Acknowledging the enactment of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) by virtue and means of formal disclosure in the Official Journal of Legislative Acts of the Turkish Republic 31499 (bis) of 02-06-2021 in the framework of the National Government’s efforts toward ensuring full regulatory compliance with the Union (EU) Legislation on medical devices;

Witnessing that Notice 2022-KK-2 of the Pharmaceuticals and Medical Devices Agency of Turkey Amending Notice 2022-KK-1 in the context of provisions regarding Applications for Registration of Medical Devices and their corresponding Certificates issued per MDR unto the Agency’s Product Tracking System (Notice 2022/KK-1) is currently in effect and subject to further modifications and alterations from time to time;

Having due regard, in particular, to the provisions of Article 11 of the Turkish Medical Device Regulation and Article 12 of the Turkish In-Vitro Diagnostic Device Regulation, both enacted on publication in the OJLA 31449 (bis) of 02-06-2021, which read as follows (cited):

“Authorised representative

Article 11 (Art. 12 of the In-Vitro Diagnostic Device Regulation (IVDR)) – (1) For the manufacturer of a device not established in Turkey or a Member State, the device may only be placed on the Turkish or Union market if the manufacturer designates a sole authorised representative.

(2) The designation shall constitute the mandate of the authorised representative, be valid only when accepted in writing by the same representative and effective at least for all devices of the same generic device group.

(3) The authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The said representative shall provide the Agency with a copy of the mandate at its request.