Anyone who has ever been to a hospital has heard the term ‘clinical evaluation report’ quite a few times. On hearing this, the first question that comes to any non-specialist’s mind is what is CER. This report documents essentially concludes a clinical evaluation of a medical device.

The data found in these documents are either collected from a clinical study of your device or the results of studies done on substantially similar devices. This test basically denotes that your device is able to perform its intended function without exposing the patients or users to any risk.

Such an evaluation is required for all kinds of medical devices used in countries like Europe. The CER has to be submitted as an attachment along with the European CE technical File to the relevant Notified Body.

This file acts as an essential step to getting the CE Marking for any medical device. This marking further tells that your device is functional and safe, and ready to be sold or distributed in the industry.

How should you Prepare for CER?

Any clinical evaluation report is formed in three steps. In the first step, the manufacturers have to identify clinical data from any prior clinical experiences, existing literature, clinical trials or a combination of all three.

The second stage consists of assessing the data’s significance, quality, applicability and relevance. This step mainly tells the testers if the gathered data is usable and in relation to the device being tested.

Then comes the third step, which requires you to note down the observations and conclusions, basing all of it on the data that has been collected.

You should always make sure to approach the clinical evaluation report as a standalone document, even though it will be included in the technical file. Some of the elements you should include in the CER are as follows:

• General information like the name of the device and manufacturer
• A concise explanation of the physical and technical aspects of the device
• The intended purpose of the device and its functions
• An outline of the intended diagnostic and therapeutic claims
• The types of clinical evaluations and data
• A comprehensive summary of the clinical data and reviews
• A description of the analysis used to test the performance, accuracy, and safety of the product
• Conclusions about the performance, safety, and conformity of the medical device

While the intricacies of a CER can vary depending on the device, the outcome should always be the same. The resulting report must be easily understandable by a third party at the notified body or agency. These reports should also contain all the necessary information in detail that will help analyse, understand and conclude the data mentioned.