Launching a new medical device in the market always need a Clinical Evaluation Report to submit to the EU Market as per the European Union’s Medical Device Regulation (MDR) introduced in May 2017. Based on the device’s risk category, the Clinical Evaluation Report can be simple or quite extensive. CER is a major portion of the technical file even though it is a stand-alone document and is required for all medical devices regardless of classification. The more at the stake, a more detailed significant report is mandatory for a device. Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards. In-spite of number of resources required to complete the medical device CER, the structure of a CER will always be same. Many companies face difficulty in understanding the MDR regulations section which defines the medical device clinical evaluation report requirements. In the present content below, you can see the answers to many questions that are revolving gin your mind before starting anew CER for the medical device to enter into EU market. With the pertinent details provided here, you also can plan ahead and commit accurate enough resources for efficient completion.