Abstract
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.
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References
Hertog, S.: A comparative assessment of labour market nationalization policies in the GCC. In: Hertog, S. (ed.) National Employment, Migration and Education in the GCC, pp. 100–102. Gerlach Press, Berlin (2012)
Lean, H.H., Smyth, R.: CO2 emissions, electricity consumption and output in ASEAN. Appl. Energy 87, 1858–1864 (2010)
Padro, F., Green, J.: Education administrators in Wonderland: figuring out policy-making and regulatory compliance when making decisions (2018). https://doi.org/10.1007/978-3-319-77751-1_7
Wilson, J.: Essentials of Business Research: A Guide to Do Your Research Project. Sage, Newcastle upon Tyne (2014). Available online: https://bit.ly/3G5ejfE
Hart, M.: The lean startup: how today’s entrepreneurs use continuous innovation to create radically successful businesses Eric Ries. New York: Crown Business, 2011. 320 pages. US$26.00. J. Prod. Innov. Manag. 29 (2012). https://doi.org/10.1111/j.1540-5885.2012.00920_2.x
Elsaman, H., El-Bayaa, N., Kousihan, S.: Measuring and validating the factors influenced the SME business growth in Germany—descriptive analysis and construct validation. Data 7, 158 (2022). https://doi.org/10.3390/data7110158
Pigou, A.: The Economics of Welfare, 1st edn. Routledge (2002). https://doi.org/10.4324/9781351304368
Easterlin, R.A.: Does economic growth improve the human lot? Some empirical evidence. In: David, P.A., Reder, M.W. (eds.) Nations and Households in Economic Growth, pp. 89–125. Academic Press (1974). ISBN 9780122050503
Hantke-Domas, M.: The public interest theory of regulation: non-existence or misinterpretation. Eur. J. Law Econ. 15(2), 165–194 (2003)
Rütten, A., Lüschen, G., von Lengerke, T., Abel, T., Kannas, L., Rodríguez Diaz, J.A., Vinck, J., van der Zee, J.: Determinants of health policy impact: comparative results of a European policymaker study. Soz. Praventivmed. 48(6), 379–391 (2003). https://doi.org/10.1007/s00038-003-2048-0.148
Maass, W., Parsons, J., Purao, S., Storey, V.C., Woo, C.: Data-driven meets theory-driven research in the era of big data: opportunities and challenges for information systems research. J. Assoc. Inf. Syst. 19(12), 1 (2018)
Schwarz, S.W., Decristoforo, C., Goodbody, A.E., Singhal, N., Saliba, S., Ruddock, P., Zukotynski, K., Ross, A.A.: Harmonization of United States, European Union and Canadian first-in-human regulatory requirements for radiopharmaceuticals: is this possible? J. Nucl. Med. (2018). Advance online publication. https://doi.org/10.2967/jnumed.118.209460
Crico, C., Renzi, C., Graf, N., Buyx, A., Kondylakis, H., Koumakis, L., Pravettoni, G.: MHealth and telemedicine apps: in search of a common regulation. Ecancermedicalscience 12, 853 (2018). https://doi.org/10.3332/ecancer.2018.853
Bernasconi, S.: How MDR and IVDR Are Reshaping Europe’s Medtech Industry. Medical Technology Report 2017. Pulse of the Industry 2017, pp. 28–29. EY—Ernst Young (2017). Available online: https://www.ey.com/Publication/vwLUAssets/ey-pulse-of-the-industry-2017/$FILE/ey-pulse-of-the-industry-2017.pdf
Ben-Menahem, S.M., Nistor-Gallo, R., Macia, G., et al.: How the new European regulation on medical devices will affect innovation. Nat. Biomed. Eng. 4, 585–590 (2020). https://doi.org/10.1038/s41551-020-0541-x
Rütten, A., Lüschen, G., von Lengerke, T., Abel, T., Kannas, L., Rodríguez Díaz, J., Vinck, J., Zee, J.: Determinants of health policy impact: a theoretical framework for policy analysis. Soz. Präventivmed. 48, 293–300 (2003). https://doi.org/10.1007/s00038-003-2118-3
Setia, M.: Methodology series module 3: cross-sectional studies. Indian J. Dermatol. 61, 261–264 (2016). https://doi.org/10.4103/0019-5154.182410
Brown, R.B.: Doing Your Dissertation in Business and Management: The Reality of Research and Writing. Sage (2006)
DiStefano, C., Zhu, M., Mindrila, D.: Understanding and using factor scores: considerations for the applied researcher. Pract. Assess. Res. Eval. 14(20) (2009). Available online: http://pareonline.net/getvn.asp?v=14&n=20
Elfil, M., Negida, A.: Sampling methods in clinical research; an educational review. Emergency 5, e52 (2017)
Elsaman, H.A., Sergio, R.P.: The psychographics of green marketing strategy vis-a-vis corporate social responsibility: implications to organisational growth. Int. J. Entrep. 25, 1–11 (2021)
Collins, H.: Creative Research: The Theory and Practice for the Creative Industries. AVA (2010). Available online: https://bit.ly/3HFecrv
Shrestha, N.: Factor analysis as a tool for survey analysis. Am. J. Appl. Math. Stat. 9(1), 4–11 (2021)
Eyduran, E., Topal, M., Sonmez, A.Y.: Use of factor scores in multiple regression analysis for estimation of body weight by several body measurements in brown trouts (Salmo trutta fario) (2010)
Guetterman, T.C.: Basics of statistics for primary care research. Fam. Med. Community Health 7(2) (2019). https://doi.org/10.1136/fmch-2018-000067
Hu, L.T., Bentler, P.M.: Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Struct. Equ. Model. Multidiscip. J. 6(1), 1–55 (1999)
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Elsaman, H.A., Japos, G.V., Said, D.S., Kousihan, S.K., Gernal, L. (2024). Effects of New Medical Regulations on Organization’s Performance—Empirical Evidence for Medical Industry in Germany from the Lens of Public Interest Theory. In: Alareeni, B., Elgedawy, I. (eds) AI and Business, and Innovation Research: Understanding the Potential and Risks of AI for Modern Enterprises. Studies in Systems, Decision and Control, vol 440. Springer, Cham. https://doi.org/10.1007/978-3-031-42085-6_26
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