أسرّة المستشفيات والأثاث الطبيبنود النظام المنسق: 9402
منتجات التنظيف والنظافة الصحيةبنود النظام المنسق: 3401, 3402, 3808
ورق صحيبنود النظام المنسق: 4818
معدات طبيةبنود النظام المنسق: 9018, 9019, 9021, 9022
السجلّ
رأتها بيرلشا أول مرة: 2026-11-02T10:45:41.628484Z
تُسجَّل التغييرات منذ 5 نوفمبر 2026. لم يتغيّر شيء منذ ذلك الحين.
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إلزاميشهادة
Conformity assessment and CE marking for medical devices (MDR)
الشهادة: علامة المطابقة الأوروبية (CE)
Medical devices for human use and their accessories must meet the general safety and performance requirements of Regulation (EU) 2017/745 (MDR); Regulation (EU) 2023/607 gives transition periods to some devices certified under the former Directives. The conformity assessment route depends on the risk class: for Class I the manufacturer draws up the technical documentation and EU declaration of conformity itself, while Classes IIa, IIb and III, and the sterility, measuring or reuse aspects of some Class I devices, need a notified body; the device then carries the CE marking, with the notified body's number where one took part. A non-EU manufacturer must first appoint an EU authorised representative; manufacturers also give each device a unique device identifier (UDI), register it in EUDAMED and keep the technical documentation for 10 years (15 for implantables). National authorities and customs at EU entry points check compliance.
RoHS substance limits, CE marking and WEEE duties for electrical and electronic equipment
الشهادة: علامة المطابقة الأوروبية (CE)
Electrical and electronic equipment (EEE), including cables and spare parts, must not exceed the RoHS limits of Directive 2011/65/EU in homogeneous materials: 0.01 % by weight for cadmium and 0.1 % for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP, save for Annex III and IV exemptions. Before placing EEE on the market, the manufacturer prepares technical documentation, carries out internal production control, issues an EU declaration of conformity, affixes the CE marking and marks its name, address and a type, batch or serial number on the product. Under Directive 2012/19/EU (WEEE), producers apply the Annex IX separate collection symbol, register with the competent authority and report data, guarantee financing for waste collection and treatment, and meet recovery targets. Since 28 June 2025, some products such as computers and smartphones must also meet the accessibility rules of Directive (EU) 2019/882. Only for electrical and electronic equipment within the scope of Directive 2011/65/EU, Directive 2012/19/EU or both.
EU customs clearance of any product from Türkiye relies on a standard set of documents. The exporter prepares the commercial invoice, always required (no set form; original and at least one copy; English translation recommended), and a packing list of the packages, their contents, marks and weights. The transport document depends on the mode: bill of lading, FIATA bill of lading, CMR, air waybill or CIM rail waybill; ATA carnets cover temporary admission and TIR carnets road transit. An insurance invoice is needed only if the commercial invoice does not show the insurance premium. The goods are declared to EU customs with the electronic H1 import declaration, which now carries the customs value data (usually the transaction value) instead of the old DV1 form. A certificate of non-preferential origin is required only where the rules opening certain agricultural quotas say so; for measures such as anti-dumping duties, customs may ask for other proof of origin.
A.TR movement certificate for industrial products under the EU–Türkiye customs union
Industrial products of HS chapters 25 to 97 fall under the EU–Türkiye customs union and can move freely between the two sides when an A.TR movement certificate shows their customs status. The EU importer therefore needs the A.TR for such goods to benefit from free circulation under the customs union. Agricultural products of chapters 01 to 24 and the steel products of chapters 72 and 73 are outside the customs union; for them a proof of preferential origin is needed instead: either the exporter's invoice declaration or a EUR.1 or EUR-MED movement certificate.
Ban on cat and dog fur and on products containing it
Regulation (EC) No 1523/2007 prohibits importing cat and dog fur, and products that contain it, into the EU, placing them on the EU market and exporting them from the EU. The ban applies both to the fur itself and to any product in which it is used. The only exception is for such fur and products intended for educational purposes or for taxidermy. Only for products with cat or dog fur covered by Regulation (EC) No 1523/2007.
EU customs clearance of any product from Türkiye relies on a standard set of documents. The exporter prepares the commercial invoice, always required (no set form; original and at least one copy; English translation recommended), and a packing list of the packages, their contents, marks and weights. The transport document depends on the mode: bill of lading, FIATA bill of lading, CMR, air waybill or CIM rail waybill; ATA carnets cover temporary admission and TIR carnets road transit. An insurance invoice is needed only if the commercial invoice does not show the insurance premium. The goods are declared to EU customs with the electronic H1 import declaration, which now carries the customs value data (usually the transaction value) instead of the old DV1 form. A certificate of non-preferential origin is required only where the rules opening certain agricultural quotas say so; for measures such as anti-dumping duties, customs may ask for other proof of origin.
A.TR movement certificate for industrial products under the EU–Türkiye customs union
Industrial products of HS chapters 25 to 97 fall under the EU–Türkiye customs union and can move freely between the two sides when an A.TR movement certificate shows their customs status. The EU importer therefore needs the A.TR for such goods to benefit from free circulation under the customs union. Agricultural products of chapters 01 to 24 and the steel products of chapters 72 and 73 are outside the customs union; for them a proof of preferential origin is needed instead: either the exporter's invoice declaration or a EUR.1 or EUR-MED movement certificate.
EU customs clearance of any product from Türkiye relies on a standard set of documents. The exporter prepares the commercial invoice, always required (no set form; original and at least one copy; English translation recommended), and a packing list of the packages, their contents, marks and weights. The transport document depends on the mode: bill of lading, FIATA bill of lading, CMR, air waybill or CIM rail waybill; ATA carnets cover temporary admission and TIR carnets road transit. An insurance invoice is needed only if the commercial invoice does not show the insurance premium. The goods are declared to EU customs with the electronic H1 import declaration, which now carries the customs value data (usually the transaction value) instead of the old DV1 form. A certificate of non-preferential origin is required only where the rules opening certain agricultural quotas say so; for measures such as anti-dumping duties, customs may ask for other proof of origin.
A.TR movement certificate for industrial products under the EU–Türkiye customs union
Industrial products of HS chapters 25 to 97 fall under the EU–Türkiye customs union and can move freely between the two sides when an A.TR movement certificate shows their customs status. The EU importer therefore needs the A.TR for such goods to benefit from free circulation under the customs union. Agricultural products of chapters 01 to 24 and the steel products of chapters 72 and 73 are outside the customs union; for them a proof of preferential origin is needed instead: either the exporter's invoice declaration or a EUR.1 or EUR-MED movement certificate.
The EU Ecolabel (Flower logo) is voluntary: furniture may be sold in the EU without it. Decision (EU) 2016/1332 covers free-standing or built-in furniture for indoor or outdoor use, for storage or for sitting, resting, eating, studying or working, including bed frames and headboards. Exclusions include mattresses, building products, second-hand or refurbished furniture, furniture fitted in vehicles and items with over 5 % by weight of materials not on the permitted list. Criteria cover hazardous substances, materials, the final product and consumer information. For non-EU goods, the manufacturer, importer or trader applies under Regulation (EC) No 66/2010 to the Competent Body of a member state where they are or will be sold, with documents and test results proving compliance. Award brings a contract on terms of use, an application fee and an annual fee; the logo is then usable in all member states until the criteria expire on 31 December 2029.
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