The Turkish Medicines and Medical Devices Agency (“TİTCK“) recently published on its website the draft Regulation on Medical Devices (“Regulation“). Within the scope of harmonization with EU legislation, the Regulation is based on the EU Directive No. 2017/745 (“Directive“). The TİTCK will collect public opinion for the Draft Regulation until December 16, 2018. Opinions may be submitted to the TİTCK in writing or to the e-mail address email@example.com.
The Regulation aims to protect the health of patients, healthcare professionals or persons who use medical devices and sets out high standards of quality and safety for medical devices. Within this scope, the Regulation establishes the principles and procedures concerning the placing on the market, making available on the market or utilization of medical devices and their accessories.
Products that do not meet the requirements under the Regulation cannot be placed on the market or utilized. In this respect, companies are required to demonstrate the conformity of their products with the general safety and performance requirements under the Regulation. The Regulation also prohibits using texts, names, trademarks, pictures or other signs that might mislead the user or the patient concerning the devices’ intended purpose.
The Regulation introduces significant obligations for both importers and manufacturers. Manufacturers must ensure that their products are designed and manufactured in line with the standards set out under the Regulation, whereas importers are required to verify that the devices are accompanied by an EU declaration of conformity and the required instructions for use.
The draft Regulation on Medical Devices, the Directive, and a comparison chart of the Regulation and the Directive are available here.
The TİTCK continues to provide guidelines for companies in the healthcare sector in line with EU regulations. Companies should benefit from this opportunity to cooperate with the TİTCK to further improve the draft Regulation and follow the principles and procedures before placing their products on the market.