Effects of New Medical Regulations on Organization’s Performance—Empirical Evidence for Medical Industry in Germany from the Lens of Public Interest Theory

The European Union’s regulatory system underwent a significant modification on May 26, 2021, with the implementation of updated regulation (EU) 2017/745 for medical devices MDD. This study is the first to conduct empirical and statistical research with primary data collection to assess the implementation of a new MDR and uncover the necessity of further investigation into these regulations. The methodology utilized by the researcher was a cross-sectional and correlational research design with the use of random sampling methods. The study finding has been validated statistically by exploratory factor analysis and descriptive and inferential data analysis techniques using SPSS 26 and SPSS Amos 26. The primary study variables are SME Organisational Performance, SME financial condition, and MDR implementation process. The study statistically highlighted and approved the negative impact of applying the MDR EU (2017/745) on SME financial performances, environmental processes, and business growth opportunities due to impractical implementations. Additionally, the study spotted the efficiency of the transparency monitoring process of MDR as an advantage for the medical devices industry. Ending by developing a practical model and recommendations for better business practice.