Turkish labelling requirements for medical devices and IVDs
If you place a medical device or an in vitro diagnostic device on the Turkish market, the information that comes with it has to be in Turkish. This guide sets out where that rule comes from, which documents it covers, who is responsible for it, and what usually goes wrong in translation.
In short
- Türkiye's Medical Device Regulation follows the EU MDR, and its IVD Regulation follows the EU IVDR. Both were published in the Official Gazette on 2 June 2021.
- The manufacturer must make sure the information supplied with the device (labels, instructions for use and related information) accompanies it in Turkish.
- Manufacturers outside Türkiye and the EU need an authorised representative before the device can be placed on the market.
- Electronic IFUs are possible for devices intended for professional users, under a separate Communiqué. Lay users still get paper.
- Devices and economic operators are registered in ÜTS, the national product tracking system run by TİTCK.
The legal basis
Medical devices in Türkiye are regulated by TİTCK, the Turkish Medicines and Medical Devices Agency. Under the EU–Türkiye Customs Union, Türkiye adopts EU product legislation, so the Turkish Medical Device Regulation (Tıbbi Cihaz Yönetmeliği) mirrors Regulation (EU) 2017/745. The In Vitro Diagnostic Medical Device Regulation (In Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği) mirrors Regulation (EU) 2017/746. Both appeared in the Official Gazette of 2 June 2021, issue 31499.
The language rule sits in the manufacturer's general obligations. Article 10(11) of the Medical Device Regulation requires manufacturers to ensure that the information set out in Section 23 of Annex I is supplied with the device in Turkish, and, where the device is supplied in an EU Member State, in the official language or languages that state requires. If you already sell in the EU, the structure of your labelling stays the same. Turkish is one more language in it.
What has to be in Turkish
Annex I, Section 23 of the Medical Device Regulation (Section 20 of Annex I in the IVD Regulation) covers the information supplied with the device. In practice that means:
| Document | What to watch |
|---|---|
| Label and outer packaging | Warnings, storage conditions, intended purpose, and any text that sits next to the standard symbols. |
| Instructions for use | The full IFU, including contraindications, warnings, precautions and the symbol glossary. |
| Sterile packaging information | Text that has to be readable before the sterile barrier is opened. |
| Implant cards and patient information | Written for patients, not clinicians, so the reading level matters as much as the terminology. |
| Software and on-device text | Where screens carry instructions or warnings, keep them identical to the IFU wording. |
Symbols from EN ISO 15223-1 do not need translating. Their explanations in the IFU do.
Conformity documentation is a separate question. Article 10 also requires manufacturers to provide the competent authority, on request, with the documentation that shows conformity, in Turkish and/or an official EU language. That is usually a request-driven translation, not a launch requirement.
Electronic instructions for use
Türkiye has a Communiqué on electronic instructions for use of medical devices, dated 6 April 2023 and amended on 22 April 2026 in line with EU Implementing Regulations 2021/2226 and 2025/1234. It allows the IFU to be provided electronically instead of on paper for devices intended for professional users. Where it is reasonably foreseeable that non-professionals will use the device, the instructions for those users have to be on paper. Earlier electronic versions have to stay available, and superseded versions must be produced on request.
An e-IFU changes the format, not the language. The electronic Turkish IFU has to say exactly what the paper one would.
Who is responsible
- The manufacturer is responsible for the Turkish information under Article 10(11), even when a distributor commissions the translation.
- A manufacturer established outside Türkiye and the EU may place a device on the market only after appointing an authorised representative, under Article 11(1). A distribution agreement does not, by itself, make a distributor your authorised representative. That takes a written mandate. See our guide to authorised representatives in Türkiye.
- Importers and distributors check, before supplying a device, that it carries the required marking, labelling and instructions. A Turkish IFU that does not match the approved source is something they are expected to catch.
- ÜTS registration covers both the devices and the economic operators. Decide at the start of the project who owns each record, because the label, the IFU and the ÜTS entry need to agree. Our guide to ÜTS documents lists what is uploaded and what needs a sworn translation.
Where Turkish translations go wrong
Most of the problems we see in Turkish device documentation come from a handful of features of the language:
- Negation is a suffix. "Dondurun" means "freeze"; "dondurmayın" means "do not freeze". One syllable separates an instruction from its opposite, and it is easy to miss in review.
- Decimal commas. Turkish writes 2,5 for two and a half and 2.500 for two thousand five hundred. A copied value can change by a factor of a thousand.
- Units and spacing. Turkish style puts a space between the number and the unit (37 °C, 5 mL), and percentages lead with the sign (%5).
- Drift between documents. The same warning translated three times, by three people, reads three different ways on the label, in the IFU and on the screen.
- Change control. When the English IFU is revised, the Turkish version has to follow. A Turkish file that is one revision behind is a non-conformity waiting to be found.
A checklist before launch
- List every item of information supplied with the device: label, packaging, IFU, sterile packaging text, implant card, patient information, software text.
- Agree a Turkish glossary for the device family before the first file is translated.
- Translate, then have a second translator revise every file against the source.
- Check every number, unit, symbol explanation and cross-reference against the English.
- Confirm the Turkish label, IFU and ÜTS data say the same thing.
- If you use an e-IFU, confirm the device is within the professional-user scope and plan the paper version for lay users.
- Put the Turkish files under the same change control as the source.
Need your labelling in Turkish?
We translate IFUs, labels and technical files for medical device and IVD manufacturers. A sworn translator does the translation, a second translator revises every file, and standard delivery is 48 hours.
Request a quote See a translation sample (PDF)This guide is general information, not legal or regulatory advice. Requirements change and depend on your device and its classification, so confirm your obligations with your regulatory adviser or notified body.
Sources: Tıbbi Cihaz Yönetmeliği, Official Gazette 31499, 2 June 2021; amendment to the e-IFU Communiqué, Official Gazette 33232, 22 April 2026; TİTCK.