How do you make a PSUR that is MDR / IVDR compliant?
Medical Device PSUR is a new requirement, but I3CGLOBAL supports small, medium, and large scale manufacturers with technical know-how, experience, and a dedicated team who knows what notified bodies want to see in PSUR.
Periodic Safety Update Report (PSUR)
A Periodic Safety Update Report is a documented report that includes a summary of data acquired through post-market surveillance. This information assists competent authorities and NBs in establishing the device’s risk-benefit ratio in accordance with EU 2017/745 and 2017/746. The information gathered through these reports assists both patients and healthcare professionals in obtaining the essential updates.
When the Post Market Surveillance Report (PMSR) is supplemented with information about high-risk devices, it is referred to as a periodic safety update report (PSUR). Periodic safety update report is prepared throughout the lifetime of moderate to the high-risk device (Class IIa, IIb and III) by summarizing the results of Vigilance, PMS & PMCF data with any rationale and description of the CAPA taken which includes:
- The main findings of the PMCF
- The conclusions of the benefit-risk determination;
- The volume of sales of the device and an estimated evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
The Periodic safety update report must be conducted by setting out the conclusions of the benefit-risk determination, the main findings of the PMCF and the volume of sales of the device, and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
EU MDR 2017/745 PSUR Requirement
The PSUR must be submitted to the Notified Body or the Competent Authority (upon request) during the conformity assessment and it is a compulsory part of the technical documentation as per article 86 of EU MDR 2017/745. It must also be updated as and when required.
As per EU MDR article 86, the Periodic Safety Update Report must be prepared by the manufacturers of moderate and high-risk devices (class IIa, IIb, and III) and must be prepared for throughout the lifetime of the device, after it has been released to the market (as it requires PMS information).
It must be submitted to the Notified body or competent authority at the time of conformity assessment and are part of the technical documentation. PSUR of class IIa device must be updated when necessary and every two years. PSUR of Class IIb and III must be updated at least annually.
New MDR insist PSURs must detail the following
- Post-market surveillance data
- A comprehensive benefit-risk analysis and conclusions of risk-benefit determination
- Vigilance report
- The device’s current market status in the EU
- Post-market clinical follow-up
- Device sales volume and user population estimation and device usage frequency
The creation of a Post Market Surveillance Report (PMSR) is mandated under Chapter VII, Article 85 of the EU Medical Device Regulation (MDR). The PMSR is intended for Class I devices with low risk. It must explain the findings and conclusions of your Post Market Surveillance (PMS) data, as well as provide a justification and explanation of any remedial measures done for items already on the market. This report forms part of your Technical Documentation and is updated as needed before being made accessible to EU Competent Authorities on request.
The Periodic Safety Update Report (MDR PSUR) is an extension of a Post Market Surveillance Report (PMSR) that contains information for higher risk devices. The PSUR is intended for devices with moderate to high risk (IIa, IIb, III). It outlines the findings and conclusions derived from your PMS data. Additional material includes an overview of post-market data, vigilance reporting, and the current status of these devices on the EU market. The PSUR, like the PMSR, requires you to give a reason and explanation of any corrective measures taken for a product that is already on the market. Article 86 of the MDR outlines the contents of this report but stages as such not mentioned.
- collection of all the information from the manufacturers such as PMS, PMCF, CAPAs was taken, benefit-risk conclusion, sales volume, characteristics of the user population, usage frequency of device;
- review of the data collected;
- documentation of the data collected in a PSUR template;
- results of the analysis;
- conclusion and final assessment.
PSUR Medical Device and Role of Consultants
I3CGLOBAL can help the medical device manufacturers to write the Periodic Safety Update Report acceptable to third parties well organized and searchable format after collecting all the relevant data such as conclusions of the PMS, benefit-risk determination, CAPAs taken with justification, information from sales volume, usage frequency, and user population information.
We are capable of writing an organized, clear, and unmistakable Periodic Safety Update Report if the following data are provided by the medical device manufacturers:
- Results from analyses of the PMS;
- Conclusions from the analyses of the PMS;
- Any rationale and description of CAPAs taken;
- Conclusions of the benefit-risk determination;
- Main findings of the PMCF;
- Data of sales volume of the device;
- Size and other characteristics of the of user population;
- Information of usage frequency of the device
When and where to conduct Medical Device PSUR?
As per EU MDR article 86, the PSUR must be prepared by the manufacturers of moderate and high-risk devices (class IIa, IIb, and III) and must be prepared for throughout the lifetime of the device, after it has been released to the market (as it requires PMS information). It must be submitted to the Notified body or competent authority at the time of conformity assessment and are part of the technical documentation.
How should I conclude PMSR?
PMS Report (PMSR) and PSUR are two different documents as of the MDR. PMSR is for class I devices and PSUR for moderate and high-risk devices. The conclusion of PMSR will be based on the data collected from PMS of the class I device and the CAPAs took for it.
The PSUR, on the other hand, must have a conclusion about the data collected from risk-benefit, PMCF, the volume of sales, usage frequency and user population information, ultimately checking the safety and performance of the devices which can be input to documentations such as CER, RMF, IFU and so on.
What will happen if I did not incorporate PSUR in my new MDR Technical File?
As per MDR article 86, it is compulsory that the manufacturers of Class IIa and above must produce a PSUR if their device is already available in the market. If it is not incorporated, the NB or the competent authority may question and withhold the CE mark application.
What should I do with my device, if my PSUR is NOT satisfactory?
EU market commercialization will be with-held by the concerned authority if the PSUR is not satisfactory, however, sales of the device to other countries can be continued.
What are the applicable PSUR regulation / Standards?
The applicable regulation is REGULATION (EU) 2017/745 and regarding PSUR is mentioned in article 86.
Benefits of Periodic Safety Update Report
- Provide an evaluation of the risk-benefit ratio
- Constant update of safety reports
- Provide insight into the worldwide safety data
- Risk identifications
- Corrective and preventive actions