Devices Manufactured Using Animal Tissues: Regulation of 14 January 2021

1. Key takeaways

Devices containing animal tissues in Turkey are subject to a double constraint: the general requirements of point 13.2 of Annex I of the device regulation, and an independent dedicated regulation on devices manufactured using animal tissues that remains in force. A separate labelling rule at point 23.2(d) of Annex I completes the picture, and the neighbouring field of human-derived materials follows its own route.

• Devices containing animal-origin tissues in Turkey are subject to a double constraint: the general requirements of point 13.2 of Ek I of the device regulation, and an independent dedicated regulation, the Regulation on Medical Devices Manufactured Using Tissues of Animal Origin (Hayvan Kaynaklı Dokular Kullanılarak İmal Edilen Tıbbi Cihazlara Dair Yönetmelik), published in the Resmî Gazete on 14 January 2021 in issue 31364, with legislation information system number MevzuatNo 36228.
• That dedicated regulation remains in force and is expressly referenced by the relevant provisions of the device regulation.
• There is also an independent labelling requirement: point 23.2(d) of Ek I sets out the marking particulars relating to animal-origin materials.
• Adjacent to this field are devices containing human-derived tissues or cells, which are governed by point 13.1 of Ek I, with reference to the Regulation on Human Tissues and Cells, Law No. 5624 on blood and the regulations related to blood products.
• Where the two sets of requirements run in parallel, GRZAN adopts strictest-applicable compliance as the default risk-control approach.

2. Legal basis

The framework rests on the dedicated regulation, the corresponding points of Ek I of the device regulation, and the first amending regulation that adjusted related wording of Ek I. Read together, they form the complete compliance base for animal-origin devices. Their identifying details are recorded below.

3. Expert insights

Insight 1: the survival of a dedicated regulation is easily overlooked. Because the device regulation was restated wholesale in 2021, many teams assume that the older sector-specific regulations were automatically repealed. But the Sayı 31364 dedicated regulation is not covered by the repeal list in Madde 110 of the device regulation, and it is still referenced. The correct practice is: after every restatement, go back and check whether the older dedicated regulations remain outside the repeal list and therefore still apply. Repeal-by-list, rather than repeal-by-implication, is the Turkish drafting style, and assuming otherwise produces silent non-compliance.

Insight 2: the compliance focus for animal-origin materials is source traceability and inactivation validation. The technical argumentation for this class of devices usually revolves around the country of animal origin, the tissue species, donor screening, viral removal and inactivation validation. Point 13.2 of Ek I and the dedicated regulation jointly demand precisely this chain of evidence. A dossier assembled for other markets may cover most of the ground, but the Turkish file should be checked point by point against both instruments so that no element of the chain is missing when the authority reviews it.

Insight 3: the labelling particulars are the most visible compliance point at the end user level. The particulars required by point 23.2(d) of Ek I appear on the smallest sales unit and are among the easiest things for an inspector to check. Managing the label artwork and the technical documentation in the same review cycle prevents the two from drifting apart, which is one of the most common and most avoidable findings in this product class.

Insight 4: the human-derived neighbour needs its own route, not a copy of the animal-origin one. Devices containing human-derived tissues or cells follow point 13.1 of Ek I, which references the Regulation on Human Tissues and Cells, Law No. 5624 on blood and the blood-product regulations. The evidence chain, the competent authorities involved and the documentation expectations differ from the animal-origin track, so reusing one dossier template for both will leave visible gaps. Companies operating in both fields should keep the two tracks separated in the quality system, with the strictest-applicable default applied whenever a product touches both sets of requirements.

4. Practical recommendations

• Establish a dedicated biological-origin materials dossier: country of origin, species, tissue type, donor screening, and viral removal and inactivation validation reports.
• Review label artwork and technical documentation in the same cycle, ensuring that the particulars of Ek I point 23.2(d) are not omitted.
• For products involving human-derived materials, check in parallel the requirements of the Regulation on Human Tissues and Cells and Law No. 5624 on blood as referenced by Ek I point 13.1.
• Apply the strictest-applicable approach whenever animal-origin and human-derived requirements run in parallel on the same product.

5. Verification checklist

• □ The product has been confirmed as a device containing animal-origin tissues, to which the Sayı 31364 dedicated regulation applies.
• □ The general requirements of Ek I point 13.2 have been satisfied in parallel.
• □ The labelling particulars of Ek I point 23.2(d) have been checked.
• □ The biological-origin materials dossier (origin, species, inactivation validation) is complete.
• □ Human-derived material products have been checked against Ek I point 13.1 and the regulations it references.

Regulatory information verified as of 29 October 2026. The dedicated regulation name, issue number (Sayı 31364), date (2021-01-14), MevzuatNo 36228 and the Ek I entries cited in this article were checked against the original texts of the Resmî Gazete and the legislation information system.

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 adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com