Topic

Device vigilance

Medical device vigilance runs alongside medicinal-product pharmacovigilance and increasingly intersects with combination products. Browse briefings on field safety notices, post-market surveillance expectations, and regulator device hubs that device vigilance leads should track.

4 matching updates · Sorted by impact priority

publicMedicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) · United Kingdom · Updated Jun 15, 2026

Unique Liaison Programme between MHRA and FDA

Monitoring

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Notice

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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 4, 2026

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Monitoring

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medicines recall/notification

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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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publicMHRA · United Kingdom · Updated Jun 29, 2026

MHRA: Updated information on the MHRA's service providing scientific and regulatory guidance to developers of innovative medical products

Monitoring

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guidance

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