Medical Device Clinical Evaluation Report SERVICE
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...