Understanding the Periodic Safety Update Report (PSUR) under IVDR 2017/746

PSUR MADE SIMPLE: YOUR BEGINNER’S GUIDE TO IVDR SAFETY REPORTING
The Periodic Safety Update Report (PSUR) is a document required under the IVDR 2017/746 to make sure that higher-risk in vitro diagnostic devices remain safe after they are placed on the market. It applies only to Class C and Class D devices. The idea is simple: once the device is used in real life, manufacturers must regularly check how it performs and whether any new risks, complaints, or trends have appeared. A PSUR includes the key findings from the manufacturer’s post-market surveillance activities. This means analysing safety data, complaints, vigilance reports, and results from Post-Market Performance Follow-up (PMPF). It also includes conclusions on the device’s benefit–risk balance, any corrective or preventive actions taken, and sales or usage data to understand how widely the device is being used. The frequency is straightforward: Class C and D devices require an updated PSUR at least once every year. For Class D, the PSUR must be submitted electronically to the Notified Body through EUDAMED, and the Notified Body reviews it. For Class C, the PSUR does not have to be submitted through EUDAMED but must be available for the Notified Body or competent authorities whenever requested. PSUR is different from the PMS Report (PMSR), which is used for lower-risk Class A and B devices. PMSRs are simpler and only summarise basic safety information. In comparison, PSURs are more detailed because they are used for higher-risk devices where continuous monitoring is more important. Overall, PSUR helps manufacturers stay compliant, maintain safety, and keep their devices on the EU market without interruption.

PSUR MADE SIMPLE: YOUR BEGINNER’S GUIDE TO IVDR SAFETY REPORTING

The Periodic Safety Update Report (PSUR) is a document required under the IVDR 2017/746 to make sure that higher-risk in vitro diagnostic devices remain safe after they are placed on the market. It applies only to Class C and Class D devices. The idea is simple: once the device is used in real life, manufacturers must regularly check how it performs and whether any new risks, complaints, or trends have appeared.

A PSUR includes the key findings from the manufacturer’s post-market surveillance activities. This means analysing safety data, complaints, vigilance reports, and results from Post-Market Performance Follow-up (PMPF). It also includes conclusions on the device’s benefit–risk balance, any corrective or preventive actions taken, and sales or usage data to understand how widely the device is being used.

The frequency is straightforward: Class C and D devices require an updated PSUR at least once every year. For Class D, the PSUR must be submitted electronically to the Notified Body through EUDAMED, and the Notified Body reviews it.

For Class C, the PSUR does not have to be submitted through EUDAMED but must be available for the Notified Body or competent authorities whenever requested.

PSUR is different from the PMS Report (PMSR), which is used for lower-risk Class A and B devices. PMSRs are simpler and only summarise basic safety information. In comparison, PSURs are more detailed because they are used for higher-risk devices where continuous monitoring is more important. Overall, PSUR helps manufacturers stay compliant, maintain safety, and keep their devices on the EU market without interruption.

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.