Main content

  1. Felicitas Kühne
  2. Ursula Rochau
  3. Daniela Schmid
  4. Uwe Siebert

Date created: | Last Updated:


Creating DOI. Please wait...

Create DOI

Category: Project

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 ( 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 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.

License: CC-By Attribution 4.0 International


Loading files...



Recent Activity

Loading logs...

OSF does not support the use of Internet Explorer. For optimal performance, please switch to another browser.
This website relies on cookies to help provide a better user experience. By clicking Accept or continuing to use the site, you agree. For more information, see our Privacy Policy and information on cookie use.

Start managing your projects on the OSF today.

Free and easy to use, the Open Science Framework supports the entire research lifecycle: planning, execution, reporting, archiving, and discovery.