PMS – Reports and Requirements
May 22, 2023
In December 2022, nearly 1.5 years after the Medical Device Regulation (EU) 2017/745 (MDR) came into force, the MDCG published the long-awaited guidance document for creating the Periodic Safety Update Reports (PSUR). Along with the documents for creating PMCF plans and reports, this provides further assistance in implementing MDR requirements for the post-market surveillance (PMS) process.
What are the Requirements?
Under the MDD, there was already a requirement to evaluate the available data within a PMS report. Under the MDR, the PMS report is only required for Class I devices. For Class IIa, IIb, and III devices, it is replaced by the PSUR. For all devices, there is an additional requirement to create a PMS plan, which involves planning in advance which data will be collected and how it will be evaluated.
Furthermore, the Post-Market Clinical Follow-Up (PMCF) introduces an additional requirement. The PMCF includes a PMCF plan and a PMCF report, both of which are required for all devices. While the PMCF plan, according to MDCG 2020-7, should be integrated into the PMS plan, the PMCF report stands as a separate document. The purpose of the PMCF is to address any gaps in clinical data.
The planned PMCF activities, such as literature searches, user surveys, or clinical investigations, must be individually planned and executed. While various PMCF measures should always be conducted for novel or high-risk devices, it may be possible to forego a PMCF report for long-established devices. If the manufacturer decides to forgo a PMCF report, this must be thoroughly justified in the PMCF plan.
The PSUR not only summarizes the evaluated PMS data but also the generated PMCF data, providing a comprehensive overview of the safety and performance of the device. The primary goal of the PSUR is to summarize the relevant results and conclusions from the analysis of post-market surveillance data to evaluate the benefit-risk ratio.
Overview of Reports
Except for the PSUR, neither the MDR nor the existing MDCG guidance documents specify the required frequency for planning and reporting. It is only required that updates be made regularly. Therefore, determining the timeframe is the responsibility of the manufacturer and should be based on the risk class or novelty of the product.
MDCG 2022-2021 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR)
Spanning almost 40 pages, the guidance outlines detailed requirements for the PSUR and provides practical assistance in its annexes, which manufacturers can use during report preparation.
The guidance includes several clear stipulations regarding report preparation:
- A PSUR reference number should be assigned and remain identical throughout the device's lifecycle.
- Similar products can be grouped, with a leading device designated within each group.
- Data collection period: For products certified under the MDR, manufacturers should finalize the PSUR exactly 1 year (Class IIa) or 2 years (Class IIb/III) after MDR certification, or submit it via the EUDAMED database, depending on the risk class. For legacy devices with valid MDD certification, the guidance specifies that the start date should be the commencement of MDR applicability, not the certification date.
The guidance emphasizes multiple times that the objective of the PSUR is not to duplicate all data and reports created under the PMS plan, but to summarize the results and conclusions.
Therefore, according to Article 86(1) of the MDR, the PSUR should include the results and conclusions of the analysis of PMS data collected as part of the PMS plan. The summary and evaluation in the PSUR should include:
- Conclusions regarding the benefit-risk ratio,
- Key findings from post-market clinical follow-up (PMCF),
- Product sales volume,
- An estimated assessment of the size and other characteristics of the population using the product, and, if possible, the frequency of product use.
What does this mean for the manufacturer?
In essence, nearly all of these requirements existed under the MDD, albeit dispersed across various regulations. The MDR now provides a clearer structure and consolidates all requirements directly into the legislative text. The establishment of more uniform reports and reporting periods enables authorities or notified bodies to more easily compare similar products, resulting in improved oversight and aligning more closely with pharmaceutical monitoring, where PSUR creation has long been established.
Through the PSUR, processes such as PMS, clinical evaluation, and risk management are further integrated. Accordingly, the text of MDCG 2022-21 indicates that any indications of potential deterioration in the benefit-risk profile should be analyzed and evaluated within the context of clinical evaluation and risk management.
This integration presents additional challenges for manufacturers.
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