IVD Classification in Turkey: Madde 49 and Classes A to D

1. Key takeaways

In vitro diagnostic devices follow a classification track of their own in Turkey, separate from the device rules in both structure and terminology. The framework is anchored in Madde 49 of the IVD Regulation, with the conformity assessment routes set out in Madde 50, and it carries an additional normative layer for the highest-risk class. The points below set out the anchors that any IVD registration plan for Turkey must be built on.

• Turkey classifies IVDs by risk into the four classes A, B, C and D. The basis is Madde 49, paragraph 1, of the In Vitro Diagnostic Medical Device Regulation, and the method follows the Ek VIII of that Regulation.
• The conformity assessment routes are written in Madde 50: before placing a product on the market, the manufacturer must complete the relevant procedure under Ek IX to Ek XI.
• Class D IVDs carry additional common specifications: TİTCK issued the Common Specifications for Certain Class D In Vitro Diagnostic Medical Devices in the form of a communiqué (Tebliğ), released in step with the third amendment of the device Regulation.
• IVDs use the system of performance studies (performans çalışması) and performance evaluation, not the device-side system of clinical trials and clinical evaluation; the two terminologies cannot be interchanged in Turkey.

2. Legal basis

The table below consolidates the instruments cited in this article, pairing each with its original Turkish title, its official reference and publication date, and the provisions on which the analysis rests. The communiqué on common specifications deserves particular attention because it operates as an independent compliance layer on top of the Regulation itself.

3. Expert insights

Insight one: Class A is treated in many markets as nearly barrier-free, but in Turkey it does not mean no action. Class A products still carry obligations of manufacturer registration, UDI (for Class A from 2027-05-26), post-market surveillance and vigilance. Reading Class A as exempt from oversight loses points directly at the ÜTS and surveillance stage. The correct reading is that the class determines the conformity assessment route, not the breadth of the general obligations, and the general obligations follow the product wherever it is classified. Teams that plan Class A products without a surveillance budget or a reporting owner therefore inherit the same post-market workload as any other class, only with less preparation behind it, and the gap becomes visible precisely at the moments when evidence is requested.

Insight two: the common specifications communiqué is an independent compliance layer. This is a normative document issued in the form of a Tebliğ (communiqué), sitting at a different hierarchical level from the Regulation itself, yet in practice it binds Class D products directly in its technical requirements. Its release alongside 2024-08-17 Sayı 32635 shows that Turkey has followed the European pace in regulating the high-risk tier of IVDs. Manufacturers of Class D products therefore need to run two checklists in parallel: one against the Regulation and its annexes, and one against the common specifications, because a product can satisfy the Regulation and still fail the finer-grained specification requirements.

Insight three: two Ek VIII annexes, nominally isomorphic but substantively different. The device Regulation has an Ek VIII and the IVD Regulation also has an Ek VIII. They share a name and a broadly similar chapter structure, but the objects they assess are entirely different. Internal documents must state clearly which Regulation’s Ek VIII is being cited; otherwise the reference points to the wrong rule spectrum. GRZAN has seen filing packages where the citation was correct in form and wrong in substance precisely because the annex name alone does not discriminate between the two regimes, and the error surfaced only when a reviewer traced the rule numbers against the wrong annex text. The remedy is mechanical and cheap: every internal citation should carry the full regulation name alongside the annex reference, and a single style rule in the document control procedure is enough to enforce it across the whole IVD portfolio.

4. Practical recommendations

• Build a two-column ledger for IVD classification: product, class, applicable rule provision, and assessment route (which of Ek IX / X / XI applies).
• For Class D projects, maintain a separate common-specifications conformance checklist, because the granularity of the common specifications is usually finer than the body text of the Regulation.
• Unify terminology internally: IVD projects must use performance study and performance evaluation throughout, and must not use clinical trial or clinical evaluation, so that submission materials are not returned or challenged.

5. Verification checklist

• □ The IVD class has been confirmed as one of A / B / C / D.
• □ The Ek VIII of the IVD Regulation (the annex file of MevzuatNo 38658) has been downloaded, not the Ek VIII of the device Regulation.
• □ Class D products have been checked item by item against the common specifications communiqué of Sayı 32635.
• □ The assessment route has been pinned down to the specific procedure in Ek IX / Ek X / Ek XI.
• □ Internal terminology has been unified to performance study and performance evaluation.

Regulatory information verified to 29 October 2026. The provisions and issue numbers listed in this article were checked against the Official Gazette index of Turkey and the original texts on the legislative 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 approval applications and UTS registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com