PV Bulletin

Role

Medical Device Vigilance Lead

Device Vigilance Leads manage post-market surveillance distinct from medicinal product pharmacovigilance yet increasingly interconnected. Monitor FDA device recalls, field safety notices, MDR vigilance obligations, and drug–device combination updates requiring coordinated safety assessment across PV and quality teams.

1 update · Sorted by impact priority

publicMhra · Updated Apr 29, 2026

MHRA issues April 2026 Safety Roundup for medicines and devices

Urgency: Medium

Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

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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