The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote global public health by providing guidance and recommendations to regulatory authorities.
Since its formation in 2011, the organization has released over forty guidance documents that serve as a benchmark for the medical device industry. These documents cover a wide range of topics, including quality management systems, regulatory assessments, software as a medical device (SaMD), unique device identification (UDI), and many more, all of them providing crucial information on regulatory requirements, standards, and best practices.
In this blog, we will be highlighting the top 40 IMDRF technical documents that every medical device professional should be aware of. Inside you’ll find descriptions of each technical document, its contents, who it’s intended for, and its authoring group. You’ll also be provided with publication dates and links to the relevant document download.
Whether you're a quality manager, regulatory affairs specialist, or an auditor, knowing and understanding these documents are essential for staying up-to-date with the latest industry standards and compliance requirements.
Table of contents
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IMDRF Code
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Technical Document
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IMDRF Standards Liaison Program Framework |
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Machine Learning-enabled Medical Devices: Key Terms and Definitions |
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Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form |
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Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews |
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Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews |
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Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews |
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Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews |
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Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes |
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Principles and Practices for Medical Device Cybersecurity |
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Definitions for Personalized Medical Devices |
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Personalized Medical Devices - Regulatory Pathways |
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Clinical Investigation |
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Clinical Evaluation |
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Post-Market Clinical Follow-Up Studies |
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Clinical Evidence - Key Definitions and Concepts |
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Principles of Labelling for Medical Devices and IVD Medical Devices |
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Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) |
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In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) |
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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification |
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Assembly and Technical Guide for IMDRF Table of Contents Submissions |
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Optimizing Standards for Regulatory Use |
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Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices |
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Competence, Training, and Conduct Requirements for Regulatory Reviewers |
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Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making |
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Methodological Principles in the Use of International Medical Device Registry Data |
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Principles of International System of Registries Linked to Other Data Sources and Tools |
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Common Data Elements for Medical Device Identification |
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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition |
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Medical Device Regulatory Audit Reports |
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MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization |
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Competence and Training Requirements for Auditing Organizations |
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Regulatory Authority Assessor Competence and Training Requirements |
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Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations |
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Software as a Medical Device (SaMD): Application of Quality Management System |
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Software as a Medical Device (SaMD): Key Definitions |
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Software as a Medical Device (SaMD): Clinical Evaluation |
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Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations |
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UDI Guidance: Unique Device Identification (UDI) of Medical Devices |
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Unique Device Identification system (UDI system) Application Guide |
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Medical Device Regulatory Review Report: Guidance Regarding Information to be Included |
IMDRF/Standards WG/N72
IMDRF Standards Liaison Program Framework
What's in this guidance document? This document outlines the IMDRF Standards Liaison Program, a framework to establish and maintain the responsibilities associated with liaison relationships to regulatory authorities and standards development organizations. It contains principles, objectives, and guidelines, as well as definitions for roles and responsibilities of Liaison Officer and IMDRF Management Committee.
What's in this guidance document? This document outlines the IMDRF Standards Liaison Program, a framework to establish and maintain the responsibilities associated with liaison relationships to regulatory authorities and standards development organizations. It contains principles, objectives, and guidelines, as well as definitions for roles and responsibilities of Liaison Officer and IMDRF Management Committee.
Who is this guidance for? Though the framework refers to the IMDRF’s liaison roles within ISO and IEC Technical Committees, the concepts within this document are relevant to anyone interested in the improvement of standards development or the push for global harmonization.
Authoring group: Standards Working Group
Publication date: May 13, 2022
Link to guidance: IMDRF/Standards WG/N72
IMDRF/AIMD WG/N67
Machine Learning-enabled Medical Devices: Key Terms and Definitions
What's in this guidance document? This document establishes relevant terms and definitions relating to Machine Learning-enabled Medical Devices (MLMD) as a way to promote consistency, support global harmonization efforts, and provide a foundation for the development of future guidelines related to MLMD.
What's in this guidance document? This document establishes relevant terms and definitions relating to Machine Learning-enabled Medical Devices (MLMD) as a way to promote consistency, support global harmonization efforts, and provide a foundation for the development of future guidelines related to MLMD.
Who is this guidance for? Anyone involved in the development, distribution, or regulation of MLMD.
Authoring group: Artificial Intelligence Medical Devices (AIMD) Working Group
Publication date: May 9, 2022
Link to guidance: IMDRF/AIMD WG/N67
IMDRF/NCAR WG/N14
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
What's in this guidance document? This document is a revision of GHTF SG2 N57 Medical Devices Post Market Surveillance: Content of Field Safety Notices, and contains guidance on a two-way communication system involving confidential information for serious public health issues, as well as the procedures and forms for exchange of reports between IMDRF members.
Who is this guidance for? Anyone involved in the National Competent Authority report (NCAR) Exchange Program, a working group used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their jurisdictions but have not yet resulted in recalls or Field Safety Corrective Actions (FSCAs).
Authoring group: National Competent Authority Report Working Group
Publication date: May 5, 2022
Link to guidance: IMDRF/NCAR WG/N14
IMDRF/GRRP WG/N59
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
What's in this guidance document? The document provides guidelines and requirements for regulatory authorities to recognize Conformity Assessment Bodies (CAB) that conduct medical device regulatory reviews. The document covers the recognition process for CABs, including the assessment of their technical competence, impartiality, and integrity. It also includes requirements for the management system and quality management system of the conformity assessment bodies, as well as the assessment of their performance.
What's in this guidance document? The document provides guidelines and requirements for regulatory authorities to recognize Conformity Assessment Bodies (CAB) that conduct medical device regulatory reviews. The document covers the recognition process for CABs, including the assessment of their technical competence, impartiality, and integrity. It also includes requirements for the management system and quality management system of the conformity assessment bodies, as well as the assessment of their performance.
Who is this guidance for? It is intended for regulatory authorities that are responsible for recognizing conformity assessment bodies that conduct medical device regulatory reviews. The document is also intended for CABs that wish to be recognized by regulatory authorities to conduct medical device regulatory reviews.
Authoring group: Global Regulatory Policy Working Group
Publication date: April 20, 2020
Link to guidance: IMDRF/GRRP WG/N59
IMDRF/GRRP WG/N66
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
What's in this guidance document? This document is part of a series intended to improve the efficiency and effectiveness of the review process for marketing of medical devices. It includes explanations for the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognized Regulatory Authority’s assessment of a Conformity Assessment Body (CAB).
Who is this guidance for? Anyone involved or interested in the process for conducting marketing review(s) of medical devices and IVD medical devices, such as device developers or individuals performing regulatory reviews.
What's in this guidance document? This document is part of a series intended to improve the efficiency and effectiveness of the review process for marketing of medical devices. It includes explanations for the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognized Regulatory Authority’s assessment of a Conformity Assessment Body (CAB).
Who is this guidance for? Anyone involved or interested in the process for conducting marketing review(s) of medical devices and IVD medical devices, such as device developers or individuals performing regulatory reviews.
Authoring group: IMDRF Good Regulatory Review Practices Working Group
Publication date: July 1, 2021
Link to guidance: IMDRF/GRRP WG/N66
IMDRF/GRRP WG/N63
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
What's in this guidance document? The document provides guidance on the competence and training requirements for regulatory authority assessors of conformity assessment bodies conducting medical device regulatory reviews. It covers the knowledge, skills, and experience required of assessors in order to ensure they are able to competently evaluate and assess the conformity of medical devices to regulatory requirements.
What's in this guidance document? The document provides guidance on the competence and training requirements for regulatory authority assessors of conformity assessment bodies conducting medical device regulatory reviews. It covers the knowledge, skills, and experience required of assessors in order to ensure they are able to competently evaluate and assess the conformity of medical devices to regulatory requirements.
Who is this guidance for? The guidance document is for regulatory authorities, conformity assessment bodies, and other stakeholders involved in the assessment and regulation of medical devices. It is intended to provide a common understanding and consistent application of the principles of competence and training for assessors conducting medical device regulatory reviews.
Authoring group: IMDRF GRRP Working Group
Publication date: September 25, 2020
Link to guidance: IMDRF/GRRP WG/N63
IMDRF/GRRP WG/N61
Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
What's in this guidance document? This document contains guidance on the method for assessing and recognizing Conformity Assessment Bodies (CAB) that conduct medical device regulatory reviews.
Who is this guidance for? This document is intended for regulatory authorities, CABs, and other stakeholders involved in the medical device regulatory process.
Authoring group: IMDRF GRRP Working Group
Publication date: September 25, 2020
Link to guidance: IMDRF/GRRP WG/N61
IMDRF/AE WG/N43
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
What's in this guidance document? This guidance document provides a list of terms and definitions related to the categorization of adverse event reporting (AER) for medical devices. It also includes codes and terminology that are used in AER, as well as an explanation of the principles behind the categorization of AER.
Who is this guidance for? This guidance document is intended for use by manufacturers and other stakeholders involved in the reporting, analysis, and assessment of adverse events associated with medical devices. It is also intended to be used by regulatory authorities and other organizations involved in the oversight of medical device safety. The document is intended to be used in conjunction with other IMDRF guidance documents related to AER, such as the IMDRF Adverse Event Case Report Form and the IMDRF AER Categorization Algorithm.
Authoring group: International Medical Device Regulators Forum (IMDRF) Adverse Event Working Group (AE WG)
Publication date: April 20, 2020
Link to guidance: IMDRF/AE WG/N43
IMDRF/CYBER WG/N60
Principles and Practices for Medical Device Cybersecurity
What's in this guidance document? This document outlines principles and practices for ensuring the cybersecurity of medical devices. It covers a range of topics related to medical device cybersecurity, including risk management, security controls, incident response, and post-market surveillance.
Who is this guidance for? The document is intended to provide guidance for manufacturers, regulators, healthcare providers, and other stakeholders involved in the development, deployment, and use of medical devices.
Authoring group: Medical Device Cybersecurity Working Group
Publication date: April 20, 2020
Link to guidance: IMDRF/CYBER WG/N60
IMDRF/PMD WG/N49
Definitions for Personalized Medical Devices
What's in this guidance document? This document provides definitions to identify and describe different categories of devices that are produced for the use of a particular individual, and also to define some other terms that are relevant to defining these types of devices.
What's in this guidance document? This document provides definitions to identify and describe different categories of devices that are produced for the use of a particular individual, and also to define some other terms that are relevant to defining these types of devices.
Who is this guidance for? It is intended for anyone involved in the development or regulatory review of personalized medical devices.
Authoring group: IMDRF Personalized Medical Devices
Publication date: November 7, 2018
Link to guidance: IMDRF/PMD WG/N49
IMDRF/PMD WG/N58
Personalized Medical Devices - Regulatory Pathways
What's in this guidance document? This document provides information on the regulatory pathways for personalized medical devices (PMDs). These devices are typically manufactured using advanced technologies such as 3D printing, gene editing, and artificial intelligence. The guidance document provides information on how to classify PMDs, how to evaluate their safety and performance, and how to navigate the regulatory process for getting them to market.
Who is this guidance for? Anyone involved in the development, marketing, or regulatory review of personalized medical devices.
Authoring group: IMDRF Personalized Medical Devices
Publication date: April 20, 2020
Link to guidance: IMDRF/PMD WG/N58
IMDRF MDCE WG/N57
Clinical Investigation
What's in this guidance document? This document provides information on the conduct of clinical investigations for medical devices. It includes information on the design, conduct, reporting, and management of clinical investigations, as well as the ethical principles and regulatory requirements that apply to them.
Who is this guidance for? This guidance document is intended for manufacturers and sponsors of medical devices, as well as regulatory authorities and other stakeholders involved in the evaluation and approval of medical devices.
Authoring group: : Medical Device Clinical Evaluation Working Group
Publication date: October 10, 2019
Link to guidance: IMDRF MDCE WG/N57
IMDRF MDCE WG/N56
Clinical Evaluation
What's in this guidance document? This document provides information on the evaluation of clinical data for medical devices. It includes information on the principles and methods used to evaluate clinical data, as well as the regulatory requirements that apply to clinical evaluations.
Who is this guidance for? This guidance document is intended for manufacturers and sponsors of medical devices, as well as regulatory authorities and other stakeholders involved in the evaluation and approval of medical devices.
Authoring group: Medical Device Clinical Evaluation Working Group
Publication date: October 10, 2019
Link to guidance: IMDRF MDCE WG/N56
IMDRF/MDCE WG/N65
Post-Market Clinical Follow-Up Studies
What's in this guidance document? This document provides guidance on the design, implementation, and appropriate use of Post-Market Clinical Follow-Up (PMCF) studies. It includes details on the requirements, objectives, design, and implementation of PMCF studies.
What's in this guidance document? This document provides guidance on the design, implementation, and appropriate use of Post-Market Clinical Follow-Up (PMCF) studies. It includes details on the requirements, objectives, design, and implementation of PMCF studies.
Who is this guidance for? Anyone involved in the post-marketing of medical devices, whether that means device developers, clinical researchers, quality professionals, or regulatory authorities auditing post-market activities.
Authoring group: Medical Device Clinical Evaluation Working Group
Publication date: May 20, 2021
Link to guidance: IMDRF/MDCE WG/N65
IMDRF MDCE WG/N55
Clinical Evidence - Key Definitions and Concepts
What's in this guidance document? This document provides key definitions and concepts related to clinical evidence for medical devices. It also includes information on the types of clinical evidence and the criteria used to evaluate clinical evidence.
Who is this guidance for? This guidance document is intended for manufacturers and sponsors of medical devices, as well as regulatory authorities and other stakeholders involved in the evaluation and approval of medical devices.
Authoring group: Medical Device Clinical Evaluation Working Group
Publication date: October 10, 2019
Link to guidance: IMDRF MDCE WG/N55
IMDRF/GRRP WG/N52
Principles of Labelling for Medical Devices and IVD Medical Devices
What's in this guidance document? This document outlines the principles of labelling for medical devices and in-vitro diagnostic medical devices. It includes information on the content and format of labels, as well as the regulatory requirements that apply to labelling.
What's in this guidance document? This document outlines the principles of labelling for medical devices and in-vitro diagnostic medical devices. It includes information on the content and format of labels, as well as the regulatory requirements that apply to labelling.
Who is this guidance for? The document is intended for manufacturers of medical devices and IVDs, as well as regulatory agencies, or anyone else involved in the regulatory review of medical device labelling.
Authoring group: IMDRF Good Regulatory Review Practices
Publication date: March 21, 2019
Link to guidance: IMDRF/GRRP WG/N52
IMDRF/RPS WG/N9
Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
What's in this guidance document? This document provides an internationally harmonized, modular, format for use when filing medical device submissions to regulatory authorities for market authorization.
What's in this guidance document? This document provides an internationally harmonized, modular, format for use when filing medical device submissions to regulatory authorities for market authorization.
Who is this guidance for? It is intended for anyone preparing or reviewing medical devices submissions.
Authoring group: Regulated Product Submissions Table of Contents Working Group
Publication date: March 21, 2019
IMDRF/RPS WG/N13
In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
What's in this guidance document? This document provides ToC formatting guidance for in-vitro diagnostics medical device (IVD) market authorization submissions. Similarly to IMDRF/RPS WG/N9, the document contains recommendations for both the layout of ToC documents and the content that should be included.
Who is this guidance for? It is an industry-wide applicable document, specifically for those involved with the in-vitro diagnostic medical device (IVD) market authorization submission process.
Authoring group: Regulated Product Submissions Table of Contents Working Group
Publication date: March 21, 2019
Link to guidance : IMDRF/RPS WG/N13
IMDRF/IVD WG/N64
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
What's in this guidance document? The document provides guidance on the principles of classification for In Vitro Diagnostic (IVD) Medical Devices. It covers the criteria and decision-making process for determining the classification of IVD devices, including the use of performance characteristics, intended use, and the level of risk associated with the device.
Who is this guidance for? This guidance document is for manufacturers, regulatory authorities, and other stakeholders involved in the classification and regulation of IVD medical devices. It is intended to provide a common understanding and consistent application of the principles of classification for IVD devices
Authoring group: Medical Device Clinical Evaluation Working Group
Publication date: January 21, 2021
Link to guidance: IMDRF/IVD WG/N64
IMDRF/RPS WG/N27
Assembly and Technical Guide for IMDRF Table of Contents Submissions
What's in this guidance document? This document provides specific guidelines for building a Table of Content (ToC) submission including harmonized guidelines for the acceptable folder structure and file format. The guidance document includes a template for both IVD and non-IVD devices.
Who is this guidance for? This industry-wide technical document is intended for anyone involved in the submission process for medical devices, particularly for individuals who are interested in the push for global harmonization of standards.
Authoring group: Regulated Product Submissions Table of Contents WG
Publication date: March 20, 2019
Link to guidance: IMDRF/RPS WG/N27
IMDRF/Standards WG/N5
Optimizing Standards for Regulatory Use
What's in this guidance document? This document provides strong recommendations to regulatory authorities, standardization development organizations, and other relevant stakeholders for improving standards for use in medical device regulatory activities. It includes suggestions for the development of standards, optimization and harmonization of standards, and the communication of regulatory authorities and other stakeholders.
What's in this guidance document? This document provides strong recommendations to regulatory authorities, standardization development organizations, and other relevant stakeholders for improving standards for use in medical device regulatory activities. It includes suggestions for the development of standards, optimization and harmonization of standards, and the communication of regulatory authorities and other stakeholders.
Who is this guidance for? This guidance is directed primarily at all those who participate directly in the standards development process, as well as all individuals interested in the application of standards to support regulatory frameworks.
Authoring group: IMDRF Standards Working Group
Publication date: November 12, 2018
Link to guidance: IMDRF/Standards WG/N5
IMDRF/GRRP WG/N47
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
What's in this guidance document? This document provides globally harmonized guidance to follow in the design and manufacturing of medical devices in order to ensure that they are safe and perform as intended. It includes essential definitions, guidelines, and principles to be followed by any medical device manufacturer.
What's in this guidance document? This document provides globally harmonized guidance to follow in the design and manufacturing of medical devices in order to ensure that they are safe and perform as intended. It includes essential definitions, guidelines, and principles to be followed by any medical device manufacturer.
Who is this guidance for? It is intended for use by regulatory authorities, conformity assessment bodies, industry and other stakeholders involved in establishing an economic and effective approach to the control of medical devices in the interest of public health.
Authoring group: IMDRF Good Regulatory Review Practices Group
Publication date: November 7, 2018
Link to guidance: IMDRF/GRRP WG/N47
IMDRF/GRRP WG/N40
Competence, Training, and Conduct Requirements for Regulatory Reviewers
What's in this guidance document? This document provides guidance on the requirements for regulatory reviewers involved in the review and assessment of medical devices. The document covers areas such as education and training, as well as the responsibilities of regulatory reviewers.
Who is this guidance for? This document is intended for regulatory authorities, regulatory review bodies, and relevant stakeholders in the medical device industry.
Authoring group: IMDRF Good Regulatory Review Practices
Publication date: March 16, 2017
Link to guidance: IMDRF/GRRP WG/N40
IMDRF/Registry WG/N46
Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making
What's in this guidance document? This document identifies key processes and features to be considered in assessing the usability of registry data for regulatory purposes.
Who is this guidance for? It is intended for registry organizations that want their data to be considered in regulatory decision-making.
Authoring group: Patient Registries Working Group
Publication date: March 27, 2018
Link to guidance: IMDRF/Registry WG/N46
IMDRF/Registry WG/N42
Methodological Principles in the Use of International Medical Device Registry Data
What's in this guidance document? The document provides guidance on the principles and methodology for using international medical device registry data in regulatory decision-making. It covers topics such as data quality, data collection, data privacy, and data sharing. The aim of the document is to ensure that medical device registry data is used in a consistent and transparent manner by regulatory authorities globally.
Who is this guidance for? This document is intended for regulatory authorities, medical device manufacturers, healthcare providers, and other stakeholders involved in the use of medical device registry data.
Authoring group: IMDRF Registry Working Group
Publication date: March 16, 2017
Link to guidance: IMDRF/Registry WG/N42
IMDRF/Registry WG/N33
Principles of International System of Registries Linked to Other Data Sources and Tools
What's in this guidance document? The document provides guidance on the principles and considerations for linking international medical device registry data with other data sources and tools. It covers topics such as data sharing, data privacy, data security, and data interoperability. The aim of the document is to ensure that medical device registry data is linked effectively with other data sources and tools in a manner that enhances its value and use.
Who is this guidance for? This document is intended for regulatory authorities, medical device manufacturers, healthcare providers, and other stakeholders involved in the linking of medical device registry data with other data sources and tools.
Authoring group: IMDRF Registry Working Group
Publication date: September 30, 2016
Link to guidance: IMDRF/Registry WG/N33
IMDRF/RPS WG/N19
Common Data Elements for Medical Device Identification
What's in this guidance document? This document outlines the common data elements for medical device identification that may be used through regulatory activities or processes, including the future possibility of electronic regulatory submission of device identification information.
Who is this guidance for? This document suggests a harmonized standard of tracking pre-market devices at the point of its initial regulatory submission. As such, it is intended for medical device manufacturers and regulatory authorities around the world.
Authoring group: IMDRF RPS Working Group
Publication date: March 24, 2016
IMDRF/MDSAP WG/N3
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
What's in this guidance document? The document provides guidance on the requirements that medical device auditing organizations must meet in order to be recognized by regulatory authorities for the Medical Device Single Audit Program (MDSAP). It covers topics such as organizational structure, personnel, policies and procedures, and quality management systems.
Who is this guidance for? This document is intended for medical device auditing organizations and regulatory authorities involved in the recognition of medical device auditing organizations for the MDSAP.
Authoring group: IMDRF MDSAP Working Group
Publication date: March 24, 2016
Link to guidance: IMDRF/MDSAP WG/N3
IMDRF/MDSAP WG/N24
Medical Device Regulatory Audit Reports
What's in this guidance document? This document is one of a series relating to MDSAP, and describes the format and content of MDSAP medical device regulatory audit reports submitted to Regulatory Authorities. It includes guidance on MDSAP-implementation, report language, sequencing of the report sections, and how audit report information should be utilized by regulatory authorities and manufacturers alike.
Who is this guidance for? It is intended for both medical device manufacturers and regulatory authorities, alike. It could also be beneficial for stakeholders in the improvement of regulatory audit programs worldwide.
Authoring group: IMDRF MDSAP Working Group
Publication date: October 2, 2015
Link to guidance: IMDRF/MDSAP WG/N24
IMDRF/MDSAP WG/N11
Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making
What's in this guidance document? This document is part of a series intended to implement the concept of a Medical Device Single Audit Program (MDSAP). It contains explanations for the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognized Competent Authority’s assessment of an Auditing Organization.
Who is this guidance for? Anyone involved or interested in AO and other individuals performing regulatory audits.
Authoring group: IMDRF MDSAP Working Group
Publication date: October 20, 2021
Link to guidance: IMDRF/MDSAP WG/N11
IMDRF/MDSAP WG/N4
Competence and Training Requirements for Auditing Organizations
What's in this guidance document? This document is part of a series intended to implement the concept of a Medical Device Single Audit Program (MDSAP). Specifically, this document is intended to specify competence and training requirements that shall be demonstrated and maintained by recognized Auditing Organizations for personnel involved in medical device regulatory audits and decision making.
Who is this guidance for? Anyone involved in the audits and decision making functions for assessing conformity with regulatory requirements for medical device manufacturers.
Authoring group: IMDRF MDSAP Working Group
Publication date: October 20, 2021
Link to guidance: IMDRF/MDSAP WG/N4
IMDRF/MDSAP WG/N6
Regulatory Authority Assessor Competence and Training Requirements
What's in this guidance document? This document is part of a series intended to implement the concept of a Medical Device Single Audit Program (MDSAP). Specifically, this document is intended to specify competence and training requirements that shall be demonstrated and maintained by recognized regulatory authorities for personnel involved in medical device regulatory audits and decision making.
What's in this guidance document? This document is part of a series intended to implement the concept of a Medical Device Single Audit Program (MDSAP). Specifically, this document is intended to specify competence and training requirements that shall be demonstrated and maintained by recognized regulatory authorities for personnel involved in medical device regulatory audits and decision making.
Who is this guidance for? Anyone involved in the audits and decision making functions for assessing conformity with regulatory requirements for medical device manufacturers.
Authoring group: IMDRF MDSAP Working Group
Publication date: October 21, 2021
Link to guidance: IMDRF/MDSAP WG/N6
IMDRF/MDSAP WG/N8
Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
What's in this guidance document? This document provides guidance to the Regulatory Authority assessors when conducting the assessment of an Auditing Organization according to the method presented in IMDRF/MDSAP WG/N5, chapter 6. It includes guidance on processes like management, use of external resources, analysis, auditing, and certification.
What's in this guidance document? This document provides guidance to the Regulatory Authority assessors when conducting the assessment of an Auditing Organization according to the method presented in IMDRF/MDSAP WG/N5, chapter 6. It includes guidance on processes like management, use of external resources, analysis, auditing, and certification.
Who is this guidance for? This document is intended for regulatory authorities involved in the recognition and monitoring of medical device auditing organizations.
Authoring group: IMDRF MDSAP Working Group
Publication date: October 2, 2015
Link to guidance: IMDRF/MDSAP WG/N8
IMDRF/SaMD WG/N23
Software as a Medical Device (SaMD): Application of Quality Management System
What's in this guidance document? The document provides guidance on the application of quality management systems to software as a medical device (SaMD). It covers topics such as software development, testing, and maintenance. The aim of the document is to ensure that SaMD products are developed and maintained in a manner that ensures their safety and effectiveness.
What's in this guidance document? The document provides guidance on the application of quality management systems to software as a medical device (SaMD). It covers topics such as software development, testing, and maintenance. The aim of the document is to ensure that SaMD products are developed and maintained in a manner that ensures their safety and effectiveness.
Who is this guidance for? This document is intended for software developers, medical device manufacturers, regulatory authorities, and other stakeholders involved in the development and maintenance of SaMD products.
Authoring group: SaMD Working Group
Publication date: October 2, 2015
Link to guidance: IMDRF/SaMD WG/N23
IMDRF/SaMD WG/N10
Software as a Medical Device (SaMD): Key Definitions
What's in this guidance document? The document provides definitions of key terms used in the context of software as a medical device (SaMD). It covers topics such as SaMD, medical device software, and medical device data systems. The aim of the document is to ensure that stakeholders have a common understanding of the terms used in the context of SaMD.
Who is this guidance for? This document is intended for software developers, medical device manufacturers, regulatory authorities, and other stakeholders involved in the development and classification of SaMD products.
Authoring group: SaMD Working Group
Publication date: December 18, 2013
Link to guidance: IMDRF/SaMD WG/N10
IMDRF/SaMD WG/N41
Software as a Medical Device (SaMD): Clinical Evaluation
What's in this guidance document? This document contains guidance on the clinical evaluation process for medical devices classified as software as a medical device (SaMD). It includes steps for the activities needed to clinically evaluate SaMD.
Who is this guidance for? This document is relevant to anyone involved in SaMD products. However, it does not contain key definitions for basic terms, so it is best utilized by those who are already familiar with this industry.
Authoring group: Software as a Medical Device Working Group
Publication date: September 21, 2017
Link to guidance: IMDRF/SaMD WG/N41
IMDRF/SaMD WG/N12
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
What's in this guidance document? The document provides guidance on a possible framework for the risk categorization of software as a medical device (SaMD) products. It covers topics such as the principles of risk categorization, the key elements of the risk categorization framework, and the considerations for each risk category. The aim of the document is to provide a consistent and transparent approach to the risk categorization of SaMD products.
Who is this guidance for? This document is intended for software developers, medical device manufacturers, regulatory authorities, and other stakeholders involved in the development and classification of SaMD products.
Authoring group: SaMD Working Group
Publication date: September 18, 2014
Link to guidance: IMDRF/SaMD WG/N12
IMDRF/UDI WG/N7
UDI Guidance: Unique Device Identification (UDI) of Medical Devices
What's in this guidance document? The document provides guidance on the implementation of unique device identification (UDI) systems for medical devices. It covers topics such as UDI data elements, labeling, and marking requirements.
Who is this guidance for? This document is intended for medical device manufacturers, regulatory authorities, and other stakeholders involved in the implementation of UDI systems for medical devices.
Authoring group: UDI Working Group
Publication date: December 18, 2013
Link to guidance: IMDRF/UDI WG/N7
IMDRF/UDI WG/N48
Unique Device Identification system (UDI system) Application Guide
What's in this guidance document? This document is to be used as a supplement to the IMDRF UDI Guidance (IMDRF/WG UDI/N7) which was developed as a high-level conceptual framework containing the basic core concepts of a UDI system.
What's in this guidance document? This document is to be used as a supplement to the IMDRF UDI Guidance (IMDRF/WG UDI/N7) which was developed as a high-level conceptual framework containing the basic core concepts of a UDI system.
Who is this guidance for? Anyone involved in the global medical device manufacturing market, as UDI is fast on its way to becoming a requirement throughout the world.
Authoring group: IMDRF UDI Working Group
Publication date: March 21, 2019
Link to guidance: IMDRF/UDI WG/N48
IMDRF/GRRP WG/N71
Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
What's in this guidance document? This document provides guidance for preparing a regulatory review report and the expectations of a Conformity Assessment Board (CAB). It includes direction for the structure, content, and accepted types of clinical and non-clinical evidence.
Who is this guidance for? This document applies to all medical devices except IVD medical devices and does not apply specifically to products that do not meet the definition of a medical device in this guidance; however, the contents and approach within this guidance may be relevant to document your evaluation that a product is not a medical device.
Authoring group: Good Regulatory Review Practices
Publication date: February 7, 2023
Link to guidance: IMDRF/GRRP WG/N71
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BONUS EBOOK:
Top 40 IMDRF Technical Documents for Medical Devices
Top 40 IMDRF Technical Documents for Medical Devices
