Whereas, the European Commission has issued the Regulation (EU) 2017
/ 745 of the European Parliament and of the Council, setting forth transitory
provisions concerning the placing on the market and retention of the standing
stocks of existing products that require the immediate attention of or are
covered by the duty and reference frames already recognised for it; and
Whereas, the currently ongoing joint effort of the Turkish Ministry of Commerce
and the EU Commission on harmonisation of the local legislation with
that of the EU’s on this matter, which is expected to come to an end by 26 April
2021, forthwith publication of the new harmonised regulation to gain full effect
at national level,

The Medicines and Medical Devices Agency of Turkey, acting under
and on authority of the Turkish Ministry of Health has adopted, and is committed
to implementing a major change in processes and procedures affecting
both the products that were previously placed on the market and are already
registered in the Product Tracking System (PTS) under the Medical Device and
Active Implantable Medical Devices Regulations of the Turkish Republic and
products updated according to the new regulation of concern, as follows: