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:
- The scope of medical device definitions has widened to include software products that drive or affect the use of a device.
- Additional clinical data will be collected and clinical evaluation reports will be required for medical devices that are deemed high-risk.
- The obligations regarding the safety and performance of the devices will be increased. The security and performance of the devices will be continuously monitored through post-marketing surveillance reports and periodic security update reports.
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.