UTS and EUDAMED Dual-Track Post-Market Data Obligations in Turkey

1. Key takeaways

Turkey structures its post-market data obligations on two parallel tracks. The Medical Device Regulation points to the European database EUDAMED through Madde 33 and to the national product tracking system ÜTS through Madde 34, and the wording of Madde 34 makes clear that the two tracks accumulate rather than replace each other. This article explains the relationship and its operational consequences.

• Turkey’s post-market data obligations for devices follow a dual-track structure: Madde 33 points to the European medical device database (EUDAMED) at the European level, while Madde 34 points to the national product tracking system (ÜTS) at the domestic level.
• The opening sentence of Madde 34 paragraph 1 fixes the relationship between the two: without prejudice to the EUDAMED obligations contained in the regulation, in the original wording, in the Turkish text, without impairment. In other words, ÜTS obligations are stacked on top of EUDAMED obligations, not substituted for them.
• The purposes of EUDAMED listed in Madde 33 paragraph 1 include: enabling the public to be adequately informed about devices placed on the market, the relevant certificates and the economic operators; enabling devices to be uniquely identified and facilitating their traceability; providing public access to information on clinical investigations and enabling sponsors to fulfil their corresponding obligations; and enabling manufacturers to fulfil the information obligations contained in Madde 85—88 or in documents adopted by the Commission.
• Madde 34 paragraph 2, for its part, leaves the content of the ÜTS obligations to be determined by regulations issued by the Kurum.
• The operational conclusion that follows: doing everything properly on the European side does not equal compliance on the Turkish side. The data actions for the two systems must be assigned to separate responsible persons.

2. Legal basis

Three instruments matter here: the two parallel articles of the Medical Device Regulation, the amending regulation that touched the related wording, and the TİTCK guideline that translates Madde 34 into operational steps. The table below records their identifying details.

3. Expert insights

Insight 1: the phrase without impairment is the key to understanding the Turkish system. In legal texts this phrase means that one obligation must not be damaged or diminished by the fulfilment of another. It expressly rules out any reading under which completing the European side would excuse the domestic side. Any judgement that defers ÜTS actions on the grounds that the company is already registered in EUDAMED therefore has no foundation in Turkey. The two obligations coexist, and each is assessed on its own terms by the authorities.

Insight 2: the two systems have different functional orientations. EUDAMED leans towards information disclosure and regulatory cooperation, since the purposes listed in Madde 33 paragraph 1 include public information and unique identification. ÜTS leans towards physical flow traceability, covering stock intake, dispatch, returns, destruction and end use. Because the data structures and update frequencies differ, the two cannot share a single operational procedure. A workflow designed for one system will systematically leave gaps in the other, which is why separate owners and separate procedures are needed rather than a merged process.

Insight 3: the rules for ÜTS come from institutional regulations, so they iterate faster. Madde 34 paragraph 2 entrusts the ÜTS obligations to regulations issued by the Kurum. This contrasts with the EUDAMED side, which depends on a European-level trigger through Madde 111 paragraph 1 subparagraph (a). The practical effect is that the ÜTS side changes more often than teams expect, because guideline versions and institutional announcements can be revised without any European-level event. Monitoring of TİTCK announcements therefore needs to be a standing, routine activity rather than a one-off project task.

4. Practical recommendations

• Establish a dual-track responsible-person system: designate separate owners for the EUDAMED side and the ÜTS side, and define the data sources and update frequencies for each.
• State explicitly in internal SOPs that the two systems do not substitute for each other, and emphasise in training materials the structure of the opening sentence of Madde 34 paragraph 1.
• Set subscriptions to TİTCK announcements and version changes of the ÜTS guideline as trigger-based review events, so that each new version prompts a documented assessment of what changed.
• Align the two tracks in reporting lines, so that management sees a single post-market data picture even though the operational owners differ.
• Re-check the assignment of owners whenever either side changes hands internally, for example after a reorganisation or a handover of the Turkey market, so that the dual-track structure never loses coverage.

5. Verification checklist

• □ It has been confirmed that Madde 33 and Madde 34 are parallel obligations, not substitutes.
• □ Responsible persons have been designated separately for the EUDAMED side and the ÜTS side.
• □ Data completeness has been checked against the four purposes listed in Madde 33 paragraph 1.
• □ The current ÜTS operational document (2026-05-13, V4.0) has been obtained.
• □ Subscriptions to TİTCK announcements and version-change alerts have been set up.
• □ Internal SOPs and training materials reflect the non-substitution relationship between the two systems.

Regulatory information verified as of 29 October 2026. The provisions cited in this article were checked against the current text on the Turkish legislation information system (MevzuatNo 38657); the publication date and version marking of the ÜTS guideline were taken from the TİTCK website.

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 adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com