6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations

 

Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device.

Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio.

MEDDEV 2.7/1 Rev 4 of the clinical guidance document was released in June 16 and is aligned more with the European Medical Devices Regulation. The guidelines are more detailed and explicit and help manufacturers to conduct systematic clinical evaluations in a more robust manner so as to demonstrate the efficacy, safety & performance of their device.



The complexity of a Clinical Evaluation Report can vary significantly, but the result should be the same. The performing report should be good enough to read and understood by notified body. It should contain sufficient detail for deciding the data, analysis, and all conclusions to demonstrate device safety for sale in European Markets.

IZiel completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators.


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