Do you need to complete a medical device evaluation report to bring your device into the market? You are probably concerned with factors like how detailed the report needs to be and what resources you will need to complete it. In recent years, the advent of technological innovation in the field of medicine has forced Medical Device Regulation (MDR) authorities around the world to introduce comprehensive guidelines for Clinical Evaluation Reports (CER) concerned with medical devices.
This article will dig deep into the intricacies of formulating a CER. We will look at its structure and the resources used throughout the process. Once you get the hang of its writing procedure, you will be able to direct your time and efforts effectively to prepare a stellar CER.
What is a Clinical Evaluation Report?
A Clinical Evaluation Report is a crucial document containing the conclusions of a clinical evaluation conducted on a medical device based on all data available. It validates a device and ensures that its potential benefits outweigh any possible risks associated with its use.
The amount of details in a Clinical Evaluation Report is directly concerned with the functionality of the device. This implies that a device that is at a greater risk of compromising the patient’s health and safety will have a more in-depth CER.
Manufacturers of a medical device must prove that the device meets all relevant safety and performance requirements before obtaining a CE marking in the EU. The CER demonstrates that your medical device achieves its intended purpose without exposing users or patients to further risk. Clinical Evaluation Reports are a mandatory requirement for all medical devices to be sold in Europe and an integral part of the CE Technical File.
Stages of Writing a Clinical Evaluation Report
As mentioned, a CER streamlines the conclusions obtained from a clinical evaluation of your medical device. The report encompasses a range of data, ranging from pre-market to post-market analysis of the device. Findings of the CER will determine if your device is fit to be used in medical procedures. More importantly, every CER must include an analysis of clinical performance and clinical safety. To help you understand how clinicians evaluate the efficacy of a medical device, we have divided the entire process into distinct stages.
Set a Benchmark for Your CER Strategy
The first step is to identify the relevant performance and safety requirements outlined by the regulating authority, the MDR in Europe. Keep in mind that your device needs to fulfill all the listed requirements to be approved for clinical use. Conducting a well-defined performance, safety, and risk, benefits evaluation will provide further credence to your report.
Compare Devices to Demonstrate Equivalence
Equivalence is defined as the performance-based comparison of the medical device under evaluation with a similar pre-existing device that has been clinically approved. Contrary to popular belief, equivalence is demonstrated based on a framework that is defined by the manufacturer instead of the regulating authority. That means manufacturers have complete freedom to emulate the working model of a pre-approved clinical device. The equivalence process and demonstration must be fully justified in the CER to avoid any gaps in the evaluation criteria.
As modern technology keeps on churning out new and improved medical equipment, regulating authorities like the FDA are in a constant process of upgrading their equivalence policies. For example, most authorities around the world have made it compulsory for manufacturers to exhibit a strong connection between their product and the outlined requirements.
Carry Out a Comprehensive Literature Review
Once you have successfully demonstrated equivalence, the next step is to extract clinical data from previous studies on relevant topics. This is known as a literature review. As stated at https://www.citemedical.com/cost-savings/, the literature review process can be time-consuming and costly. Surprisingly, a large chunk of your time is spent on revisions and error corrections. Similarly, the overall cost of writing a CER adds up as the research phase keeps on dragging. Therefore, you may want to hire a professional if you are considering the option of outsourcing your CER project.
Here are a few tips on how to streamline the literature review process for optimal results:
- Before starting, formulate a comprehensive protocol for your literature search and stick to it religiously
- Identify your research requirements and make use of relevant databases, keywords, and inclusion/exclusion criteria to yield quick and specific results
- Within your search items, define the benchmark safety and performance standards derived from the equivalent products
- Read through articles from different journals and document relevant information.
- Carry out data analysis with the help of peer reviews to identify potential gaps and give recommendations
- Finally, summarize all your findings in the form of a conclusion to be included in your CER.
Now that you have collected and assimilated all the information, you are all set to finalize your CER and present it to the governing body. Keep in mind is that the credibility of your CER depends on how regularly you update its content. Therefore, make sure that you keep up with the market trends by evaluating data and analyzing all equivalent products.