The scope is limited to medical devices planned for a clinical evaluation using clinical data obtained from works of literature. Medical Device Literature Search and Review plan should be developed and executed by identified persons with expertise in information retrieval, having due regard to the scope of the clinical evaluation.
Medical Device Literature Search results and conclusion should include the data derived from each literature and its relevancy to answer the review question. If the data is not enough to conclude, it should justify, and more data requirements should be specified.