REF
REF stands for Reference Number and identifies a specific product model within a manufacturer's range. The symbol is standardised in ISO 15223-1 and must appear on medical device labels in compliance with MDR (EU) 2017/745.
Together with the LOT number, REF forms the basis of full product traceability. While REF identifies what the product is, LOT identifies which production batch it comes from. In the UDI (Unique Device Identification) system, the REF is part of the Device Identifier (DI).
In practice, REF is used on purchase orders, delivery notes, invoices, and clinical documentation to ensure that the correct product is selected. This is particularly critical where multiple variants of the same product exist – for example, gloves in different sizes, materials, or sterility states.
For procurement teams and healthcare professionals, the REF is the primary reference point when reordering or substituting products. Any product change must be accompanied by a REF update to maintain regulatory and clinical clarity.
Frequently asked questions
What does the REF symbol on a medical device package mean?
The REF symbol indicates the manufacturer-assigned article number (product reference). It uniquely identifies the product model and is mandatory on medical device packaging under ISO 15223-1.
What is the difference between REF and LOT?
REF identifies the product model (article number); LOT identifies the specific production batch. Together they provide full traceability of a medical device.
Is REF mandatory on medical device labelling?
Yes. Under MDR (EU) 2017/745, the product reference must appear on the label. The standardised symbol is defined in ISO 15223-1.