Member sites
- Australia Therapeutic Goods Administration
- Brazil Brazilian Health Regulatory Agency (ANVISA)
- Canada Health Canada
- China National Medical Products Administration
- European Union European Commission – Directorate-General for Health and Food Safety
- Japan Pharmaceutical and Medical Devices Agency (PMDA)
- Russia Russian Ministry of Health
- Singapore Health Sciences AuthoritySouth Korea Ministry of Food and Drug Safety
- United Kingdom Medicines and Healthcare products Regulatory Agency
- United States of America US Food and Drug Administration
Affiliate members
Official observers
- Argentina, National Administration of Drugs, Food and Medical Devices
- World Health Organization (WHO)
- Swissmedic
Documents
- IMDRF/MC/N78 FINAL:2023 IMDRF Strategic Plan 2021-2025 – Progress Report Card 8 May 2023
- IMDRF/MC/N77 White Paper – 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA on the importance of post-market related activities 24 April 2023
- IMDRF/MC/N76 Strategic Principles for IMDRF trainings 24 April 2023
- Outcome statement IMDRF 23rd MC Meeting Brussels March 2023 – Outcome Statement 21 April 2023
- IMDRF/CYBER WG/N73 Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity 13 April 2023
- IMDRF/PMD WG/N74 Personalized Medical Devices – Production Verification and Validation 11 April 2023
- IMDRF/CYBER WG/N70 Principles and Practices for the Cybersecurity of Legacy Medical Devices 11 April 2023
- IMDRF/NCAR WG/N14 Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form 11 April 2023
- IMDRF/GRRP WG/N71 Medical Device Regulatory Review Report: Guidance Regarding Information to be Included 7 February 2023
- IMDRF/MC/N69 FINAL:2023 IMDRF Membership Application Form 7 February 2023
- IMDRF/MC/N75 FINAL:2022 IMDRF Working Group Membership Application Form 19 December 2022
- Australia Virtual Meeting outcome statement 27 September 2022
- Australia Virtual Meeting outcome statement 14 June 2022
- IMDRF/Standards WG/N72 (Edition 1) IMDRF Standards Liaison Program Framework 13 May 2022
- IMDRF/AIMD WG/N67 (Edition 1) Machine Learning-enabled Medical Devices: Key Terms and Definitions 9 May 2022
- Korea Virtual Meeting outcome statement 19 November 2021
- IMDRF/MDSAP WG/N11 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization 20 October 2021
- IMDRF/MDSAP WG/N4 Competence and Training Requirements for Auditing Organizations 20 October 2021
- IMDRF/MDSAP WG/N6 Regulatory Authority Assessor Competence and Training Requirements 20 October 2021
- IMDRF/GRRP WG/N66 Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews 1 July 2021
- IMDRF/MDCE WG/N65 Post-Market Clinical Follow-Up Studies 20 May 2021
- Korea Virtual Meeting outcome statement 25 March 2021
- IMDRF/IVD WG/N64 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification 21 January 2021
- IMDRF/GRRP WG/N63 Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews 25 September 2020
- IMDRF/GRRP WG/N61 Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews 25 September 2020
- IMDRF/MC/N39 IMDRF Strategic Plan 2021-2025 25 September 2020
- Singapore Virtual Meeting outcome statement 25 September 2020
- IMDRF/AE WG/N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes 20 April 2020
- IMDRF/CYBER WG/N60 Principles and Practices for Medical Device Cybersecurity 20 April 2020
- IMDRF/GRRP WG/N59 Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews 20 April 2020
- IMDRF/PMD WG/N58 Personalized Medical Devices – Regulatory Pathways 20 April 2020
- Closed session management committee meeting outcome statement 18 March 2020
- IMDRF MDCE WG/N57 Clinical Investigation 10 October 2019
- IMDRF MDCE WG/N56 Clinical Evaluation 10 October 2019
- IMDRF MDCE WG/N55 Clinical Evidence – Key Definitions and Concepts 10 October 2019
- Russia Yekaterinburg meeting outcome statement 19 September 2019
- IMDRF/GRRP WG/N52 Principles of Labelling for Medical Devices and IVD Medical Devices 21 March 2019
- IMDRF/UDI WG/N48 Unique Device Identification system (UDI system) Application Guide 21 March 2019
- IMDRF/RPS WG/N9 Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) 21 March 2019
- IMDRF/RPS WG/N13 In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) 21 March 2019
- IMDRF/RPS WG/N27 Assembly and Technical Guide for IMDRF Table of Contents Submissions 20 March 2019
- IMDRF/Standards WG/N51 Optimizing Standards for Regulatory Use 12 November 2018
- IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices 7 November 2018
- IMDRF/PMD WG/N49 Definitions for Personalized Medical Devices 7 November 2018
- IMDRF/Registry WG/N46 Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making 27 March 2018
- IMDRF/SaMD WG/N41 Software as a Medical Device (SaMD): Clinical Evaluation 21 September 2017
- Ottawa meeting outcome statement 19 September 2017
- IMDRF/GRRP WG/N40 Competence, Training, and Conduct Requirements for Regulatory Reviewers 16 March 2017
- IMDRF/Registry WG/N42 Methodological Principles in the Use of International Medical Device Registry Data 16 March 2017
- IMDRF/REGISTRY WG/N33 Principles of International System of Registries Linked to Other Data Sources and Tools 30 September 2016
- IMDRF/MDSAP WG/N3 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition 24 March 2016
- IMDRF/RPS WG/N19 Common Data Elements for Medical Device Identification 24 March 2016
- IMDRF/MDSAP WG/N24 Medical Device Regulatory Audit Reports 2 October 2015
- IMDRF/SaMD WG/N23 Software as a Medical Device (SaMD): Application of Quality Management System 2 October 2015
- IMDRF/MDSAP WG/N8 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations 2 October 2015
- IMDRF/SaMD WG/N12 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations 18 September 2014
- IMDRF/MC/N16 MDRF Document Format and Style Guide 23 April 2014
- IMDRF/UDI WG/N7 UDI Guidance: Unique Device Identification (UDI) of Medical Devices 18 December 2013
- IMDRF/SaMD WG/N10 Software as a Medical Device (SaMD): Key Definitions 18 December 2013
- IMDRF/MDSAP WG/N5 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations 18 December 2013
- Brussels meeting outcome statement 12 November 2013
- IMDRF Chair and Secretariat rotates to Europe 21 January 2013
- Media statement – Successful Launch to the IMDRF 28 March 2012
- Ottawa, Canada meeting outcome statement 7 October 2011
- Moscow meeting outcome statement
- China (Beijing) meeting outcome statement
- China meeting outcome statement
- Vancouver meeting outcome statement
- Florianópolis meeting outcome statement
- Brazil meeting outcome statement
- Kyoto meeting outcome statement
- Tokyo meeting outcome statement
- Washington D.C meeting outcome statement
- San Fransisco meeting outcome statement
- France meeting outcome statement
- Sydney meeting outcome statement
- Singapore meeting outcome statement