Hello and welcome to today’s session which is focusing on how to navigate the obstacles associated with writing PSURs with pending MDR approvals.
As a reminder, PSURs are Periodic Safety Update Reports that are intended to summarize and analyze the results of Post Market Surveillance or PMS data. These do generally include a high level overview of the device (or devices); however the focus is on summarizing product performance and safety data within the most recent reporting period with a comparison to data from previous reporting periods (this can include sales, complaints, PMCF studies, literature, etc). As we also know, in March 2023 the MDR transitional period was extended. As many of the devices that are due for an initial or updated PSUR are pending approval during this period, we have encountered some barriers in determining the most appropriate inputs, language, and presentation formats in this scenario. So our question becomes: considering the recent extension of the MDR transitional period, how do we best navigate writing PSURs for devices pending MDR approval?
Firstly, I will highlight the affected areas of the document and proceed by breaking down each section with items of note, potential questions, and tips to ensure accurate and consistent documentation. As we see here, this does affect several sections of the PSUR, including the executive summary, device description, labeling information, and the sales, PMS, and PMCF data.
For the executive summary, we need to know what regulations we are claiming compliance with—in this case it would be AIMDD/MDD versus MDR or both, depending on the approval status of the devices. If MDR is included, then we must verify the approval status of all devices within scope first. Be sure to check all models if you are working with a large device family, as the models in scope of a single PSUR may receive MDR certification at different times. In the executive summary, please identify the approval status of devices and note any changes since the previous version of the PSUR. If any of the models in scope were recently approved under the MDR, then this is where we should address how you will be presenting the data throughout the rest of the document. Generally, we have found that if there were no major changes to indications or fundamental function of the device as it was presented for MDR certification, then it is safe to combine the data from before and after the date of MDR certification. However, if there has been a major change e.g. an additional indication, then we should consider separating the data. When separating the data, it is important to identify a specific stop date for reporting and designate the time periods that you will be using throughout the PSUR.
Next is the device description. For PSURs, the device description section is very high level. If available, an SSCP generally provides a great high-level description for input. Of course, the CER or other manufacturer documentation are also great resources, just remember to keep it high level. Here is where sourcing becomes critical: if the devices in scope of the PSUR are pending MDR certification, we cannot use the documents from that submission, even if they are approved in your QMS system. If this is the case, we need to use the MDD/AIMDD-compliant versions of source documents instead. This means the information may not be as up to date, but it is compliant with what we are claiming within the PSUR.
Moving forward, the same principle applies for the labeling section. We should be pulling directly from IFUs for this section. Ensure that the IFUs for these sections have been approved under the MDR; otherwise, source previous versions that are in alignment with the current certification status.
Finally, we reach our new data inputs. Here we must present our data in accordance with the decision laid out in our executive summary. For combined data, we can present simply by standard reporting periods. For data separated by MDD or AIMDD versus MDR, we should use the predetermined stop date and present data separately for those reporting periods. This applies to sales, PMS, and PMCF data so be sure to note these in the relevant data tables and narratives within these sections. We recommend adding a footnote onto data tables to signify the approval status of the devices in scope, as shown here in the example.
In conclusion, we have developed a few best practices to help mitigate some of these issues and streamline your PSUR writing process. When initiating a new PSUR, we recommend that you confirm and/or source the following: which regulations for compliance (AIMDD/MDD vs MDR vs both), the approval status of all the devices in scope (especially if you have a large family of devices), ensure that the source documents provided are in alignment with their approval status as we mentioned before, and if indicated, discuss whether you will be approaching with a combined or separated data format related to device changes or updates.
This concludes our topic for today. Thank you for your time!
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