EUDAMED Obligations in Turkey from 28 May 2026

1. Key takeaways

The Turkish Medical Device Regulation turns the activation of EUDAMED-related obligations into a precise formula anchored in the Medical Device Regulation itself. This article reconstructs that formula, identifies the European and Turkish trigger documents, and shows why a one-day difference between the calculated date and the announced date matters for compliance planning.

• The Medical Device Regulation sets out the starting mechanism for EUDAMED-related obligations as a formula: Madde 111 paragraph 1 subparagraph (a) provides that the obligations corresponding to each of the electronic systems referred to in Madde 33 paragraph 2 apply six months after the date of publication in the Official Journal of the European Union of a notice announcing that the system in question is functional and meets the functional specifications.
• On the European side, the trigger instrument is Commission Implementing Decision (AB) 2025/2371, published in the Official Journal of the European Union on 27 November 2025, declaring that four modules are functional.
• TİTCK issued a corresponding announcement on 11 December 2025, clarifying that the relevant electronic systems become mandatory as of 28 May 2026.
• One detail worth recording: counting six months from the European publication date of 2025-11-27 yields 2026-05-27, which differs from the 2026-05-28 date announced by TİTCK by one day. TİTCK did not explain this difference in the announcement, and as a practical estimate the TİTCK announcement date governs.
• The affected provisions are listed one by one in Madde 111 paragraph 1 subparagraph (a), covering registration obligations (Madde 29, 31, 32), EUDAMED (Madde 33 paragraph 3), vigilance obligations (Madde 85, 86, 87, 88), PSUR obligations (Madde 84 paragraph 2) and clinical investigation obligations (Madde 70—80), among others.

2. Legal basis

The starting mechanism rests on three documents: the Turkish Medical Device Regulation itself, the amending regulation that carried the relevant wording, and the TİTCK announcement that supplied the concrete date. The table below reproduces the identifying details that should appear in any internal compliance file on this topic.

3. Expert insights

Insight 1: this is a mechanism triggered outside the system but activated inside it. The triggering event, namely the European publication of the notice declaring functionality, happens outside Turkey, yet the obligations take effect through a domestic Turkish provision, Madde 111 paragraph 1 subparagraph (a). A company that only watches the Resmî Gazete may well miss the true trigger, because the decisive document first appeared in the Official Journal of the European Union. Conversely, a company that only watches TİTCK announcements cannot independently verify whether the counting logic behind the announced date is correct. Both lines must be monitored at the same time.

Insight 2: an enumerative list means that anything not listed is unaffected. Madde 111 paragraph 1 subparagraph (a) identifies the affected provisions by naming each one individually. The reverse reading of this drafting technique is that obligations not on the list do not start running from that date. When building a compliance schedule, teams should tick off the list item by item rather than concluding in general terms that the launch of EUDAMED has changed everything. This discipline matters because the list mixes registration, vigilance, PSUR and clinical investigation provisions, and not every post-market duty of a manufacturer sits behind an electronic system.

Insight 3: the value of the TİTCK announcement of 11 December 2025 lies in supplying a date. The European decision by itself only declares functional readiness; it is the Turkish announcement that becomes specific about the day the systems must be used. An announcement of this kind, being deterministic, can be written directly into an internal control calendar with countdown milestones. Companies should treat the announcement, the European decision and the underlying regulation as a single documentary chain, and keep copies of all three in the same compliance file so that the starting logic can be demonstrated to auditors or notified partners without reconstruction.

4. Practical recommendations

• Work through the enumerative list in Madde 111 paragraph 1 subparagraph (a) and mark, item by item, whether each obligation falls within the scope of your own portfolio.
• Enter 2026-05-28 into the internal control calendar as the operative node and set preparation milestones at 90 / 60 / 30 days before that date.
• In parallel, verify the status of registrations on the EUDAMED side, confirming whether SRN issuance, UDI data and certificate information are already recorded in the system.
• Keep the European decision (AB) 2025/2371, the TİTCK announcement of 2025-12-11 and the regulation text together in one file so that the counting logic and the announced date can be evidenced end to end.

5. Verification checklist

• □ The six-month counting logic in Madde 111 paragraph 1 subparagraph (a) and its itemised list of obligations have been confirmed.
• □ The 2026-05-28 node and its countdown milestones have been entered in the calendar.
• □ The trigger document (AB) 2025/2371 (Official Journal of the European Union, 2025-11-27) has been checked.
• □ The exact date in the TİTCK announcement of 2025-12-11 has been checked.
• □ EUDAMED-side registration data (SRN, certificates, UDI) have been reconciled.
• □ The one-day difference between the calculated date and the announced date has been documented, with the TİTCK date adopted as the governing date as a practical estimate.

Regulatory information verified as of 29 October 2026. The provisions of Madde 111 paragraph 1 subparagraph (a) cited in this article were checked against the current text on the Turkish legislation information system (MevzuatNo 38657); the content and dates of the TİTCK announcement were taken from the TİTCK website. The one-day difference between the announcement date and the date derived from adding six months is resolved, as a practical estimate, in favour of the TİTCK announcement.

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