The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical device’s clinical evaluation.

Although there is no official definition of the CDP, one may simply refer to it as an overview of all the clinical investigations that have either been performed, are ongoing, or are planned in the near future, presented in the Clinical Evaluation Plan (CEP) of the medical device under evaluation.

This article is intended to assist medical device manufacturers and medical writers to leverage the CDP as a tool to showcase their clinical evaluation strategy and plan.