Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have not shifted, leaving manufacturers struggling to understand precisely how to be compliant.
As with anything related to medical device and IVD regulation, the biggest challenge is interpreting the regulation because there are many gray areas. Manufacturers are also challenged by the complexity of the documents and an unprecedented level of regulatory scrutiny and attention. When it comes to post-market surveillance, manufacturers are eager to get guidance on how to:
- Gather correct and complete source data.
- Determine how to present the data.
- Identify trends and detect signals.
- Perform a complete and insightful analysis of data.
Guidance for periodic safety update reports (PSURs) and post-market surveillance (PMS) reports is forthcoming but hasn’t yet been released. Although guidance is currently expected to be released later this year, the release date continues to be pushed. Unfortunately, there is no time to wait for a PSUR guidance document as looming deadlines approach. In the meantime, RQM+ experts have come up with a list of top 10 suggestions for creating a PSUR or PMS report under MDR and IVDR.
Requirements for PSUR and PMS Reports
Under EU MDR, manufacturers are required to prepare PSURs on an annual basis for Class IIb and III medical devices. For Class IIa devices, PSURs must be prepared when necessary but at least on a biannual basis. PSURs for Class IIa and IIb need to be made available upon request, and for Class III, they must be submitted via EUDAMED. Under IVDR, manufacturers of Class C devices are required to prepare PSURs on an annual basis and make them available upon request. Manufacturers of Class D devices are required to prepare PSURs and submit them to the notified body on an annual basis.
Under EU MDR, manufacturers of Class I devices, and under IVDR, manufacturers of Class A and B devices, are required to prepare PMS reports when necessary and make them available upon request. Both documents are similar, but the PSUR is more comprehensive than the PMS and has additional sections required.
Top 10 Tips for Writing PSURs and PMS Reports
While the PMS sections of the regulations can be easily understood, there is some room for interpretation about what goes into a PSUR or PMS report. This is why manufacturers rely on guidance documents to help determine the best practices for writing these reports. In the absence of clear guidance, manufacturers are left to interpret the regulations on their own, but following these recommendations can help.
1. Keep the goal top of mind.
As you create a PSUR/PMS report, keep in mind that the primary role of the document is to provide a comprehensive, concise, and critical analysis of the PMS data relating to a device or a group of devices, with the goal of identifying any potential changes to the benefit/risk profile of the device(s). The goal is not to create paperwork but rather to improve device(s) and provide a full and accurate picture of a device’s post-market performance. Keeping this in mind throughout the process can help you determine what data to include.
2. Align your report with your PMS plan.
As you create a PSUR/PMS report, keep in mind that it must be aligned with the corresponding device’s PMS plan, being mindful of any changes required to that PMS plan based on experience and learnings gained throughout the PSUR/PMS report creation process. Consider the PMS plan a living document and update it as needed based on the PSUR/PMS report and any other relevant reports.
3. Identify and gather source data.
When embarking on the creation of a PSUR/PMS report, you need to identify and gather source data. Before doing that, it is essential that you invest the time to fully understand the data and conduct careful up-front planning to ensure that the data can be consistently retrieved, compiled, and presented. The creation and use of templates can be very beneficial, but it’s important to know that each template must be tailored to the manufacturer’s unique process and data sources. Additionally, it is helpful to do a trial run to ensure that systems in place contain data in a format that is usable for the PSUR/PMS report.
4. Meet the minimum data requirements outlined in the regulation.
Ultimately, a PSUR/PMS report should include any data that is relevant, but you must ensure that data referenced in the document includes at a minimum:
- Data regarding sales and usage
- Product complaints
- Reporting of serious incidents
- Field safety corrective actions
- Trend reports
- Relevant data from literature research
- Corrective and preventive actions
5. Perform data analysis.
One of the most common mistakes manufacturers make is simply compiling and presenting the data in the PSUR/PMS report. This is a sure way to generate questions from a notified body and prolong the process. In addition to presenting the data, you should also analyze it in order to identify any trends or signals that may have an adverse impact on the benefit/risk ratio of the device(s). The PSUR/PMS report should communicate what the data means for the device(s). To do this successfully, expertise with both spreadsheets and data analysis is critical.
6. Reference previous PSURs/PMS reports.
The work is not done after the initial PSUR/PMS report submission, and notified bodies are paying attention to the actions manufacturers are taking based on the information in these documents. You should always review the previous PSUR/PMS report because it is essential that all previous actions required have been carried out or are being carried out. Additionally, monitoring of potential adverse trends from the previous PSUR/PMS report is required.
7. Review literature on a regular basis.
Literature should be reviewed regularly—at least quarterly, but more frequently is better—to ensure that new important safety information is identified and addressed. Bear in mind that there may be information relevant to your device’s risks that need to be reviewed. Additionally, information on patterns of use may need to be summarized. By incorporating literature review into other regularly scheduled management reviews, potential risks can be identified and addressed early.
8. Develop a process to identify and address signals and trends.
MDR and IVDR require manufacturers to monitor trends and signals. It is up to manufacturers to develop their own clear processes, but they must include alert limits and should also include detection, validation, assessment, and recommendations for action. Any signals that are new, ongoing, or closed during the PSUR/PMS reporting period should be included in the report.
The statistical significance of trending methods should be clear and tailored to the risk class and residual risk of the device. For example, if a trend threshold is complaints above the average plus 3-sigma for a defined period, then for a higher-risk product, it may be necessary to set the trend threshold differently, maybe to an average plus 2-sigma.
9. Follow all PMS-related line items in the regulation.
Refer to guidance on SSCP and PMCF/PMPF to learn more about how the MDR and IVDR are being interpreted, including the guidance provided in MDCG 2020-7 and 2020-8. By closely reviewing these guidance documents, manufacturers can get a sense of how the regulations are being interpreted and apply the same logic to PMS sections.
10. Coordinate with a cross-functional group.
Perhaps one of the most important tips for creating successful PSURs/PMS reports will not be found in any guidance document. Coordinate with a cross-functional group to generate and approve the PSUR/PMS report and create a continuous feedback loop of information that flows between the PSUR/PMS report, CER/PER, SSCP/SSP, and PMCF/PMPF. All deliverables in the MDR and IVDR regulations are interconnected, and organizational alignment is key to streamlining the application and approval process.
RQM+ Is Here to Help
A PSUR/PMS report is just one element of the many requirements under MDR and IVDR. Whether you need assistance creating these documents or strategic guidance for developing an integrated approach, RQM+ offers a full range of services to support your team.
→ For more tips on PSURs and PMS reports, watch RQM+ Live! #35 — “Preparing for PSURs” today.