IVD Regulation and Its Alignment with the EU IVDR

1. Key takeaways

Turkey regulates in vitro diagnostic medical devices under a separate regulation that was adopted on the same day and in the same gazette issue as the Medical Device Regulation, taking the European IVDR as its blueprint. Because the two regulations look similar but are numbered independently, cross-reading articles between them is the most frequent source of citation errors in Turkish IVD projects. The points below identify the provisions that matter most.

• The In Vitro Diagnostic Medical Devices Regulation (İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği) and the Medical Device Regulation were published on the same day and in the same issue: both on 2 June 2021 in Official Gazette issue 31499 (1. Mükerrer).
• Its blueprint is European Union act (AB) 2017/746 (IVDR), and the linking clause is Madde 106; the European documents incorporated at the same time also include (AB) 2022/112, (AB) 2023/607, (AB) 2023/503 and others.
• The provisions binding on operators apply from 26 May 2022 (Madde 108 paragraph 1 point d); UDI obligations advance by class, with Class D from 2023-05-26, Classes B and C from 2025-05-26, and Class A from 2027-05-26. The staggered schedule means that an IVD labelling or coding project must be planned against several dates rather than one, and the applicable date depends on the class of each product in the portfolio.
• The repealed predecessor is the Regulation on In Vitro (İn Vitro) Diagnostic Medical Devices published on 9 January 2007 in issue 26398 (Madde 107).
• The numbering of the obligation articles of the IVD Regulation is not aligned with that of the device Regulation. For example, the vigilance provisions are Madde 82–85 in the IVD Regulation but Madde 85–88 in the device Regulation; copying article numbers across the two instruments is highly error-prone.

2. Legal basis

The table below lists the IVD Regulation itself, the amendment regulations that have modified it in step with the device Regulation, and the repealed predecessor. The European documents incorporated through Madde 106 should always be checked against the consolidated Turkish text, because the list in that clause, and not the European list, defines what has been received into Turkish law.

3. Expert insights

Insight 1: IVD and MD are two independent regulations, and articles must not be cross-cited. Although the two instruments were published on the same day and are amended at the same rhythm, their article numbering systems are independent. A common corporate error is to apply Madde 11 of the device Regulation (authorised representative) directly to an IVD, even though the corresponding provision carries a different number in the IVD Regulation. In IVD projects GRZAN always builds a separate mapping table and never reuses the article mapping of the MD side. The mapping table is cheap to maintain once created, and it removes the recurring cost of re-checking every citation whenever a vigilance report, a field safety notice or a registration form must name its legal basis.

Insight 2: the transition arrangements for old certificates differ from the MD side. The transitional provisions on the IVD side are likewise set out in Geçici Madde 1, but the deadlines for certificates issued under the former directive (IVDD) differ from those on the MD side. Classes D, C and B each carry their own independent dates, and preconditions must be satisfied. When citing these arrangements, the Turkish original text must be opened and the corresponding sub-items checked; the two deadlines of the MD side cannot be carried over. Files that carry over MD deadlines to an IVD product tend to pass internal review unnoticed, because the numbers look plausible, and the error surfaces only when a customer or an authority asks for the provision behind each date.

Insight 3: the time gap between UDI class dates is a production planning variable. The UDI obligation for Class A IVDs applies only from 26 May 2027. For manufacturers of low-risk reagents this is a genuine production planning window, and it also means that completing Class A coding preparation during 2026 is still a leading move rather than a late one. Aligning the internal coding roadmap with the class dates also protects the launch sequence, because labelling artwork and UDI carriers feed directly into the packaging steps that precede release.

4. Practical recommendations

• When compiling citation tables for IVD projects, create a separate column for the applicable regulation, marking expressly whether each provision comes from the MD Regulation or from the IVD Regulation.
• Where both MD and IVD product lines are held, maintain two separate sets of compliance documentation, especially the vigilance report templates and the record retention periods.
• Enter the IVD UDI class dates (2023-05-26 / 2025-05-26 / 2027-05-26) into the Gantt chart of the product launch plan.

5. Verification checklist

• □ Confirm that the instrument cited is the IVD Regulation (MevzuatNo 38658) and not the MD Regulation (MevzuatNo 38657).
• □ Confirm that the former law of issue 26398 (2007-01-09) has been repealed and is not cited as a basis in force.
• □ Confirm whether the European list in Madde 106 reflects the most recently amended text.
• □ Check the UDI class dates: Class D 2023-05-26; Classes B and C 2025-05-26; Class A 2027-05-26.
• □ Check that the transition of old certificates relies on the corresponding sub-items of Geçici Madde 1, and not on the dates of the MD side.

Regulatory information verified as of 29 October 2026. This article was checked against the Turkish Official Gazette and the original text in the Legislation Information System (MevzuatNo 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 registrations aligned with the EU MDR/IVDR framework, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com