Periodic Safety Update Report (PSUR) under EU MDR 2017/745 – A Practical Guide for Medical Device Manufacturers

EU Medical Device Regulation (EU) 2017/745 (MDR) has significantly strengthened the requirements for post-market surveillance (PMS). Regulatory authorities now expect manufacturers to continuously monitor the safety, clinical performance, and benefit-risk profile of medical devices even after they have been placed on the market.

Within this lifecycle approach, the Periodic Safety Update Report (PSUR) plays a central role in ensuring that devices remain safe and effective when used in real-world clinical settings.

PSUR is not simply a regulatory formality - it is a strategic document that demonstrates a manufacturer’s commitment to patient safety, regulatory compliance, and continuous product improvement.

Regulatory Background of PSUR (Article 86)

PSUR requirements are defined under Article 86 of EU MDR 2017/745, which mandates manufacturers of Class IIa, Class IIb, and Class III devices to systematically review and summarize data collected through their PMS system. However, Class I devices are excluded from PSUR requirements and are instead subject to the Post‑Market Surveillance Report (PMSR) described in Article 85. The MDR emphasizes a proactive approach, where manufacturers must:

• Continuously collect and analyse post-market data
• Identify new risks or changes in known risks
• Confirm that the benefit-risk ratio remains acceptable
• Implement corrective and preventive actions where necessary

The Medical Device Coordination Group (MDCG) issued guidance document MDCG 2022‑21 on the harmonised implementation of Article 86 of the MDR, providing clarification on the scope, structure, content, and best practices for Periodic Safety Update Reports (PSURs).

What is a Periodic Safety Update Report (PSUR)?

A Periodic Safety Update Report (PSUR) is a standalone PMS document that provides a comprehensive summary of safety and performance data collected over a defined reporting period.

PSUR evaluates whether the medical device:

• Perform as intended
• Meet applicable safety requirements
• Maintain a favourable benefit-risk profile
• Confirm Clinical Safety and Performance Claims
• Comply with EU MDR regulatory expectations

The report integrates information from various sources, including complaints, vigilance data, literature review, Post-Market Clinical Follow-up (PMCF), and Corrective and Preventive Actions (CAPA).

Why PSUR is Critical for MDR Compliance

Under MDR, manufacturers are responsible for demonstrating continuous oversight of their devices throughout the product lifecycle.

PSUR supports:

• Early detection of safety signals
• Continuous clinical evaluation updates
• Evidence-based risk management
• Regulatory transparency
• Audit readiness

A well-prepared PSUR helps ensure that devices continue to meet General Safety and Performance Requirements (GSPR) and maintain their CE certification.

Devices within the Scope of the PSUR

Article 86 of Regulation (EU) 2017/745 of the European Parliament and Council and MDCG 2022-21 guidance on periodic safety update report (PSUR) in accordance with Regulation (EU) 2017/745 (MDR) explicitly stated that PSUR is required for the following devices:

• Class IIa Devices
• Class IIb Devices
• Class III Devices
• Custom made Devices (Class IIa, Class IIb and Class III)
• Legacy devices approved under the previous Medical Device Directive (MDD) that fall within Class IIa, Class IIb, and Class III categories are subject to these requirements and available in the European Market.
• Active medical devices previously regulated under the AIMDD are also subject to these requirements if they fall within Class IIa, Class IIb, or Class III and available in the European Market.

PSUR is not required for: 

• Class I devices
• Devices that are no longer placed on the EU Market before MDR date of application

Required Frequency for Updating PSUR:

PSUR Submission Requirements (EUDAMED & Notified Body):

PSUR must be submitted through EUDAMED once the PSUR module becomes fully functional.

Until full EUDAMED implementation:

• Class III device PSURs must be submitted to the Notified Body
• Implantable Class IIa and Class IIb PSURs must also be reviewed by the Notified Body
• Competent Authorities may request PSUR at any time

Manufacturers and Economic Operators must ensure PSUR is readily available upon request.

PSUR Structure as per MDCG 2022-21 guidance:

MDCG 2022-21 guidance recommends including the following information:

• Manufacturer and device identification details
• Notified Body information
• PSUR reference number, version number, and reporting period
• Executive summary
• Device description and intended use
• Sales volume, distribution, and patient exposure data
• Summary of vigilance data, incidents, and complaints
• Trend analysis and signal evaluation
• CAPA and preventive actions
• PMCF results and clinical evidence update
• Risk management feedback and RMF alignment
• Benefit–risk evaluation
• Overall conclusions on device safety, performance, and need for follow‑up actions

Key Data Sources for PSUR Preparation:

PSUR relies on multiple data sources collected through the PMS system:

• Complaint records
• Serious incident reports
• Field Safety Corrective Actions (FSCA)
• Post-Market Clinical Follow-up studies
• Clinical literature
• Feedback from healthcare professionals
• Distributor feedback
• Service and maintenance reports
• Risk management updates

Integration of these sources ensures a comprehensive safety evaluation.

Manufacturers often face practical challenges when preparing PSUR:

• collecting data from multiple sources
• maintaining consistency between CER, PMS, and RMF
• generating sufficient PMCF evidence
• performing statistically justified trend analysis
• estimating patient exposure data
• aligning vigilance and CAPA records
• maintaining updated technical documentation
• understanding MDCG expectations
• ensuring timely updates
• preparing for Notified Body review

A structured PMS system helps address these challenges effectively.

Best Practices for Developing a High-Quality PSUR:

Manufacturers can improve PSUR quality by:

• establishing strong PMS procedures
• maintaining traceability across CER, PMCF and RMF
• defining clear responsibilities for data collection
• using standardized templates
• performing periodic internal reviews
• applying structured trend analysis methods
• ensuring cross-functional collaboration between RA, QA and Clinical teams

Planning PSUR activities early helps avoid last-minute data gaps.

Concluding Insights:

PSUR is a critical component of the EU MDR framework, ensuring continuous evaluation of medical device safety and performance throughout the product lifecycle.

Rather than being viewed solely as a regulatory obligation, PSUR should be considered a valuable tool for improving product quality, strengthening clinical evidence, and maintaining patient safety.

Manufacturers who implement a proactive PMS strategy and maintain well-structured PSUR documentation will be better positioned to demonstrate compliance and sustain long-term success in the European market.