Post-market surveillance is an essential component of regulatory compliance for medical devices and in vitro diagnostics sold in the United Kingdom. The UK Medical Device Regulations (UK MDR) and the In Vitro Diagnostic Regulations (IVDR) both mandate ongoing safety monitoring and vigilance activities after a device is placed on the market. The PMS process includes several key components such as developing a PMS plan, data collection, data analysis, reporting, corrective actions, among others. These requirements ensure continued patient protection and safety, early detection of risks, and timely corrective actions as part of lifecycle compliance.
In this article, we explain the UK MDR post-market surveillance obligations, how IVDR vigilance UK fits into the overall framework, and the role of MHRA safety monitoring in maintaining regulatory conformity.
Understanding Post-Market Surveillance Under UK MDR and IVDR
Under both UK MDR and IVDR frameworks, manufacturers are required to establish and maintain a systematic post-market surveillance system. This is not a one-time activity but an ongoing process that must be proportionate to the risk class, intended use, and performance characteristics of the device.
As per the new UK’s regulation, the definition of serious events has been expanded to includes side effects which have negative impact on the health of the users. It is the responsibility of the manufacturer to report the incident if the devices cause death, or a serious deterioration in health, even if no harm occurred due to a pre-use check. The timeline for reporting is 10 calendar days for death and deterioration and 2 days for public health threat and serious incidents with 15 days. Non-serious incidents arising from non-conformities should be dealt with and documented internally. The surveillance system must be well-documented, actively monitored, and regularly updated throughout the lifecycle of the product.
Key Elements of UK MDR Post-Market Surveillance
- Proactive Collection of Post-Market Data
One of the core pillars of UK MDR post-market surveillance is the systematic collection of data from real-world use. This involves:
- Feedback from end users
- Device performance metrics
- Field safety notices
- Quality complaints and incident reports
Data collection should be ongoing and proportionate to the risk associated with the device.
- Regular Safety and Performance Evaluation
Manufacturers must periodically review collected data to assess whether the device continues to perform as intended without compromising safety. Analysis should include trend evaluation and risk assessment to identify emerging issues before they escalate.
This is a critical aspect of MHRA safety monitoring that aligns with regulatory expectations for transparency and risk mitigation.
- Documentation and Reporting
All findings from post-market surveillance must be well documented. This includes:
- Surveillance plans
- Periodic summary reports
- Risk assessments
- Corrective and preventive actions (CAPAs)
These documents form part of the technical file and must be made available during regulatory audits or inspections.
IVDR Vigilance UK Requirements
For in vitro diagnostic devices (IVDs), the surveillance and vigilance obligations mirror many of the requirements under UK MDR but are tailored to the unique risks associated with diagnostic products.
- Incident Reporting and Trend Analysis
Under IVDR vigilance UK, manufacturers are required to report incidents that lead to or could lead to serious public health consequences. The reporting timeline is defined by the risk severity, and manufacturers must also monitor trends that could indicate systemic problems.
- Field Safety Corrective Actions (FSCAs)
When potential safety issues are identified post-market, manufacturers must initiate field corrective actions promptly. These actions must be documented and reported to the Medicines and Healthcare products Regulatory Agency (MHRA) where appropriate.
This is part of robust MHRA safety monitoring and is intended to prevent harm to users.
- Periodic Safety Update Reports (PSURs)
For higher-risk IVDs, manufacturers are often required to produce and submit Periodic Safety Update Reports, summarizing the outcomes of surveillance activities and any corrective actions taken.
These reports form an essential component of compliance under IVDR vigilance UK and must be retained in the technical documentation.
The Role of MHRA Safety Monitoring
The UK competent authority, the Medicines and Healthcare products Regulatory Agency (MHRA), oversees post-market activities and enforces compliance with both UK MDR and IVDR requirements.
Key functions of MHRA safety monitoring include:
- Reviewing incident and trend reports submitted by manufacturers
- Evaluating field corrective actions
- Performing compliance audits and inspections
- Issuing safety communications or enforcement actions when necessary
MHRA also provides guidance on expected vigilance practices and reporting pathways for market participants.
Integrating Surveillance Into a Quality Management System
Both UK MDR and IVDR require that post-market surveillance be integrated into the overall quality management system (QMS) of the manufacturer. A compliant QMS should include:
- Pre-defined surveillance objectives
- Routine performance evaluation
- Corrective action triggers
- Oversight mechanisms for trend analysis
- Regular reporting schedules
Integration ensures consistency and helps maintain regulatory compliance over time.
Conclusion
Meeting post-market surveillance obligations under both UK MDR post-market surveillance and IVDR vigilance UK is essential for ensuring ongoing safety and effectiveness of medical devices and IVDs in the UK market. These requirements emphasize proactive data collection, incident reporting, trend analysis, and corrective action—all supported by transparent and timely MHRA safety monitoring practices.
Regulatory compliance is not static; it is a continuous commitment that begins after product approval and extends throughout the lifecycle. A systematic approach to post-market surveillance strengthens patient safety, reduces risk, and supports long-term marketplace success.