On 6 April 2023, the Turkish Medicines and Medical Devices Agency (Agency) published a new Communiqué on Electronic Instructions for Use of Medical Devices (Turkish language) (Communiqué) in the Official Gazette numbered 32155. The Communiqué replaced the version dated 2 April 2015 numbered 29314 and entered into force on the day of its publication.
The Communiqué has been updated in line with Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices (see Legal update, New Commission Implementing Regulation on electronic instructions for use of medical devices.) It does not introduce any fundamental amendments. However, it aims to update the references to the Turkish Medical Device Regulation that entered into force on 2 June 2021 after being published in the Official Gazette numbered 31499.
First published by Practical Law Life Sciences Monthly Newsletter in Apr 27, 2023.