Top 40 IMDRF Technical Documents for Medical Devices

March 10, 2023

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.

FREE DOWNLOAD: Click here to download our guide to the Top 40 IMDRF Guidance Technical Documents for Medical Devices.

Table of contents

IMDRF Code	Technical Document
IMDRF/Standards WG/N72	IMDRF Standards Liaison Program Framework
IMDRF/AIMD WG/N67	Machine Learning-enabled Medical Devices: Key Terms and Definitions
IMDRF/NCAR WG/N14	Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
IMDRF/GRRP WG/N59	Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
IMDRF/GRRP WG/N66	Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
IMDRF/GRRP WG/N63	Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
IMDRF/GRRP WG/N61	Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
IMDRF/AE WG/N43	Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
IMDRF/CYBER WG/N60	Principles and Practices for Medical Device Cybersecurity
IMDRF/PMD WG/N49	Definitions for Personalized Medical Devices
IMDRF/PMD WG/N58	Personalized Medical Devices - Regulatory Pathways
IMDRF MDCE WG/N57	Clinical Investigation
IMDRF MDCE WG/N56	Clinical Evaluation
IMDRF/MDCE WG/N65	Post-Market Clinical Follow-Up Studies
IMDRF MDCE WG/N55	Clinical Evidence - Key Definitions and Concepts
IMDRF/GRRP WG/N52	Principles of Labelling for Medical Devices and IVD Medical Devices
IMDRF/RPS WG/N9	Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
IMDRF/RPS WG/N13	In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
IMDRF/IVD WG/N64	Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
IMDRF/RPS WG/N27	Assembly and Technical Guide for IMDRF Table of Contents Submissions
IMDRF/Standards WG/N5	Optimizing Standards for Regulatory Use
IMDRF/GRRP WG/N47	Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF/GRRP WG/N40	Competence, Training, and Conduct Requirements for Regulatory Reviewers
IMDRF/Registry WG/N46	Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making
IMDRF/Registry WG/N42	Methodological Principles in the Use of International Medical Device Registry Data
IMDRF/Registry WG/N33	Principles of International System of Registries Linked to Other Data Sources and Tools
IMDRF/RPS WG/N19	Common Data Elements for Medical Device Identification
IMDRF/MDSAP WG/N3	Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
IMDRF/MDSAP WG/N24	Medical Device Regulatory Audit Reports
IMDRF/MDSAP WG/N11	MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
IMDRF/MDSAP WG/N4	Competence and Training Requirements for Auditing Organizations
IMDRF/MDSAP WG/N6	Regulatory Authority Assessor Competence and Training Requirements
IMDRF/MDSAP WG/N8	Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
IMDRF/SaMD WG/N23	Software as a Medical Device (SaMD): Application of Quality Management System
IMDRF/SaMD WG/N10	Software as a Medical Device (SaMD): Key Definitions
IMDRF/SaMD WG/N41	Software as a Medical Device (SaMD): Clinical Evaluation
IMDRF/SaMD WG/N12	Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
IMDRF/UDI WG/N7	UDI Guidance: Unique Device Identification (UDI) of Medical Devices
IMDRF/UDI WG/N48	Unique Device Identification system (UDI system) Application Guide
IMDRF/GRRP WG/N71	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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Link to guidance: IMDRF/RPS WG/N9

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.

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.

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.

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

Link to guidance: IMDRF/RPS WG/N19

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.

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.

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.

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.

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.

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.

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

FREE DOWNLOAD: Click here to download our guide to the Top 40 IMDRF Guidance Technical Documents for Medical Devices.

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If you’ve made it through this list of the top 40 IMDRF guidance documents, we have to admit that we’re impressed. Medical device standards aren’t everyone’s favorite reading, but the real ones know the significant contribution they make to improving the quality of life. As fellow fans of True Quality in MedTech, we’d like to introduce ourselves.

Greenlight Guru is an industry-best QMS software, and the only one designed by medical device professionals specifically to meet the unique needs of medical device companies. We’ve aligned our end-to-end solution with the best practices of IMDRF and ISO, as well as regulatory agencies around the world, to help you better manage quality processes, product development, and clinical data.

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Etienne Nichols

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...