MDR Language Requirements in Turkey

Turkey is an important market for medical device manufacturers, as of the end of 2024, the Turkish MD market is estimated at $3.3 billion with 75% (approx. $2.5 billion) composed of imported devices. Therefore, market entry in Turkey is crucial, yet dependent on smooth translation and regulatory documentation processes.

This guide explains MDR language requirements in Turkey across labelling, IFU, Declaration of Conformity, implant related patient information, safety notices, technical documentation, and software UI. This should help to get the gist of the Turkish MDR language requirements.

If you want to dive into the general EU requirements or specific EU country analysis, check out our MDR language requirements blog.

Turkey MDR alignment and where to validate official requirements

A practical starting point for official information is the Turkey Product Rules Database sector guide for medical devices, which maps applicable legislation and links to the legal texts used for market access.

For the legal text itself, use the official Turkish legislation portal to verify the official Turkish Medical Device Regulation.

Language Requirements for IFU and Labelling

In Turkey, language requirements are tied to the information that must accompany the device and to what competent authorities can request during review.

Tıbbi Cihaz Yönetmeliği (TR-MDR), Article 10(11)

“Manufacturers shall ensure that the information specified in Annex I, section 23 accompanies the device, in accordance with subparagraph (ğ) of the first paragraph of Article 7 of Law No. 7223 and, where applicable, in the EU official language(s) determined by the EU Member State in which the device is made available to the user or patient.”

Annex I, Section 23 defines the information that must accompany a medical device. This includes the label, Instructions for Use (IFU), warnings, precautions, symbols, manufacturer identification and other information necessary for the safe and intended use of the device.

Law No. 7223 is Türkiye's Product Safety and Technical Regulations Law. Article 7 requires manufacturers to ensure that the safety information, instructions and other information accompanying the product are provided in Turkish.

Tıbbi Cihaz Yönetmeliği (TR-MDR), Article 10(14)(a)

“Manufacturers shall provide, upon request, to the competent authority all information and documentation required to demonstrate the conformity of the device, in Turkish and/or in the relevant EU official languages.”

The competent authority in Türkey is the Turkish Medicines and Medical Devices Agency (TİTCK). While certain technical documentation may be accepted in English where the legislation permits, Turkish remains the authority's official working language and the default language for regulatory compliance. Manufacturers should double check beforehand which type of documents are accepted in English.

Language requirements for the Declaration of Conformity

The Declaration of Conformity is often treated as an EU only document. In Turkey, the regulation explicitly addresses Turkish translation when the declaration exists in other languages.

Tıbbi Cihaz Yönetmeliği (TR-MDR), Article 19(1)

“The EU declaration of conformity shall include at least the information specified in Annex IV and, for devices placed on the domestic market, if the declaration is drawn up in other languages, a Turkish translation of the declaration shall be attached.”

Compliance risk: the problem is rarely just missing Turkish. The common issue is inconsistency between the Turkish DoC, the Turkish IFU, and the product’s intended purpose wording should match across the Turkish document set.

Language requirements for implant related patient information

Implantable devices add patient facing documentation, where misunderstandings can have higher safety consequences. The Turkish regulation explicitly sets out language for the patient supplied implant information, including Turkish and, when necessary, English.

Tıbbi Cihaz Yönetmeliği (TR-MDR), Article 18(2)

The information referred to in paragraph 1 shall be provided to the patient in whom the device is implanted, in a manner enabling rapid access, in Turkish and, where necessary, together with English.

The regulation also requires this information to be written in a way that is easily understood by a lay person and updated where appropriate. Manufacturers must therefore treat implant cards and accompanying patient information as controlled, patient-facing regulatory content.

Practical guidance: use clear language suitable for non-specialist readers and plan the layout early, as implant cards are space-constrained and Turkish wording may affect readability. Manufacturers should also check whether the device falls within one of the exemptions listed in Article 18(4), such as dental crowns. We always recommend trusting your layouting to professional multilingual service providers.

Language Requirements for Field Safety Notices and Vigilance

For field safety corrective actions in Turkey, Article 87(8) requires manufacturers to inform users without delay through a Field Safety Notice (FSN). The notice must be prepared in Turkish for Turkey, identify the affected device and manufacturer, explain the reasons and risks clearly, and specify the actions users must take. Except in emergencies, the draft must be submitted to TİTCK for comment before issue.

For vigilance reporting, manufacturers should use the official Turkish-language forms published on the TİTCK Medical Device Vigilance Forms page.

You will find:

• Announcement Regarding the Medical Devices Warning System
• Healthcare Facility Adverse Event Reporting Form
• Field Safety Corrective Action Form
• Manufacturer Adverse Event Report Form

These forms are provided in Turkish and should be incorporated into the manufacturer’s controlled post-market procedures.

Software and UI MDR language Requirements in Turkey

According to the European Commission’s language-requirements table, graphical user interfaces intended for patients or lay users should be available in Turkish. For professional users, the interface may be in Turkish or English, provided that the Instructions for Use are supplied in Turkish.

This distinction is not expressly stated in the Turkish Medical Device Regulation itself, so manufacturers should confirm the applicable approach with TİTCK or their Turkish authorised representative for the specific device.

The Commission itself states that “the provisions of the Member States implementing the MDR in respect of language requirements take precedence over the information in this table”.

In any case, manufacturers should always choose professional software translation services and avoid relying on machine translation output or simple AI-output. Software localization is inherently context and country dependent and need human review in order to make sense out of UI texts.

Conclusion and Recommendations for manufacturers

To reduce delays and rework, treat Turkish as a controlled part of your regulatory documentation system for the medical device translation. Start early, lock terminology, review by risk, validate final formats, and prepare post market templates. Always double-check the MDR language requirements in Turkey that are specific to your risk class and device type.

If you want a single supplier for regulated workflows that accompanies the full product lifecycle across borders, make sure to choose a professional translation service provider that can demonstrate minimum quality standards such as ISO 9001 or ISO 17100 and preferably specialised providers who are certified under ISO 13485. That way you can make sure your products and its accompanying information is handled by experts who are experienced with translations for healthcare and life sciences.