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Documents

This page contains final documents only for both IMDRF and GHTF.

IMDRF documents

IMDRF code Document title Date posted Pages
IMDRF/REGISTRY WG/N33 FINAL:2016 Principles of International System of Registries Linked to Other Data Sources and Tools - PDF (873kb) Principles of International System of Registries Linked to Other Data Sources and Tools - DOCX (203kb) 30 September 2016 28
IMDRF/MDSAP WG/N3 FINAL:2016
(Edition 2)
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - DOCX (173kb) 24 March 2016 30
IMDRF/RPS WG/N19 FINAL:2016 Common Data Elements for Medical Device Identification - PDF (747kb) Common Data Elements for Medical Device Identification - DOCX (135kb) 24 March 2016 17
IMDRF/MDSAP WG/N8 FINAL:2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - PDF (256kb) Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - DOCX (154kb) 2 October 2015 53
IMDRF/MDSAP WG/N24 FINAL:2015 Medical Device Regulatory Audit Reports - PDF (154kb) Medical Device Regulatory Audit Reports - DOCX (80kb) 2 October 2015 17
IMDRF/SaMD WG/N23 FINAL:2015 Software as a Medical Device (SaMD): Application of Quality Management System - PDF (364kb) Software as a Medical Device (SaMD): Application of Quality Management System - DOCX (749kb) 2 October 2015 34
IMDRF/NCAR WG/N14 FINAL:2015 Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - PDF (195) Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - DOC (133) 26 March 2015 18
IMDRF/SaMD WG/N12 FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb) Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations - DOCX (176kb) 18 September 2014 30
IMDRF/MDSAP WG/N11 FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb) MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - DOCX (485kb) 18 September 2014 36
IMDRF/RPS WG/N13 FINAL:2014 In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (650kb) In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - DOCX (288kb) 14 August 2014 50
IMDRF/RPS WG/N9 FINAL:2014 Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC) - PDF (650kb) Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC) - DOCX (288kb) 14 August 2014 49
IMDRF/MDSAP WG/N3 FINAL:2013
See also Edition 2
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - DOCX (133kb) 18 December 2013 24
IMDRF/MDSAP WG/N4 FINAL:2013 Competence and Training Requirements for Auditing Organizations - PDF (232kb) Competence and Training Requirements for Auditing Organizations - DOC (129kb) 18 December 2013 22
IMDRF/MDSAP WG/N5 FINAL:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - PDF (363kb) Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - DOC (313kb) 18 December 2013 32
IMDRF/MDSAP WG/N6 FINAL:2013 Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb) Regulatory Authority Assessor Competence and Training Requirements - DOCX (124kb) 18 December 2013 18
IMDRF/UDI WG/N7 FINAL:2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices - PDF (324kb) UDI Guidance: Unique Device Identification (UDI) of Medical Devices - DOCX (130kb) 18 December 2013 19
IMDRF/SaMD WG/N10 FINAL:2013 Software as a Medical Device (SaMD): Key Definitions - PDF (119kb) Software as a Medical Device (SaMD): Key Definitions - DOCX (68kb) 18 December 2013 9
Procedural documents
IMDRF/MC/N39 FINAL:2015 IMDRF Strategic Plan 2020 - PDF (59kb) IMDRF Strategic Plan 2020 - DOCX (62kb) 2 October 2015 5
IMDRF/MC/N16 FINAL:2014 IMDRF Document Format and Style Guide - PDF (75kb) IMDRF Document Format and Style Guide - DOCX (79kb) 23 April 2014 14
IMDRF/MC/N17 FINAL:2014 IMDRF Document Template - DOCX (44kb) 23 April 2014 6
IMDRF/MC/N18 FINAL:2014 IMDRF Presentation Template - PPT (116kb) 23 April 2014 3
IMDRF/MC/N2 FINAL:2014 (Edition 2) IMDRF Standard Operating Procedure - PDF (217kb) IMDRF Standard Operating Procedure - DOCX (86kb) 2 January 2015 21
IMDRF/MC/N1 FINAL:2014 (Edition 3) IMDRF Terms of Reference - PDF (95kb) IMDRF Terms of Reference - DOCX (98kb) 2 January 2015 9
Information documents
IMDRF/MDSAP WG/N29 FINAL:2015 Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes - PDF (41Kb) Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes - DOCX (47Kb) 2 October 2015 2
IMDRF/NCAR WG/N30 FINAL:2015 Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb) Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - DOCX (62Kb) 2 October 2015 7
IMDRF/NCAR WG/N31 FINAL:2015 Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material - PDF (562Kb) 2 October 2015 43
IMDRF/RPS WG/N32 FINAL:2015 Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb) Strategic Assessment of Electronic Submission Messaging Formats - DOCX (125Kb) 2 October 2015 36
IMDRF/MC/N34 FINAL:2015 Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" - PDF (55Kb) Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" - DOCX (56Kb) 2 October 2015 3
IMDRF/MC/N35 FINAL:2015 Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes" - PDF (55Kb) Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes" - DOCX (53Kb) 2 October 2015 3
IMDRF/MC/N36 FINAL:2015 Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - PDF (35Kb) Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - DOCX (58Kb) 2 October 2015 3
IMDRF/MC/N37 FINAL:2015 Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - PDF (53Kb) Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - DOCX (56Kb) 2 October 2015 3
IMDRF/MC/N38 FINAL:2015 Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" - PDF (34kb) Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" - DOC (51kb) 2 October 2015 3
IMDRF/RPS WG/N26 FINAL:2015 (Edition 2) IMDRF Table of Contents (ToC) Pilot Plan - PDF (403Kb) IMDRF Table of Contents (ToC) Pilot Plan - DOCX (73Kb) 8 July 2015 14
IMDRF/MC/N25 FINAL:2015 Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice" - PDF (59Kb) Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice" - DOCX (23Kb) 7 April 2015 4
IMDRF/Standards WG/N15 FINAL:2014 Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014 - PDF (200Kb) Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014 - DOCX (399Kb) Recognised standards - Australia - PDF (393kb) Recognised standards - Brazil - PDF (516kb) Recognised standards - Canada - PDF (420kb) Recognised standards - China - PDF (529kb) Recognised standards - Europe - PDF (402kb) Recognised standards - Japan - PDF (722kb) Recognised standards - Russia - PDF (611kb) Recognised standards - USA - PDF (581kb) 21 November 2014 17
IMDRF/MDSAP WG/N22 FINAL:2014 MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes - PDF (153Kb) MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes - DOCX (232Kb) 18 September 2014 2
IMDRF/RPS WG/N20 FINAL:2014 Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb) Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - DOCX (84Kb) Comment form for 'Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS' - XLSX (153Kb) 30 June 2014 11
IMDRF/RPS WG/N21 FINAL:2014 RPS Beta Testing Document - PDF (1.2Mb) 16 May 2014 145
Outcome statements
N/A Florianópolis meeting outcome statement - PDF (373kb) Florianópolis meeting outcome statement - DOCX (70kb) 13-15 September 2016 4
N/A Brazil meeting outcome statement - PDF (92kb) Brazil meeting outcome statement - DOCX (70kb) 8-10 March 2016 4
N/A Kyoto meeting outcome statement - PDF (52kb) Kyoto meeting outcome statement - DOCX (71kb) 17 September 2015 4
N/A Tokyo meeting outcome statement - PDF (57kb) Tokyo meeting outcome statement - DOCX (70kb) 26 March 2015 4
N/A Washington D.C meeting outcome statement - PDF (57kb) Washington D.C meeting outcome statement - DOCX (66kb) 1 October 2014 4
N/A San Fransisco meeting outcome statement - PDF (33kb) San Fransisco meeting outcome statement - DOCX (64kb) 27 March 2014 3
N/A Belgium meeting outcome statement - PDF (31kb) Belgium meeting outcome statement - DOC (76kb) 12 November 2013 2
N/A France meeting outcome statement - PDF (60kb) France meeting outcome statement - DOC (159kb) 19 March 2013 2
N/A IMDRF Chair and Secretariat rotates to Europe - PDF (35kb) IMDRF Chair and Secretariat rotates to Europe - DOCX (25kb) 21 January 2013 1
N/A Sydney meeting outcome statement - PDF (63kb) Sydney meeting outcome statement - DOC (160kb) 25 September 2012 2
N/A Singapore meeting outcome statement - PDF (56kb) Singapore meeting outcome statement - DOC (58kb) 28 Feburary 2012 2
N/A Media statement - Successful Launch to the IMDRF - PDF (41kb) Media statement - Successful Launch to the IMDRF - DOC (29kb) 28 March 2012 1

For a list of IMDRF meeting minutes and outcome statements, see the Meetings page.

For a list of IMDRF proposed documents, see the Consultations page.

GHTF final documents

These documents were created by the Global Harmonization Task force (GHTF). These are final documents and are still current. As the work of IMDRF progresses, these documents will be reviewed and published as IMDRF documents. Until that time, these documents are provided for the use of interested parties. If you become aware that any of these documents are out of date, please advise the IMDRF Secretariat so that a review can be scheduled on the IMDRF work plan.

To access archived GHTF documents, including meeting minutes, see the GHTF Archived Documents page.