Why is Clinical Evaluation so Important?

 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.

If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with Medical Devices Regulation (MDR) 2017/745. Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements; but Emergo has the experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER.

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.

·         Frequent updates

·         Demonstrate scientific accuracy

·         Qualifications of evaluators

·         Measurable objectives for CER

·         Establishing equivalent