What Will Be the Economic Impact of the New Medical Device Regulation? An Interrupted Time-Series Analysis of Foreign Trade Data

Objectives: To date, the economic effects of medical device directives compared with the clinical and regulatory effects have not been sufficiently studied. We believe that the financial obligations and responsibilities imposed on the stakeholders by the legal regulations have a corresponding economic indicator in the medical device market. Methods: In this study, we selected 2 crucial legal regulations on medical devices in Turkey: the Medical Device Directive that has been harmonized from the European Union and the Medical Device Sales, Advertising, and Promotion Directive. The impacts of these regulations on foreign trade were investigated using interrupted time-series analysis. Turkey's monthly medical device export and import data from 2008 to 2019 were obtained under 56 6-digit custom codes. Results: The results show that the selected directives have significantly affected the foreign trade trend level, and they may be breakpoints in the Turkey's foreign trade trend curve. We also reported the significant differences between the Medical Device Directive and the European Union's new medical device regulation (MDR) (2017/745 MDR). Conclusions: We concluded that the MDR, which has more strict requirements, will result in increased costs for economic operators in comparison with the current directive and would further increase the import of medical devices by the importing countries. To prevent this, Turkey should aim to have a manufacturer's position by improving their clinical trial capabilities and manufacturing infrastructures with innovation-based approaches.

Automated summary

This study examines the economic effects of medical device directives compared with the clinical and regulatory effects in Turkey. The results indicate that these directives have significantly impacted the country's foreign trade level. The new medical device regulation imposes stricter requirements, leading to increased costs for economic operators and higher import of medical devices. Therefore, Turkey should focus on improving their clinical trial capabilities and manufacturing infrastructures with innovative approaches to position themselves as manufacturers.