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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
Final documents
IMDRF/RPS WG/N13FINAL: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/N9FINAL: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/WG/N3FINAL:2013 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (553kb) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - DOCX (129kb) 18 December 2013 24
IMDRF/WG/N4FINAL:2013 Competence and Training Requirements for Auditing Organizations - PDF (558kb) Competence and Training Requirements for Auditing Organizations - DOC (239kb) 18 December 2013 22
IMDRF/WG/N5Final:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - PDF (550kb) Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - DOC (639kb) 18 December 2013 32
IMDRF/WG/N6FINAL:2013 Regulatory Authority Assessor Competence and Training Requirements - PDF (525kb) Regulatory Authority Assessor Competence and Training Requirements - DOCX (119kb) 18 December 2013 18
IMDRF/WG/N7FINAL:2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices - PDF (951kb) UDI Guidance: Unique Device Identification (UDI) of Medical Devices - DOCX (129kb) 18 December 2013 19
IMDRF/WG/N10FINAL:2013 Software as a Medical Device (SaMD): Key Definitions - PDF (502kb) Software as a Medical Device (SaMD): Key Definitions - DOCX (68kb) 18 December 2013 9
Procedural documents
IMDRF/MC/N16FINAL:2014 IMDRF Document Format and Style Guide - PDF (75kb) IMDRF Document Format and Style Guide - DOCX (79kb) 23 April 2014 14
IMDRF/MC/N17FINAL:2014 IMDRF Document Template - DOCX (44kb) 23 April 2014 6
IMDRF/MC/N18FINAL:2014 IMDRF Presentation Template - PPT (116kb) 23 April 2014 3
IMDRF/MC/N2FINAL:2013 IMDRF Standard Operating Procedure - PDF (319kb) IMDRF Standard Operating Procedure - DOCX (83kb) 17 December 2013 21
IMDRF/MC/N1FINAL:2013 IMDRF Terms of Reference - PDF (67kb) IMDRF Terms of Reference - DOC (101kb) 18 November 2013 9
Information documents
IMDRF/RPS WG/N20FINAL: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/N21FINAL:2014 RPS Beta Testing Document - PDF (1.2Mb) 16 May 2014 145
Outcome statements
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.