With the “Communiqué on the Amendment to the Communiqué on Electronic Instructions for Use of Medical Devices” (“Communiqué”) published in the Official Gazette dated 22.04.2026 and numbered 33232, significant changes have been introduced to the existing regulations regarding electronic instructions for use.
A. Main Amendments Introduced Under the Communiqué
The Scope of Electronic Instructions Has Been Expanded.
Under the new regulation, manufacturers are explicitly allowed to provide instructions for use in electronic format for devices designed for professional users. This amendment will provide operational convenience, particularly for hospitals and healthcare institutions. However, in cases where it is reasonably foreseeable that a device may also be used by non-professionals, it is made mandatory to provide instructions for use intended for such users in paper format. This approach is considered to prioritize patient safety.
The Definition of Fixed Installed Devices Has Been Clarified.
The definition of “fixed installed devices” included in the Communiqué has been revised. Within this scope, devices that are fixed to a specific healthcare institution, cannot be transported, or can only be dismantled using special tools and equipment are clearly defined. This amendment aims to eliminate uncertainties encountered in practice, particularly regarding the use and supervision processes of large-scale medical equipment
The Storage and Accessibility of Electronic Instructions Have Been Regulated.
Manufacturers are required to keep all electronic versions of the instructions for use, along with their publication dates, available on their websites for specified periods. In addition, previous versions that are no longer valid must also be kept available to be provided upon request. This regulation is expected to enhance transparency, particularly in audit processes.
An Obligation to Notify the UDI Database Has Been Introduced.
With the new regulation, manufacturers are required to notify the internet address where the instructions for use are located to the UDI (Unique Device Identification) database during the registration of devices. This obligation is expected to increase traceability of devices and contribute to faster identification of potential risks.
B. Entry into Force and Evaluation
The Communiqué entered into force on the date of its publication, to be effective as of 16.07.2025. In this respect, it should be taken into consideration that the regulation may have retroactive effects.
The new regulations are expected to accelerate digitalization in the medical devices sector, facilitate access to instructions for use, and establish a more standardized structure in practice. However, due to the increased obligations regarding record-keeping and accessibility for manufacturers, it is important that compliance processes are carefully managed.