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GHTF Study Group 1 - Pre-market Evaluation

This page contains final documents produced by the GHTF Study Group 1. For a list of archived documents, see GHTF Archived Documents.

GHTF code Document title Date posted Pages
Technical documents
GHTF/SG1/N78:2012 GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb) GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - DOC (66kb) 2 November 2012 17
GHTF/SG1/N77:2012 GHTF SG1 Principles of Medical Devices Classification - November 2012 - PDF (772kb) GHTF SG1 Principles of Medical Devices Classification - November 2012 - DOC (505kb) 2 November 2012 30
GHTF/SG1/N68:2012 GHTF SG1 - Essential Principles of Safety and Performance of Medical Devices - November 2012 - PDF (446kb) GHTF SG1 – Essential Principles of Safety and Performance of Medical Devices - November 2012 - DOCX (91kb) 2 November 2012 24
SG1 N071:2012 GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - DOC (42kb) GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb) 16 May 2012 6
SG1 N70:2011 GHTF SG1 - Label and Instructions for Use for Medical Devices - September 2011 - DOC (133kb) GHTF SG1 - Label and Instructions for Use for Medical Devices - September 2011 - PDF (129kb) 16 September 2011 17
GHTF/SG1/N063:2011 GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - March 2011 - DOC (420kb) GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - March 2011 - PDF (157kb) 17 March 2011 30
GHTF/SG1/N065:2010 GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - DOC (125kb) GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb) 27 August 2010 12
GHTF/SG1/N055: 2009 GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - DOC (82kb) GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb) 26 March 2009 7
N046:2008 GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - DOC (128kb) GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb) 31 July 2008 15
N044:2008 GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - DOC (94kb) GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb) 5 March 2008 10
N055R6 GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - DOC (75kb) GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb) 26 February 2008 7
N011:2008 GHTF SG1 – Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) - February 2008 - DOC (364kb) GHTF SG1 – Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) - February 2008 - PDF (519kb) 21 February 2008 21
N045:2008 GHTF SG1 - Principles of IVD Medical Devices Classification - February 2008 - DOC (118kb) GHTF SG1 - Principles of IVD Medical Devices Classification - February 2008 - PDF (199kb) 19 February 2008 15
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