On 13 April 2022, the European Commission published the notice (Notice To Stakeholders) to regulate trade relations between Turkey and the European Union and ratify the provisions of the Customs Union Agreement.

TURKEY: Customs Union Agreement to market medical device
TURKEY: Customs Union Agreement to market medical device

Turkey, not being an EU member state, needs a customs union agreement to remove trade barriers and ensure the free movement of Medical Devices and in vitro diagnostic devices in the European Union.

The establishment of the Customs Union took place gradually and the alignment of Turkish legislation to the MDR (EU) 2017/745 and the IVDR (EU) 2017/746 was confirmed by the EU-Turkey Customs Union Committee by the declarations of 21 May 2021 and 13 September 2021.

With the notice of last April, additional requirements regarding, for example, the appointment of the Authorized Representative and the certifications issued by the Notified Bodies, have been made official.

What is the impact for companies?

The Notice To Stakeholders focuses on two main aspects of the Customs Union Agreement between the European Union and Turkey:

  • Appointment of an Authorised Representative

Manufacturers based in Turkey are not required to appoint a European Authorised Representative to market their devices in the EU;as well as Manufacturers based in the European Union are not required to appoint an Authorized Representative in Turkey to export their devices in the Turkish market.With regard to Manufacturers located outside both Turkey and the EU, in order to place their DM or IVD on the market in these two territories, they shall appoint an Authorized Representative in Turkey or in Europe.

  • Notified bodies

Turkey is authorised to designate Notified Bodies in accordance with EU Regulations 2017/745 and 2017/746; it follows that Notified Bodies established in Turkey have the same rights and obligations as NBs established in the EU. The Notice To Stakeholders published by the European Commission confirms that Medical Devices and IVDs covered by a certificate duly issued by a Turkish Notified Body, can circulate freely in the European Union, and also states that DM and IVD certified by a Notified Body based in the EU can move freely in Turkey.

Thanks to agreements with the European Union, the marketing of Medical Devices and IVDs in Turkey is certainly facilitated. This does not mean, however, that there are no further pre-market regulatory requirements to place devices on the territory. We would like to recall, for example, that all Medical Devices and IVDs must be registered in the online database of the Turkish Ministry (TITUBB, Turkish Drug and Medical Device National Databank) in order to be sold in Turkey.

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Notice to stakeholders. EU-Turkey Customs Union Agreement in the field of medical device, European Commission, 13 aprile 2022