Senior Regulatory Affairs Executive
4 Years of Experience Medical device regulatory professional specializing in EU MDR 2017/745
PSUR compliance for medical device manufacturers is an essential part of post-market surveillance under the European Union Medical Device Regulation (EU MDR 2017/745). A Periodic Safety Update Report (PSUR) helps manufacturers evaluate real-world device performance, review safety information, assess the benefit-risk profile, and document corrective and preventive actions throughout the device lifecycle.
Under Article 86 of the EU MDR, manufacturers of Class IIa, Class IIb, and Class III medical devices must prepare and maintain PSURs according to the applicable requirements. The report must reflect findings from post-market surveillance (PMS), including post-market clinical follow-up (PMCF), where applicable.
This guide explains PSUR requirements, update frequency, essential report contents, and nine practical rules manufacturers should follow to maintain regulatory compliance.
What Is a Periodic Safety Update Report (PSUR)?
A Periodic Safety Update Report (PSUR) is a regulatory document that summarizes and evaluates post-market surveillance data gathered for a medical device or a justified group of devices.
The main objective of post-market surveillance is to show that the device remains safe and effective once it is in the market. The PSUR also provides a summary of the manufacturer’s assessment of new risks, the benefit-risk ratio and any preventive or corrective actions taken.
The PSUR is one of the post-market surveillance requirements under Article 86 of the EU MDR. It supports the continuous risk management and provides relevant information to notified bodies and competent authorities.
Who Needs to Prepare a PSUR Under EU MDR?
PSUR requirements generally apply to manufacturers of the following medical devices under the EU MDR:
PSURs for Class IIa medical devices must be updated at least every two years and as needed.
PSURs for Class IIb medical devices must be updated at least once a year.
PSURs for Class III medical devices must be updated at least once a year.
Custom-made devices: Documentation for Class IIa, IIb, and III custom-made devices is handled in accordance with the applicable MDR provisions, and they are subject to applicable PSUR requirements.
Annex XVI products: Depending on their classification and applicable regulations, products falling under the MDR’s applicable scope are subject to pertinent requirements.
Legacy devices: Devices that are still being marketed under applicable transitional provisions should be evaluated against the relevant regulatory requirements and guidance.
PSUR vs PMS Report: What Is the Difference?
In the EU MDR, Class I medical devices usually need a Post-Market Surveillance Report (PMSR) in accordance with Article 85, not a PSUR under Article 86. The PMSR includes the results and conclusions of the PMS activities, the rationale and description of any preventive and corrective actions taken. It should be updated as required.
The following table summarises the main differences.
| Requirement | PSUR | PMS Report (PMSR) |
|---|---|---|
| Applicable devices | Class IIa, IIb, and III | Class I |
| Regulatory reference | Article 86, EU MDR | Article 85, EU MDR |
| Update frequency | At least every two years for Class IIa; annually for Class IIb and III | When necessary |
| Main purpose | Periodic evaluation of safety, performance, and benefit-risk | Summary of post-market surveillance results and conclusions |
| Regulatory availability | Made available or submitted according to applicable requirements | Made available to competent authorities upon request |
Requirements should always be confirmed against the device classification, applicable MDR provisions, and relevant guidance.
What Information Should a Medical Device PSUR Include?
A compliant PSUR should provide a clear and evidence-based assessment of the device’s post-market performance. The report must summarize the PMS data under Article 86 and include the manufacturer’s rationale and description of the preventive and corrective actions.
Key information includes:
Benefit-risk determination: Conclusions on whether the device’s benefit-risk profile remains acceptable.
Post-market clinical follow-up (PMCF): Main findings from PMCF activities, where applicable.
Sales and distribution data: Device sales volumes and estimates of the size and characteristics of the population using the device.
Usage information: Frequency of device use, where practicable.
PMS findings: Relevant information collected through the post-market surveillance plan.
Corrective and preventive actions: Details of actions taken, including their rationale and outcomes.
Safety and performance trends: Analysis of relevant complaints, incidents, emerging risks, and other applicable post-market information.
The report should be consistent with the manufacturer’s risk management documentation, clinical evaluation, PMCF documentation, and other relevant technical records.
PSUR Update Frequency Under EU MDR
The frequency of PSUR updates depends on the classification of the medical device.
| Device classification | Minimum update frequency |
|---|---|
| Class IIa | At least every two years |
| Class IIb | At least annually |
| Class III | At least annually |
Manufacturers should also amend reports as appropriate based on relevant findings from the PMS. For devices made to order, and for particular device configurations, the applicable requirements should be verified.
How Are PSURs Submitted or Made Available?
Article 86 distinguishes between the applicable reporting and availability arrangements.
Class III and implantable devices: PSURs are submitted via the relevant electronic system to the notified body which was involved in the conformity assessment, in accordance with Article 86 and the applicable guidance.
Other devices for which a PSUR is required: the manufacturer makes the PSUR available to the notified body involved in the conformity assessment and, upon request, to the competent authorities.
For practical details on preparation, grouping, and submission, manufacturers should refer to the European Commission’s MDCG 2022-21 guidance on PSURs.
Common Mistakes to Avoid in PSUR Preparation
Manufacturers can improve reporting quality by addressing these common issues:
Incomplete data collection: Excluding relevant complaint, clinical, literature, or field safety information.
Weak benefit-risk conclusions: Presenting data without clearly explaining its implications for device safety and performance.
Poor traceability: Failing to connect PSUR findings with risk management, clinical evaluation, and corrective action records.
Missed reporting deadlines: Overlooking the applicable annual or biennial update schedule.
Inconsistent device grouping: Grouping devices without a clear rationale or appropriate regulatory alignment.
Unclear corrective action documentation: Reporting actions without explaining their rationale, implementation, or follow-up.
Insufficient review and approval controls: Failing to maintain evidence of internal assessment and authorization.
A structured PSUR preparation process helps manufacturers address these gaps before regulatory review.
How Operon Strategist Supports PSUR Compliance
Operon Strategist provides medical device regulatory consulting to support manufacturers with post-market compliance, technical documentation, quality management, and international regulatory requirements.
Support can include:
PSUR preparation support: Organizing relevant post-market information and developing structured report documentation.
Regulatory gap assessment: Reviewing existing documentation against applicable regulatory requirements.
Post-market surveillance alignment: Supporting consistency between PSURs, PMS plans, risk management files, and clinical evaluation documentation.
Quality management support: Helping establish documented processes for data collection, review, corrective actions, and regulatory record maintenance.
Global regulatory consulting: Supporting market access and regulatory compliance across the EU, United States, India, the United Kingdom, Saudi Arabia, and other markets.
Related services include European CE Marking, ISO 13485 quality management systems, FDA 510(k) submissions, and medical device regulatory consulting.
For manufacturers seeking assistance with PSUR documentation, post-market surveillance processes, or EU MDR compliance, Operon Strategist can help assess documentation needs and identify practical next steps.
Need support with PSUR compliance for medical devices?
Contact Operon Strategist to discuss medical device regulatory documentation and post-market compliance requirements.
Senior Regulatory Affairs Executive | 4 Years of Experience
Medical device regulatory professional specializing in EU MDR 2017/745 technical documentation, CE marking, risk management, clinical and biological evaluation, and post-market surveillance. His expertise includes SFDA MDMA submissions, CDSCO licensing, ISO 13485, MDSAP, US FDA regulatory requirements, and BIS certification.
