MDR’s Impact on Standards Usages and the Relevance for In-house Production of Medical Devices

Abstract: The current regulation for Medical Devices (MDR) entered into force on 26 May 2021, which has entailed major changes to relevant legislation for in-house production of medical devices in healthcare. The relevance for updating existing, or the development of new standards is currently not well documented and determined and the aim of this report is to make recommendations for how the development of standards may be improved and how departments of medical technology (DMT) in practice apply standards at in-house production of medical devices. The sub-areas that are dealt with in in-house production are reprocessing of single use devices, 3D printing and medical technology software. How standards are used to support departments of medical technology in manufacturing in these areas is described and analyzed in this report. Information for the study was collected through semi-structural interviews with several DMTs and relevant authorities. The information was analyzed, discussed, and compared with previous research. The use of standards varied between DMTs, but all interviewees used standards to some extent. The study concluded that there was an interest from DMTs and a potential need to update existing standards and the production of new standards to meet DMT’s needs.