What is a PSUR under MDR?

A Periodic Safety Update Report (PSUR) is a post-market surveillance document required by MDR 2017/745. It provides a summary of the results and conclusions of post-market surveillance data, including sales volume, population exposure, serious incidents, field safety corrective actions (FSCAs), and benefit-risk determinations.

Who is required to prepare a PSUR?

Under MDR, manufacturers of Class IIa, IIb, and III devices must prepare PSURs. - Class IIa: PSUR every 2 years. - Class IIb & III: PSUR annually. Manufacturers of Class I devices do not need a PSUR, but must maintain a Post-Market Surveillance (PMS) Report.

How does CDSCO view PSUR in India?

In India, CDSCO has adopted PSUR requirements primarily for pharmaceuticals (Schedule Y of Drugs and Cosmetics Rules). For medical devices, CDSCO requires Periodic Safety Update Reports/Periodic Performance Update Reports (PPR/PSUR) in line with post-market vigilance obligations, especially for higher-risk devices. The format is harmonized with EU MDR to support global submissions.

What is the content of a PSUR?

As per MDR Article 86 and CDSCO’s guidance, the content includes: - Results of PMS data collection and analysis - Sales volume & population exposure estimate - Summary of vigilance reports & FSCA implementation - Benefit-risk assessment based on new evidence - Conclusion on overall safety and performance

What is the difference between a PSUR and PMS Report?

PMS Report → Required for Class I devices; updated as needed. PSUR → Required for Class IIa, IIb, and III devices; structured, time-bound reporting to authorities or notified bodies. In CDSCO context, higher-risk medical devices are aligned closer to the MDR’s PSUR concept.

Who reviews the PSUR?

In EU: PSURs for Class III and implantable devices are uploaded to EUDAMED and reviewed by the Notified Body. In India: PSURs submitted to CDSCO are reviewed by Subject Expert Committees (SECs) and CDSCO officers for safety signal detection and compliance.

How often must PSURs be submitted?

EU MDR: - Class IIa → every 2 years - Class IIb & III → annually CDSCO: - For drugs: every 6 months for the first 2 years, then annually. - For medical devices: submission frequency follows risk class and approval conditions, often in line with global requirements.

What happens if a PSUR identifies new risks?

Both MDR and CDSCO require manufacturers to: - Update the risk-benefit profile - Implement corrective or preventive actions - Update IFUs and labeling if necessary - Submit Field Safety Corrective Actions (FSCA) if risks are serious

Do PSUR requirements apply to imported devices in India?

Yes. Importers/License Holders must maintain and submit PSURs to CDSCO as per approval conditions. These reports should consolidate global safety data, not just India-specific cases.

Is there a template or format for PSUR submission?

EU MDR: Format is based on MDCG guidance and Annex III MDR. CDSCO: Accepts structured safety update reports; applicants often adapt EU MDR PSUR formats to Indian submissions.

Navigating PSUR Requirements under the Medical Device Regulation (MDR)

The Periodic Safety Update Report (PSUR) is a Key element of the European Union’s Medical Device Regulation (MDR 2017 745), introduced under Article 86, to ensure the continuous evaluation of medical device safety and effectiveness post-market. This report is an essential requirement for manufacturers to review and monitor any issues related to their products after they have been released to the market, based on real-world data gathered from post marketing surveillance (PMS) activities. The PSUR plays a crucial role in assessing whether a device’s performance and safety align with the original expectations established during clinical trials and bench testing.

PSUR and Medical Device Notified Bodies: Ensuring EU MDR Compliance

A PSUR (Periodic Safety Update Report) is that medical device companies create to check on the safety and effectiveness of their products once they are being used by the public. Think of it as a regular check-up for a device after it’s been released for sale.

Device Identification and Scope

Exact specification of the device(s) in the PSUR, detailing model/version and intended purpose.
Explanation if the report covers a group or family of devices rather than a single product.

Benefit-Risk Assessment

A concise evaluation confirming whether the benefits of the device continue to outweigh any known or potential risks, based on the latest available data.

Post-Market Clinical Follow-up (PMCF) Summary

A summary of ongoing clinical data collected from real-world usage, highlighting any new or emerging safety or performance information.

Analysis of Sales and Usage Data

Data on device sales volume, user demographics, and usage patterns, which helps identify any trends suggestive of safety concerns.

Post Marketing Surveillance (PMS) Findings

Insights gathered from incident reports, user feedback, technical literature, and other relevant sources that contribute to safety monitoring.

Corrective and Preventive Actions (CAPA)

Documentation of any safety-related actions taken or planned to address identified risks or issues surfaced through PMS or PMCF activities.

Summary and Conclusions

Overall conclusions about device safety and performance, stating if the benefit-risk profile remains favorable and whether any updates to risk management are necessary.

Administrative Information (where applicable)

For certain device classes (notably Class III and implantables), include relevant administrative details such as report reference numbers, versioning, and medical device notified bodies involvement.

The PSUR is important because it keeps an ongoing check on the device’s performance in the real world, so that any problems can be spotted early, ensuring the device is safe and effective for continued use.

PSUR (Periodic Safety Update Report) frequency requirements based on device class

Class IIb and Class III Devices:

Manufacturers must update and submit a PSUR for these devices at least once every year.
The report should be submitted within a year of the device’s certification date or when the device transitions to the new MDR (Regulation 2023/607).
Even if the full MDR assessment hasn’t been completed, manufacturers are required to act on any new data or trends promptly.

Class IIa Devices:

Manufacturers of these devices must provide a PSUR at a minimum of once every two years.
However, in some cases, more frequent updates might be necessary based on the situation.

Class I Devices:

A PSUR is not applicable to Class I devices that fall under the categories of measuring, reusable, or sterile

Custom-Made Devices:

custom-made medical devices, the PSUR is required as part of the documentation according to the rules under Annex XIII of the MDR. This helps ensure that the safety and performance of the device are continually monitored, even after it has been made and delivered.

PSUR Preparation for Medical Devices: Post Marketing Surveillance Under EU MDR

PSUR Preparation Timeline

After collecting the data, manufacturers must work within a set timeline to analyze it, prepare the PSUR, and submit it to the authorities.This preparation phase must be planned well in advance to ensure timely compliance.

Content of the PSUR

The report must include:

Cover Page – Manufacturer & device details, NB info, PSUR ref/version, data period, contents.
Executive Summary – Key actions since last PSUR, NB actions, benefit–risk status statement.
Device Description & Intended Use – Classification, dates, status, purpose, Basic UDI-DIs/EMDN, grouping justification.
Sales & Population Data – Units sold, population size & characteristics.
PMS Data – Serious incidents (IMDRF-coded), trend reporting, FSCA summary, CAPA list.
PMCF & Other PMS Sources – Complaints, literature, registries, public data, other sources.
Specific PMCF Activities – Findings & conclusions from studies.
Conclusions – Data validity, new risks/benefits, benefit–risk change statement, actions taken.

Periodic Safety Update Report Submission and Review Process

PSUR submission requirements differ according to the device classification :

Class III and Implantable Devices: These devices require electronic submission of the PSUR to the Notified Body responsible for the device’s conformity assessment. The Notified Body reviews and evaluates the report, which is then uploaded to the European Database on Medical Devices (EUDAMED) for access by competent authorities.

Other Device Classes: Manufacturers must make PSURs available to the Notified Body and competent authorities upon request. The PSUR may be requested as part of routine surveillance, or in cases where safety signals or new risks associated with the device arise.

MDR Regulation and PMS Plan: Ensuring Medical Device Compliance

Under Article 83 of the MDR, manufacturers are required to have a post marketing surveillance(PMS) plan in place, detailing how they will collect and assess safety and performance data from a variety of sources. These sources include:

Incident Reports: Data from serious and non-serious incidents related to the device.
User Feedback: Information from device users regarding performance or issues encountered in the field.
Technical Literature: Studies and articles relating to the device or similar devices.
Publicly Available Information: Data about similar devices and general safety and performance trends.

This PMS plan is critical for ensuring compliance with MDR requirements and for maintaining the safety of devices over time.

Implementing PSUR Requirements: Key Guidance for Manufacturers

In December 2022, the Medical Device Coordination Group (MDCG 2022-21) released guidance to help manufacturers implement Periodic Safety Update Report (PSUR) requirements. The document provides clarification on key terms, including the “device certification date,” and details the procedure for submitting PSURs for legacy devices. While manufacturers are encouraged to adjust their quality management systems to meet these requirements, some flexibility is permitted, as long as the core compliance with Article 86 is maintained.

Conclusion

The Periodic Safety Update Report (PSUR) plays a critical role in maintaining the safety and performance of medical devices throughout their lifecycle. By mandating regular updates and detailed assessments of post marketing surveillance (PMS) data, the Medical Device Regulation (MDR) ensures that potential risks are identified and addressed quickly, allowing devices to remain safe for both users and regulators. Manufacturers must comply with the PSUR submission and update obligations to stay in line with regulatory standards and support the continued success and safety of their products.
For any additional guidance or questions regarding your PSUR requirements, it’s advisable to reach out to your Notified Body or the relevant regulatory authority.

REFERENCES

MDR 2017 745

Article 86: Requires manufacturers to submit a Periodic Safety Update Report (PSUR) to assess the safety and performance of the device post-market.
Article 83: Outlines the post marketing surveillance (PMS) obligations, including the need for a PMS plan and collection of safety data.
Annex XIII: Provides guidelines for custom-made and legacy devices regarding PSUR requirements.
MDCG 2022-21: Guidance on post marketing surveillance and Post-Market Clinical Follow-up under MDR” – Provides details on PSUR frequency, content, and submission process.