Other

Subheading 9018 39 of the Combined Nomenclature covers needles, catheters, cannulae and similar instruments other than the tubular metal needles of subheading 9018 32. The subheading encompasses peripheral intravenous cannulae (venflon-type IV cannulae consisting of a plastic catheter over a metal introducer needle), urological catheters (Foley, Nelaton, Tiemann-type), central venous catheters (CVC, PICC lines), arterial cannulae, parenteral nutrition lines, chest drainage catheters, haemodialysis and apheresis needles and lines, as well as nasogastric and nasojejunal feeding tubes. These devices may be manufactured from medical-grade PVC, polyurethane, silicone, nylon or other polymers. The essential distinction from subheading 9018 32 is that the cannula or catheter of 9018 39 is a flexible or relatively long tubular element providing sustained vascular access or bodily fluid drainage. Catheters incorporating medicinal substances (heparin-coated, antibiotic-coated or drug-eluting catheters) may require separate classification as a combination device subject to additional pharmaceutical regulatory requirements. Classification is governed by GRI 1 and 6 and by the Notes to Chapter 90 CN and the HS Explanatory Notes to heading 9018. In cases of doubt, a BTI ruling from the competent customs authority provides binding legal certainty for three years throughout the EU.

Intravenous cannulae, urological catheters and similar devices of subheading 9018 39 are medical devices subject to Regulation (EU) 2017/745 (MDR). The device risk class depends on the clinical application: short-term peripheral IV cannulae are generally Class IIa (Rule 5 MDR - short-term invasive devices), central venous catheters and haemodialysis lines are typically Class IIb or Class III (Rule 6 MDR - prolonged contact with the cardiovascular system), and active or drug-eluting catheters may require Class III classification with involvement of the EMA. Before being placed on the EU market, each device must undergo a conformity assessment by a Notified Body (Notified Body) designated under MDR, have Technical Documentation compiled in accordance with Annex II MDR, an EU Declaration of Conformity, CE marking with the Notified Body identification number, and registration in EUDAMED. Invasive devices in contact with blood (central catheters, haemodialysis lines) are subject to extensive biocompatibility testing under EN ISO 10993 and must meet pyrogen and sterility requirements. Each device must carry a Unique Device Identifier (UDI) affixed to the label and 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). Required import documents: EORI number, customs declaration 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 documentation.

Intravenous cannulae, urological catheters and similar devices of subheading 9018 39 fall within Chapter 90 CN - heading 9018 covers medical, surgical and veterinary 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 rates within the 9018 39 subheading may differ according to the specific TARIC code. Preferential zero rates may be available under EU FTA agreements: CETA (Canada), EPA (Japan), KOREU (South Korea), EU-UK TCA, and under the GSP and GSP+ scheme for developing countries - subject to compliance with rules of origin and submission of a valid proof of origin (EUR.1, exporter's declaration or REX). Sterile devices require special storage and transport conditions to maintain sterile barrier integrity throughout the supply chain in accordance with EN ISO 11607. Drug-eluting or drug-incorporating catheters are subject to dual regulation under MDR and pharmaceutical legislation - importers should verify the applicable regulatory pathway and, where necessary, consult the EMA. 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.

Subheading CN 9018 39 covers IV cannulae, urological catheters, central venous catheters (CVC), infusion sets, and drainage tubes. MDR risk classification depends on contact duration and invasiveness: peripheral cannulae are Class IIa, central catheters Class IIb, and long-term implantable catheters may be Class III. Import requires full MDR documentation, sterilisation certificate, and UDI number. The customs duty rate is 0%.