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