The Ministry of Health (“Ministry“) published the draft communiqué on The Electronic Instructions For Use of Medical Devices, which was prepared in line with the Commission Implementing Regulation (EU) 2021/2226.
What does the Draft Communiqué on The Electronic Instructions For Use of Medical Devices introduce?
On 30 May 2022, the Ministry published the draft communiqué on The Electronic Instructions For Use of Medical Devices. The draft communiqué regulates requirements that manufacturers must fulfill in providing the instructions for use in electronic form as set forth under the Medical Devices Regulation. The draft communiqué is available here (in Turkish).
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The draft communiqué does not cover nonmedical product groups such as contact lenses; equipment used to reduce, remove or break up adipose tissue; laser devices for skin resurfacing, tattoo removal or other skin applications.
Manufacturers may provide instructions for use in electronic form instead of in paper form in the (i) implantable and active implantable medical devices and their accessories, (ii) fixed installed medical devices and their accessories, and (iii) medical devices and their accessories with a built-in system where instructions for use are displayed. Additionally, such devices and accessories must be intended for exclusive use by professional users.
Manufacturers can also provide instructions for use in electronic form instead of paper form in the software where the instructions are provided by means of the software itself.
The main requirements regarding the instructions for use to be provided in electronic form are as follows:
- Instructions for use of medical devices that will be placed on the market in Turkey must be in Turkish and in the official language of the relevant EU country if the device will be used in the EU.
- Manufacturers that provide instructions for use in electronic form instead of in paper form to users must undertake a risk assessment on the issues such as knowledge and experience of the users on the use of the device and user needs, characteristics of the environment in which the device will be used, knowledge and experience of the user on the hardware and software needed to display the instructions for use in electronic form, access of the user to the electronic resources, safety measures against access problems, and evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request.
- The aforementioned risk assessment must demonstrate that providing instructions for use in electronic form maintains or improves the level of safety of the instructions for use in paper form.
- The manufacturers must be able to provide the instructions for use in paper form at no additional cost to the users at the latest within seven days upon the user’s request or at the time of delivery if the request was made during the order.
- The manufacturers must provide information on foreseeable medical emergency situations and the information on how to start the devices with a system displaying the instructions for use on the device or a leaflet.
- The manufacturers must provide information on software and hardware requirements needed to display the instructions for use in their catalog or other appropriate device support materials.
- The manufacturers must have a system where the users can view the time and reasons of the revisions made on the instructions for use. All previous electronic versions of the instructions for use must be available on the manufacturer’s website.
- For devices with a defined expiry date, except implantable devices, the manufacturers must keep the instructions for use available for users in electronic form for ten years after the last device has been placed on the market and at least two years after the expiry date of the last produced device. For devices without a defined expiry date and implantable devices, this period is fifteen years after the last device has been placed on the market.
- Manufacturers must clearly indicate that the instructions for use of the device are supplied in electronic form instead of in paper form on the label, packaging or sales packaging. In fixed installed medical devices, this information must be provided on the device itself.
- The information on how to access the instructions for use in electronic form must contain information such as manufacturer contact details, how instructions for use in paper form can be requested, device name and model.
- Where manufacturers provide the instructions for use on an electronic storage medium together with the device, or where the instructions are displayed in the system on device, the instructions for use must also be made accessible by the users through a website.
Upon the entry of the draft communiqué into force, the Communiqué on the Electronic Instructions for Use of Medical Devices will be repealed but will continue to be applied to devices placed on the market until 26 May 2024 within the scope of the Provisional Article 1/5 of the Medical Devices Regulation.
The Ministry continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the newly published regulations and take necessary actions to ensure compliance.