GHTF – Global Harmonization Task Force – Guidelines

GHTF Study Group 1 – Pre-market Evaluation
Document	Download	Language	Number	Published
Principles of Conformity Assessment for Medical Devices		EN	GHTF/SG1/N78:2012	2 November 2012 17
Principles of Medical Devices Classification		EN	GHTF/SG1/N77:2012	2 November 2012 30
Essential Principles of Safety and Performance of Medical Devices		EN	GHTF/SG1/N68:2012	2 November 2012 24
Definition of Terms Medical Device and In Vitro Diagnostic Medical Device		EN	GHTF/SG1 N071:2012	16 May 2012
Label and Instructions for Use for Medical Devices		EN	GHTF/SG1 N70:2011	16 September 2011
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices		EN	GHTF/SG1/N063:2011	17 March 2011
Registration of Manufacturers and Listing of Medical Devices		EN	GHTF/SG1/N065:2010	27 August 2010
Definition Terms – Manufacturer – Authorised Representative – Distributor and Importer		EN	GHTF/SG1/N055: 2009	26 March 2009
Principles of CA for IVD Medical Devices		EN	GHTF/SG/N046:2008	31 July 2008
Standards in Assessment of Medical Devices		EN	GHTF/SG1/N044:2008	5 March 2008
Definition of the Terms of Manufacturer		EN	GHTF/SG1/N055R6	26 February 2008
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)		EN	GHTF/SG1/N011:2008	21 February 2008
Principles of IVD Medical Devices Classification		EN	GHTF/SG1/N045:2008	19 February 2008

 

GHTF Study Group 4 – Auditing
Document	Download	Language	Number	Published
EU – GHTF Guidelines for Auditing Mfg Control of Supplier – Part 5		EN	GHTF/SG4/N84:2010	08/2010
EU – GHTF Guidelines for Multi-Site Auditing of QMS Part 4		EN	GHTF/SG4/N83:2010	08/2010