PSURs: Obstacles with Pending MDR Approval

There are many obstacles associated with writing PSURs for devices with pending MDR approval. Here at GLOBAL, we have some tips on how to navigate these challenges.

What are PSURs

PSURs are Periodic Safety Update Reports; these are reports that are intended to summarize and analyze the results of Post Market Surveillance data. The reports include a high-level overview of the device; however, the focus is on summarizing product performance and safety data within the most recent reporting period. This includes a comparison to data from previous reporting periods, which can include sales, complaints, PMCF studies, literature, and more.

The Impact of the Extension of MDR Transitional Period

In March 2023, the MDR transitional period was extended. Many of the devices that are due for an initial or updated PSUR are pending approval under MDR during this period. Many manufacturers have encountered some barriers in determining the most appropriate inputs, language, and presentation formats in this scenario. The question becomes: considering the recent extension of the MDR transitional period, how do we best navigate writing PSURs for devices pending MDR approval?

Let’s 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. This extension affects several sections of the PSUR, including the executive summary, device description, labeling information, and the sales, PMS, and PMCF data.

Executive Summary

For the executive summary, we need to know what regulations we are claiming compliance with—i.e. AIMDD/MDD, MDR, or both. If MDR is included, then we must verify the approval status of all devices within the PSUR scope. We suggest checking 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, identify the approval status of devices and note any changes since the previous version of the PSUR. If any ofthe 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.

Device Description

For PSURs, the device description section is very high level, similar to what might be included in an SSCP. Of course, the CER and other documentation are also great resources, but these may include more detail than is needed in the PSUR. 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.

Labeling Section

Labeling information should be pulled directly from IFU(s) for this section. Ensure that the IFU(s) for these sections have been approved under the MDR; otherwise, source previous versions that are in alignment with the current certification status.

Data Inputs

Finally, we reach our new data inputs. Data for a PSUR includes sales, PMS, and PMCF data. 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 explaining that the devices are currently CE marked under the MDD, approval under the MDR is pending.

Best Practices to Streamline PSUR Writing

Here at GLOBAL, 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 the regulations for compliance (AIMDD/MDD vs MDR vs both) and the approval status of all the devices in scope. It is crucial to ensure that the source documents provided are in alignment with their approval status, and if indicated, discuss whether you will be approaching the PSUR with a combined or separated data format related to device changes or updates.

These details will ensure an accurate and compliant PSUR, increasing efficiency in the approval process.

If you would like assistance with PSURs or other medical device writing, reach out for a consultation today!