PSUR Template

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What is a PSUR? A Complete Guide to Periodic Safety Update Reports Under EU MDR

The EU Medical Device Regulation (MDR) 2017/745 places strong emphasis on continuous monitoring of device performance and safety after CE marking. One of the key tools introduced for this purpose is the Periodic Safety Update Report (PSUR).

If your device falls into Class IIa, IIb, or III, PSUR is no longer optional—it is a legal obligation under Article 86. In this article, we explain what a PSUR is, when it is required, and how to prepare it to remain compliant with MDR requirements.

What is a PSUR?

A Periodic Safety Update Report (PSUR) is a structured report that summarizes and evaluates the post-market surveillance (PMS) data collected for a medical device over a defined period.

The goal of the PSUR is to provide a consolidated assessment of:

Benefit-risk ratio
Residual risks and emerging risks
The effectiveness of risk control measures
Volume of sales and usage patterns
Relevant field safety corrective actions (FSCA)
Serious incidents and complaints

The PSUR serves as a living document to demonstrate that the manufacturer continues to monitor and ensure the device’s safety and performance after it is on the market.

Who Needs a PSUR and When?

Under Article 86 of MDR, PSUR is required for:

Class III and implantable devices – PSUR must be updated at least annually.
Class IIb and IIa devices – PSUR must be updated at least every two years.

Class I devices are exempt from PSUR but must still maintain PMS reports (Article 85).

For devices with multiple variants under one Basic UDI-DI, a single PSUR may be prepared per device family, provided the risk profile is consistent across variants.

What Must a PSUR Include?

According to Article 86(1) and Annex III of MDR, a compliant PSUR must contain the following elements:

Executive summary
Device description including Basic UDI-DI
PMS data analysis, including volume of sales, usage, and geographical distribution
Summary of serious incidents, FSCA, and vigilance reports
Results of benefit-risk evaluation
Main findings from PMCF activities
Conclusion on continued conformity, need for updates to CER or RMF
Corrective or preventive actions taken
Recommendations for safety or performance improvements

The PSUR should be data-driven, clearly referenced, and traceable to internal documentation (CER, RMF, PMS Plan, PMCF Plan).

PSUR Submission Requirements

Class III and implantable devices: PSUR must be submitted to the Notified Body via EUDAMED once operational, or directly by other agreed means.
Class IIa and IIb devices: PSUR must be made available upon request by authorities or the Notified Body.

Note: Even if submission is not mandatory, PSUR must be prepared, signed, and dated, and kept ready for audit or inspection.

How Does PSUR Relate to Other MDR Documents?

The PSUR is not a standalone report. It should align with:

PMS Plan and PMS Report (Annex III)
PMCF Plan and PMCF Evaluation Report (Annex XIV)
Risk Management File (RMF) (ISO 14971)
Clinical Evaluation Report (CER) (Annex XIV, Part A)

If new findings from the PSUR affect the benefit-risk balance, they must trigger updates to the CER, RMF, labeling, or instructions for use (IFU).

Common Pitfalls in PSUR Preparation

Manufacturers often encounter these issues:

Lack of quantitative data, such as device sales or exposure volume
Vague or generic conclusions on safety or benefit-risk
Poor traceability between PSUR, RMF, and CER
Failure to include PMCF findings or integrate PMS data
Missing justification for delayed or absent FSCA

Avoiding these issues requires a cross-functional approach, combining regulatory, clinical, quality, and post-market surveillance teams.

How AF Pharma Can Help

At AF Pharma, we support medical device manufacturers at every stage of their MDR compliance journey. Our PSUR services include:

PSUR templates aligned with MDR Article 86 and MDCG 2022-21
Data integration from CER, RMF, PMS and PMCF
Literature monitoring and signal detection
Writing and formatting PSURs for Class IIa/IIb/III devices
Submission support for Notified Body review

Whether you are building your first PSUR or optimizing your existing reporting process, we help ensure your documentation is compliant, audit-ready, and integrated into your overall PMS strategy.

Need support with your PSUR or PMS process?Contact us at: www.afpharmaservice.com or email maria@afpharmaservice.com

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