The Communiqué Amending the Communiqué on Electronic Instructions for Use for Medical Devices (“Communiqué”) (“Amending Communiqué”) was published in the Official Gazette numbered 33232 on 22 April 2026, entering into force on the same date.
It has been stipulated that the provisions of the Amending Communiqué shall apply retroactively as of 16 July 2025.
With the amendments, the regulatory framework governing electronic instructions for use for medical devices has been updated; in this context, the principles regarding the provision, storage, and accessibility of such instructions, as well as manufacturers’ obligations and data sharing requirements, have been revised.
The main amendments introduced under the Amending Communiqué are as follows:
- The definition of “fixed installed devices” has been revised; such devices are defined as devices that are fixed to a specific location within a healthcare institution and that cannot be moved, or cannot be dismantled without the use of tools or equipment.
- It has been made possible for manufacturers to provide instructions for use in electronic format instead of paper format for devices intended to be used by professional users.
- It has been stipulated that, where it is reasonably foreseeable that a device intended for professional users may also be used by lay persons, the instructions for use intended for such users must be provided in paper format.
- It has been regulated that manufacturers shall keep all published electronic versions of the instructions for use, together with their publication dates, available on their websites, or make outdated versions available upon request.
- It has been regulated that manufacturers are required to notify the internet address providing access to the electronic instructions for use to the UDI database upon device registration.
- It has been stated that the reference to Commission Implementing Regulation (EU) 2025/1234 has been added to the Communiqué as a basis for its preparation.
Details of the Amending Communiqué can be found through this link (only available in Turkish).
