UDI

Unique Device Identification (UDI) is a system for marking and identifying medical devices within healthcare systems. The UDI system assigns a unique numeric or alphanumeric code to each medical device, enabling consistent identification throughout distribution and use.

UDI components:

1. UDI-DI (Device Identifier)
- Static portion identifying the device model
- Assigned by an issuing agency
- Linked to device master data in database

2. UDI-PI (Production Identifier)
- Dynamic portion with production details
- Includes lot/batch number, serial number
- May include manufacturing date, expiration date

UDI format:
```
(01)00860123456789(17)221231(10)ABC123(21)12345
↑ UDI-DI ↑ Expiry ↑ Lot ↑ Serial
```

FDA UDI requirements:
- Label with UDI in plain text and AIDC (barcode)
- Submit data to GUDID (Global UDI Database)
- Implementation by device class timeline
- Class III: 2014, Class II: 2016, Class I: 2018

EU MDR UDI requirements:
- Similar system mandated under EU MDR
- Submit to EUDAMED database
- Implementation dates 2021-2027 by class

Issuing agencies:
- GS1 (most common globally)
- HIBCC (Health Industry Bar Code Council)
- ICCBBA (blood products)
- IFA (German agency)

Benefits of UDI:
- Improved patient safety
- Faster recall effectiveness
- Better supply chain visibility
- Enhanced post-market surveillance
- Reduced medical errors

Device exemptions:
- Custom devices (limited)
- Investigational devices
- Individual patient devices
- Some Class I devices

Implementation considerations:
- Update labels and packaging
- Integrate with manufacturing systems
- Submit to applicable databases
- Train staff on requirements