How often does the clinical evaluation report need to be updated?

 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.The overall aim of a clinical evaluation is to assess and analyze clinical data regarding the medical device to provide evidence for the product’s clinical safety and performance.

Key Steps for Clinical Evaluation Report

·         Identification of regulatory requirements to be supported by clinical data

·         Identification of available clinical data for the device under evaluation and state of the art for the intended use

·         Determination if there is sufficient clinical data for the safety and performance of the device under evaluation

·         If clinical data is not sufficient, generation of additional clinical data

·         Determination of the device’s clinical safety and performance and benefit/ risk ratio

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.

For all devices, every time there is change in the information available on the device based on post-marketing surveillance (PMS) that affects the evaluation or conclusion of the device, the CER needs to be updated. For high-risk devices, CERs need to be updated annually at the minimum, while low-risk and well-established devices can update CERs every 2-5 years.