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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

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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