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GHTF Study Group 1 - Pre-market Evaluation documents

This page contains archived GHTF documents only. Not all documents generated by GHTF are featured in this archive. For a list of final GHTF documents, see the Documents page.

For a list of procedural GHTF documents, see the GHTF Procedural Documents page.

GHTF code Document title Date posted Pages
Technical documents
SG1(PD)/N71R04 GHTF SG1 - Definition of the Term Medical Device - March 2011 - DOC (68kb) GHTF SG1 - Definition of the Term Medical Device - March 2011 - PDF (43kb) 15 March 2011 6
SG1-(PD)-N011R20 GHTF SG1 - Essential Principles of Safety and Performance of Medical Devices (STED)-March 2007 - DOC (278kb) GHTF SG1 - Essential Principles of Safety and Performance of Medical Devices (STED)-March 2007 - PDF (141kb) 5 March 2007 26
SG1-(PD)-N045R12 GHTF SG1 - Principles of In Vitro Diagnostic (IVD) Medical Device Classification - February 2007 - DOC (102kb) GHTF SG1 - Principles of In Vitro Diagnostic (IVD) Medical Device Classification - February 2007 - PDF (72kb) 9 February 2007 14
SG1-(PD)-N046R3 GHTF SG1 - Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices-February 2007 - DOC (109kb) GHTF SG1 - Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices-February 2007 - PDF (88kb) 9 February 2007 16
SG1(PD)/N044 GHTF SG1 - Role of Standards in the Assessment of Medical Devices (revised) - DOC (77kb) GHTF SG1 - Role of Standards in the Assessment of Medical Devices (revised) - PDF (93kb) 3 October 2006 12
GHTF SG1/N15:2006 GHTF SG1 - Principles of Medical Devices Classification - DOC (628kb) GHTF SG1 - Principles of Medical Devices Classification - PDF (596kb) 27 June 2006 27
GHTF SG1/N40:2006 GHTF SG1 - Principles of Conformity Assessment for Medical Devices - DOC (138kb) GHTF SG1 - Principles of Conformity Assessment for Medical Devices - PDF (107kb) 26 June 2006 16
SG 1 PD N015 GHTF SG1 - Principles of Medical Devices Classification - September 2005 - DOC (406kb) GHTF SG1 - Principles of Medical Devices Classification - September 2005 - PDF (187kb) 15 September 2005 28
SG 1 PD N040 GHTF SG1 - Principles of Conformity Assessment for Medical Devices - September 2005 - DOC (116kb) GHTF SG1 - Principles of Conformity Assessment for Medical Devices - September 2005 - PDF (83kb) 15 September 2005 16
SG1 N43:2005 GHTF SG1 - Labelling of Medical Devices - June 2005 - PDF (70kb) 3 June 2005 10
SG1 N29R16:2005 GHTF SG1 - Definition of the Term "Medical Device" - May 2005 - PDF (49kb) 20 May 2005 6
SG1 N41R9:2005 GHTF SG1 - Principles of Safety and Performance of Medical Devices - May 2005 - PDF (90kb) 20 May 2005 16
SG1/N015R22 GHTF SG1 - Principles of Medical Devices Classification - 17 November 2003 - DOC (406kb) GHTF SG1 - Principles of Medical Devices Classification - 17 November 2003 - PDF (156kb) 17 November 2003 28
SG1/N011R17 GHTF SG1 - Summary Documentation Conformity to Safety and Performance of Medical Devices - 25 October 2002 - DOC (208kb) GHTF SG1 - Summary Documentation Conformity to Safety and Performance of Medical Devices - 25 October 2002 - PDF (91kb) 25 October 2002 20
SG1/N044R4 GHTF SG1 - Role of Standards in the Assessment of Medical Devices - InVitro Diagnostic Devices - 5 October 2002 - DOC (64kb) GHTF SG1 - Role of Standards in the Assessment of Medical Devices - InVitro Diagnostic Devices - 5 October 2002 - PDF (63kb) 5 October 2002 12
GHTF-SG1-N012R10 Role of Standards in the Assessment of Medical Devices - DOC (72kb) Role of Standards in the Assessment of Medical Devices - PDF (48kb) 24 February 2000 10
GHTF-SG1-N009R6 Labelling For Medical Devices - DOC (42kb) Labelling For Medical Devices - PDF (42kb) 24 February 2000 7
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GHTF Study Group 1 - Pre-market Evaluation meeting dates and meeting minutes

Date Location Meeting minutes Doc code
7-10 February 2011 London, United Kingdom GHTF SG1 - Meeting Minutes - February 2011 London - DOC (101kb) GHTF SG1 - Meeting Minutes - February 2011 London - PDF (68kb) N082
5-8 October 2010 Santa Rosa, USA GHTF SG1 - Meeting Minutes - October 2010 Santa Rosa - DOC (103kb) GHTF SG1 - Meeting Minutes - October 2010 Santa Rosa - PDF (59kb) N081
7-10 June 2010 Sydney, Australia GHTF SG1 - Meeting Minutes - June 2010 Sydney - DOC (57kb) GHTF SG1 - Meeting Minutes - June 2010 Sydney - DOCX (30kb) GHTF SG1 - Meeting Minutes - June 2010 Sydney - PDF (144kb) N/A
18-21 May 2010 Tokyo, Japan GHTF SG1 - Meeting Minutes - May 2010 Tokyo - DOC (116kb) GHTF SG1 - Meeting Minutes - May 2010 Tokyo - PDF (62kb) N080
23-26 March 2010 Washington, USA GHTF SG1 - Meeting Minutes - March 2010 Washington - DOC (56kb) GHTF SG1 - Meeting Minutes - March 2010 Washington - PDF (27kb) GHTF.SG1.IVD
26-29 January 2010 Sao Paulo, Brazil GHTF SG1 - Meeting Minutes - January 2010 Sao Paulo - DOC (96kb) GHTF SG1 - Meeting Minutes - January 2010 Sao Paulo - PDF (59kb) N079
16-19 November 2009 San Jose, USA GHTF SG1 - Meeting Minutes - November 2009 San Jose - PDF (25kb) GHTF SG1 - Meeting Minutes - November 2009 San Jose - DOC (53kb) GHTF.SG1.IVD
13-16 October 2009 Brussels, Belgium GHTF SG1 - Meeting Minutes - October 2009 Brussels - DOC (100kb) GHTF SG1 - Meeting Minutes - October 2009 Brussels - PDF (45kb) N076
10-12 May 2009 Toronto, Canada GHTF SG1 - Meeting Minutes - May 2009 Toronto - DOC (88kb) GHTF SG1 - Meeting Minutes - May 2009 Toronto - PDF (46kb) N075
20-23 January 2009 Sydney, Australia GHTF SG1 - Meeting Minutes - January 2009 Sydney - DOC (116kb) GHTF SG1 - Meeting Minutes - January 2009 Sydney - PDF (62kb) N074
14-17 October 2008 Ottawa, Canada GHTF SG1 - Meeting Minutes - October 2008 Ottawa - DOC (105kb) GHTF SG1 - Meeting Minutes - October 2008 Ottawa - PDF (56kb) N073
8-11 July 2008 Buenos Aires, Argentina GHTF SG1 - Meeting Minutes - July 2008 Buenos Aires - DOC (122kb) GHTF SG1 - Meeting Minutes - July 2008 Buenos Aires - PDF (90kb) N072
6-8 February 2008 Bonn, Germany GHTF SG1 - Meeting Minutes - February 2008 Bonn - DOC (116kb) GHTF SG1 - Meeting Minutes - February 2008 Bonn - PDF (68kb) N067
5 February 2008 Bonn, Germany GHTF SG1-SG3-SG4 - Meeting Minutes - February 2008 Bonn - DOC (192kb) GHTF SG1-SG3-SG4 - Meeting Minutes - February 2008 Bonn - PDF (138kb) SG1 N068
30 September-2 October 2007 Washington DC, USA GHTF SG1 - Meeting Minutes - Washington - DOC (107kb) GHTF SG1 - Meeting Minutes - Washington - PDF (62kb) SG1 N066
12 May 2007 Los Angeles, USA GHTF SG1 - Meeting Minutes - Los Angeles - DOC (88kb) GHTF SG1 - Meeting Minutes - Los Angeles - PDF (53kb) SG1 N064
7-9 February 2007 Kyoto, Japan GHTF SG1 - Meeting Minutes - February 2007 Kyoto - DOC (71kb) GHTF SG1 - Meeting Minutes - February 2007 Kyoto - PDF (46kb) N062
3-6 October 2006 Ghent, Belgium GHTF SG1 - Meeting Minutes - October 2006 Ghent - DOC (94kb) GHTF SG1 - Meeting Minutes - October 2006 Ghent - PDF (56kb) N060
28-31 March 2006 Sydney, Australia GHTF SG1 - Meeting Minutes - March 2006 Sydney - DOC (82kb) GHTF SG1 - Meeting Minutes - March 2006 Sydney - PDF (49kb) N058
16 September 2005 Washington, USA GHTF SG1 - Globally Harmonized Premarket Oversight Presentation - September 2005 Washington - PDF (52kb) N/A
21-24 February 2005 Morges, Switzerland GHTF SG1 - Meeting Minutes - February 2005 Morges - DOC (78kb) GHTF SG1 - Meeting Minutes - February 2005 Morges - PDF (27kb) N056
5-6 October 2004 Lisbon, Portugal GHTF SG1 - Meeting Minutes - October 2004 Lisbon - DOC (71kb) GHTF SG1 - Meeting Minutes - October 2004 Lisbon - PDF (40kb) N055
18-19 February 2004 Canberra, Australia GHTF SG1 - Meeting Minutes - February 2004 Canberra - PDF (24kb) GHTF SG1 - Meeting Minutes - February 2004 Canberra - DOC (70kb) N054S
8-10 September 2003 London, United Kingdom GHTF SG1 - Meeting Minutes - September 2003 London - DOC (38kb) GHTF SG1 - Meeting Minutes - September 2003 London - PDF (13kb) N/A
23-25 March 1999 Brussels, Belgium GHTF SG1 - Meeting Minutes - March 1999 Brussels - DOC (40kb) GHTF SG1 - Meeting Minutes - March 1999 Brussels - PDF (22kb) N/A
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