Turkey is not a member state of the EU, but has aligned its regulatory requirements for medical device manufacturers with EU requirements.

This article describes

  • what simplifications this will bring for EU manufacturers who want to market their products in Turkey, and
  • what additional requirements you need to consider.
1. Turkey, an interesting market

Due to the large population, which is even higher than that of Germany, Turkey represents a relevant market for European medical device manufacturers. However, expenditure on the healthcare system is significantly lower than in Germany (see table).

Turkey Germany Hospital beds per 1,000 inhabitants 2.85 8 doctors per 1,000 inhabitants 1.76 4.21 Gross national product 690 billion 3,570 billion inhabitants 85 million 83 million Life expectancy m/f 75/81 79/83 2. The legal framework a) General: Customs Union

Turkey is effectively a third country for the EU. But the customs union between Turkey and the EU significantly simplifies the movement of commercial goods. As part of this agreement, Turkey has adapted its law to EU law.

b) Special: Medical devices

This also applies to medical device law. Turkey had already harmonized the EU Medical Devices Directives (MDD, IVDD, AIMDD). Meanwhile, the Turkish Medicines and Medical Device Agency has brought the Turkish regulations on medical devices and IVD into line with the EU regulations (MDR, IVDR).

Additional information

The Turkish law is also called Medical Device Regulation . You can access it here (in Turkish).

3. Simplifications a) Harmonized requirements and CE marking

Turkey has aligned its legal requirements with European requirements. Therefore, products that have successfully passed a conformity assessment procedure in Europe and have a CE mark also meet the Turkish requirements.

This means: Medical products that have a CE mark may also be sold in Turkey - with the below mentioned


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