What Is CER And Why Is It Important?
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