A CER (Clinical Evaluation Report) is a document that can be prepared for a medical device that is being considered for marketing in the United States market (also called Premarket Approval or PMA).
This means that the report may be required when a new medical device is entered into the U.S. market, certain changes are made to a medical device, or an indication for use of a medical device is added.
In this blog, I’ll summarize what you should know about the CER process and provide a series of links to resources with more information on how they are used in the U.S. market.
Medical device clinical evaluation reports (CERs) are an important document submitted to the United States Food and Drug Administration (FDA) when seeking regulatory approval for a medical device.
Medical device makers must submit one or more CERs that address all of the required points in their premarket submission, or PMA (Premarket Approval). The information included in a CER varies by the type of medical device, i.e., Class I vs. Class II vs. Class III, and by the submission type, e.g., a 510(k), IDE, or PMA, though some general information is required throughout.
What is a clinical evaluation report?
A clinical evaluation report is a document that describes the results of a medical device’s clinical trial. It provides the reader with information about how the device performed during testing, including the device’s safety and efficacy. The report may also include data about adverse events, if any.
The FDA requires that all manufacturers submit this information as part of the premarket approval application process. Manufacturers must also submit an annual report that includes any new information about adverse events or problems with their devices.
Why do we need them?
Clinical evaluation reports provide important information about how well a medical device works and how safe it is for use on humans. If you’re considering having surgery or other procedures done with a new device, it’s important to know what kind of results have been achieved with similar devices in the past. Clinical evaluation reports can help you make an informed decision about whether or not you want to go through with the procedure at all
What is the purpose of a clinical evaluation report?
A clinical evaluation report is a document that summarizes the results of a clinical trial. It may also include other related information such as patient demographics, trial methodology and results.
The purpose of a clinical evaluation report is to inform readers about the safety and effectiveness of a medical device. It can be used to support regulatory submissions to gain approval for marketing and sale of the device in specific countries.
Clinical Evaluation Reports are usually written by an independent group of experts or an authoring organization like I3CGLOBAL.
How do you write a clinical evaluation report?
First, you should make sure that your data is accurate and contains no errors or mistakes. This will help ensure that people will take your conclusions seriously and continue using them in their own research projects.
Next, always cite any sources from which you obtain information from in your paper; this shows that you have done your research thoroughly and have not plagiarized any material from another source (which could get you into trouble). T
Thirdly, make sure that your paper has an introduction, body paragraphs and conclusion so that readers can easily follow along with what you are saying throughout the course of your essay.
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