EM25 Recording: EU MDR Clinical Evaluation Report (CER) Foundations Workshop

While claiming equivalence can be beneficial, it’s a highly scrutinized area. Manufacturers must specifically identify the equivalent device, provide a clear description of its models, sizes, components, accessories, and regulatory history. For each claimed equivalent device, a full assessment across technological, biological, and clinical aspects is required. For Class III and implantable devices, a contract demonstrating access to the equivalent device’s technical documentation is mandatory. It’s vital to remember that “same is not similar” under MDR, and thorough justification for the level of access to data supporting equivalence is expected. The more detailed and clear the justification, the smoother the review process will be.

At least two literature searches are essential for a CER: a “State of the Art” (SOTA) search to define the clinical condition and establish safety/performance objectives for your device, and a “Subject Device” search to identify existing clinical data (favorable and unfavorable) for your device or its equivalent. A strong search protocol must be comprehensive, clear, and transparent, demonstrating all efforts to retrieve available data. This includes using multiple databases with clear justifications, defining the review’s objective (e.g., using PICO or PRISMA frameworks), employing clear and exact search terms, and justifying any timelines or cutoff points. A clear exclusion/inclusion criteria and a plan for data collection and management are also crucial to minimize bias and ensure data integrity.

Clinical claims should be presented clearly, ideally in a dedicated section within the CER. Tabulating claims with direct references to supporting evidence is highly recommended for clarity and ease of review. All claims, whether clinical or non-clinical, must be supported by robust evidence. The analysis of literature should be based on full-text articles and reported in a scientific, unbiased manner. Manufacturers should focus on data with the highest sufficiency (quality and quantity) as identified by their appraisal plan. It’s also critical to describe how each article supports the device’s intended purpose and indications, impacting factors like disease, patient populations, and intended users.

The Benefit-Risk Assessment is a critical component and must describe the benefit-risk profile for each specific indication of the device. This assessment should consider all data within the CER, clearly outlining the expected benefits and potential risks. It needs to be proportionate to the device’s risk classification, meaning higher-risk devices require a deeper and more thoroughly justified assessment. The assessment should consider benefits and risks for both the user and the patient, and explicitly explain how the benefits outweigh the risks or how the risks are justified given the indication. This assessment is not a one-time event; it feeds into and is continually informed by post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities, demonstrating a continuous, iterative process of evaluation throughout the device’s lifecycle.

The most immediate impact of implemeting a platform like DistillerSR for clinical evaluation reports and performance evaluation reports is improved efficiency, as research teams spend less time fixing preventable mistakes. However, the true impact extends further. The platform enables a more transparent, repeatable, and auditable process, which allows manufacturers to create and implement a standard framework for literature reviews that can then be inserted into all CER and PER program management plans consistently across every device product, division, and research groups.  Over time DistillerSR will become the central source for standardized, verified literature evidence and can be used for claims management, KOL identification, literature monitoring and more.