Notice No. 2023/KK-2

Regarding Applications for Registration/Record Updates of Medical Device Products Qualified for an Extension by the MDR Transition Period and of their Associated Documentation in the Product Tracking System Following the Initial Filing to the Agency pursuant to Notice No. 2023/KK-1 For the Enforcement of the Regulation (EU) 2023/607

The Pharmaceuticals and Medical Devices Agency of Turkey;

Bearing in mind that the Turkish “Medical Device Regulation” and “In Vitro Diagnostic Devices Regulation” have gained full force and effect on publication and disclosure in the Official Journal of Legislative Acts Release 31499 (bis) of June 2^nd, 2021, as the final outcome of efforts towards transposing the lexical context of the Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical devices (“MDR”) and the Regulation (EU) 2017/746 of the European Parliament and of the Council on In Vitro Medical Devices into National Legislation, and

Having due regard to the “Regulation (EU) 2023/607 of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic devices”, as published in the Official Journal of the European Union on March 20^th, 2023 with effect therefrom,

HEREBY PROCLAIMS AS FOLLOWS: