Türkiye's device labeling rules sit at the intersection of the European framework, adopted through the EU–Türkiye Customs Union, and national law — principally the Turkish Medical Device Regulation (TR-MDR), which mirrors EU Regulation 2017/745, together with Law No. 7223 and Circular No. 2022/1. Manufacturers often assume either that a CE-marked device with English labeling is automatically acceptable, or that everything must be translated into Turkish. Neither is correct: the language requirement in Türkiye depends above all on who uses the device.
The instructions for use are the one element with no exception, the IFU must be provided in Turkish regardless of the user. The label and software interface, however, depend on the intended user. For a device used by a healthcare professional, an English primary and secondary label is acceptable and the software interface (GUI) may remain in English. For a device used by a lay user, the primary and secondary label and the GUI must both be in Turkish. The intended-user classification — not the CE certificate — is what sets the translation scope, and it is where manufacturers most often either overspend on unnecessary translation or fall short.
Beyond language, an EU MDR-compliant label is largely portable: TR-MDR symbol and labeling requirements (23.1 and 23.2) correspond to EU GSPR 23.1 and 23.2, and labels must carry a UDI in line with TR-MDR Article 24 and Annex V. The same language rules apply to devices placed under the TR-MDR and to legacy devices still marketed under an MDD certificate through the EU 2023/607 extension; legacy status does not relax the Turkish-language requirements, though it adds documentation (a Manufacturer Declaration and Notified Body confirmation letter) at the registration stage.
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