Label language and symbol requirements for OEM diagnostic product exports
When a brand commissions a factory to produce pregnancy or ovulation tests under its own trademark, the responsibility for information on the packaging is often underestimated.
Even if the product is manufactured by the factory, the manufacturer name, address, and EU authorized representative information on the label must be consistent with the relationship between the brand and the actual producer—cases such as "brand address filled in as factory address" or "EU rep information left blank" are not acceptable.
On language, for self-testing IVD products destined for the EU market, instructions and labels generally need to cover the official language of the destination member state. In Spain, for example, if the packaging provides only English without Spanish, the product may be rejected by pharmacy channels even if the product itself is compliant. In addition, the size ratio of the CE mark and the placement of the notified body number have formal requirements; brands should cross-check the print-ready artwork against regulatory documents with the factory before finalizing.
MeiBao's OEM service includes cross-review of packaging artwork against existing certification documents, but ultimate legal responsibility rests with the brand as the "placer on the market"—this should be clarified at the outset of cooperation.
