UDI — Unique Device Identification (UK)
UDI requirements for medical devices in Great Britain are being implemented by MHRA under the UK MDR 2002 as amended and MHRA guidance. The UDI system is being phased in by device class. UDI requirements in Northern Ireland follow the EU MDR/IVDR timeline and EUDAMED.
What is UDI?
A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters created through internationally accepted device identification standards. It allows unambiguous identification of specific medical devices on the market. Every UDI has two components:
| Component | Definition | Example purpose |
|---|---|---|
| Device Identifier (DI) | Identifies the specific device version/model (manufacturer + device type) | Identifies "what" the device is |
| Production Identifier (PI) | Identifies the specific production unit (lot/batch number, serial number, manufacture/expiry date) | Identifies "which specific unit" |
UK UDI implementation
MHRA is phasing in UDI requirements for GB. Unlike the EU MDR/IVDR (which has a fully operational EUDAMED UDI database), the UK's UDI infrastructure is still being developed.
Current status (as of May 2026):
- MHRA requires manufacturers to include UDI on device labels for higher-risk device classes (Class III, AIMD, and certain Class IIb devices) from specified dates
- MHRA has indicated its intention to implement a full UK UDI database (separate from EUDAMED)
- Specific implementation dates by class are published in MHRA guidance — always check the current position
For manufacturers with EU MDR/IVDR UDI compliance: MHRA has indicated it will accept international UDI standards (GS1, HIBCC, ICCBBA) that are also accepted in the EU. Manufacturers with EU-compliant UDI on their devices will largely satisfy the UK UDI labelling requirements for the GB market.
UDI on the label
Where UDI is required, it must appear on:
- The device label (or outermost packaging)
- Higher levels of packaging where applicable
- Implant cards (for implantable devices)
UDI must be in both human-readable interpretation (HRI) and AIDC (Automatic Identification and Data Capture) format — typically a barcode or QR code using GS1, HIBCC, or ICCBBA standards.
UK UDI vs EU EUDAMED UDI
| Aspect | UK (GB market) | EU/NI market |
|---|---|---|
| Database | UK UDI database (in development) | EUDAMED |
| Who submits | Manufacturer or UKRP | Manufacturer or EU REP |
| Standards accepted | GS1, HIBCC, ICCBBA | GS1, HIBCC, ICCBBA |
| Labelling requirement | By class, phased | By class, phased under EU MDR/IVDR |
Related pages
- MHRA registration overview
- Device-level registration requirements
- Labelling requirements
- What's New — for latest UDI implementation updates
Official references
| Reference | Description |
|---|---|
| MHRA: Unique device identification | MHRA's UDI guidance and implementation timeline |
| GS1 UK | GS1 UDI standards |
| EU MDR 2017/745, Art. 27 | EU UDI requirements (applies in NI — comparative reference) |