Periodic Safety Update Report (PSUR) Overview
Post-market surveillance has evolved from a compliance-driven activity to a continuous, data-driven process, where regulators expect manufacturers to demonstrate ongoing control over device safety and performance. Within this framework, the PSUR for medical devices and IVDs serves as a structured, periodic reassessment of the benefit-risk profile, reflecting real-world evidence generated throughout the product lifecycle.
Under the EU MDR and IVDR, a PSUR is required for higher-risk devices and is an integral part of the technical documentation. It is expected to demonstrate alignment across key regulatory documents, including the risk management file (RMF), clinical evaluation reports (CER) or performance evaluation reports (PER), and PMS systems, ensuring that post-market data is consistently analysed and reflected across the documentation ecosystem.
Freyr supports manufacturers in developing robust PSURs by integrating data from PMS, vigilance, and PMCF/PMPF activities into structured, audit-ready documentation. With a strong understanding of MDR and IVDR expectations and Notified Body review practices, Freyr enables the development of PSURs that demonstrate clear data traceability, defensible benefit-risk conclusions, and alignment across the entire regulatory framework
Periodic Safety Update Report (PSUR) under EU MDR vs IVDR (Key Comparison)
PSUR requirements under EU MDR and IVDR differ in scope, frequency, and submission expectations
| Document Aspect | EU MDR (Medical Devices) | EU IVDR (IVDs) |
|---|---|---|
| Regulation | EU 2017/745 | EU 2017/746 |
| Article | PSUR Article 86 MDR | PSUR Article 81 IVDR |
| Applicable Classes | Class IIa, IIb, III | Class C, D |
| Update Frequency | IIa: Every 2 years IIb & III: At least annually | Class C & D: At least annually |
| Data Focus | Safety and clinical performance | Safety and analytical/clinical performance |
| Post-Market Input | PMCF | PMPF |
| Submission | PSUR EUDAMED / NB (based on class & rollout) | PSUR EUDAMED / NB |
Freyr’s Periodic Safety Update Report (PSUR) Services
Freyr provides end-to-end PSUR services for the development, evaluation, and lifecycle management of Periodic Safety Update Reports under the EU MDR and IVDR. Our approach focuses on integrating fragmented post-market data into structured, regulator-ready documentation, ensuring that PSURs not only meet compliance requirements but also withstand detailed Notified Body scrutiny
PSUR Development and Authoring
Freyr supports the preparation of PSURs by consolidating data across PMS, vigilance, and clinical/performance systems to ensure completeness and consistency. Our approach includes:
- Structuring PSURs in line with MDR Article 86 / IVDR Article 81 and MDCG guidance
- Performing trend analysis and signal detection using real-world data
- Integrating PMCF (MDR) / PMPF (IVDR) outputs
- Developing clear, evidence-based benefit-risk conclusions
- Ensuring alignment with CER/PER, RMF, and PMS documentation
The objective is to deliver PSURs that demonstrate ongoing control over device safety and performance, rather than simply presenting data.
PSUR Review and Remediation
Freyr conducts detailed assessments of existing PSURs to identify deficiencies that may impact Notified Body review outcomes. Our remediation approach focuses on:
- Strengthening data traceability and source linkage
- Enhancing trend interpretation and justification
- Resolving inconsistencies across PSUR, CER/PER, RMF, and CAPA records
- Addressing Notified Body observations and queries
This enables manufacturers to transition from descriptive reports to analytically robust, review-ready documentation.
PSUR Gap Assessment
Freyr performs structured gap assessments to evaluate PSUR documentation against current MDR and IVDR compliance expectations, including MDCG guidance and Notified Body review practices. The assessment typically covers:
- Completeness and relevance of PMS data sources
- Robustness and methodology of trend analysis
- Adequacy of benefit-risk justification
- Alignment with supporting documentation and lifecycle updates
The outcome is a prioritised, risk-based remediation roadmap.
PSUR Lifecycle Management
PSUR is a recurring regulatory obligation that must reflect evolving post-market data and maintain consistency across reporting cycles. Freyr supports PSUR lifecycle management by:
- Updating PSURs based on new vigilance, complaint, and post-market surveillance data
- Incorporating PMCF/PMPF findings and evolving evidence
- Tracking risk trend evolution and risk profile changes
- Ensuring consistency across reporting cycles
- Aligning updates with regulatory expectations and audit timelines
This ensures PSUR documentation remains current, consistent, and audit-ready throughout the product lifecycle.
PSUR Strategy and Portfolio Structuring
For manufacturers with multiple devices, Freyr supports the development of PSUR strategies at the portfolio level. This includes:
- Defining scope at device family / Basic UDI-DI level
- Identifying opportunities for grouped PSURs
- Establishing a leading device approach
- Aligning with Notified Body expectations and certification strategy
This helps optimise documentation effort while maintaining regulatory compliance.
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Post-Market Surveillance Documentation
- Strong experience across PSUR MDR and IVDR requirements
- Strong understanding of MDCG 2022-21 guidance
- Understanding of Notified Body review expectations
- Expertise in aligning PSUR with CER, PER, RMF, and PMS systems
- Capability to manage multi-device and grouped PSUR strategies
- Reduced Notified Body queries and review cycles
- Improved audit readiness and documentation quality
- Strong data traceability and justification of conclusions
- Consistent cross-document alignment
- Support for complex PSUR scenarios
- Scalable lifecycle and portfolio support
Why Partner with Freyr?
- Proven experience supporting PSUR across diverse portfolios
- Strong alignment with MDR, IVDR, and MDCG guidance
- Practical, execution-focused regulatory approach
- Integrated quality, clinical, and risk expertise
- Flexible engagement models
- Global delivery capability
Frequently Asked Questions (FAQs)
01. What is a PSUR for medical devices and IVDs?
A PSUR (Periodic Safety Update Report) is a structured regulatory document used to evaluate post-market surveillance data and confirm the ongoing safety, clinical performance, and benefit-risk profile of medical devices and IVDs. It consolidates real-world evidence, including complaints, vigilance data, and PMCF/PMPF findings, to support continuous compliance with EU MDR and IVDR requirements.
02. Which devices require a PSUR under MDR and IVDR?
Under the EU MDR, a PSUR is required for Class IIa, IIb, and III medical devices, whereas under the IVDR, it applies to Class C and D IVDs. Lower-risk devices instead require a PMS Report (PMSR). This classification-based requirement ensures that higher-risk devices undergo more structured, periodic evaluations of safety, performance, and benefit-risk throughout the product lifecycle.
03. How often should a PSUR be updated?
PSUR update frequency depends on device classification. Under MDR, Class IIa devices are typically updated every two years, while Class IIb and III devices require at least annual updates. Under IVDR, Class C and D devices must be updated at least annually, reflecting the need for continuous monitoring of performance and safety based on real-world post-market data.
04. What information should a high-quality PSUR include?
A high-quality PSUR includes a structured analysis of post-market data, including complaints, vigilance events, trend evaluation, and PMCF/PMPF findings. It should clearly demonstrate how this evidence supports benefit-risk conclusions and any corrective or preventive actions taken. Strong PSURs also ensure consistency with CER, PER, and risk management documentation.
05. How is a PSUR submitted?
PSUR submission depends on device classification and regulatory requirements. For higher-risk devices, PSURs are typically uploaded to EUDAMED for Notified Body review, whereas for other devices, they must be made available upon request. Submission practices continue to evolve with the implementation of EUDAMED and regulatory updates under the MDR and IVDR frameworks.
06. When is the first PSUR required?
The first PSUR is generally required within one or two years after a device is placed on the market, depending on its classification. It typically covers the initial post-market period and may incorporate earlier PMS data where relevant, particularly for legacy or transitioning devices under MDR or IVDR frameworks.
07. Can multiple devices be included in a single PSUR?
Yes, PSURs can be prepared for a group of devices, typically at a device family or Basic UDI-DI level, provided they share similar characteristics, risk profiles, and regulatory conditions. Grouping must be justified and aligned with Notified Body expectations, ensuring consistency across data sources, analyses, and benefit-risk evaluations.
08. What is the difference between PSUR and PMSR?
PSUR and PMSR are both post-market surveillance documents, but they apply to different device classes. PSUR is required for higher-risk devices and involves a detailed evaluation of safety, performance, and benefit-risk. PMSR applies to lower-risk devices and provides a more concise summary of PMS activities and outcomes, reflecting a proportionate regulatory approach.
09. Why is Freyr regarded as a leading partner for PSUR?
Manufacturers should evaluate a PSUR service provider based on regulatory expertise, experience with MDR and IVDR, and the ability to integrate PSUR with related documentation, such as CER, PER, and risk management files. Freyr combines cross-functional expertise with practical Notified Body insight, enabling development of structured, audit-ready PSURs aligned with real-world regulatory expectations.
