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Device Vigilance

Medical device vigilance spans MDR reporting, field safety corrective actions, and post-market clinical follow-up. PV Bulletin tracks FDA device recalls, EU MDR vigilance expectations, MAUDE and EUDAMED-related safety themes, and cross-over drug–device combination product updates for device vigilance leads.

1 update · Sorted by impact priority

publicTga · Australia · Updated May 24, 2026

Australia: TGA refreshes device post-market monitoring hub and responsibilities

Monitoring

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Devices

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