UK MHRA Guidances: Strengthening Device Oversight: Periodic Safety Update Reports (PSURs) for Medical Devices
- Sharan Murugan
- Jun 18
- 3 min read
In the ever-evolving landscape of medical device regulation, the Periodic Safety Update Report (PSUR) plays a pivotal role in ensuring patient safety through continuous monitoring and transparent reporting. Introduced under the UK Medical Devices Regulations (UK MDR) 2002 (as amended), PSURs are now mandatory for certain device classes, aligning Great Britain with global best practices in post-market surveillance.
A Periodic Safety Update Report (PSUR) is a comprehensive document that manufacturers of medical devices must submit to approved bodies. Its purpose is to provide a periodic, structured assessment of a device’s benefit-risk profile throughout its lifecycle, based on real-world data and post-market experience. The requirement applies to manufacturers of:
Class IIa and IIb medical devices
Class C and Class D in vitro diagnostic devices (IVDs)
Class I and Class A/B IVD devices are not required to submit PSURs but must maintain Post-Market Surveillance (PMS) reports, which are less intensive.
The PSUR process strengthens post-market surveillance by:
Providing a systematic, data-driven approach to monitoring device performance and safety.
Facilitating early identification of safety signals and trends.
Ensuring timely implementation of corrective actions.
Supporting transparent communication between manufacturers, regulators, and healthcare providers
Structure and Content of a PSUR
A well-prepared PSUR must follow a specific format and include:
Executive Summary: Overview of findings and conclusions.
Device Description: Unique Device Identification (UDI), risk class, intended use.
Market and Sales Data: Geographic coverage, volumes, and distribution.
Incident and FSCA Analysis: Evaluation of reported adverse events and field safety corrective actions.
Benefit-Risk Update: Evidence-based assessment using clinical data, literature, and vigilance findings.
Trend Reporting: Analysis of non-serious incidents or complaints that may indicate emerging risks.
Corrective/Preventive Actions: Summary of safety enhancements undertaken since the last report.
These reports must be updated at defined intervals:
Annually for Class III, Class IIb implants, Class D IVDs.
Every two years for Class IIa and other Class IIb devices.
Every five years for Class C IVDs.
PSURs are not standalone—they are a key output of a manufacturer’s Post-Market Surveillance (PMS) system, alongside:
Incident reporting
Trend analysis
FSNs and FSCAs
Vigilance communications
By feeding into the PMS framework, PSURs ensure data transparency, enable proactive risk mitigation, and support a culture of safety and accountability.
To further support risk monitoring, MHRA has released tailored guidance for high-risk, life-supporting devices. Here's a brief overview of each:
This guidance outlines vigilance reporting requirements for coronary stents, including in-use failures, vessel damage, and thrombosis. It emphasizes early detection and analysis of stent-related complications due to their critical nature in cardiac intervention.
Targeting pacemakers, defibrillators, and leads, this guidance stresses the need for prompt reporting of battery failures, sensing anomalies, or pacing malfunctions. It ensures long-term patient safety in life-sustaining devices.
Given their permanent implantation and vital role in circulatory health, this guidance prioritizes vigilance around valve thrombosis, infection, structural failure, and migration, requiring close clinical monitoring and robust PMS.
Focused on retrievable and permanent IVC filters, the guidance mandates tracking of migration, fracture, and embolization risks. It underscores the importance of retrieval tracking and patient follow-up systems.
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