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Description: This review is one of the tasks in the Horizon 2020 project Coordinating Research and Evidence for Medical Devices (CORE-MD), which started in April 2021 and will end in March 2024 (https://www.core-md.eu). Its mission is "Translating expert knowledge into advice for EU regulatory guidance and building expertise in regulatory science in the clinical community". This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ or send a letter to Creative Commons, PO Box 1866, Mountain View, CA 94042, USA. The objectives of this systematic review are firstly to identify guidance on the design, conduct, analysis, and reporting of confirmatory pivotal clinical trials and other clinical investigations for high-risk medical devices, from regulators, international standardization organizations, medical professional associations, academic consortia, and HTA agencies; secondly, to compare their similarities and differences; and thirdly, to identify gaps for further research on trial methodology.