Turkey Medical Device Compliance Calendar 2026-2028

1. Key takeaways

Every Turkish obligation covered by this series can be placed on a specific calendar date. This article consolidates the dates already verified across the preceding articles into a calendar that can be used directly, separating events that have already occurred from deadlines still ahead and from the recurring actions that must repeat throughout the period.

• The Turkish obligations can all be placed on concrete dates. This article assembles a calendar that can be used directly.
• Nodes that have already occurred (for judging whether the current state is compliant): publication of the regulation on 2021-06-02; three amendments on 2022-07-29 / 2023-04-02 / 2024-08-17; UDI class deadlines 2021-05-26 / 2023-05-26 / 2025-05-26 (with re-usable direct-part marking carriers in 2023 / 2025 / 2027); entry into force of Madde 10/A on 2025-01-10; mandatory use of the EUDAMED-related electronic systems from 2026-05-28.
• Deadlines still ahead: on the device side, the legacy deadlines of 2027-12-31 (class III and certain implantable IIb) and 2028-12-31 (remaining IIb, IIa, class I sterile or with a measuring function); on the IVD side, 2027-12-31 (class D) / 2028-12-31 (class C) / 2029-12-31 (class B and sterile class A); UDI for re-usable class I devices with direct-part marking by 2027-05-26.
• Recurring actions: inspections of sales centres at least once every two years; PSUR for class IIb / III devices at least once per year; the TİTCK price list is updated annually (the basis for this verification is the version with update date 2026-03-23); supply interruption notification 6 months in advance; document retention for 10 years (15 years for implantable devices).
• It is recommended to maintain the calendar as a one-page table with three-month countdown reminders, kept by a single responsible person.

2. Legal basis

The calendar items below are anchored to the instruments on which they rest. Each row identifies the underlying regulation, announcement or transitional provision, together with the date that drives the calendar entry.

3. Expert insights

Insight 1: stringing the dates together reveals the rhythm of the regulation. 2021 legislation, then amendments in 2022, 2023 and 2024, then the supply chain obligations taking effect in 2025, then the system and operational layer switch in 2026, and finally the exit of legacy certificates in 2027 and 2028. This through-line shows that the regulatory centre of gravity in Turkey has shifted from building the framework to running it. The corporate response has to shift accordingly, from reading and understanding provisions to completing actions on time.

Insight 2: the greatest value of calendaring is that it exposes conflicts. When the annual PSUR update for class IIb / III devices, the two-yearly inspection of sales centres and the six-month advance notice of supply interruption are all placed on one timeline, resource conflicts become visible in a way that department-by-department management never shows. The same team that looks unremarkable in a departmental view may turn out to be the bottleneck on three concurrent statutory deadlines in the same month.

Insight 3: the calendar must be maintained by a single responsible person. The Turkish system is characterised by three publishing layers: regulations, guidelines and announcements. Maintaining one calendar across all three layers is more effective than having each department subscribe separately, and it is also easier for the client side to verify end to end, because every entry can be traced back to a named, dated source.

4. Practical recommendations

• Build a one-page compliance calendar: obligation name on the left, statutory date in the middle, owner and completion status on the right.
• Set three-month countdown reminders, and open a separate remediation ledger for items already overdue.
• Compare the calendar against the TİTCK website at least once a year, confirming whether the price list, guideline versions and announcements have been updated.
• Assign the calendar to a single named owner so that every statutory date has exactly one person answerable for it.
• Where an entry depends on a versioned document, record the exact version actually relied upon, so that the calendar can be re-based cleanly without guessing at the next annual comparison round.

5. Verification checklist

• □ The calendar covers the three groups of deadlines: 2027-12-31 and 2028-12-31 (MD) and 2027 / 2028 / 2029-12-31 (IVD).
• □ The 2026-05-28 node for the EUDAMED electronic systems and the obligations that follow it have been entered.
• □ The UDI node of 2027-05-26 (re-usable class I devices with direct-part marking) has been entered.
• □ The recurring actions are calendared: PSUR once per year, inspections once every two years, supply interruption notice 6 months in advance, retention 10 / 15 years.
• □ A single responsible person has been designated, and the website is compared annually for updates.

Regulatory information verified as of 29 October 2026. All dates in this calendar are taken from official sources already verified in articles 01—49 of this series, and each can be traced back to the Resmî Gazete, the Mevzuat Bilgi Sistemi and publicly available TİTCK publications.

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