Importing IVD Raw Materials into the EU and US: Documents to Prepare

A practical checklist of documentation for importing IVD raw materials into the EU and US, from the commercial invoice to the certificate of origin.

Core Commercial Documents

Cross-border shipments of biological raw materials move on paperwork as much as on logistics. The commercial invoice identifies the goods, the quantity and the agreed terms, and should use the same product description and catalogue number as the datasheet. The packing list details what is in each box. The certificate of origin states where the goods were produced. These three documents form the basis of the customs entry, and inconsistencies between them are a common cause of delay at the border. A correctly prepared set is quicker to clear than a shipment that must be held for correction.

Product-Specific Documents

For biological materials, customs and import authorities may request additional documents. A material safety data sheet describes hazards and handling. A Certificate of Analysis provides lot-specific test data. Some jurisdictions require a statement of the material's biological origin and, for certain categories, import permits or declarations. Requirements depend on the material, its classification and the destination, and they change over time. Confirm the current requirements with your freight forwarder or customs broker before dispatch rather than after it arrives.

Before the Shipment Leaves

Ensure the invoice, packing list and certificate of origin agree on description, quantity and declared value. Confirm the correct tariff classification and any restrictions that apply to the material. Check that the cold-chain packaging and any temperature-monitoring devices are declared, and that the recipient's address and contact details are complete. Keep copies of all documents, because the same set is often needed for a sample return or a repeat order. Treat documentation as part of the shipment's integrity, not as an administrative task.

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