On 19 July 2023, the Medicines and Medical Devices Agency published Guidelines for withdrawal and recall of medical devices and in vitro diagnostic devices (Turkish language) on its official website.
The Guidelines regulate the procedures to be implemented to prevent unsafe and non-conforming medical devices from being placed on the market and the responsibilities of the relevant parties pursuant to Law No 7223 on Product Safety and Technical Regulations. In this regard, the Guidelines indicate the procedure on withdrawal and recall of medical devices and in vitro diagnostic devices from the market, and duties, authorities and responsibilities of the Agency and the medical devices companies.
The Guidelines were prepared according to the recent amendments made to the Turkish Medical Device Regulation and In Vitro Medical Device Regulation in line with the EU regulations.
First published by Practical Law Life Sciences Monthly Newsletter in Aug 10, 2023.