On 8 July 2022, the Regulation on Medical Device Clinical Trials (Turkish language) (Regulation) was published in the Official Gazette numbered 31890, repealing the former regulation dated 6 September 2014. The Regulation, which came into force on its day of publication, introduces amendments to ensure clinical trials comply with the Turkish Medical Device Regulation.
The Regulation sets rules in connection with the functionality date of the European Database on Medical Devices (EUDAMED) and the rules on observational studies have been redefined as post-market research. The provisions of articles 62 to 80 of the Turkish Medical Device Regulation, which also regulates clinical trials, are still in force and shall be applied together with the provisions of the new Regulation.
First published by Practical Law in Jul 08, 2022.