UDI

Unique Device Identification

A UDI has two parts and the distinction is practical. The device identifier is static — it identifies the labeller and the specific version or model. The production identifier is variable and carries whatever the labeller uses in production: lot or batch number, serial number, expiry date, manufacturing date. Together they let a specific device, from a specific production run, be identified anywhere in distribution or use.

The carrier must be both machine-readable (barcode, RFID, or other AIDC form) and human-readable on the label, and in some cases marked directly on the device itself — for reusable devices that are reprocessed between uses, where a label would not survive. Identifiers are issued through accredited issuing agencies such as GS1, HIBCC, or ICCBBA rather than invented by the manufacturer.

The purpose is traceability that actually works under pressure. In a recall, UDI lets affected devices be found precisely instead of by broad description; in adverse-event reporting, it identifies exactly which version failed; in clinical use, it supports accurate documentation of what was implanted or used. Data are submitted to public databases — the FDA GUDID in the US and EUDAMED under EU MDR — so the information is available beyond the manufacturer.

• —Two parts: device identifier (static — labeller and model) and production identifier (variable — lot, serial, expiry).
• —Carrier must be machine-readable and human-readable; direct part marking for reprocessed reusable devices.
• —Identifiers come from accredited issuing agencies (GS1, HIBCC, ICCBBA).
• —Data submitted to FDA GUDID (US) and EUDAMED (EU).
• —Enables precise recall scope, accurate adverse-event attribution, and clinical documentation.
• —Rollout is phased by device risk class in both regimes.

US: 21 CFR Part 830 and 21 CFR 801 Subpart B (Unique Device Identification), with the GUDID; EU: Regulation (EU) 2017/745 (MDR) Articles 27-29 and Annex VI Part C, with EUDAMED; IVDR Regulation (EU) 2017/746 for in-vitro diagnostics.