Deemed Manufacturer under Madde 16 of the Turkish Medical Device Regulation

1. Key takeaways

Certain downstream actors in the Turkish supply chain can become full manufacturers without ever designing a device. Madde 16 of the Medical Device Regulation defines the three triggering situations, the one important exception, and the consequences of being deemed a manufacturer, which reach every obligation in the Regulation. This article explains when and how the role change occurs.

• Madde 16 paragraph 1 provides that distributors, importers or other natural or legal persons bear all the obligations of the manufacturer in three situations: (a) they place devices on the market under their own name, their registered trade name or their registered trademark; (b) they change the intended purpose of devices already placed on the market or already put into service; or (c) they modify devices in a way that may affect conformity.
• Point (a) contains one important exception: it does not apply if the distributor or importer has concluded an agreement with the original manufacturer, and the device is still labelled under the name of the original manufacturer, who continues to be responsible for the requirements imposed on manufacturers by the Regulation. This exception can hold only through the combined conditions of contract and label.
• Madde 17 paragraph 2 (as amended by Sayı 31907) treats the reprocessor of single-use devices as a manufacturer, and states expressly that it is a manufacturer within the meaning of Article 6 of the Law on Product Safety and Technical Regulations.
• The consequences of being deemed a manufacturer are comprehensive: technical documentation, the declaration of conformity, the affixing of the CE marking, UDI, registration, vigilance and post-market surveillance all pass over.

2. Legal basis

The deemed-manufacturer rules sit in Madde 16 and Madde 17 of the device Regulation, the latter as amended by the first amendment regulation, and they connect to the general product safety law through its definition of the manufacturer. The citation set below should be retained in any file where a private-label or reprocessing arrangement is contemplated.

3. Expert insights

Insight 1: private labelling (OEM/ODM) in Turkey is a change of role, not a commercial arrangement. A common configuration in the overseas expansion of Chinese companies is that a Turkish importer wishes to list the products under its own brand. Once the importer’s own name or trademark appears on the label, the importer becomes a subject of the manufacturer’s obligations. If the Chinese company misjudges the situation as one in which it is merely a supplier, the result in fact is an obligation subject that has neither technical documentation, nor ISO 13485, nor vigilance capability. The risk erupts first on the Turkish side, but its source is the transfer of technical data from the Chinese side. If the technical documentation, the quality system records and the vigilance files are never handed over, the deemed manufacturer holds obligations it cannot perform, and the gap is discovered precisely when a market problem occurs and documents must be produced quickly.

Insight 2: the two conditions of the exception cannot be separated. The exception in Madde 16 paragraph 1 point (a) requires, at the same time, that a contract exists and that the label still identifies the original manufacturer, who continues to bear responsibility. Two failures are common in practice: first, a contract is signed but a local brand is printed separately on the packaging; second, the label keeps the name of the original manufacturer while secondary processing is carried out locally. Either situation can slide back into the deemed-manufacturer status. The remedy is procedural rather than legal: fix both conditions in one document set, review the labelling artwork before every print run, and treat any request for localisation of the artwork as a trigger for a fresh assessment rather than a routine design change.

Insight 3: changing the intended purpose is easier to trigger than one imagines. Examples: a device originally supplied only to professional healthcare institutions is placed on the market for home use through the instruction for use and promotional materials; or new indications are added in the local instruction for use. Such changes do not need to touch the physical design, and they still trigger Madde 16 paragraph 1 point (b). For this reason the review of translated materials must include the promotional layer, not only the instruction for use, since a marketing brochure can change the intended purpose just as effectively as a technical document.

4. Practical recommendations

• In the responsibility clauses of distribution agreements, state expressly whether the exception of Madde 16 paragraph 1 point (a) is invoked, and fix as an annex to the agreement the condition that the label continues to identify the original manufacturer.
• If the private-label route is chosen, assess at the same time whether the local party that takes over can perform the duties of technical documentation, vigilance and post-market surveillance; otherwise the manufacturer role should be retained by the Chinese headquarters.
• Run an intended purpose consistency review on every localised version of the instruction for use, eliminating any indication description that exceeds the original CE scope.

5. Verification checklist

• □ The presentation of the local partner on the label (name, trademark, or distribution only) has been confirmed.
• □ If the exception is invoked, a valid contract has been signed and the label continuously identifies the original manufacturer.
• □ The intended purpose in the local instruction for use is fully identical to the original CE scope.
• □ No local modification, secondary assembly or combination into a system takes place.
• □ The reprocessing scenario has been assessed: where reprocessing of single-use devices is involved, the manufacturer obligations under Madde 17 have been evaluated.

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).

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