The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community (ECC). Already established in 1963, the Agreement creates a Customs Union, which facilitates the trade between the EEC and Turkey. Over the years, other implementations, legislations, and statements further defined this Customs Union. The most recent statements are from May 2021 and September 2021. Additionally, on April 13, 2022, the European Commission published a Notice to Stakeholders to inform about reciprocal recognition in the field of medical devices. Thus, Turkey is aligned with both MDR and IVDR of the European Union. We present the implications on the AR and Notified Bodies below.
Do I need to designate an AR to sell in Turkey?
Manufacturers from the European Union do not have the obligation to designate an authorised representative if they want to place their medical devices and IVDs on the Turkish market.
Non-EU manufacturers must designate an Authorised Representative in Turkey or in the European Union to place their devices on the Turkish market.
Do I need to designate an AR to sell in the EU?
There is no obligation for Turkish manufacturers to designate an Authorised Representative if they wish to place their medical devices and IVDs on the EU market.
Non-EU manufacturers must designate an Authorised Representative in Turkey or in the European Union to place their devices on the EU market.
Certifications and Notified Bodies from Turkey and the EU
Turkey can designate one or more notified bodies under the EU MDR and EU IVDR. A notified body established in Turkey has the same rights and obligations than a notified body in the EU. Consequently, the European Union accepts certificates issued by Turkish notified bodies, and Turkey accepts certificates issued by EU notified bodies.