5 Main Components of a MDR Clinical Evaluation Report (CER)

European Union Medical Device Regulation (MDR)

To comply with the European Union Medical Device Regulation (MDR), medical device manufacturers are required to conduct a clinical evaluation to demonstrate conformity with general safety and performance requirements. This is documented in a clinical evaluation report (CER). Below is a brief summary of the major components of the CER. The device information (e.g., intended purpose, contraindications, potential adverse events, etc.), pre-market clinical study data, post-market clinical follow-up study data, sales, and post-market surveillance data are data that are held or generated by the manufacturer. The state of the art review and published clinical data are based on systematic literature searches.

1. Device Summary

The method of evaluation is determined at the planning stage and the level of clinical evidence required for evaluation takes into consideration the characteristics, classification, intended purpose, and risks of the device. In alignment with instructions for use and other technical document information, the device summary includes a detailed description of the device, intended purpose, contraindications, and warnings. Device classification and regulatory history should also be included in this section.

2. Manufacturer Data

Clinical data generated and/or held by the manufacturer to be presented in the CER may include pre-market study data, post-market clinical follow-up study data, sales, and post-market surveillance data including . All relevant data should be presented regardless of whether it is favorable or unfavorable to the device’s safety and performance.

3. State of the Art Review

The state of the art review describes the current standard of care and alternative treatments relevant to the device and its intended purpose. The goal is to specify parameters for safety and performance from aggregate data sources such as meta-analysis and society guidelines. This is a critical piece since these will be the specified parameters used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio of the subject device under evaluation according to its intended purpose. A systematic literature search process is critical for reproducibility and to minimize any potential for bias. For more information on the importance and challenges of a systematic literature search, check out our blog.

4. Publicly Available Data

Published clinical data about the device under evaluation are identified through a systematic literature search. After identification, data are qualitatively appraised to assess the level of evidence, bias or limitations in the data, and all relevant safety and performance data are summarized in alignment with the pre-established clinical outcome parameters. Data from a similar device may also be presented; these data may inform the risk profile of the device but are not supportive as clinical evidence. Both favorable and unfavorable data should be included.

5. Benefit/Risk Analysis

The data outline above is used for the benefits/risk analysis. The benefits are summarized and weighed against the risks. The risks identified in the clinical evaluation should align with the device manufacturer’s risk management documents, instructions for use, and promotional material. The determination of benefit-risk acceptability for the subject device under evaluation is performed by comparing the parameters from the state of the art review with the available data included in the CER

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