Tubular metal needles and needles for sutures

Subheading 9018 32 of the Combined Nomenclature covers tubular metal needles intended for use with syringes and other hollow metal needles for hypodermic, intramuscular and intravenous injection. These are hollow cannulas manufactured from surgical-grade stainless steel, tipped with a ground bevel (standard bevel, back bevel or Huber point), mounted in plastic or metal hubs with a Luer or Luer-Lock fitting. The subheading covers hypodermic needles, so-called butterfly needles for peripheral venous access, pen needles for insulin self-injection devices and needles for blood collection. The goods must be intended exclusively for medical use - industrial hollow needles that do not constitute medical devices are classified outside heading 9018. The essential distinction from cannulae and catheters of subheading 9018 39 is that the tubular metal needle of 9018 32 is a short, rigid piercing element, whereas a catheter is a flexible tube of greater length intended for prolonged intraluminal access. Classification is determined by the General Rules for the Interpretation (GRI) 1 and 6 and by Note 2 to Chapter 90 CN together with the HS Explanatory Notes to heading 9018. Where the correct subheading is uncertain, Binding Tariff Information (BTI) ruling from the competent customs authority is advisable - a BTI is binding for three years throughout the entire EU customs territory.

Tubular metal hypodermic needles of subheading 9018 32 are medical devices within the meaning of Regulation (EU) 2017/745 (MDR). Their risk class depends on the intended purpose: disposable hypodermic needles for subcutaneous or intramuscular injection are generally Class IIa devices (Rule 5 MDR - short-term invasive devices), while needles intended for prolonged intravenous infusion access may qualify as Class IIb (Rule 6 MDR - devices in contact with the cardiovascular system). Before any such device may be placed on the EU market, the manufacturer must conduct a conformity assessment involving a Notified Body (Notified Body) designated under MDR, compile Technical Documentation in accordance with Annex II MDR, issue an EU Declaration of Conformity, affix the CE marking with the Notified Body identification number, and register the device in the European database on medical devices EUDAMED. Each device must carry a Unique Device Identifier (UDI) - the UDI-DI identifying the device model and the UDI-PI identifying the specific batch - both registered in the UDI module of EUDAMED. A manufacturer based outside the EU must appoint an authorised representative established in the EU (Article 11 MDR). Disposable needles must comply with EN ISO 7864 (sterile hypodermic needles for single use) and sterile packaging standards (EN ISO 11607). Required import documents: EORI number, customs declaration in AIS/IMPORT, commercial invoice with CN code and customs value, transport document, EU Declaration of Conformity under MDR, Notified Body certificate, UDI number and sterility certification.

Tubular metal hypodermic needles of subheading 9018 32 fall within Chapter 90 CN under heading 9018 covering medical and surgical instruments and apparatus. The MFN duty rate for the specific 10-digit TARIC code must be verified in the European Commission TARIC database on each occasion, as duty rates for medical devices within Chapter 90 vary according to the exact TARIC code. Preferential zero rates may be available under EU free trade agreements: CETA (Canada), EPA (Japan), KOREU (South Korea), EU-UK TCA and under the GSP and GSP+ scheme for developing countries. The prerequisite for a preferential rate is compliance with the applicable rules of origin and submission of a valid proof of origin (EUR.1, exporter's declaration or REX registration). Sterile medical devices require particular attention to storage and transport conditions to preserve the integrity of the sterile barrier throughout the supply chain in accordance with EN ISO 11607. Hypodermic needles intended for retail sale may be subject to national dispensing or pharmacy requirements in the Member State of destination. Imports from Russia and Belarus may be subject to EU sanctions restrictions. Goods in Chapter 90 are not subject to the CBAM mechanism. VAT is charged at the national rate on importation. All current duty rates and trade measures should be verified in TARIC before filing the customs declaration.

Tubular metal needles (CN 9018 32) are subject to Directive 2010/32/EU on prevention of sharp injuries in healthcare. Import of safety needles (with retraction or shielding mechanisms) is growing. Needles are Class IIa medical devices (MDR 2017/745). This includes hypodermic, intramuscular, intravenous, and fine-needle aspiration needles. Acupuncture needles are also classified here. The customs duty rate is 0%.