After the long-awaited Regulation on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has entered into force, Medical Device Regulation, which was designed following MDR, was published in the Official Gazette numbered 31499 on June 2, 2020. Various effective dates have been foreseen for several articles in accordance with the EU transition process to provide a transition period for the new regulations introduced by the Regulation.
The Medical Device Regulation entered into force on the same date as the MDR, to which it is compatible, and announcements of the TMMDA guide industry stakeholders to ensure compatibility with all EU practices. Nevertheless, while it was necessary to plan the compatibility with the MDR in the preparation of the Regulation, it is observed that not all regulations in force in Turkey are considered. The definitions in the Medical Device Regulation taken directly from the EU legislation have caused incompatibilities with other local legislations.
However, separate legislation exists, which is not included in the EU legislation and contains detailed provisions on companies’ sales, advertising, and promotional activities. The Regulation on Medical Device Sales, Advertising and Promotion (“Medical Device Promotion Regulation”) regulates the obligation of medical device companies in Turkey to register their products in the Product Tracking System (“UTS”), as well as imposes several additional obligations.
Although a significant development was not introduced in the field of medical devices in terms of legislation in 2022, the economically damaging practices that have been going on for years due to the failure to update the exchange rate applied to medical device prices have made it difficult for medical device companies to continue their activities without making a loss. For this reason, although no changes are foreseen in the legislation in this area, there may be some differences in the implementation.