Classification of Medical Devices in Turkey: Madde 51 and Annex VIII Rules

1. Key takeaways

Classification is the gateway decision for every medical device entering Turkey, because the risk class determines the conformity assessment route, the notified body involvement and the depth of the technical documentation. Under the Turkish Medical Device Regulation, the classification framework rests on Madde 51 and the rules collected in Ek VIII (Annex VIII). The points below summarise how the system works, how disputes are resolved, and why an overseas manufacturer should secure its Turkish or European positioning before any classification argument begins.

• Turkey classifies devices into the four risk classes I, IIa, IIb and III. The legal basis is paragraph 1 of Madde 51 of the Medical Device Regulation, and the assessment method follows Ek VIII.
• Classification applies a dual benchmark based on the intended purpose of the device and its inherent risks, rather than mechanically assigning classes by product category. Paragraph 1 of Madde 51 expresses this as taking into account the risks that devices carry by reason of their intended purpose and their construction.
• Classification disputes have an explicit resolution path, set out in paragraph 2 of Madde 51:
  • (a) disputes between the relevant notified body and a manufacturer registered and established within Turkey are submitted to the Kurum for decision; disputes between a manufacturer registered within the European Union and a notified body designated in Turkey are submitted to the competent authority of the EU Member State in which the manufacturer has its registered place of business.
  • (b) where the manufacturer has no registered place of business in Turkey or in an EU Member State and has not yet designated an authorised representative, the dispute is handled in the country where its authorised representative registered in Turkey or in an EU Member State is established.
• Hidden inside this clause is a sequencing requirement: an overseas manufacturer that wishes to contest a classification must first have a positioning on the Turkish (or European) side, otherwise even the subject entitled to submit the dispute cannot be determined.

2. Legal basis

The instruments cited in this article are consolidated in the table below, pairing each with its original Turkish title, its official reference and publication date, and the specific provisions on which the analysis rests. Note that the classification rules themselves do not sit in the body text of the Regulation but in the separate Annex VIII file, which must be downloaded independently.

3. Expert insights

Insight one: Ek VIII is the sole method of classification and it is not in the body text. Many users download only the 111 articles of the Regulation and then search in vain for the classification rules. The rules are written in full in the Ek VIII annex file, and that annex is a standalone document that must be downloaded separately. In GRZAN’s delivery of Turkish projects, the first step is usually to file Ek VIII and Ek I before any discussion of product classification begins. Teams that treat the annex as an afterthought discover late in the project that the rule texts they need for the classification rationale are not even in their document set, which delays the entire conformity assessment conversation with the notified body.

Insight two: the dispute resolution mechanism exposes a legislate-the-landing-first orientation. Paragraph 2 of Madde 51 sets out the situation of an entity that has not designated an authorised representative as a separate case, which in substance makes having a positioning in Turkey or the European Union a precondition for exercising the right to dispute. For Chinese manufacturers, this means that the appointment of the authorised representative should precede any classification dispute, rather than being patched together after a disagreement arises. Waiting until a notified body challenges the class before arranging representation leaves the manufacturer without a forum in which to argue, because neither the Kurum route nor the Member State route is open to an entity with no registered position and no representative.

Insight three: IVDs have a classification system of their own. Madde 49 of the IVD Regulation divides in vitro diagnostic devices into the four classes A, B, C and D, assessed under Ek VIII in the same structural manner. The two product families must not share classification logic: the Ek VIII of the device Regulation and the Ek VIII of the IVD Regulation are two annexes with the same name but entirely different content. Applying device rules 1 through 22 to an IVD, or IVD rules to a device, produces a class that has no legal footing, and every downstream decision built on that class inherits the defect.

4. Practical recommendations

• Produce a written Classification Rationale: work through the rules of Ek VIII one by one, stating which rule applies and why the rules that would yield a higher class do not apply.
• For products sitting in the overlap between two rules, prefer a written consultation with TİTCK and file the reply in the registration dossier.
• In project scheduling, fix the representative first and the classification second. Under paragraph 2 of Madde 51, without a representative there is no complete dispute remedy path.

5. Verification checklist

• □ The applicable class has been confirmed as one of I / IIa / IIb / III (or A / B / C / D, if the product is an IVD).
• □ The original text of the Ek VIII annex has been filed, annotated with the product name and the applicable rule numbers.
• □ A written classification rationale has been issued, including the exclusion reasons for why higher-scoring rules do not apply.
• □ A Turkish (or European) authorised representative has been designated, ensuring the dispute remedy path is available (Madde 51, paragraph 2).
• □ Where an overlap zone exists, a written TİTCK opinion has been obtained and filed.

Regulatory information verified to 29 October 2026. The provisions listed in this article were checked against the original texts on the Turkish legislative information system (MevzuatNo 38657, 38658); the body of the classification rules is located in the Ek VIII annex file.

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