Post-Market Overview

Once listed under MDACS, the LRP assumes ongoing post-market obligations:

Obligation	Detail
Adverse event reporting	Report to MDD within 10 or 30 calendar days
FSCA management	Initiate and coordinate field safety corrective actions
Complaint handling	Maintain documented complaint handling system
Device traceability	Track specified devices to user level
Post-market surveillance	Systematically gather and analyse post-market safety data
Change notification	Notify MDD of significant changes to device or LRP
Service support	Arrange maintenance and service support where applicable

The LRP is the primary point of contact for all post-market matters. MDD may conduct independent investigations and requires full LRP cooperation.