CE Marking Legal Status in Turkey: Madde 20 and Madde 24

1. Key takeaways

In Turkey the CE marking is a legally mandatory mark, not a voluntary quality label. Its form, the moment of affixing and the market access right that corresponds to it are set out in a small cluster of provisions of the Medical Device Regulation, reinforced by a separate Turkish decree on the form of the mark itself. This article pulls those provisions together and shows where the apparent freedom of the CE route stops.

• The CE marking in Turkey is a legally mandatory mark, not a voluntary quality mark. Under Madde 20 paragraph 1, except for custom-made devices and investigational devices, devices that are found to conform to the requirements of the Regulation shall bear the CE conformity marking according to the pattern shown in Ek V.
• The form of the CE marking is governed by an independent Turkish decree: Article 10 of the CE Marking Regulation (“CE” İşareti Yönetmeliği), established by Presidential Decree No. 4021 of 26 May 2021, provides the general principles (Madde 20 paragraph 2). This point is often mistaken for a wholesale application of European rules.
• The moment of affixing is before placing on the market; the objects of affixing include the device itself or the packaging that keeps it sterile, and the mark must also appear on the instruction for use of every device and on every sales package (Madde 20 paragraphs 3 and 4).
• Where a notified body is involved, the identification number of that body must follow the CE marking (Madde 20 paragraph 5).
• Madde 24 grants the corresponding market access right: devices that fulfil the requirements shall not be refused, prohibited or restricted in their placing on the market or their being put into service.

2. Legal basis

Three instruments together define the legal status of the CE marking in Turkey: the device Regulation itself, the decree that governs the form of the mark, and the most recent amendment that adjusted the related provisions. The citations below should be reproduced in labelling files and in distribution agreements alike, because the form requirements and the access right sit in different instruments.

3. Expert insights

Insight 1: the formal legal source of the CE marking is a Turkish national decree. Under Turkish law, the provisions of the European MDR on the form of the CE marking are expressly replaced, by Madde 20 paragraph 2, with Article 10 of the Turkish CE Marking Regulation. This is a localisation point that is easily overlooked: a company that designs its labels by reference only to the European template may miss the formal requirements on the Turkish side. The cost of missing them is not cosmetic, because a mark that does not follow the required pattern can be treated as absent, and a missing mark is a conformity defect rather than a printing error.

Insight 2: only two categories of product are exempt from affixing the CE marking. Madde 21 paragraph 1 lists two situations in which the CE marking need not be affixed. The first covers investigational devices supplied to investigators for clinical research, which must satisfy the conditions set out in Madde 62–79, Madde 80 and Ek XV. The second covers custom-made devices that conform to Madde 52 paragraph 7 and Ek XIII. Any other claim of exemption does not hold.

Insight 3: the no-refusal rule of Madde 24 is not an absolute protection. The complete reading of Madde 24 is that the protection applies unless otherwise provided (aksi belirtilmediği sürece). This means that when other obligations remain undischarged, such as the ÜTS obligations (Madde 34), the language requirements or the vigilance duties, Madde 24 grants no exemption from them. This is the precise legal breach point of the belief that holding a CE certificate allows a product to be sold. In file reviews, GRZAN therefore treats the CE certificate and the Turkish-side obligations as two separate chapters, each with its own evidence set, so that neither is assumed to cover the other.

4. Practical recommendations

• In the label review checklist, list three CE checkpoints separately: the pattern follows Ek V; the placement covers the device, the sterile packaging, the instruction for use and the sales packaging; and the notified body identification number follows the mark.
• For shipments of custom-made devices and investigational devices, issue a written determination of the reasons, available for inspection, and retain the declaration documents required by Ek XIII.
• State in the distribution agreement that the validity of the CE certificate and the ÜTS status are two independent commitments, and that the failure of either one constitutes a ground of breach.

5. Verification checklist

• □ Confirm that the CE pattern matches Ek V and that the proportions and legibility meet the requirements.
• □ Confirm that the affixing was completed before placing on the market, and that the instruction for use and the sales packaging are both covered.
• □ Confirm that the notified body identification number follows the mark (where Madde 20 paragraph 5 applies).
• □ Confirm that the form of the CE marking also satisfies the general principles of Madde 10 of Presidential Decree No. 4021.
• □ If an exemption is claimed, confirm that it falls within one of the two situations of Madde 21 paragraph 1 and that the documents available for inspection are complete.

Regulatory information verified as of 29 October 2026. The articles and dates listed in this article were checked against the Turkish Official Gazette and the original text in the 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