IMDRF and GHTF documents

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Every IMDRF document record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

1. Australia Virtual Meeting outcome statement
2. Australia Virtual Meeting outcome statement
3. Brazil meeting outcome statement
4. China Beijing meeting outcome statement
5. China meeting outcome statement
6. Closed session Management Committee meeting outcome statement
7. Closing statement from GHTF Chair
8. Florianópolis meeting outcome statement
9. ghtf-ahwg-grm-n1r13-2011GHTF SC - Ad Hoc - Regulatory Model - April 2011
10. ghtf-sc-n4-2012-edition-2Glossary and Definition of Terms Used in GHTF Documents
11. ghtf-sg1-n055-2009GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and…
12. ghtf-sg1-n065-2010GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices
13. ghtf-sg1-n77-2012GHTF SG1 Principles of Medical Devices Classification - November 2012
14. ghtf-sg1-n78-2012GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012
15. ghtf-sg2-n008r4GHTF SG2 - Vigilance Reporting Guidance - June 1999
16. ghtf-sg2-n016r5GHTF SG2 - Charge and Mission Statement - June 1999
17. ghtf-sg2-n33r11-2002GHTF SG2 - Medical Device Postmarket Vigilance and Surveillance - Timing of Adverse Event…
18. ghtf-sg2-n47r4-2005GHTF SG2 - Review of Requirements on Postmarket Surveillance
19. ghtf-sg2-n54r8-2006GHTF SG2 - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event…
20. ghtf-sg2-n57r8-2006GHTF SG2 - Guidance - Content of Field Safety Notices
21. ghtf-sg2-n61r4-2004GHTF SG2 - PMS Harmonization Chart - November 2001
22. ghtf-sg2-n79r11-2009GHTF SG2 - Medical Devices Post Market Surveillance - February 2009
23. ghtf-sg3-n17-2008GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of…
24. ghtf-sg3-n18-2010GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and…
25. ghtf-sg3-n19-2012GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for…
26. ghtf-sg3-n99-10-2004GHTF SG3 - QMS - Process Validation Guidance - January 2004
27. ghtf-sg5-n4-2010GHTF SG5 - Post-Market Clinical Follow-Up Studies - November 2009
28. ghtf-sg5-n5-2012Reportable Events During Pre-Market Clinical Investigations
29. ghtf-sg5-n6-2012GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012
30. ghtf-sg5-n7-2012GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012
31. ghtf-sg5-n8-2012GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012
32. IMDRF 23rd MC Meeting Brussels March 2023 - Outcome Statement
33. IMDRF 24th MC Meeting Berlin Germany September 2023 - Outcome Statement
34. IMDRF 25th MC Meeting Washington March 2024 - Outcome Statement
35. IMDRF 29th MC Meeting Singapore March 2026 - Outcome Statement
36. imdrf-aet-wg-n85-final-2024Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators
37. imdrf-aet-wg-n86-final-2026IMDRF AET WG N86 Considerations for the Selection of IMDRF AE Terminologies
38. Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
39. imdrf-ae-wg-n44-final-2017Maintenance of IMDRF AE Terminologies
40. Maintenance of IMDRF AE Terminologies
41. Maintenance of IMDRF AE Terminologies
42. Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
43. imdrf-aimd-wg-n67Machine Learning-enabled Medical Devices: Key Terms and Definitions
44. imdrf-aiml-wg-n88-final-2025Good machine learning practice for medical device development: Guiding principles
45. IMDRF Brussels meeting outcome statement
46. IMDRF Chair and Secretariat rotates to Europe
47. imdrf-cyber-wg-n60final-2020Principles and Practices for Medical Device Cybersecurity
48. imdrf-cyber-wg-n70IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final
49. IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final
50. Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity…
51. IMDRF Document Implementation Report 1st September 2025
52. IMDRF France meeting outcome statement
53. imdrf-grrp-wg-n40-final-2017Competence, Training, and Conduct Requirements for Regulatory Reviewers
54. imdrf-grrp-wg-n40-final-2024IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2)
55. imdrf-grrp-wg-n47final-2018Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
56. IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)
57. imdrf-grrp-wg-n52final-2019Principles of Labelling for Medical Devices and IVD Medical Devices
58. IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)
59. imdrf-grrp-wg-n59final-2020Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies…
60. IMDRF/GRRP WG/N59 FINAL:2024 (Edition 2)
61. imdrf-grrp-wg-n61final-2020Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity…
62. IMDRF/GRRP WG/N61 FINAL:2024 (Edition 2)
63. imdrf-grrp-wg-n63final-2020Competence and Training Requirements for Regulatory Authority Assessors of Conformity…
64. IMDRF/GRRP WG/N63 FINAL:2024 (Edition 2)
65. imdrf-grrp-wg-n66final-2021Assessment and Decision Process for the Recognition of a Conformity Assessment Body…
66. IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2)
67. IMDRF GRRP WG N71 Guidance Regarding Information to be included_GRRP
68. IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2)
69. imdrf-grrp-wg-n89-final-2026IMDRF GRRP WG N89 Reliance Playbook
70. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
71. imdrf-mc-n16-final-2014IMDRF Document Format and Style Guide
72. IMDRF Terms of Reference
73. IMDRF/MC/N1FINAL:2022 (Edition 5)
74. IMDRF Terms of Reference_2023 (N1 ToR)
75. IMDRF MC N1 Terms of Reference_2024 (Edition 7)
76. IMDRF/MC/N1FINAL:2025(Edition 8)
77. imdrf-mc-n25-final-2015Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for…
78. IMDRF Standard Operating Procedures
79. IMDRF Standard Operating Procedures
80. IMDRF Standard Operating Procedures
81. IMDRF Standard Operating Procedures December 2022
82. IMDRF/MC/N2FINAL:2023 (Edition 10)
83. IMDRF/MC/N2FINAL:2023 (Edition 9)
84. IMDRF/MC/N2 FINAL:2024 (Edition 12)
85. IMDRF/MC/N2FINAL:2025 (Edition 13)
86. IMDRF/MC/N2FINAL:2025 (Edition 13 Version 2)
87. imdrf-mc-n34-final-2015Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk…
88. imdrf-mc-n35-final-2015Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle…
89. imdrf-mc-n36-final-2015Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General…
90. imdrf-mc-n37-final-2015Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices…
91. imdrf-mc-n38-final-2015Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products…
92. imdrf-mc-n39-final-2015IMDRF Strategic Plan 2020
93. IMDRF Strategic Plan 2021-2025
94. imdrf-mc-n69-final-2021IMDRF Membership Application Form
95. imdrf-mc-n69-final-2022IMDRF Membership Application Form
96. IMDRF Template 2023 - Membership Application Form N69 FINAL2023 - Edition 6
97. IMDRF Template 2023 - Membership Application Form N69 Final 2023 - Edition 7
98. IMDRF/MC/N69 FINAL:2023 (Edition 8)
99. imdrf-mc-n75-final-2022IMDRF Working Group Membership Application Form
100. IMDRF Working Group Member Application (N75 Ed2)
101. imdrf-mc-n76-final-2023Strategic Principles for IMDRF trainings
102. imdrf-mc-n77-final-2023White Paper - 23rd IMDRF Session Joint Workshop by IMDRF - DITTA and GMTA on the…
103. imdrf-mc-n78-final-2023IMDRF Strategic Plan 2021-2025 Progress Report Card (N78)
104. imdrf-mc-n79IMDRF MC N79 - Guiding Principles to Support Medical Device Health Equity_final
105. imdrf-mc-n80IMDRF Berlin Workshop: White Paper - Specialized Regulatory Pathways
106. imdrf-mc-n82-final-2024IMDRF 25th Session Workshop - White Paper on Reliance
107. imdrf-mc-n84-final-2024IMDRF Document Implementation Report 30 August 2024
108. imdrf-mc-n87-final-2024IMDRF 26th Session Workshop - White Paper on Developing a Regulatory Framework
109. imdrf-mc-n91-final-2025IMDRF Strategic Plan 2026-2030
110. Clinical Evidence - Key Definitions and Concepts
111. Clinical Evaluation
112. Clinical Investigation
113. Post-Market Clinical Follow-Up Studies
114. imdrf-mdsap-wg-n11final-2014MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
115. MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
116. imdrf-mdsap-wg-n22final-2014MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related…
117. imdrf-mdsap-wg-n24final-2015Medical Device Regulatory Audit Reports
118. imdrf-mdsap-wg-n29final-2015Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes
119. Requirements for Medical Device Auditing Organizations for Regulatory Authority…
120. Requirements for Medical Device Auditing Organizations for Regulatory Authority…
121. imdrf-mdsap-wg-n4final-2013Competence and Training Requirements for Auditing Organizations
122. Competence and Training Requirements for Auditing Organizations
123. imdrf-mdsap-wg-n5-final-2013Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical…
124. imdrf-mdsap-wg-n6final-2013Regulatory Authority Assessor Competence and Training Requirements
125. Regulatory Authority Assessor Competence and Training Requirements
126. imdrf-mdsap-wg-n8-final-2015Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing…
127. imdrf-ncar-wg-n14-edition5Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
128. Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
129. imdrf-ncar-wg-n14final-2015Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
130. Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
131. Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
132. Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange…
133. Post Market Surveillance National Competent Authority Report Exchange Criteria and Report…
134. imdrf-ncar-wg-n30final-2015Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report…
135. imdrf-ncar-wg-n31final-2015Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR)…
136. IMDRF Ottawa meeting outcome statement
137. imdrf-pmd-wg-n49final-2018Definitions for Personalized Medical Devices
138. imdrf-pmd-wg-n58final-2020Personalized Medical Devices - Regulatory Pathways
139. Personalized Medical Devices - Regulatory Pathways
140. IMDRF/ PMD WG/ N74 FINAL: 2023
141. imdrf-registry-wg-n33IMDRF/REGISTRY WG/N33FINAL:2016
142. Principles of International System of Registries Linked to Other Data Sources and Tools
143. Methodological Principles in the Use of International Medical Device Registry Data
144. Methodological Principles in the Use of International Medical Device Registry Data
145. Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making
146. Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making
147. IMDRF RPS Communication - 24 January 2019
148. In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
149. IMDRF/RPS WG/N13Final:2024 (Edition 4)
150. imdrf-rps-wg-n19final-2016Common Data Elements for Medical Device Identification
151. imdrf-rps-wg-n20final-2014Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions…
152. imdrf-rps-wg-n21final-2014RPS Beta Testing Document
153. IMDRF Table of Contents (ToC) Pilot Plan
154. imdrf-rps-wg-n27-final-2019Assembly and Technical Guide for IMDRF Table of Contents Submissions
155. imdrf-rps-wg-n27final-2019Assembly and Technical Guide for IMDRF Table of Contents Submissions
156. imdrf-rps-wg-n32final-2015Strategic Assessment of Electronic Submission Messaging Formats
157. imdrf-rps-wg-n45final-2017Data Exchange Guidelines - Common Data Elements for Medical Device Identification
158. imdrf-rps-wg-n50final-2018Round 2, RPS Beta Testing Report
159. Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
160. IMDRF/RPS WG/N9Final:2024 (Edition 4)
161. imdrf-samd-wg-n10final-2013Software as a Medical Device (SaMD): Key Definitions
162. imdrf-samd-wg-n12final-2014Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding…
163. imdrf-samd-wg-n23final-2015Software as a Medical Device (SaMD): Application of Quality Management System
164. imdrf-samd-wg-n41final-2017Software as a Medical Device (SaMD): Clinical Evaluation
165. imdrf-samd-wg-n81-final-2025Characterization Considerations for Medical Device Software and Software-Specific Risk
166. IMDRF - San Fransisco meeting outcome statement
167. IMDRF Singapore meeting outcome statement
168. Standards WG: Final Report: 'List of international standards recognized by IMDRF…
169. Optimizing Standards for Regulatory Use
170. imdrf-standards-wg-n72IMDRF Standards Liaison Program Framework
171. IMDRF Standards Liaison Program Framework
172. IMDRF Sydney meeting outcome statement
173. imdrf-udi-wg-n48final-2019Unique Device Identification system (UDI system) Application Guide
174. imdrf-udi-wg-n53final-2019Use of UDI Data Elements across different IMDRF Jurisdictions
175. imdrf-udi-wg-n54final-2019System requirements related to use of UDI in healthcare including selected use cases
176. imdrf-udi-wg-n7final-2013UDI Guidance: Unique Device Identification (UDI) of Medical Devices
177. IMDRF Washington D.C meeting outcome statement
178. Korea Virtual Meeting Outcome Statement
179. Korea Virtual Meeting outcome statement
180. Kyoto meeting outcome statement
181. MDRF 26th MC Meeting Seattle, Washington September 2024 - Outcome Statement
182. Message from the outgoing Australian chair
183. n044-2008GHTF SG1 - Standards in Assessment of Medical Devices - March 2008
184. n046-2008GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008
185. n055r6GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008
186. Ottawa meeting outcome statement
187. Russia Moscow meeting outcome statement
188. Russia Yekaterinburg meeting outcome statement
189. Sapporo, Japan (Hosted by Japan)
190. sg1-n071-2012GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May…
191. sg2-n87-2012GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data
192. sg3-n15r8GHTF SG3 - Risk Management Principles and Activities within a QMS - May 2005
193. Singapore Virtual Meeting Outcome Statement
194. Tokyo, Japan (Hosted by Japan)
195. Tokyo meeting outcome statement
196. Vancouver meeting outcome statement
197. Web statement regarding the future of GHTF