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EU-TURKEY CUSTOMS UNION AGREEMENT IN THE FIELD OF MEDICAL DEVICES

“Whenever the EU instrument listed above [i.e. Regulations 2017/745 or 2017/746] and the relevant Turkish provisions giving effect to that instrument contain references to the territories of the Parties, the references shall, for the purpose of Decision No 1/95 of the EC-Turkey Association Council, be understood to comprise the territory of the EU Turkey Customs Union".


Manufacturers established in the EU have no obligation to designate an authorised representative in Turkey in order to place devices on the Turkish market. Vice versa, manufacturers established in Turkey have no obligation to designate an authorised representative on the EU territory in order to place medical devices on the EU market.


Decision No 1/2006 states that an authorised representative has to be nominated "in Turkey or in the Community". Therefore, manufacturers established outside the territory of the EU or Turkey only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey.


Turkey is entitled to designate notified bodies in accordance with Regulations 2017/745 and 2017/746. In addition, following Article 2(1) of Decision No 1/2006 concerning the notification of Turkish conformity assessment bodies, it is possible for Turkey to designate more than one notified body.





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