Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map.

Abstract

Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects. We developed a search for EMBASE that identified clinical investigations of medical devices during two discrete 3-month