Periodic Safety Update Report (PSUR) MDCG guidelines: What advantages do IVD manufacturers get?
The Medical Device Coordination Group (MDCG) released a new guidance paper last year (MDCG-2022-21). This paper covers Periodic Safety Update Report (PSUR) in accordance with EU Regulation 2017/745 (MDR). The PSUR serves as a guideline for both medical devices and in-vitro diagnostic medical devices (IVDs) in Europe. This regulation ((EU) 2017/746 (IVDR)) states that manufacturers of both class C and class D IVDs are required to create, maintain, and regularly update a PSUR. Article 81 and Annex III outline the necessary steps for this process. Notably, they state that the PSUR should include the results of a risk-benefit analysis, the main findings of the post-market performance follow-up (PMPF), the number of devices currently on the market, an estimate of the demographic information of device users, and ideally an estimate of how often the device is used.
Not Required, but Still Useful
IVDs are not actually governed by MDCG-2022-21, but it can still serve as a helpful document for IVD manufacturers, since it will provide useful guidance on how to meet PSUR legal requirements. The MDCG also suggests that guidance for IVDR may be similar to the guidance for MDR, at least for overlapping or similar parts. Even manufacturers of class A and class B IVDs will find useful information in these guidelines even though PSURs are not required for these devices. PSUR guidelines include information about how to present information in a post-market surveillance (PMS) report, as is required by IVDR Article 80.
How Legacy Devices are Affected
Legacy IVD medical devices have been governed by PMS and PMPF standards since May 26, 2022. Certain exceptions do apply for legacy devices, as outlined in MDCG-2022-8. This includes the absence of a requirement to update the Summary of Safety Perrformance (SSP) and Performance Evaluation report (PER), since these documents were not required by the IVDD. PMS results for all legacy devices can be reported in a PMS report, as outlined in Article 80, without the need to create a PSUR, as outlined in Article 81, thanks to different classification methods between IVDD and IVDR. Manufacturers of legacy devices still have the option of creating a PSUR for these devices if they so choose.
What should the PSUR Include?
It is important to note that, as outlined in MDCG-2022–21 for IVDs, the PSUR should be its own separate document included as part of the technical file. It should provide a summary of all post-market surveillance activities and all data gathered, and also include an analysis based on that device’s PMS plan. This doesn’t mean that it’s necessary to repeat all of the statistics and reports from the PMS Plan. A summary of the results and conclusions are all that’s required, and manufacturers will need to include a clear explanation of any unnecessary facts in the report. While a general overview of statistics and results is all that’s required for a PSUR, it should also include detailed information about any serious incidents regarding safety and corrective actions taken, as well as information about less-serious incidents and unwanted side effects. PSURs should also include information from relevant literature including databases, registers, specialist and technical reports, as well as trend reporting, information from users, distributors, and importers, and a clear record of complaints and feedback. PSUR reports must also include any publicly-available information about similar devices to provide a basis for comparison.
Timetables for Legacy Devices
The organizational template for the PSUR is outlined in Annex I of MDCG-2022–21. Annex II includes tables which show how to present necessary information on sales volume, estimated size, and population characteristics of device users, as well as serious incidents and FSCA and CAPA as they relate to the device in question. Each device or group/category of devices needs its own PSUR, and manufacturers must identify a “leading device” that dictates the schedule for that PSUR. Data collection should start on the date that the device is certified by the IVDR, and end on the date of the IVDR certificate’s anniversary or an agreed-upon timetable as negotiated with the Notified Body. For the first PSUR, legacy devices should start their data collection time on May 26, 2022, and also treat that date as the IVDR Date of Application (DoA).
