The preparation of a Periodic Safety Update Report (PSUR) by medical device manufacturers is amongst the new requirements set forward by EU MDR 2017/745.
What is a Periodic Safety Update Report (PSUR)?
Periodic Safety Update Report (PSUR) is a documented report that contains a summary of data gathered from post-market surveillance.
Which Classes of Medical Devices Require PSUR?
For devices that belong to Class I, the Market Surveillance Report replaces the Periodic Safety Update Report.
Requirements of the Periodic Safety Update Report
Article 86 of EU MDR 2017/745 defines the requirements for the content to be included in the PSUR.
According to the EU MDR 2017 /745, PSUR should be prepared for every medical device or medical device category. It should include
- results and conclusions of analyses of data collected from post-market surveillance
- rationale and description of preventive and corrective measures taken.
What is Benefit-Risk Analysis (BRA)?
The benefit-risk analysis is a continuous process, and it is part of the risk-management process. The benefit-risk analysis uses the information obtained from post-market surveillance. The manufacturer must perform the BRA throughout the life-cycle of the medical device. But the factors that are needed to be considered for this risk-assessment process vary from device to device.
Findings of Post-market Clinical Follow-up
Regarding each specific medical device class, PSUR should include findings of any completed or ongoing post-market clinical follow-up.
Medical Device & its Sales Volume
Estimate Number of Devices Sold
According to EU MDR, the PSUR will include an estimate of the devices that have been sold. The grouping of these devices will be done by their basic UDI-DI level or reference code level.
The Volume of Sales of Medical Devices
The number of devices that are being provided should be based upon their worldwide volume of sales. They must be divided into the volume of sales in EEA+CH+TR and worldwide manner.
Based on their product type, the issues given in the illustration below can be used for reporting medical devices:
Also, the manufacturer should provide information regarding the device’s distribution numbers if the post-market use of the device has occurred in special populations.
Frequency of Documenting Periodic Safety Update Report (PSUR)
The preparation requirement of PSUR will start from 26 May 2021, which is the day of implementation of EU MDR. While preparing the PSUR, manufacturers can take help from the document Guidance on Sampling of MDR Class IIa/ Class IIb and IVDR Class B/ Class C for the Assessment of Technical Documentation.
Competent Authorities and PSUR
As part of their vigilance investigations, clinical trial reviews, and market surveillance activities, the Competent Authorities can request and review the PSURs. The results of these processes can either be added or not added into the database.
Post-Market Surveillance & Guidelines of EU MDR
To provide practical guidelines to post-market surveillance activities, EU MDR 2017/745 provides medical device manufacturers with necessary guidelines. These guidelines comprise the manufacturers’ requirements to prepare an EU MDR compliant Product Safety Update Report.
Want to Know More About PSUR Preparation?
If you are a medical device manufacturer looking forward to preparing an EU MDR complied PSUR for your medical device, consult TS Q & E. We excel in providing services that help the medical device industry and manufacturers become compliant with EU MDR and ISO 11135. Contact us today at our website https://tsquality.ch/.