SG1 - Archived Documents

SG1(PD)/N46/R3

Word PDF

SG1(PD)/N045R12

Word PDF

Study Group 1 initiated the revision of the STED in 2006. The revision was based on the public comments received to date, and on GHTF’s growing experience with the use of the Proposed STED Document within member jurisdictions. The revision was completed in March 2007. The guideline now provides more descriptive information and additional recommendations on the use and the content of the STED.

GHTF believes that the recent revisions are substantial enough to warrant a new public consultation. Therefore, before proceeding to a Final Document, Study Group 1 is seeking comments on the revised SG1(PD)/N011: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) of 5 March 2007 http://www.ghtf.org/sg1/sg1-proposed.html.

Please submit your comments to the Study Group 1 Chairperson, Dr. Ginette Michaud, at ginette.michaud@fda.hhs.gov no later than May 4, 2007. We recommend that you submit your comments in the “comments template” format (see “Comments Template” at http://www.ghtf.org/sg/sg1/sg1.html).

Role of Standards in the Assessment of Medical Devices (revised)

Before proceeding to a Final Document, SG1 is seeking comments on the revised document. In particular, it seeks feedback on Section 5.2 Revision or Replacement of Recognised Standards. This section addresses the use of a recognised standard (i.e. one that provides presumption of conformity with certain GHTF Essential Principles of Safety and Performance) during the transitional period when it is being replaced by a revised version. This revision includes added guidance for in vitro medical devices and guidance on revision or replacement of recognised standards. This document supersedes the previous version.

Principles of Medical Devices Classification

Note: This document is published after extensive discussion within the Study Group.

Before proceeding to a Final Document, SG1 seeks comments on all aspects of its contents. In particular, we would draw attention to the manner in which we have defined "Central Circulatory System", and specifically the inclusion of vessels associated with the aorta. (Section 4.0, page 6 of 28).

Principles of Conformity Assessment for Medical Devices

Note: This document is published after extensive discussion within the Study Group.

Before proceeding to a Final Document, SG1 seeks comments on all aspects of its contents. In particular, we would draw attention to the manner in which we have referred to the conformity assessment procedure known as ‘type examination’ (Section 6.2, on Page 14 of 16).