Premarket Sequencing in Turkey: Entity Registration, CE Applications and UDI Timelines

1. Key takeaways

The question of sequencing, whether entity registration precedes the notified body application, has a written answer in the Turkish Regulation, and the answer fixes the order for every project that needs notified body involvement. Alongside the registration rule, the UDI obligations run on their own class-based timetable, so a complete plan has to manage several parallel timelines at once. The points below set out the sequence rule, the SRN and the UDI dates.

• The sequencing question has an explicit answer in Turkey: paragraph 1 of Madde 31 provides that manufacturers, authorised representatives and importers that are not yet registered must enter the information listed in Section 1 of Part A of Ek VI into the electronic system referred to in Article 30 before placing devices on the market; in particular, where the conformity assessment procedure requires the involvement of a notified body, this information must be entered before submitting the application to the notified body.
• This means official registration precedes the notified body application, rather than obtaining the CE mark first and completing registration afterwards. An inverted order leaves the process chain without continuity on the official side, and the likelihood of being asked to make corrections rises accordingly.
• After registration is completed, the Kurum issues the individual registration number (münferit kayıt numarası / SRN) through the electronic system (paragraph 2 of Madde 31).
• On the UDI side a separate timetable applies (paragraph 1 (c) of Madde 111, corresponding to paragraph 4 of Madde 27): Class III and implantable devices from 2021-05-26; Class IIa and IIb from 2023-05-26; Class I from 2025-05-26; for reusable devices that come with a UDI carrier directly on the label, Class III and implantables from 2023-05-26, Class IIa and IIb from 2025-05-26, and Class I from 2027-05-26.

2. Legal basis

The table below consolidates the instruments cited in this article. The third amending Regulation appears because it revised paragraph 1 (a) of Madde 111, the provision whose subparagraph (c) carries the UDI timetable relied on in this article.

3. Expert insights

Insight one: the last sentence of paragraph 1 of Madde 31 is an iron rule of scheduling. The Regulation is unambiguous here: for projects requiring notified body involvement, registration in the electronic system must be completed before the application to the notified body. For teams accustomed to considering local registration only once the certificate is in hand, this is a process order that has to be rebuilt from the ground up. The consequence of the old habit is not merely administrative untidiness: because the registration record is missing when the application lands, the file looks inconsistent on the official side, and correction requests consume weeks that the schedule did not contain.

Insight two: three timelines run in parallel and cannot share a single Gantt chart. Official registration (Madde 31, ahead of the notified body application), the CE certificate (whose cycle is determined by the notified body), and the UDI effective dates (Madde 111(1)(c), fixed by class). GRZAN schedules these as three separate swim lanes, each with its own milestones and owners. The lanes interact at specific points, most obviously where registration must precede the application, but between those points each lane advances on its own clock, and merging them into one bar hides the dependencies that actually drive the critical path.

Insight three: the SRN is the primary key for every subsequent action. The individual registration number issued under paragraph 2 of Madde 31 is used in a range of later obligations. Treating it as an ordinary system account is inaccurate: it is the formal identity marker of the enterprise within this system, and changing the responsible entity means an identity change, not a simple account change. Because downstream submissions, declarations and database entries all reference the SRN, an entity change propagates through the documentation estate, which is why the choice of the registering entity deserves the same care as the choice of the authorised representative.

4. Practical recommendations

• At the project kick-off meeting, lay out four steps first: confirmation of the legal vehicle (representative / importer) → official registration to obtain the SRN → formal application to the notified body → UDI and entry of the Part A of Ek VI data.
• For Class I devices in particular, watch the 2025-05-26 node, the effective date of the UDI obligation for the lowest risk class; for reusable Class I devices carrying their own label carrier, watch 2027-05-26.
• Write the notified body application submission date and the official registration completion date into the same milestone table, and ensure the latter precedes the former. This is the simplest way of demonstrating compliance with evidence.

5. Verification checklist

• □ Official registration has been confirmed as completed before the application to the notified body (Madde 31, paragraph 1).
• □ The SRN issued upon registration has been obtained and recorded in the registration ledger.
• □ The information listed in Section 1 of Part A of Ek VI has been entered in full into the electronic system referred to in Article 30.
• □ The Basic UDI-DI has been assigned and entered in the UDI database before placing on the market (Madde 29).
• □ The UDI effective nodes have been checked by class: the classes and reusable devices corresponding to 2021 / 2023 / 2025 / 2027.

Regulatory information verified to 29 October 2026. The provisions and dates listed in this article were checked against the current text on the Turkish legislative 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 approval applications and UTS registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com