A Complete Guide to the Periodic Safety Update Report and the GSPR Checklist for Medical Devices

[I3CGLOBAL]

In the highly regulated world of medical devices, manufacturers must maintain strict vigilance over the safety and performance of their products. Regulatory frameworks such as the EU MDR (Medical Device Regulation 2017/745) mandate continuous monitoring throughout a device’s lifecycle—not just during pre-market phases. Two essential components of this process are the Periodic Safety Update Report (PSUR) and the GSPR Checklist. Together, they help manufacturers ensure compliance, improve product quality, and safeguard patient well-being.

This article explores what the Periodic Safety Update Report entails, the role of the GSPR Checklist, and how effectively integrating both can streamline compliance.

What Is a Periodic Safety Update Report (PSUR)?
A Periodic Safety Update Report is a comprehensive document required under the EU MDR for Class IIa, IIb, and III medical devices. It is designed to summarise post-market surveillance (PMS) data at defined intervals. While Class IIa devices require PSUR updates every two years, Class IIb and III devices must be updated annually.

The PSUR is more than just a regulatory formality—it is a structured evaluation of real-world performance. Its purpose is to ensure that manufacturers remain accountable for their devices, even after market launch.

Key Components of a PSUR
A strong periodic safety update report should include:

1. Summary of Post-Market Surveillance Findings
Manufacturers gather data from adverse events, user feedback, complaints, trend reports, vigilance activities, and clinical follow-up.

2. Benefit-Risk Evaluation
The PSUR must reassess the device’s benefit-risk profile using real-world evidence. If new risks emerge, corrective actions may be required.

3. Sales and Usage Data
Assessing exposure can help regulators understand the scale and impact of any identified risks.

4. Corrective and Preventive Actions (CAPA)
Any CAPA measures taken during the reporting period must be documented clearly.

5. Integration with PMCF Activities
If a device requires Post-Market Clinical Follow-up (PMCF), the PSUR should summarise findings and their effect on safety and performance claims.

In short, the periodic safety update report acts as a direct link between ongoing device performance and regulatory oversight.

The Role of the GSPR Checklist in EU MDR Compliance
While the PSUR focuses on periodic safety evaluation, the GSPR Checklist is all about ensuring initial and sustained compliance with the General Safety and Performance Requirements (GSPRs) under Annex I of the EU MDR.

The GSPRs outline a set of essential criteria that every medical device must meet. These requirements cover everything from chemical properties and biological safety to usability, cybersecurity, and clinical evaluation.

What Does the GSPR Checklist Contain?
Manufacturers use the GSPR Checklist to systematically demonstrate conformity. It typically includes:

A list of all applicable GSPRs for the device.

Evidence and documentation showing compliance for each requirement.

References to technical file elements, such as risk management documentation, biocompatibility reports, and clinical evidence.

Rationales for non-applicable requirements, if justified.

The GSPR Checklist is essential during the conformity assessment stage, but it also plays a crucial role throughout the device’s lifecycle.

How the PSUR and GSPR Checklist Work Together
Although the periodic safety update report and the GSPR Checklist serve different functions, they complement each other perfectly within the MDR framework.

1. Closing the Loop Between Pre-Market and Post-Market Phases
The GSPR Checklist ensures that the device is initially compliant, while the PSUR confirms that the device continues to meet safety and performance requirements over time.

2. Ensuring a Living Technical Documentation System
Under MDR, technical documentation is not a one-time exercise. The PSUR provides new data that may update or reinforce GSPR evidence. For example:

New clinical findings may strengthen clinical evaluation claims.

New risk information may require updates to the risk management file.

Emerging cybersecurity threats may require updates to design controls.

3. Supporting Regulatory Inspections and Notified Body Audits
During audits, Notified Bodies increasingly examine the alignment between the periodic safety update report and the GSPR Checklist. Consistency between the two documents demonstrates strong quality management and regulatory maturity.

Best Practices for Aligning PSUR and GSPR Documentation
To streamline compliance and reduce regulatory risk, manufacturers should adopt these best practices:

1. Establish a Robust PMS Data Collection System
Accurate PSURs depend on strong post-market surveillance channels.

2. Maintain a Dynamic Technical File
Keep the GSPR Checklist updated as new evidence emerges.

3. Create Cross-Functional Review Teams
Involve regulatory, clinical, quality, engineering, and risk management teams in both PSUR and GSPR updates.

4. Use Digital Tools for Documentation
Modern software platforms can automate data collection, version control, and traceability.

5. Review and Update Benefit-Risk Assessments Regularly
This ensures ongoing alignment with GSPR requirements.

Conclusion
The Periodic Safety Update Report and the GSPR Checklist are fundamental pillars of EU MDR compliance. While the GSPR Checklist confirms that a medical device meets safety and performance requirements at the design and development stage, the PSUR ensures these claims hold true throughout the device’s commercial life. By integrating both documents effectively, manufacturers can achieve regulatory readiness, improve product quality, and enhance patient safety.

If you need help preparing a PSUR, PMCF plan, or a complete GSPR Checklist, expert MDR consultants or regulatory specialists can provide valuable support.