Turkish-Language Labelling and Instructions for Use

1. Key takeaways

Labelling and instructions for use are where regulatory intent meets the end user, and Turkish law addresses them with unusually concrete provisions. This article gathers the statutory requirements that define the minimum standard for CE marking on documents and packaging, the retention duties that underpin them, and the internal control logic that turns those duties into a repeatable process. Read together, the provisions form a chain: information duties create the content, CE marking rules govern where the mark must appear, and retention duties fix how long the evidence trail must survive. Each link is testable on its own.

• The minimum requirements for Turkish compliance in labelling and instructions for use have explicit provision-level support. Paragraphs 3 and 4 of Madde 20 require the CE mark to appear on every set of instructions for use and on every sales package, and the affixing must be completed before the device is placed on the market.
• The manufacturer is the primary responsible party. Paragraph 1 of Madde 10 requires the manufacturer to ensure that its devices are designed and manufactured in accordance with the requirements of the Regulation, which includes the correctness of the information supplied; paragraph 8 of Madde 10 additionally requires the manufacturer to keep the technical documentation, the declaration of conformity and the relevant certificates for at least 10 years (at least 15 years for implantable devices) and to make them available to the Kurum on request.
• The exact provision location of the language-acceptability criterion must be taken from the corresponding entry in the official text of Ek I; on this occasion the number of that entry could not be retrieved from the official text, so the relevant statement is handled as a practical estimate.
• From these provisions follows a workable internal standard: bring all documents directed at patients, users and healthcare institutions — labels, instructions for use and packaging text — into a single localisation review process, with the CE affixing check as the final gate before release.

2. Legal basis

Two instruments frame this topic: the parent Regulation, whose articles 10 and 20 and Annex I carry the substantive duties, and the amendment regulation through which related provisions were aligned. The table below records both, together with the precise articles cited throughout this article.

3. Expert insights

Insight one: the cost of language compliance comes from the number of versions, not from the price per word of translation. Once a product is supplied in Turkey over the long term, labels, instructions for use, packaging text and promotional materials are all retranslated as models change and claims are updated. What truly needs managing is a version matrix: model × language version × revision. GRZAN usually recommends that clients establish a two-layer structure of a single-language master file (Master IFU) plus localised derivative files. With that structure in place, each change ripples through a controlled set of derivatives instead of an uncontrolled set of ad-hoc translations, and the audit trail stays intact. The matrix should live in the quality system rather than in a project folder, so that ownership survives personnel changes and product-line reorganisations.

Insight two: the retention period is the evidential foundation of language responsibility. The retention requirement in paragraph 8 of Madde 10 — 10 years, or 15 years for implantable devices — means that translation review records, glossaries and version histories also need traceability over the same period. If a localised version is ever challenged as inconsistent with the actual product, the manufacturer must be able to produce the decision evidence from that time. A translation programme without an archive is, from a compliance standpoint, a programme that never happened. Glossaries, in particular, should be version-controlled artefacts: terminology drift between revisions is one of the quietest ways for a localised document to depart from its master.

Insight three: the CE affixing checkpoints run through the whole output. Paragraph 3 of Madde 20 covers three locations at once: the device (or its sterile packaging), every set of instructions for use, and every sales package. Turning these three locations into a single checklist posted on the production line is more effective than an after-the-fact audit, because the check operates at the moment the label is applied rather than months later when the defect can no longer be traced to a single batch or shift. A line-side checklist also produces its own records, which then serve as the evidence base for the periodic reviews the quality system already requires.

4. Practical recommendations

• Establish a two-layer documentation system of master file plus derivative files, where any change to the master automatically triggers retranslation and re-review of the derivatives.
• In the translation stage, apply a glossary and dual review (language plus regulatory), and retain the signed review records.
• Add the three CE checkpoints and a check of the local-language version number to the pre-release inspection sheet.

5. Verification checklist

• □ The CE mark appears on every set of instructions for use and on every sales package (Madde 20, paragraph 3).
• □ Affixing has been completed before placing on the market (paragraph 4).
• □ Retention of technical documentation, declaration of conformity and certificates is executed at 10 years / 15 years for implantables (Madde 10, paragraph 8).
• □ Translation, review and sign-off records of local-language versions are traceable.
• □ The exact number of the language-related entry in Ek I has been confirmed with TİTCK or a professional body (practical estimate portion).

Regulatory information verified to 29 October 2026. The Madde 10 and Madde 20 provisions and retention periods listed in this article were checked against the current text on the Turkish legislative information system (MevzuatNo 38657); the specific number of the language provisions in Ek I was not available in the original text, and the relevant statements are handled as a practical estimate.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team prepares CE/UTS-compliant documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com