Medical devices placed on the European market must not only demonstrate compliance at the time of CE marking but also maintain safety and performance throughout their lifecycle. To achieve this, the European Union Medical Device Regulation (EU MDR 2017/745) introduced more rigorous post-market surveillance (PMS) requirements, among which the Periodic Safety Update Report (PSUR) is a cornerstone for higher-risk devices.
What is PSUR?
The PSUR is a structured, recurring regulatory document that summarizes and evaluates data collected through PMS activities for a medical device. It provides evidence that the device continues to meet the General Safety and Performance Requirements (GSPRs) over time, ensures continuous benefit-risk evaluation, and supports transparency with regulators. More than just a compliance requirement, the PSUR is a strategic tool that consolidates real-world data, drives corrective and preventive actions, and informs stakeholders about the device’s ongoing safety and performance throughout its lifecycle.
Which devices require a PSUR?
PSUR requirements are outlined in Article 86 of the EU MDR, supported by MDCG 2022-21 guidance. It mandates that manufacturers of Class IIa, IIb, and III devices prepare PSURs at defined intervals.
- Class IIa devices – PSUR must be updated at least every two years.
- Class IIb and Class III devices – PSUR must be updated annually.
Purpose of PSUR
The PSUR ensures that manufacturers:
- Provide regular updates on device safety and performance.
- Continuously assess the benefit-risk profile.
- Identify emerging risks or trends from post-market data.
- Share findings with the Notified Body and competent authorities as required.
What Goes Into a PSUR?
A well-crafted PSUR includes:
- Device identification: UDI-DI, trade name, and basic device details.
- Summary of PMS Data: Complaints, incidents, trending, vigilance reports, and feedback.
- Benefit-risk evaluation: Updated evaluation based on post-market data
- Volume of sales and usage data: Data on how many devices are on the market and in use.
- PMCF outcomes (if applicable)
- Regulatory actions taken: CAPAs, updates to IFU, labeling, or design
- Conclusions: Demonstrating continued compliance with GSPRs.
Why does PSUR matter?
The PSUR is not just a compliance exercise—it is a proactive tool that:
- Strengthens patient and user safety.
- Increases regulatory trust and smooth audits.
- Helps manufacturers identify market trends and opportunities for improvement.
- Support proactive risk management
- Ensures devices remain competitive and compliant in the EU market.
Strategic Preparation Tips
To streamline PSUR development:
- Integrate PMS and PMCF systems: Use automation to collect and analyze data continuously
- Visualize trends: Infographics and dashboards help communicate findings to internal and external stakeholders
- Align with CER and CAPA: Ensure consistency across regulatory documentation
- Use modular templates: Facilitate updates and reduce turnaround time
Challenges in preparing a PSUR
- Collecting high-quality real-world evidence.
- Integrating data from multiple sources (complaints, vigilance, PMCF, registries).
- Ensuring alignment with the Clinical Evaluation Report (CER) and Risk Management File.
- Meeting strict update timelines (annual/biannual).
In summary, the PSUR is the backbone of continuous safety monitoring under EU MDR. By systematically evaluating post-market data, it ensures that medical devices consistently meet safety, performance, and regulatory expectations throughout their lifecycle.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/
Stay informed, stay compliant!