PART ONE
Preamble, Scope, Grounds and Definitions
Preamble
Section
1
—
(1) This guidance intends to set forth and lay down the procedures and rules for implement-
ing unique device tracking processes based on their movements.
Scope
Section
2
—
(1) This guidance covers and governs the procedures and rules to be followed by users of the
Product Tracking System (
PTS) for tracking individual movements of unique medical devices that are subject to
the Medical Device Directives & Regulations within the same at all stages from their manufacture or imports to fi-
nal delivery to end-users.