Digital Health Regulation in Asia-Pacific: Overview and Best Practices

Regulation - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR)

Regulation - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)

Regulation - Proposal for a Regulation Laying down Harmonized Rules on Artificial Intelligence (AI Act)

Notice - Commission notice The ‘Blue Guide’ on the implementation of EU product rules 2022

Position Paper - Language Requirements for Texts Displayed On IVD Screens and Software

Guidance - Classification of medical devices (MDCG 2021-24)

Guidance - Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (MDCG 2020-1)

Guidance - UDI Assignment to Medical Device Software (MDCG 2018-5)

Guidance - Cybersecurity for Medical Devices (MDCG 2019-16)

Information Sheet - Medical Device Software

Guidance - Guide for App Developers, Manufacturers and Distributors

Guidance - Medical Device Cyber Security Guidance for Industry

Webinar - TGA - Regulation of Software As a Medical Device

Webinar - TGA - The Role of the TGA in Digital Health

Website - ANDHealth - Australia's National Digital Health Initiative

Guidance - TGA - Is My Software Regulated?

White Paper - Introduction to Standards for Artificial Intelligence

Form - TGA - Notification Form: Clinical decision support software exemption - Therapeutic Goods Administration - Citizen Space

Guidance - TGA - Exemption for Certain Clinical Decision Support Software

Guidance - TGA - Clinical Decision Support Software – Scope and Examples

Guidance - TGA - Clinical Evidence Guidelines for Medical Devices

Supporting Document - TGA - Medical Device Cyber Security – Consumer Information

White Paper - Realising the value of digital health in Asia and the Pacific

Guidance - TGA - Medical Device Cyber Security Information For Users – Consumers, health professionals, small business operators and large scale service providers

Guidance - TGA - Digital tools and medical devices – Guidance for the mental health sector

Factsheet – TGA - Digital Mental Health: Software Based Medical Devices

Guidance - TGA - Classification of Active Medical Devices (including software-based medical devices)

Guidance - TGA - Examples of Regulated and Unregulated Software (excluded) Software Based Medical Devices

Guidance - TGA - Regulatory Changes for Software Based Medical Devices

Website - TGA - Software-based medical devices FAQs

Guidance - TGA - How the TGA Regulates Software Based Medical Devices

Standard - IEC/TR - IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Standard - IEC - IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices

Guidance - IMDRF - Principles of Labeling for Medical Devices and IVD Medical Devices

Standard - ISO - ISO 18113-1:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

Standard - ISO - ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Standard - ISO - ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer

White Paper - Digitalization of China Medical Device Industry

Publication - WHO - Global strategy on digital health 2020-2025

Guidance - IMDRF - Software as a Medical Device (SaMD): Key Definitions (SaMD WG/N10)

Guidance - IMDRF - Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (SaMD WG/N12)

Guidance - IMDRF - Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Guidance - IMDRF - Principles and Practices for the Cybersecurity of Legacy Medical Devices

Guidance - IMDRF - Principles and Practices for Medical Device Cybersecurity

Guidance - IMDRF - Software as a Medical Device (SaMD): Clinical Evaluation (SaMD WG/N41)

Standard - ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice

Standard - ISO 20916:2019 - In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

Guidance - IMDRF - Machine Learning-enabled Medical Devices: Key Terms and Definitions (AIMD WG/N67)

Publication - WHO - Generating Evidence for Artificial Intelligence Based Medical Devices: A Framework for Training Validation and Evaluation

Guidance - IMDRF - Machine Learning-enabled Medical Devices: Key Terms and Definitions (IMDRF/AIMD WG/N67)

White Paper - BSI/AAMI - Machine Learning AI in Medical Devices

Guidance - MHRA - Medical devices: software applications (apps)

Website - MHRA - Medical devices regulations: compliance and enforcement

White Paper - MHRA - Impact of AI on the regulation of medical products

Standard - ISO - ISO/TR 20416:2020 - Medical devices — Post-market surveillance for manufacturers

Standard - IEC - IEC 62304:2006 - Medical device software — Software life cycle processes

Standard - AAMI - AAMI TIR45 – Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software

Standard - ISO - ISO/TS 82304-2:2021 - Health software — Part 2: Health and wellness apps — Quality and reliability

Standard - ISO - ISO 15189:2022 - Medical laboratories — Requirements for quality and competence

Standard - ISO - ISO 13485 - Quality management for medical devices

Standard - ISO - ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes

Standard - ISO - ISO 9001:2015 - Quality management systems

Guidance - IMDRF - Software as a Medical Device (SaMD): Application of Quality Management System (QMS) (SaMD WG/N23)

Standard - TIR - AAMI TIR57 – Principles For Medical Device Security – Risk Management

Standard - TIR - AAMI TIR97:2019 – Principles for medical device security – Postmarket risk management for device manufacturers

Standard - IEC/TR - IEC/TR 80002-3 — Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Standard - IEC/TR - IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

Standard - ISO - ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971

Standard - ISO - ISO 14971:2019 - Medical devices — Application of risk management to medical devices

Standard - IEC - IEC 60601-1-12:2014 - Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the

Standard - IEC - IEC 60601-1-11:2015 - Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the

Standard - ISO - ISO/TR 17791:2013 - Health informatics — Guidance on standards for enabling safety in health software

Standard - IEC - IEC 82304-1:2016 - Health software — Part 1: General requirements for product safety

Standard - ISO- ISO/IEC 27001:2022 - Information security, cybersecurity and privacy protection — Information security management systems — Requirements

Standard - ISO - ISO/IEC 27000:2018 - Information technology — Security techniques — Information security management systems — Overview and vocabulary

Regulation - Collegiate Board Resolution – RDC n°. 657/2022 about Software as a Medical Device (SaMD

Guidance - HC - Pre-market guidance for machine learning-enabled medical devices - Canada.ca

Guidance - HC - Software as a Medical Device (SaMD): Definition and Classification

Guidance - FDA - Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission | FDA

Guidance - FDA - Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

Guidance - FDA - Medical Device Accessories - Describing Accessories and Classification Pathways

Supporting Document - FDA - Using Artificial Intelligence & Machine Learning in the Development of Drug and Biological Products

Supporting Document - FDA - Artificial Intelligence in Drug Manufacturing

Website - FDA - Artificial Intelligence and Machine Learning (AI/ML) for Drug Development

Guidance - FDA - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

Guidance - FDA - Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Guidance - FDA - Software as a Medical Device (SAMD): Clinical Evaluation

Guidance - FDA - Clinical Decision Support Software | FDA

Guidance - FDA - Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act

Supporting Document - FDA - Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)

Website - FDA - Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"

Website - NIST - Cybersecurity Framework

Website - FDA - Cybersecurity

Factsheet - FDA - The FDA's Role in Medical Device Cybersecurity

Discussion Paper - FDA - Best Practices for Communicating Cybersecurity Vulnerabilities to Patients

Guidance - FDA - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

Guidance - FDA - Postmarket Management of Cybersecurity in Medical Devices

Video - FDA - Cybersecurity Awareness for Connected Medical Devices

Document - MITRE - Playbook for Threat Modeling Medical Devices

Guidance - FDA - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA

Guidance - FDA - Policy for Device Software Functions and Mobile Medical Applications

Guidance - FDA - Multiple Function Device Products: Policy and Considerations

Guidance - FDA - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

Guidance - FDA - Device Software Functions Including Mobile Medical Applications

Website - FDA - Digital Health Terms

Guidance - FDA - Applying Human Factors and Usability Engineering to Medical Devices

Guidance - FDA - Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

Guidance - FDA - Medical Device Interoperability

Guidance - FDA - Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals | FDA

FDA has developed this guidance document to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form.

Guidance - FDA - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

Guidance - FDA - Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

Guidance - FDA - General Wellness: Policy for Low Risk Devices

Guidance - FDA - Off-The-Shelf Software Use in Medical Devices

Website - FDA - Digital Health Software Precertification (Pre-Cert) Pilot Program

Guidance - FDA - Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only | FDA

Website - FDA - Software as a Medical Device (SaMD)

Guidance - FDA - Content of Premarket Submissions for Device Software Functions

Guidance - FDA - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Guidance - HealthIT.gov - Telemedicine and Telehealth

Website - FDA - Wireless Medical Devices

Website - FDA - Artificial Intelligence and Machine Learning in Software as a Medical Device

Website - FDA - Medical Device Interoperability

Guidance - IMDRF - Good Machine Learning Practice for Medical Device Development - Guiding Principles

White Paper - BSI - Medical Device Lifetime - Addressing the Lifetime Requirements of the MDR (EU) 2017/745

Guidance - TGA - Regulatory Changes for Software based Medical Devices