Medical Device Regulation 2021: Legal Origin and Amendment History

1. Key takeaways

The Medical Device Regulation currently in force in Turkey was published in 2021 and replaced two older instruments dating from 2011. Its legal origin, its link clause to European Union acts and its amendment history determine which rules actually apply on Turkish territory. This article sets out that chain so that citations made in registration files can be verified against Turkish sources rather than European ones.

• The current Medical Device Regulation (Tıbbi Cihaz Yönetmeliği) was published on 2 June 2021 in Official Gazette issue 31499 (1. Mükerrer, the repeated issue), and at the same time repealed the former Medical Device Regulation and the Active Implantable Medical Devices Regulation published on 7 June 2011 in issue 27957.
• Madde 2 of the Regulation states its legislative basis as Article 4 of Law No. 7223 on Product Safety and Technical Regulations and Articles 508 and 796 of Presidential Decree No. 4.
• The connection of the Regulation to the European Union is concentrated in Madde 109, which lists the European documents incorporated, including (AB) 2017/745 (MDR) and its subsequent amendments, among which (AB) 2023/607 (the extension of the transition period) was introduced through issue 32151 of the Official Gazette. The list in that clause is the single point through which European rulemaking enters Turkish law for devices, which is why every citation of a European act in a Turkish file should be checked against it.
• The practical meaning of this structure: Turkey does not automatically apply amendments of European Union law. Every amendment at European level takes effect in Turkey only after it has entered the Madde 109 list through an amendment of the national Regulation.

2. Legal basis

The entries below cover the parent Regulation and the three amendment regulations that have modified it so far. Each amendment is identified by its own Official Gazette issue number and date, and the affected provisions are noted in the last column. A registration file should be able to show, for any provision relied upon, which instrument and which gazette issue delivered the version being cited.

3. Expert insights

Insight 1: the legislative basis clause is a verifiable provenance document. When compiling registration dossiers, a company can cite Madde 2 and Madde 109 on the cover pages to answer two questions at once: under what authority this Regulation is valid, and which version of the European rules it follows. In the regulatory ledgers that GRZAN builds for clients, these two articles are set as mandatory template fields, so that every subsequent citation inherits a verifiable anchor. The same two entries also answer the questions auditors and distributors ask most often about the status of the Turkish framework, which reduces the time spent re-explaining the structure in each new project.

Insight 2: the three amendments have localised the European extension. The European Union extended the MDR transition period through (AB) 2023/607, and Turkey did not become bound by it automatically. The amendment regulation of 2023-04-02 (Sayı 32151) introduced that extension into the national text, and the amendment regulation of 2024-08-17 (Sayı 32635) further adjusted the wording and the entry into force arrangements. This chain shows that the deadline of the Turkish transition period can only be determined from the Turkish text; European dates cannot be quoted directly. For a company that runs parallel submissions in several markets, the difference is not academic, because the Turkish deadline and the European deadline are set by different instruments and must each be tracked in its own ledger.

Insight 3: the amendment annotations inside the provisions are a usable time fingerprint. In the body of the Regulation, each amended provision carries an annotation in parentheses in the format (Değişik:RG-date-issue); for example, the annotation on Madde 17 reads (Değişik:RG-29/7/2022-31907). This format allows a reader to identify directly the source of the current version of a provision, and it makes it easy to trace back an earlier version in a dispute. GRZAN is accustomed to citing provisions together with the annotation in parentheses, so that version confusion is avoided. The habit costs nothing at drafting time and saves considerable effort when a distributor, an auditor or an authority asks which version of a provision was actually relied upon.

4. Practical recommendations

• Build a legislative history table specific to Turkey: the parent Regulation plus the 3 amendment regulations, recording provision by provision which gazette issue modified which article. Keep the table next to the product file rather than in a separate archive, so that the person drafting a submission can confirm the currency of each provision without leaving the workspace.
• When citing European documents, state the Turkish adoption path at the same time. Write, for example, that (AB) 2023/607 was introduced into the Turkish Madde 109 list through Resmî Gazete Sayı 32151 (2023-04-02), rather than citing the European act number alone.
• For the most recent European amendments that have not yet entered the Madde 109 list, treat them as not applicable by default, and record them in internal memoranda as pending adoption by Turkey. Reviewing the list at a fixed interval prevents the opposite error as well, namely continuing to treat a provision as pending after it has in fact been adopted through a new amendment regulation.

5. Verification checklist

• □ Confirm that the version cited is Sayı 31499 (1. Mükerrer), and not an incorrect issue number circulating in secondary sources.
• □ Confirm that Madde 110 expressly repealed the former Regulation of issue 27957 (2011).
• □ Confirm whether the provision intended for citation carries a (Değişik:RG-...) annotation, and record the gazette issue from which it originates.
• □ Confirm whether the European document intended for reliance is already inside the Madde 109 list.
• □ Register the 3 national amendment gazette issues: 31907 / 32151 / 32635.

Regulatory information verified as of 29 October 2026. The articles, issue numbers and dates 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