The “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation”, which were prepared in full compliance with the “Regulation (EU) 2017/745 on Medical Devices” and the “Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices”, respectively, were published in the Turkish Official Gazette. In this manner;

• The “Medical Device Regulation” prepared completely in line with the “Regulation (EU) 2017/745 on Medical Devices”  was published in the Official Gazette on 02.06.2021 and entered into force in a way that is valid as of 26/05/2021.

• The “In vitro Diagnostic Medical Devices Regulation” prepared completely in line with the “Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices” was published in the Official Gazette on 02.06.2021 and will enter into force on 26/05/2022.

Respectfully brought to the attention of the public.

For more detailed information on the Regulations, please click