Three Amendments to the Turkish Medical Device Regulation: 31907, 32151, 32635

1. Key takeaways

The device Regulation in force since 2021 has been amended three times, and each amendment left visible traces inside the consolidated text. Reading those traces is the fastest way to establish which version of a provision governs a given product. This article reconstructs the three amendments and explains the two clauses that matter most for transition planning and supply chain security.

• Since its publication on 2021-06-02, the current device Regulation has undergone three amendments: Sayı 31907 (2022-07-29), Sayı 32151 (2023-04-02) and Sayı 32635 (2024-08-17). Knowing the three issue numbers by heart is worth more than any summary document, because every later dispute about the currency of a provision will be resolved by tracing it back to one of these gazette issues.
• The first amendment (31907) left traces searchable in the body of the text, for example Madde 17 (reprocessing of single-use devices) and Madde 26, which are marked as (Değişik:RG-29/7/2022-31907).
• The second amendment (32151) introduced European act (AB) 2023/607, writing the extension of the transition period formally into the Turkish text; it also left wording-change traces such as (Değişik ibare:RG-2/4/2023-32151) on Madde 29 and other provisions.
• The third amendment (32635) was a broad synchronised update, touching Madde 111 paragraph 1 point (a) and several items of Geçici Madde 1, and adding Madde 10/A (notification of supply interruptions), which applies from 2025-01-10.
• Every amendment amended the IVD Regulation at the same time, so version management for MD and IVD must advance in step.

2. Legal basis

Each amendment regulation is a separate instrument with its own gazette issue and date, and each carries its own set of affected provisions. The table below is the basic version-control reference for any Turkish registration file that relies on provisions touched by the amendments.

3. Expert insights

Insight 1: the amendment traces themselves are a version management tool. The Turkish regulation uses the practice of inserting an annotation of the form (Değişik:RG-date-issue) directly at the amended provision. As soon as the current text is obtained, the amendment history can be reconstructed by searching these annotations. This practice lowers the risk of version confusion, but it also requires users to cite in a search-based way: writing Madde 17 alone without checking whether an amendment annotation exists is not sufficient. In practice, the search takes seconds and can be delegated to any team member, which makes the annotation system one of the more convenient features of the Turkish drafting style for foreign compliance teams.

Insight 2: issue 32151 is the key to understanding the transition period. Chinese-language materials widely circulate the statement that the MDR transition period was extended to 2027 or 2028, but few point out that this entered the Turkish text only through Sayı 32151. For companies compiling regulatory compliance arguments, the correct formulation relies on Geçici Madde 1 paragraphs 4 and 5 (as amended through Resmî Gazete Sayı 32151 and 32635), and neither of the two issue numbers can be omitted. A reviewer who reads only the first issue will miss the adjustments made by the second, and a reviewer who reads only the second will miss the original introduction of the extension into the Turkish text.

Insight 3: Madde 10/A, added by issue 32635, is the starting point of the supply chain security duty. Under this provision, when a manufacturer foresees an interruption or discontinuation of supply that could cause serious harm, it must in principle notify the Kurum, and the economic operators, healthcare institutions and health professionals it directly supplies, 6 months in advance, stating the reasons. For Turkish customers that depend on a single production site in China, this is a continuing obligation of performance. It cannot be discharged once and archived, because the duty renews itself whenever the supply situation changes, and the notification clock runs against the date on which the interruption becomes foreseeable rather than the date on which it is confirmed.

4. Practical recommendations

• Build a comparison table of the three amendments: issue number, date, affected provisions, and an impact assessment for the company’s own product lines. Once built, the table turns every future regulatory question about a provision into a lookup instead of an investigation, and it gives the annual management review a ready-made item to check.
• When citing the transition provisions, write both amendment issue numbers together (32151 and 32635), avoiding reliance on one alone.
• Integrate the 6-month advance notice of Madde 10/A into the supply chain change management process, covering situations triggered by discontinuation, transfer of production and expiry of certificates. The trigger list should name, for each situation, the person who assesses foreseeability and the person who issues the notification, so that the 6-month window is not consumed by internal routing.

5. Verification checklist

• □ The issue numbers and dates of the 3 amendments have been recorded: 31907 / 32151 / 32635.
• □ The provisions intended for citation have been checked for (Değişik:RG-...) amendment annotations.
• □ The transition period argument cites both Sayı 32151 and Sayı 32635.
• □ An internal trigger list and responsible persons for the Madde 10/A supply interruption notification have been established.
• □ Version management for IVD projects is updated in step with MD.

Regulatory information verified as of 29 October 2026. The issue numbers and dates listed in this article were checked against the Turkish Official Gazette index and the original text in the Legislation Information System (MevzuatNo 38657).

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 manages TITCK registrations aligned with the EU MDR/IVDR framework, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com