The Turkish Medicines and Medical Devices Agency (“TITCK”) recently announced that the legislative process for the adoption of the EU Regulation No. 2017/745 on Medical Devices (“MDR“) is ongoing. In this scope, the TİTCK published a Turkish translation of the MDR to be taken as a basis during the adoption period.
Compared to the previous regulation, MDR provides more detailed rules and introduces new obligations regarding medical devices, including:
drive or affect the use of a device.
The full text of the translation of the MDR and its annexes are available here.
Medical devices companies should carefully review the new MDR text before its adoption into the Turkish legislation and take the necessary steps to ensure compliance.