1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > SG1 - Final Documents |
| Title | Description | Posted Date | Size | Comments To |
|---|---|---|---|---|
| SG1-N46:2008 PDF Word |
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices | 26 August 2008 | 15 pages | |
| SG1-N45:2008 PDF Word |
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | 23 June 2008 | 15 pages | |
| SG1-N11:2008 PDF Word |
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) | 29 May 2008 | 21 pages | |
| SG1-N44:2008 PDF Word |
Role of Standards in the Assessment of Medical Devices | 16 April 2008 | 10 pages | |
| SG1-N15:2006 PDF Word |
Principles of Medical Devices Classification | 31 August 2006 | 27 pages | |
| Principles of Conformity Assessment for Medical Devices | 31 August 2006 | 16 pages | ||
| SG1-N43:2005 |
Labelling for Medical Devices | 29 August 2005 | 10 pages | |
| SG1-N29R16:2005 |
Information Document Concerning the Definition of the Term "Medical Device" | 21 July 2005 | 6 pages | |
| SG1-N41R9:2005 |
Essential Principles of Safety & Performance of Medical Devices | 21 July 2005 | 16 pages | |
|
|
Role of Standards in the Assessment of Medical Devices | 15 March 2000 *Re-posted: 23 October 2000 |
10 pages, 50Kb-PDF 73Kb-Word |
*Reposted dates indicate when the document was reposted with a standard format cover sheet.
Updated 26 August 2008
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