CEPs and CERs 

Regulatory complaint Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)

For European market-access, medical device manufacturers are required to submit a Clinical Evaluation Report to Notified Bodies to guide CE Marking. However, developing a CER with comprehensive clinical data that would lead to successful licensing requires robust planning. The MDCG emphasizes the development of a good Clinical Evaluation Plan with proper identification of General Safety and Performance requirements (GSPR) that will support the relevant clinical data.

Our team of experts work with Medical Device Manufacturers to develop regulatory compliant CEPs with focus on the MDCG and Meddev Rev 4 guidelines. Thereafter,  Aolete’s qualified and experienced CER writers work with the Manufacturers to gather and review clinical data that will generate robust clinical evidence to complete a compliant Clinical Evaluation Document.