Literature searches are an integral part of the clinical evaluation process. They may be regarded the foundation of the clinical evaluation to define the state-of-the-art therapy on one hand and generate safety and performance endpoints on the other. Clinical evaluation – in turn – is the systematic and planned process to continuously generate, collect, analyze & assess clinical data pertaining to a device in order to demonstrate the safety and performance, including clinical benefits, of the device when used as intended. Clinical evaluation is required under Article 61 and Annex XIV of the European Medical Device Regulation 2017/745 (EU-MDR).

Important aspects of the literature search are: definition of the scope, databases involved, definition of search terms, application of PICO process, definition of inclusion & exclusion criteria and finally the appraisal process. At the end, data-analysis and transfer of the relevant data to the Clinical Evaluation Report (CER). To structure the process, sound literature search protocols are key. The seminar will provide an overview of the requirements to conduct and realize a sound literature search and a systematic, stepwise approach which facilitates the process to obtain compliant literature search reports.