TR-TR 
EN-US 
Turkish Medicines and Medical Devices Agency (“TITCK”) has recently announced that the Turkish Standards Institution (“TSE”) will no longer operate as a notified body regarding the Regulation on in vitro Diagnostic Medical Devices as of October 15, 2020. TSE had been operating as a notified body regarding the Regulation on in vitro Diagnostic Medical Devices since November 3, 2011.
TSE Continuous to Operate as a Notified Body under 93/42/AT Medical Device Regulation
Although TSE will no longer operate as a notified body regarding the Regulation on in vitro Diagnostic Medical Devices, TSE will continue to operate as a notified body under the scope of 93/42/AT Medical Device Regulation(“Regulation”). The purpose of this Regulation is to determine the basic requirements that medical devices and accessories must meet, and to regulate the procedures and principles of the relevant issues in order to protect the health, safety and hazards of patients, practitioners, users and third parties during the use of these devices and their accessories. One of the duties of TSE, as a notified body, is to control whether the devices are produced in accordance with the regulation. If the notified body determines that the relevant provisions of this Regulation have not been complied with by the manufacturer or the certificate has been given inadvertently; TSE can suspend, cancel or restrict the given certificate by the principle of proportionality until the corrective measures are taken by the manufacturer and the relevant requirements are ensured. TSE may inform the Ministry of Health if it deems necessary. The Ministry of Health notifies the necessary matter to the EU Commission electronically or through the Undersecretariat of Foreign Trade. TSE also has to have the necessary personnel and technical facilities to carry out the technical and administrative procedures required by the assessment and verification activities in order to carry its notified body obligations.
Eda Kurt
