UK Post-Market Surveillance (PMS), PMSR & PSUR

Great Britain strengthened its medical-device post-market surveillance requirements from 16 June 2025. Manufacturers must treat PMS as a structured regulatory system that continuously evaluates safety, performance and emerging risk throughout the product lifecycle.

Strengthen Your GB Post-Market System

The Closed-Loop Post-Market Evidence System

We connect real-world post-market data directly back into the technical file and risk management system:

Complaint / Incident

Signal Detection

Risk Reassessment

CAPA Action

PMS / PSUR Update

Technical File Refinement

Regulatory Action

12 Key PMS & PSUR Deliverables

PMS system gap assessment against new GB post-market regulations

Proactive PMS Plan development, review and lifecycle remediation

Post-Market Surveillance Report (PMSR) authoring for Class I devices

Periodic Safety Update Report (PSUR) strategy and scheduling for Class IIa, IIb, III & IVDs

Complaint data evaluation, statistical trending and threshold monitoring

Safety and performance signal evaluation and emerging risk detection

Benefit-risk reassessment based on commercial clinical experience

Corrective and Preventive Action (CAPA) linkage and investigation support

ISO 14971 risk management file and hazard traceability updates

Technical documentation feedback loops and CER / PER data refreshes

Structured information flow governance between foreign manufacturer and UKRP

Periodic executive reviews and continuous post-market lifecycle maintenance

Vigilance, Incident Reporting & FSCA Support

1Incident triage and adverse event causality determination

2Serious-incident reportability assessment against MHRA guidance criteria

3MHRA submission support via the MORE (Medicines & Medical Devices Online Reporting) portal

4Statistically significant trend reporting and adverse signal alerts

5Field Safety Corrective Action (FSCA) root-cause and containment strategy

6Field Safety Notice (FSN) drafting, customer notification and MHRA review

7Initial, follow-up and final closure reporting within mandatory statutory timelines

8CAPA integration preventing recurrence of field device failures

9UKRP representation and direct liaison with MHRA vigilance enforcement officers

10Coordinated global vigilance alignment preventing conflicting international notices

Our Approach

Post-Market Intelligence That Protects Market Authorization

The objective is not only to file periodic reports on time, but to determine whether post-market data changes the known risk profile, performance conclusions, labeling, corrective actions or commercial strategy.

Mandatory Reporting Timelines

Serious Public Health Threat: Report to MHRA within 2 days

Death or Unanticipated Deterioration: Report to MHRA within 10 days

Other Serious Incidents: Report to MHRA within 15 days

Audit Your PMS System

Ensure your post-market surveillance aligns with the June 2025 GB statutory rules.

Request PMS Assessment

Establish an Audit-Proof Post-Market Surveillance & Vigilance Engine

Our post-market specialists handle PMSR, PSUR, and MORE incident reporting with precision.

Book a Consultation