SG2 - Archived Documents

Title	Description	Date Posted
SG2(PD) / N54R6 [PDF][Word]	Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices	17 November 2005
SG2(PD) / N57R6 [PDF][Word]	Medical Devices: Post Market Surveillance: Content of Field Safety Notices	17 November 2005
SG2(PD) / N79R5 [PDF][Word]	Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form	17 November 2005
SG2/N31R8 PDF	Medical Device Postmarket Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative	22 December 2003
SG2/N32R5 PDF	Medical Device Postmarket Vigilance and Surveillance: Universal Data Set for Manufacturer Adverse Event Reports	22 December 2003
SG2-N36R7 PDF	Manufacturer's Trend Reporting of Adverse Events	28 March 2003
SG2-N9R11 PDF	Global Medical Device Competent Authority Report [Contains link to fillable WORD version of form]	28 March 2003
SG2-N33R11 PDF	Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse Event Reports	28 March 2003
SG2-N20R10 PDF Word	Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria	12 July 2002
SG2-N21R8 PDF	Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative	Unknown *Reposted: 15 October 2000

Updated 21 November 2007