UK Vigilance & Field Safety Corrective Action (FSCA)
When a safety issue arises, the regulatory response must be grounded in event seriousness, device relationship, recurrence potential, and risk to patients. We provide end-to-end incident triage, MORE reporting, and FSCA execution.
13 Core Vigilance & FSCA Capabilities
Connecting Vigilance Directly to the Technical File
We do not separate vigilance from the technical file. A serious incident can change the benefit-risk profile, trigger CAPA, affect labeling, require additional verification or validation, and alter the post-market evidence plan. We assess the regulatory consequence beyond the individual incident report.
MORE Reporting Portal
All serious adverse incidents in Great Britain must be reported electronically via the MHRA MORE (Medicines & Medical Devices Online Reporting) system. Our team handles account administration and direct XML/portal lodgements.
Active Field Action?
Have an urgent adverse incident or potential field safety corrective action in the UK?
Contact Vigilance TeamProtect Patient Safety and Regulatory Good Standing in the UK
Our vigilance specialists navigate MHRA reporting, Field Safety Notices, and rapid incident resolution.