Economic Operators in Turkey: Four Roles and Their Obligations

1. Key takeaways

Turkey follows the European structure of four categories of economic operators, and assigns to each of them a dedicated set of statutory duties that cannot be moved between the roles by contract. On top of the four roles, the Regulation imposes a personnel requirement on manufacturers that is easy to overlook, and a supply chain transparency duty that reaches down to the healthcare institutions served. The points below summarise the allocation.

• Turkey follows the European four-category economic operator structure: İmalatçı (manufacturer), Yetkili Temsilci (authorised representative), İthalatçı (importer) and Dağıtıcı (distributor), whose duty provisions are Madde 10, 11, 13 and 14 respectively.
• Manufacturers carry one further personnel requirement that is easily overlooked: Madde 15 requires the manufacturer to have within its organisation at least one person with the necessary expertise in the field of medical devices who is responsible for regulatory compliance.
• The arrangements for changing the authorised representative are set out in Madde 12; an importer may place on the market only devices that conform to the Regulation (Madde 13 paragraph 1).
• The supply chain identifiability duty is set out in Madde 25 paragraph 2: operators must be able to provide the Kurum with information on the parties they directly supplied, the sources from which they were supplied, and the healthcare institutions or health professionals to which the devices were delivered.

2. Legal basis

The duty provisions of the four roles sit in the Medical Device Regulation, while the IVD Regulation carries a parallel set of provisions with shifted numbering. Both citation sets are given below, because a company active in both product families must be able to cite the correct instrument for each role without ambiguity.

3. Expert insights

Insight 1: the duties of the four categories of operator are not joint liability but separate functions. Each category of operator has its own statutory actions, and those duties cannot be transferred between the operators by contract. One example: Madde 13 requires the importer to place only devices that conform to the Regulation. If an importer releases goods because the certificate provided upstream has expired, the importer cannot escape its own responsibility by arguing that it already exercised due care in reviewing the documents; an independent duty of verification exists here. The same logic applies down the chain, which is why a distributor that only stores and delivers goods still carries its own residual duties and cannot contract them away.

Insight 2: Madde 15 is a hard constraint on the organisational structure of the company. The requirement of at least one person with the necessary expertise responsible for compliance corresponds to Article 15 of the European MDR (the person responsible for regulatory compliance). For Chinese manufacturers the practical meaning is that Turkish compliance cannot be outsourced entirely to a local representative while no corresponding responsible person exists at headquarters. At project start GRZAN usually recommends that clients designate this role in writing and retain evidence of the person’s qualifications.

Insight 3: Madde 25 paragraph 2 turns the supply chain into an auditable ledger. Operators must retain, within the period referred to in Madde 10 paragraph 8, the ability to provide the Kurum with lists of their direct upstream and downstream parties and the terminal healthcare institutions. This means that distribution contracts, invoices and dispatch records must be able to reconstruct the flow of goods on a single map. This is the documentary precondition of the ÜTS inventory movement reporting. A ledger that satisfies Madde 25 paragraph 2 will, almost by construction, also supply the data elements that the ÜTS declarations require, so building the ledger first avoids maintaining two parallel record systems.

Insight 4: the numbering on the IVD side is shifted forward by one. In the IVD Regulation, the change of authorised representative is Madde 13, the importer is Madde 14, the distributor is Madde 15, and the requirement for the compliance person is Madde 16. If an IVD project applies the numbering of the MD Regulation, it will point to the wrong provisions.

4. Practical recommendations

• Build a duty mapping table for each of the four categories of operator, appending the Turkish article number to each duty, so that the division of work is not left to verbal arrangements. The table also becomes the natural checklist for supplier audits and for reviewing draft distribution agreements before signature.
• Designate the person responsible for compliance in writing at headquarters (Madde 15), and retain that person’s education, experience and role description for inspection.
• Add an information provision clause to distribution contracts, stating expressly that the counterparty must cooperate in providing the supply chain information required by Madde 25 paragraph 2.

5. Verification checklist

• □ The role of the company in different batches of business has been confirmed (it may be manufacturer and importer at the same time).
• □ The person responsible for compliance has been designated and recorded in writing (MD Madde 15 / IVD Madde 16).
• □ Lists of upstream and downstream supply chain parties have been established and can be provided within the period of Madde 10 paragraph 8.
• □ The mandate of the authorised representative covers at least all devices of the same generik (same family) device group (MD Madde 11 paragraph 2).
• □ IVD projects use the article numbering of the IVD Regulation and have not applied the MD numbering.

Regulatory information verified as of 29 October 2026. The articles listed in this article were checked against the original text in the Turkish Legislation Information System (MevzuatNo 38657 and 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