What is a PSUR under the Medical Device Regulation (MDR) and Why Is It Important?
What is a PSUR and Why Is It Relevant in the US? In the EU, PSURs are a mandatory document for certain device classes, providing a structured summary of post-market surveillance data and analysis. For US manufacturers, a similar approach aligns with FDA’s requirements for post-market monitoring, such as Medical Device Reporting (MDR) and compliance with 21 CFR Part 803. Incorporating PSUR elements into US regulatory practices can enhance safety and provide a consistent, systematic review of devices once they reach the market.
In a typical PSUR, manufacturers include:
- Conclusions from benefit-risk assessments.
- Key findings from Post-Market Clinical Follow-Up (PMCF).
- Data on device sales, usage, and the characteristics of the user population.
How Often Should You Update Your PSUR? PSUR Frequency Requirements by Device Class
Frequency of Updates To maintain device safety and compliance, the frequency of PSUR updates is guided by device class:
- High-Risk Devices (Class III and IIb): PSURs should be updated annually, mirroring FDA's expectations for ongoing post-market assessment of high-risk devices.
- Moderate-Risk Devices (Class IIa): Updates should occur at least biennially.
- Custom-Made Devices: PSURs are included within the device’s post-market documentation.
Note: PMS requirements of the EU MDR also apply to legacy devices under the MDD/AIMDD. For these devices, classification is under the Directive and the manufacturer’s issuance of the PSUR remains mandatory after the transition period until the end of the device lifetime defined in the technical documentation
PSUR Submission and Review Process under the Medical Device Regulation (MDR)
PSUR Submission and Review Processes While EU regulations require submission to a Notified Body, US manufacturers can use similar review structures with the FDA, incorporating findings from PSUR-like data into FDA-mandated reporting tools, such as the FDA’s eMDR system. For high-risk devices, regular updates aligned with PSUR standards could be requested by the FDA, particularly if post-market data reveals safety concerns.
Key Components of a PSUR under the Medical Device Regulation (MDR)
Key Components of a PSUR for Enhanced Safety A US-adapted PSUR approach would focus on:
- Benefit-Risk Analysis: Continuous, evidence-based assessments to confirm that device benefits outweigh risks, aligning with the FDA’s risk management principles.
- Post-Market Clinical Data: Consistent real-world data from follow-up programs, providing insights similar to those outlined in FDA’s PMCF guidance.
- Sales and Usage Metrics: Data on sales volume and device user demographics, which can help pinpoint any usage trends that impact safety.
Compliance and the Role of the PMS Plan
Manufacturers must demonstrate compliance with Article 83 of the MDR through a detailed PMS plan. This plan outlines how the manufacturer will collect and use information from various sources, including:
- Serious incident reports.
- Non-serious incident data.
- Technical literature.
- Feedback from users.
- Publicly available information about similar devices.
The Role of a Robust PMS Plan Under Article 83 of the MDR, a PMS plan is essential to ensuring safety, which closely parallels the FDA’s Quality System Regulation (21 CFR Part 820). A strong PMS plan outlines the collection of data from:
- Incident reports.
- Non-serious adverse events.
- Clinical literature and user feedback.
- Information from similar devices on the market.
In the US, a well-documented PMS plan incorporating these elements can strengthen compliance and enhance overall device reliability.
Guidance and Implementation
Guidance and Industry Support Guidance issued by the Medical Device Coordination Group (MDCG) can serve as a model for US manufacturers, offering a structured approach to quality management and PMS strategies. Although US regulations differ, adopting these principles can support a quality management system that meets FDA standards while remaining globally informed.
Conclusion
The PSUR is an essential tool for maintaining the safety and efficacy of medical devices throughout their lifecycle. By requiring regular updates and thorough analysis of PMS data, the MDR aims to ensure that any risks associated with medical devices are identified and mitigated promptly. Manufacturers must stay vigilant and adhere to the guidelines to ensure their devices remain safe and effective for users.
If you are unsure about your PSUR requirements, please contact your DQS representative and we can explain the timing.
