What Is CER And Why Is It Important?

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CER, which is better known as Clinical Evolution Report are the final report of your medical device which is concluded through clinical evaluation. A CER is concluded by analyzing your device or by the clinical result of your device. The CER assures that it successfully does the job that it was meant to do without risking the life of the patients for whom the device was designed.

Clinical Evolution Report has been mandatory for all medical devices across Europe. To release your medical device in the market, you will need to submit your Clinical Evolution Report to a notified body who grants the permission.


The technical file which contains the final report of your device is a vital step for acquiring a CE Marking for your device. With CE Marking, you won’t be able to distribute or sell your device in the market.

How to prepare a Clinical Evolution Report as per the Clinical Evaluation Report Consultant
The Clinical Evolution Report is carried out in three steps. In the initial step, the manufacturers will identify the vital clinical data from the existing clinical trials, experience, or from a combination of the both. In stage two, you will need to check the applicability, relevance, as well as the quality of the same. In the third stage, you will need to articulate the conclusion in regards to the Clinical Evolution Report which will be based on the data that you have collected.

You will need to approach the Clinical Evolution Report as a standalone document bit at the same time you will also need to include the design dossier as well as the other technical files. Few of the essential things that you will need to include in your CER are:

·         Technical device and concise physical description of the application
·         Manufacturer name, device description, and all the other general information
·         Outline of the diagnostic claims or intended therapeutic
·         Review and clinical data summary
·         A safety, conformity and performance conclusion

A few of the required updates regarding CER

You will need to regularly update the Clinical Evolution Report as a part of your vigilance activities and post-market surveillance. You will need to record and update any notable changes immediately.

And if you are looking for a Medical Device Consultant who can do all this tedious task for you, then Thomas Regulatory Resolutions is the right choice for you.


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