DIN EN ISO 14155:2020
The standard DIN EN ISO 14155:2020 regulates and controls the requirements for clinical trials of medical products. This includes, among other things, optimal standards with regard to the planning, execution, as well as documentation and analysis of clinical studies. For producers of medical devices, the standard represents a guideline for the practical application of Good Clinical Practice for clinical research studies. The aim of DIN EN ISO 14155:2020 is to guarantee and ensure the protection of the health of study participants. Scientific compliance with standardized norms also helps to demonstrate the results and clinical benefits of a new medical product. It further helps to compare them on an international level. The standard also includes information on the required mandatory conduct of sponsors and principal investigators. The ISO standard is included in the MDR and the current amendments are valid until May 26, 2021.