Developments in the field of Medical Devices

After the long-awaited Regulation on Medical Devices numbered 2017/745 (EU Regulation) prepared by the EU Commission entered into force, Turkey’s Medical Device Regulation, designed to be compatible with the EU’s Regulation, was published in the Official Gazette numbered 31499 on June 2, 2020. Several articles are expected to be brought into effect in accordance with the EU transition process to provide a similar transition process in Turkey.

The Medical Device Regulation entered into force on the same date as the EU Regulation, and announcements by the TMMDA continue to guide industry stakeholders to ensure compatibility with all EU practices. However, it has become clear that not all regulations in force in Turkey were considered in the preparation of the Medical Device Regulation. Certain definitions taken directly from the EU legislation have led to incompatibility with local legislation.

Additional leglislation contains detailed provisions on companies’ sales, advertising, and promotional activities in the field. 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 other obligations.

Although 2022 saw no new legislation pertaining to medical devices, the economically damaging practices 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. Despite no leglislative changes being foreseen, there may be some differences in implementation of existing rules for this area.

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