EU Regulation 2023/607 Transition Extension and Its Turkish Implementation

1. Key takeaways

The European extension of the MDR and IVDR transition periods does not flow into Turkey of its own force; it enters the Turkish framework through domestic amendment, which changes both the citation practice and the verification duty. The operative deadlines, however, preserve the familiar double-cut structure on the device side and a three-step ladder on the IVD side. The points below set out the mechanism and every deadline a planning table needs.

• The EU (AB) 2023/607 (MDR transition period extension) does not apply automatically in Turkey. Turkey absorbed it into the Medical Device Regulation through its own amending Regulation: introduced by Sayı 32151 (2023-04-02) and adjusted again in wording by Sayı 32635 (2024-08-17).
• On the device side, the staggered deadline arrangement is written in paragraphs 4 and 5 of Geçici Madde 1 (Transitional Provision 1), forming a double cut:
  • 31 December 2027: all Class III devices, and Class IIb implantable devices other than sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, needles, clips and connectors;
  • 31 December 2028: the remaining Class IIb, Class IIa and Class I devices that are sterile or have a measuring function; and legacy self-declaration devices for which a conformity assessment statement was issued before 2021-05-26 but which require notified body involvement under the new Regulation.
• On the IVD side there are three additional deadline points (Geçici Madde 1 of the IVD Regulation): for legacy self-declaration devices, Class D by 2027-12-31, Class C by 2028-12-31, and Class B and sterile Class A by 2029-12-31.
• The proper formulation when citing this extension is: pursuant to Geçici Madde 1 (as amended by Sayı 32151 and Sayı 32635); both issue numbers are indispensable.

2. Legal basis

The table below consolidates the instruments cited in this article. The two amending Regulations appear as separate rows because the extension argument is only complete when both issue numbers are cited together with the transitional provision itself.

3. Expert insights

Insight one: the Turkish extension is an absorption, not an inheritance. The step is completed through domestic legislation, so the original basis is the amending Regulation published in the Turkish Official Gazette, not the EU decision itself. When enterprises cite (AB) 2023/607 in compliance arguments, tender documents and customer communications, the Turkish acceptance path must be added; otherwise the argument chain is incomplete. A citation that jumps straight from the EU regulation to a Turkish deadline reads as authoritative to a European counterpart but leaves a Turkish reviewer looking for the domestic instrument that actually created the deadline. Auditing the citation format across the document estate once, and fixing the template wording at the same time, is far cheaper than relitigating the argument chain in front of a tender committee or a customer auditor.

Insight two: sutures, dental fillings and the other named Class IIb implants enjoy the longer stretch, to 2028-12-31. This carve-out matches the handling under the MDR in the European Union and is frequently skipped in Chinese-language materials. For domestic exporters of sutures and dental screws, it means the product line still has a comparatively generous window in which legacy certificates remain usable. The list of named implant categories is closed and specific, so the check is mechanical: find the product on the list, and apply the later date only if the answer is yes.

Insight three: the IVD extension is looser than the device extension. On the IVD side the latest deadline reaches 2029-12-31 (Class B and sterile Class A), a full year later than the 2028-12-31 cut on the device side. This difference originates in the transition arrangements of the IVDR itself and is preserved in the Turkish text. IVD planning must therefore not reuse device dates. Teams that run one master timeline for both product families systematically overstate the urgency on the IVD side, or worse, discover late that their device-side rows carry deadlines one year earlier than the template assumed. The remedy is to keep the two sides in separately dated blocks within the same ledger, so that a filter by product family yields a correct deadline list without manual editing of shared rows.

4. Practical recommendations

• Build a ledger of the usable-until dates of legacy certificates: record product class, whether implantable, whether on the named exception list, and the corresponding deadline, item by item.
• Mark two dates on each SKU: the certificate expiry date and the regulatory deadline; take the earlier one as the production-planning constraint.
• When citing the extension, always write out all three items in documents: Geçici Madde 1 plus Sayı 32151 plus Sayı 32635.

5. Verification checklist

• □ It has been confirmed whether the product belongs to the device side or the IVD side, and the corresponding deadline has been obtained.
• □ Implantable Class IIb devices have been checked against the named exception list (the deadline difference is 1 year).
• □ The citation format includes both issue numbers Sayı 32151 and Sayı 32635.
• □ The validity of legacy CE certificates does not run short of the regulatory deadline (the earlier value governs).
• □ IVD projects have registered the deadlines 2027 / 2028 / 2029 separately by Class D / C / B.

Regulatory information verified to 29 October 2026. The deadlines and issue numbers listed in this article were checked against the current texts on the Turkish legislative information system (MevzuatNo 38657, 38658).

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