UDI
Unique Device Identification
UDI (Unique Device Identification) is a system to uniquely identify medical devices through distribution and use, using a standardized identifier on device labels and packages.
Complete Guide to 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:
- 1UDI-DI (Device Identifier)
- 1UDI-PI (Production Identifier)
UDI format:
```
(01)00860123456789(17)221231(10)ABC123(21)12345
โ UDI-DI โ Expiry โ Lot โ 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
Related Terms
More Compliance & Standards
View allA mandatory conformity marking for medical devices sold in the European Economic Area, indicating compliance with EU health, safety, and environmental requirements.
A system of regulations, codes, and guidelines ensuring medical devices are consistently produced and controlled according to quality standards.
The international standard for quality management systems specific to medical device organizations.
A formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives in medical device manufacturing.
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