What is UDI?
UDI stands for Unique Device Identification — a worldwide system for the unique identification and registration of medical devices. It is mandatory under regulations such as the EU MDR (Medical Device Regulation) and the FDA UDI Rule (US).
UDI = passport for every medical device, from production to patient.
The system enables better traceability, faster recalls and improved patient safety.
🧱 What does a UDI consist of?
A UDI consists of two main parts:
-
UDI-DI (Device Identifier) The fixed part of the code: product type, brand, manufacturer
-
UDI-PI (Production Identifier) The variable part: batch number, expiry date, serial number, etc.
The UDI is usually printed on the label in human-readable text and as a barcode (such as GS1, HIBC or ICCBBA format).
🎯 Why is UDI important?
- Improves patient safety and traceability
- Enables fast and targeted recalls
- Supports digital registration in central databases (such as EUDAMED in the EU, or GUDID in the US)
- Mandatory for manufacturers, distributors and healthcare institutions
- Integrates with systems such as LIMS, WMS, ERP and hospital software
🔗 Example UDI with GS1
| Element | Value (example) | Explanation |
|---|---|---|
| (01) | 08711234567890 | GTIN = UDI-DI (product code) |
| (10) | B12345 | Batch number (UDI-PI) |
| (17) | 260930 | Expiry date: 30 Sept 2026 |
| (21) | SN789456 | Serial number |
This is encoded in a GS1-128 barcode or a 2D DataMatrix.
🏭 Who is required to use UDI?
| Role | Responsibility |
|---|---|
| Manufacturer | Generate, label, upload to the database |
| Importer/distributor | Verify and register on receipt |
| Healthcare institution | Store and use for inventory, patient and recall |
| Software supplier | Integration with scanning, inventory and patient information systems |
✅ UDI and regulations
| Region | Legislation | Central database |
|---|---|---|
| EU | EU MDR 2017/745 | EUDAMED |
| US | FDA UDI Rule | GUDID |
| International | IMDRF UDI Guidelines | – |
📌 In summary
UDI is a globally mandatory identification system for medical devices that promotes safety, traceability and transparency.
Without UDI there is no access to many markets, no correct registration, and no Compliance with legislation.