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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > Study Group 1 Work Plan |
(as of 31 May 2005)
WORK ITEM |
REF. |
CURRENT STATUS |
PRIORITY |
TARGET FOR COMPLETION |
|---|---|---|---|---|
Principles of Medical Devices Classification |
SG1/N015 |
Further progress awaits advancement of Conformity Assessment document. |
1 |
2006/Q1 |
Principles of Conformity Assessment for Medical Devices |
SG1/N040 |
Revised Working Draft completed should be available for public comment after September meeting. |
1 |
2006 / Q2 |
Pilot testing of Summary Technical Documentation for Demonstrating Conformity to the Essential Principles for Safety and Performance (STED) |
SG1/N011 |
Pilot started 2002 Q1 in some regions. US pilot extended for a further year. |
1 |
2006 / Q2 |
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles for Safety and Performance (STED) |
SG1/N011 |
Proposed Document. |
2 |
2005 / Q4 |
Information Document Concerning the Definition of the Term “Medical Device” |
SG1/N029 |
Proposed to Steering Committee as Final document |
2 |
2005 / Q3 |
Labelling for Medical Devices - Revision of SG1/N009 |
SG1/N043 |
Proposed to Steering Committee as Final document |
3 |
2005 / Q3 |
Essential Principles for Safety and Performance of Medical Devices – Revision of SG1/N020 |
SG1/N041 |
Proposed to Steering Committee as Final document |
3 |
2005 / Q3 |
Role of Standards in the Assessment of Medical Devices - Revision of SG1/N012 |
SG1/N044 |
Proposed Document -comments reviewed. |
3 |
2005 / Q4 |
Classification of In Vitro Diagnostic Devices |
SG1/N045 |
Working Draft discussed by SG1 |
4 |
2006 / Q2 |
Premarket Conformity Assessment for In Vitro Diagnostic Devices |
SG1/N046 |
Sub-group preparing first draft |
4 |
2006 / Q4 |
Updated 21 November 2007
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