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Evaluating performance of implants at an early stage, long before the clinical introduction to the market, has proved to be challenging. Researchers, regulatory affairs organizations and authorities are looking for models capable of eliminating poorly performing products in order to select the right candidates for further development. This chapter was designed to provide help in the selection and interpretation of appropriate methods in order to assist the development of new bone implants.

A clinical trial is designed to provide clinical evidence of compliance with the medical device Directives. Clinical evidence can also be based on systematic and objective literature review. This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device.