The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently published on its website the draft Regulation on Medical Devices Manufactured Utilizing Animal Origin Tissue (“Regulation”).
In the scope of EU harmonization, the draft Regulation was prepared based on EU Regulation No. 722/2012 to establish the particular requirements for introducing into the market and/or putting into service medical devices, including active implantable medical devices, manufactured utilizing animal tissue.
Before filing an application for a conformity assessment for these medical devices, manufacturers must carry out the risk analysis and risk management scheme set out under the draft Regulation. 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, and subcontractors.
The draft Regulation and a comparison chart of the draft Regulation and EU Regulation No. 722/2012 are available here (in Turkish).
The TİTCK continues to provide guidance for companies operating in the healthcare sector. Companies should carefully review the requirements set forth under the draft Regulation before placing on the market or putting into service their medical devices and filing an application for a conformity assessment.