Compliance · Nº 07 · US & EU
UDI
Unique Device Identification for medical devices
Applies to — Medical-device labels
UDI is the barcode “identity” for medical devices — required by the US FDA (21 CFR Part 830, from 2013) and phased in under the EU MDR (2021–2027). It has two parts: the Device Identifier (model and manufacturer) and the Production Identifier (lot, serial, dates). It must appear two ways — human-readable text (HRI) and a machine-readable code (AIDC), such as a Data Matrix — and stay legible for the device’s life.
What it is
A unique identifier that makes a medical device traceable. The Device Identifier names the model and manufacturer; the Production Identifier carries lot or serial numbers and dates. It must be shown two ways at once: human-readable text (HRI) and a machine-readable code (AIDC) — typically a barcode or Data Matrix.
Who needs it and where it registers
Required by the US FDA (21 CFR Part 830, from 2013) and phased in under the EU MDR (2021–2027). Higher-risk (Class III) devices carry it down to the smallest unit. US data registers in GUDID; EU data in EUDAMED. Confirm the timeline and scope for your device class and market.
The durability requirement
The UDI must stay legible for the life of the device — through handling, sterilisation and storage. In practice the most reliable build is a PET facestock with a full-resin thermal-transfer ribbon, which survives abrasion and sterilisation where paper or wax-printed labels fade. Match the construction to the device’s sterilisation and service conditions.
Common questions
Answered
straight.
What are the two parts of a UDI?
The Device Identifier (model and manufacturer) and the Production Identifier (lot, serial, and dates). Both appear as human-readable text (HRI) and a machine-readable code (AIDC) such as a Data Matrix.
What label survives a UDI durability requirement?
The UDI must stay legible for the device life through sterilisation and handling. A PET facestock printed with a full-resin thermal-transfer ribbon is the most reliable build; match it to your specific sterilisation method.
General guidance — not legal advice
This is a plain-English overview to help you ask the right questions — not a legal opinion or a compliance certification. Requirements change and depend on your specific product, market, and packaging. Always confirm with your supplier’s compliance documents and, where it matters, a qualified regulatory advisor.
Official source · FDA — UDI System ↗
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