Periodic Safety Update Report under IVDR
INTRODUCTION
Under the European In Vitro Diagnostic Regulation (IVDR) 2017/746, ensuring the continued safety and performance of in vitro diagnostic devices doesn't stop after market entry. One critical mechanism supporting this ongoing vigilance is the Periodic Safety Update Report (PSUR) , a structured report required for higher-risk devices that helps manufacturers monitor real-world performance and maintain compliance throughout the device’s lifecycle.
WHAT IS A PERIODIC SAFETY UPDATE REPORT UNDER IVDR?
The Periodic Safety Update Report (PSUR) is a mandatory post-market surveillance (PMS) document required for Class C and Class D in vitro diagnostic devices. Its primary goal is to ensure that manufacturers continuously monitor the safety and performance of their devices once they are placed on the market.
According to Article 81 of IVDR 2017/746, a PSUR must include the following:
Results and conclusions from analysis of post-market surveillance data, as defined in the PMS plan under Article 79.
Rationale and description of any preventive or corrective actions taken.
Benefit-risk determination conclusions.
Main findings from the Post-Market Performance Follow-up (PMPF) activities.
Sales volume data and estimation of the population using the device, including usage frequency where possible.
These reports are updated at least annually and form part of the technical documentation in compliance with Annexes II and III of the IVDR.
FREQUENCY AND DOCUMENTATION REQUIREMENTS
Device Class | PSUR Requirement | Submission and Review Process |
Class D | Mandatory | Must be submitted electronically to the Notified Body via the EUDAMED system (Article 87). The Notified Body must review it and upload its evaluation, making it accessible to competent authorities. |
Class C | Mandatory | PSURs must be made available to the Notified Body during conformity assessment and shared with competent authorities upon request. Submission via EUDAMED is not obligatory. |
PSUR VS PMSR UNDER IVDR: KEY DIFFERENCES EXPLAINED
Both the Periodic Safety Update Report (PSUR) and the Post-Market Surveillance Report (PMSR) are essential tools under the IVDR framework to ensure that medical devices remain safe and effective throughout their lifecycle.
Criteria | PSUR (Article 81) | PMSR (Article 80) |
Applicable Device Classes | Mandatory for Class C and Class D devices (higher risk) | Required for Class A and Class B devices (lower risk) |
Frequency of Submission | Must be updated at least annually throughout the device's lifetime | Compiled when necessary, depending on risk and market performance |
Level of Detail | Highly detailed: includes benefit-risk assessment, PMPF findings, sales data, population estimates, and usage frequency | More concise: summarises PMS data and any preventive/corrective actions taken |
Notified Body Involvement | Mandatory for Class D (submitted via EUDAMED and reviewed by the Notified Body); Class C reports must be made available upon request | Not reviewed by Notified Body; shared only with authorities if requested |
Integration with Technical File | Must be part of the technical documentation (Annex II & III) | Also included in technical documentation, though less central |
Submission Method | Electronically submitted for Class D; made available for Class C | Kept internally and provided upon request to authorities |
CONCLUSION
The Periodic Safety Update Report is a critical part of the manufacturer’s lifecycle responsibility under IVDR Article 81. For IVD manufacturers with Class C and D devices, building a compliant PSUR process is essential to meet EU regulatory expectations, ensure patient safety, and maintain uninterrupted market presence.
NEED HELP WITH PSUR IMPLEMENTATION?
In Morulaa, If you're unsure how to prepare your PSUR or need a template aligned with IVDR Annex III, our regulatory team can assist. From technical documentation audits to full post-market compliance solutions, we’re here to help streamline your path to IVDR compliance.