GHTF Study Group 1 Report

The purpose of this presentation will be to update the general membership of GHTF on the activities of Study Group 1 since the last Plenary Session. Changes in Study Group membership will be discussed as well an outline of all current and recently completed work items.

Work Programme:

Study Group 1 continues to develop several work items:

a) Classification Procedures- this document is being revisited to include a justification for each suggested classification decision, and to make a link between the classification of a specific device and the accompanying conformity assessment requirements.
b) Requirements for Clinical Investigation- this document is being expanded to include a link between device classification and the requirements for clinical data/ clinical investigation.
c) Summary Technical File- a pilot study using the draft is underway and the group is continuing to revise the document template to accommodate comments received.
d) Device Terminology- the group continues to discuss ways in which to ensure consistency of device terminology amongst national conformity authorities and industry partners around the globe.

Key Documents Published During the Report Period and their Status'

Labelling for Medical Devices: approved as a GHTF Final Document

Use of Standards in Medical Device Regulation: approved as a GHTF Final Document

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