The Regulation on Medical Devices Manufactured Utilizing Animal Origin Tissue (“Regulation“) was published on the Official Gazette on January 14, 2021. The Regulation entered into force on the date of its publication.
In the scope of EU harmonization, the Regulation was prepared based on the EU Regulation dated August 9, 2012 No. 722/2012 to establish the particular requirements for introducing medical devices into the market and/or putting into service, including active implantable medical devices, that are manufactured utilizing animal tissue.
- According to the Regulation, before filing an application for a conformity assessment, the device manufacturer or authorized representative of the manufacturer must carry out the risk analysis and risk management processes.
- Approved establishments appointed within the scope of the Regulation on Active Implantable Medical Devices or the Regulation on Medical Devices must have the expertise and up-to-date knowledge to evaluate the compliance of said devices in accordance with the relevant regulations and the requirements specified in the annex of the Regulation. The Turkish Medicines and Medical Devices Agency (“TİTCK“) will monitor and verify that the approved establishments maintain the necessary up-to-date knowledge and expertise.
- The conformity assessment considers the justification for the use of animal tissues or derivatives, the manufacturer’s control of raw materials sources, finished products, production process, testing, subcontractors and the outcomes of the analysis of literature.
- The TİTCK will take all necessary precautions to ensure that medical devices are presented to the market and/or put into service only if they meet the requirements specified in the relevant regulations.
- The Law on Preparation and Application of Technical Legislation on Products No. 4703 and the Turkish Criminal Code No. 5237 and other relevant legislations will be applicable to device manufacturers and approved establishments operating contrary to the provisions of the Regulation.
The Regulation on Medical Devices Manufactured Utilizing Animal Origin Tissue is available here (in Turkish)
The TİTCK provided guidance for companies operating in the healthcare sector regarding medical devices manufactured utilizing animal origin tissue. Companies operating in this field must carry out risk analysis and risk management processes prior to putting the devices on the market, must pay attention to certain elements during the conformity assessment and must follow the requirements set forth under the Regulation.