A clinical evaluation report (CER) is a vital document that combines both pre-market and post-market clinical data of a medical device. The CER should provide essential information on the safety, performance, and clinical benefit and is a requirement for medical device manufacturers to show they meet regulatory compliance and that their devices are safe and effective for use by patients. Writing a CER can be a complex task but following these 10 important tips can help ensure that the report is comprehensive, accurate, and meets all the necessary requirements.
1. Define a CER protocol and scope
A CER should have a clearly defined scope. This should include addressing the intended use of the device, clinical indications and the patient population. This information will help ensure that the CER is focused and relevant. The Medical Device Coordination Group (MDCG) published a Clinical Evaluation Assessment Report Template (MDCG 2020-13) in July 2020. This template is meant to aid medical device manufacturers when constructing their CER and aid Notified Bodies when assessing the conclusions. It’s also important to remember that the template presents the minimum content that is required for a CER. Additional guidance documentation as well the regulation will help construct a more thorough report.
2. Conduct a thorough literature review
The literature review forms one of the critical components of the CER and should be conducted using a systematic approach. The review should include all relevant clinical studies, published articles, and other relevant data sources. Literature databases such as PubMed, Embase and ClinicalTrial.gov should be used (although don’t limit your search to these only). As a rule of thumb, try to use at least three different literature databases that cover data from various territories.
3. Understand the regulatory requirements
It’s important to understand the regulatory requirements for the medical device in question and in relation to the target market / territory in which it is being sold. Ideally your CER should go hand in hand with additional documentation that identifies and addresses the safety and performance requirements which show that the device is safe for use and performs as intended. For Europe, this would be your GSPR document.
4. Ensure you conduct a thorough, systematic evaluation of the clinical data
The clinical data should be evaluated using a robust and transparent methodology. Data should be analyzed, synthesized, and presented in a clear and concise manner. The best way to determine an appropriate analysis method would be to use the guidance documents that have been made available to you. This includes the MEDDEV and MDCG guidelines as well as the use of any international / harmonized standards.
5. Consider all available data objectively
When evaluating the clinical data, it is important to consider all available data sources in an objective way. This includes data from post-market surveillance, post market clinical follow ups, adverse event reports, literature searches, risk analyses and clinical studies. A CER should identify and address all safety and performance issues associated with the medical device including potential risks and hazards, as well as any complications that have been reported. All relevant data should be evaluated and included so as to present a complete picture around safety and performance.
6. Demonstrate equivalence
Equivalence is an important part of showing that your device is safe and performs as intended. To show equivalence, manufacturers are required to compare their medical device to another pre-existing device that has similarity and which has already been CE-marked. Similarity can be shown by comparing critical characteristics such as chemical, biological and technical parameters.
7. Ensure the report is well-structured
The CER should be well-structured with clear headings and subheadings. This will help readers navigate the report easily and find the information they need quickly and easily. Use clear and concise language. Any technical terms and complicated scientific concepts should be explained so as to avoid any questions later on. The report should be written in a style that is easy to understand for anyone reading it – this could be a clinical expert to a distributor to an end user.
8. Use visual aids to enhance understanding
Visual aids are extremely important when writing a CER as it helps enhance the understanding of complex data and clinical concepts. These visual aids can include tables, graphs and diagrams. Ensure they are appropriate and support the text.
9. Ensure the report is up-to-date
The CER should be kept up to date with the latest clinical data, market trends, and regulatory requirements. This means that it should be updated periodically to present the latest snapshot of your device clinically. An update could be triggered when there are reported adverse events, changes to any warnings or contra-indications and when post-market clinical data becomes available. This will help ensure that the report remains relevant and useful over time.
10. Highlight the benefit to risk data of your device
One of the recent requirements for medical devices is to compile a benefit-risk report which highlights quantifiable acceptance criteria around safety and performance of the device in question. This requires detail around specifying criteria used to determine acceptability of the benefit-risk ratio which in turn supports the conclusion that the device is safe, performs as intended and should be placed on the market. Ideally this data should also be highlighted in the CER and the manufacturer should show that there are more benefits than risks associated with the device.
Writing a clinical evaluation report for medical devices requires careful planning, thorough research, and attention to detail. These 10 essential tips are a start to compiling a comprehensive and accurate CER. The Medical Device Regulations and various guidance documents form an essential base from which to start when ensuring all necessary requirements for regulatory compliance are met however, despite engaging all of these documents, manufacturers can never really predict what gaps a Notified Body will pick up after review. It’s also important to treat the feedback from your Notified Body as constructive with the main goal of portraying all available information that shows the medical device in question performs as intended with the ultimate goal of putting the safety of patients first.