The customs union agreement between the European Union and Turkey is a complex and multifaceted document that covers a wide range of industries and products. One area that has been the subject of much discussion and interpretation is the field of medical devices.
The customs union agreement with Turkey allows for the free movement of goods between the EU and Turkey without the imposition of tariffs or customs duties. This includes medical devices, which are defined as any instrument, apparatus, machine, implant, or other similar article intended for use in the diagnosis, treatment, or prevention of disease or other medical conditions.
Under the terms of the agreement, medical devices produced in Turkey are subject to the same technical regulations and standards as those produced in the EU. This means that Turkish manufacturers must comply with the same safety and quality requirements as their EU counterparts, and that their products must meet the same performance standards.
In order to ensure compliance with these regulations and standards, all medical devices imported from Turkey into the EU must undergo a conformity assessment procedure. This involves a thorough examination of the device by a notified body, which is an independent organization designated by the EU to carry out such assessments.
The results of the conformity assessment determine whether or not the medical device meets the necessary safety and performance standards, and whether it can be legally placed on the market in the EU. If the device passes the assessment, it is issued a certificate of conformity, which allows it to be sold and used within the EU.
It is important to note that the customs union agreement with Turkey does not cover pharmaceuticals, which are subject to separate regulations and standards. However, medical devices that contain a pharmaceutical component may be subject to additional requirements, depending on the nature and intended use of the device.
In conclusion, the customs union agreement between the EU and Turkey has important implications for the field of medical devices. While it allows for the free movement of goods between the two entities, it also ensures that all medical devices imported from Turkey meet the same safety and quality standards as those produced in the EU. As such, it provides a level of assurance for both patients and healthcare professionals that these devices are safe and effective for use in the diagnosis, treatment, and prevention of disease.
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