Post-Market — Staying Compliant

Sub-section	Covers
Post-Market Overview	Ongoing responsibilities, key obligations by device class
Vigilance Reporting	Serious incidents, reporting timeframes, eVigilance portal
Post-Market Surveillance	PMS plan, PMS report, PSUR, PMCF/PMPF
Field Safety Corrective Actions	When an FSCA is required, process, Swissmedic notification
Labelling & UDI	MedDO Annex I §23, DE/FR/IT language requirements, UDI, eIFUs
Advertising & Promotion	TPA Chapter 4 advertising rules
Registration Maintenance	DAPI updates, significant changes

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