Step-by-Step Guide to Developing a CER

1. S St te ep p- -by by- -S St te ep p G Gu ui id de e t to o D De ev ve el lo op pi in ng g a a CE CER R Developing a Clinical Evaluation Report (CER) involves a systematic process to assess the safety and performance of a medical device. Here's a step-by-step guide to help you in developing a CER: S St te ep p 1 1: : D De ef fi in ne e t th he e S Sc co op pe e a an nd d Ob Obje ject cti iv ve es s - Clearly define the scope of your CER, including the medical device, its intended use, and any specific regulatory requirements. - Determine the objectives of the CER, such as demonstrating compliance with relevant regulations, evaluating post-market data, or supporting a new device submission. S St te ep p 2 2: I : Id de en nti tif fy y A Ap pp pl li ic ca ab bl le e R Re eg gu ul la ati tio on ns s a an nd d G Gu ui id de el li in ne es s - Familiarize yourself with the applicable regulatory requirements, such as Medical Device Regulation (MDR) in the European Union or the US FDA's guidance documents. - Identify relevant guidelines, such as MEDDEV 2.7/1 rev. 4, that provide detailed instructions on CER preparation. S St te ep p 3 3: : Co Col ll le ect ct a an nd d R Re ev vi ie ew w D Da at ta a - Gather all available data on the medical device, including preclinical and clinical studies, post-market surveillance data, complaints, adverse events, and any other relevant information. - Review the collected data to identify potential gaps, inconsistencies, or areas requiring further investigation. S St te ep p 4 4: : P Pe er rf fo or rm m a a Cl Cli in ni ic ca al l E Ev va al lu ua ati tio on n - Conduct a systematic and comprehensive clinical evaluation of the medical device. - Assess the device's safety, performance, and intended use against the defined scope and objectives. - Evaluate the clinical data and compare it with the device's risk-benefit profile. S St te ep p 5 5: : A An na al ly yz ze e a an nd d S Su um mm ma ar ri iz ze e D Da at ta a - Analyze the collected data to identify any trends, patterns, or safety concerns. - Summarize the key findings from the clinical evaluation, including the device's intended use, indications, contraindications, and identified risks. S St te ep p 6 6: : P Pr re ep pa ar re e t th he e CE CER R - Structure the CER according to the applicable guidelines, including the required sections and subsections. - Include an executive summary, introduction, device description, clinical evaluation methodology, data analysis, and conclusion sections. - Address any specific requirements outlined in the regulations or guidelines. S St te ep p 7 7: I : In nc cl lu ud de e P Po os st t- -M Ma ar rk ke et t Cl Cli in ni ic ca al l F Fo ol ll lo ow w- -u up p ( (P PM MC CF F) ) - Assess the need for post-market clinical follow-up studies based on the device's risk class and available clinical data. - If required, plan and conduct PMCF activities to gather additional clinical evidence to support the ongoing safety and performance of the device.

2. S St te ep p 8 8: R : Re ev vi ie ew w a an nd d V Va al li id da at te e th the e CE CER R - Ensure that the CER is accurate, complete, and compliant with the applicable regulations and guidelines. - Have the CER reviewed by subject matter experts, regulatory professionals, and other relevant stakeholders. - Validate the data and conclusions presented in the CER with supporting evidence. S St te ep p 9 9: : U Up pd da at te e a an nd d M Ma ai in nt ta ai in n t th he e CE CER R - Periodically update the CER as new data becomes available or when changes in regulations or guidelines occur. - Keep a record of the updates made to the CER, including the rationale and supporting documentation. - Maintain a well-organized and up-to-date CER for regulatory inspections and audits. It's important to note that developing a CER can be a complex and resource-intensive process. Seeking expert advice and staying updated with the latest regulatory requirements will greatly contribute to the success of your CER development. IZiel provides a unique solution for developing Clinical Evaluation Plan (CEP), and Clinical Evaluation Report (CER) and thereafter provides the physician’s certificate. Our partners have a network of 40+ National Board-Certified Physicians that conduct the risk-benefit analysis and provide the necessary certification.