Custom-Made Devices in Turkey: Madde 52(7) and Annex XIII Requirements

1. Key takeaways

Custom-made devices occupy a narrow but lawful side door into the Turkish market: they may be placed on the market without CE marking, but only inside a tightly defined perimeter of conditions and documentation duties. Because the perimeter is easy to misjudge, manufacturers should confirm the patient-specific character of each order before treating a product as custom-made. The points below state the legal anchors and the caveat on the extent of the exemptions.

• Turkey permits custom-made devices (ısmarlama imal edilen cihaz) to be placed on the market without CE marking. The legal basis is item (b) of paragraph 1 of Madde 21, subject to the conditions of paragraph 7 of Madde 52 and Ek XIII.
• Custom-made devices must, when placed on the market, carry the statement referred to in Article 1 of Ek XIII (paragraph 2 of Madde 21).
• The manufacturer must prepare and keep up to date the documentation required by Article 2 of Ek XIII, and submit it when the Kurum so requires (Madde 10, paragraph 5).
• Custom-made devices must still satisfy the general requirements of Madde 5. Whether obligations other than the CE affixing duty are also exempted must be checked provision by provision against the Turkish original text. This review did not obtain a complete list of exemptions from the official text, and all statements involving exemptions are handled as practical estimates.

2. Legal basis

The instruments cited in this article are consolidated below. The structure of the citation matters: the market-access permission and the statement duty sit in Madde 21, the procedural conditions sit in paragraph 7 of Madde 52, and the content obligations sit in the two articles of Ek XIII, with the general duty to keep documentation and submit on demand resting on Madde 10.

3. Expert insights

Insight one: custom-made devices are the statutory exception to the CE obligation of Madde 20. Paragraph 1 of Madde 20 expressly excludes custom-made devices and devices for research from the duty to affix CE marking; paragraph 1 of Madde 21 then adds a positive guarantee from the angle that market placement must not be obstructed. Together the two provisions form a closed loop: not affixing CE is permitted, but lawful status must be obtained through another set of conditions (Ek XIII). Companies that read the exception as an open door, rather than as a conditional route with its own paperwork, fail the loop at its second half.

Insight two: the Ek XIII statement is aimed at a specific patient or user. The original wording of paragraph 2 of Madde 21 is limited to devices custom-made for a specific patient or user identified by name, initials or a numeric code. This means volume-produced products with batch-level customisation or order-based option selection cannot use this route, which is the most common misapplication among Chinese enterprises. A genuine custom-made device is a single-instance fabrication addressed to individual anatomical parameters. Where a product line is standard with configurable options, the correct route is conformity assessment of the standard product, not the custom-made exception, however attractive the exception may look on cost grounds. Misusing the route does not merely create a technical non-conformity: it deprives the product of the conformity assessment record that tender committees and hospital procurement teams increasingly ask for, so the shortcut taken at the start reappears as a commercial obstacle at the point of sale.

Insight three: what is exempted is the CE mark, not the obligations in their entirety. GRZAN draws one risk-control line here: even where the custom-made route applies, the general obligations of the manufacturer remain in force, and in particular an evidence chain for traceability and complaint handling must be preserved. Treating custom-made status as a blanket exemption leaves the company passive when a vigilance event occurs, because the incident review will ask who manufactured the device, under which design record, and with what traceability to the affected patient or user, and the Ek XIII documentation is precisely the evidence set that answers those questions. Building the file at the design stage, when the parameters are still fresh, costs far less than reconstructing it from correspondence after an incident has already been reported.

4. Practical recommendations

• Set a custom-made determination switch in the order-taking system: is this a single-instance fabrication for a specific patient? Volume-produced configurator products do not take this route.
• Issue an Ek XIII Article 1 statement for each custom-made device, and archive it together with the order, the design parameters and the delivery record.
• Build a custom-made device documentation template on Article 2 of Ek XIII, covering the design, the manufacture, the performance data and the correspondence of device identification information; and ensure submission to the Kurum within the required time limit on demand.

5. Verification checklist

• □ The product has been confirmed as custom-made within the meaning of a specific patient or user identified by name, initials or numeric code (Madde 21, paragraph 2).
• □ An Ek XIII Article 1 statement has been issued with each device.
• □ The Ek XIII Article 2 documentation has been prepared and is kept continuously up to date (Madde 10, paragraph 5).
• □ Compliance with the procedural requirements of Madde 52, paragraph 7, has been confirmed.
• □ A custom-made device list has been established and can be submitted when the Kurum so requires.

Regulatory information verified to 29 October 2026. The provisions listed in this article were checked against the original text on the Turkish legislative information system (MevzuatNo 38657); a complete official list of the exemptions for custom-made devices was not obtained, and the statements concerned are handled as practical estimates.

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