Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File. The Technical File is an essential step to obtaining CE Marking for your device, which is required to sell or distribute medical devices in Europe.
AiCE is an LTTS’ integrated AI tool perform systematic review and reporting related to clinical literature, along with any other additional databases that may be added to the report for their inclusion in CER.