Medical device regulation and its impact on the industry: A case study of Czech companies

Abstract

The implementation of regulations is often seen as a necessary tool to mitigate market failures and safeguard consumer interests. The Medical Device Regulation (MDR) is a recent regulation specifically designed for the production of medical devices, aiming to ensure their safety and effectiveness. This article focuses on Czech companies and seeks to examine and quantify the effects of the MDR on their operations, considering both economic and procedural impacts. Through the analysis of primary and secondary data, this study endeavors to shed light on the repercussions of the MDR on the companies in question. The findings suggest that the MDR will have a negative impact on the profitability of these companies, consequently influencing their operational strategies. One key factor contributing to this negative outcome is the inability of the companies to transfer the increased costs resulting from regulatory requirements to their customers. As a result, affected companies are forced to make adjustments to their product portfolios, reducing their range of offerings. The research reveals that the perception of the MDR among the companies is predominantly negative. This negative sentiment arises primarily due to the financial burdens imposed by the regulation and the other associated impacts discussed in the article. Furthermore, the MDR is not perceived as a catalyst for innovation within the industry. By quantifying the effects of the MDR on Czech companies, this article provides valuable insights into the real-world implications of this regulatory framework. The findings highlight the challenges faced by companies in adapting to and complying with the MDR, particularly in terms of its impact on profitability and product offerings. This research serves as a reminder of the complex interplay between regulations, economic outcomes, and industry dynamics. Ultimately, it emphasizes the importance of considering the potential ramifications of regulations and their effects on businesses and markets. © 2024, Technical University of Liberec. All rights reserved.