Note: Discrepancy Between GHTF/SG1/N040:2006 and GHTF/SG1/N011:2008

DISCREPANCY BETWEEN GHTF/SG1/N040:2006 Principles of Conformity Assessment for Medical Devices and GHTF/SG1/N011:2008 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

In SG1’s guidance document SG1-N11:2008 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) it is stated that a STED for either a C lass A or a Class B device should be prepared and submitted only at the request of a RA/CAB. This statement reflects the outcome of a long discussion on the matter.

However, in SG1’s guidance document SG1-N40:2006 Principles of Conformity Assessment for Medical Devices that predates that on the STED, different guidance is given in that it recommends that a STED for either a C lass A or a Class B device should be prepared and held by the manufacturer until such time as the RA/CAB requires it.

This discrepancy will be resolved when the guidance document on conformity assessment is next revised and in the meantime, the recommendation in the guidance document on the STED applies.

Please address any questions on this subject to the Chair of SG1 whose contact details may be found on the GHTF website.

Updated 8 September 2008

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