UDI consists of a unique device identifier (UDI) made up of a device identifier (DI) and production identifier(s) (PI). The DI is a static number assigned to each product model, while the PI contains variable information like serial number or lot number. UDI is displayed both visibly and in machine-readable form on medical devices and their packaging. Requiring UDI helps reduce medical errors, simplify data integration, and improve recall effectiveness. Exemptions may apply if direct marking could impact safety, performance, or additional processing is needed for single-use devices.

1. UDI

2. Take away of this session
• What is UDI
• What is DI & PI
• What is UDI Scope
• Why UDI required in medical devices

3. What is UDI
UDI is a unique Numeric or Alphanumeric code; display both in readable
(plain text) & machine readable (AIDC) form; on a device label, its
packaging, or directly marked on the device itself.
UDI is consist of two parts Device Identifier (DI) and Production Identifier(s)
(PI)

4. What make up a UDI
Device Identifier (DI)
Production Identifier(s) (PI)
Therefore, UDI = DI + PI.

5. Who Provide DI (Device Identification)
The accepted standard DI formats are currently provided by 3
companies.
 GS1- Used by the majority of industry.
 HIBCC-Health Industry Business Communication Council.
 ICCBBA-International Council for commonality in Blood Banking
Automation.

6. (DI) Device Identifier
• DI is a mandatory, static unique number assigned to all product model
at each packaging level.
• This number must use an accepted standard format.(GTIN -Global
trade item number )

7. (PI) Product Identifier
• PI is a conditional, dynamic/variable number that identifies how the
product is currently controlled.
• It can include one or all of the following
• Serial number
• Lot Number
• Expiration Date
• Manufacturing Date

8. What make up a UDI-continuation

9. All products placed into the U.S. market that fall within the definition of a medical
device.
• Items not subject to FDA UDI DPM Requirements
• Single Use.
• Sterile Product.
• Kits.
• Sets.
• Veterinary Products.
What is UDI Scope.
9

10. Exemption In UDI
• (1) Any type of direct marking would interfere with the safety or performance of
the device;
• (2) The device cannot be directly marked because it is not technologically
feasible. (space constrain)
• (3) The device is a single-use device and is subjected to additional processing
and manufacturing for the purpose of an additional single use.
• (4) The device has been previously marked.
• Exemption status & reasons to be documented in DHF

11. What are the Benefits of UDI
• Reduce medical errors (by enabling rapid and precise identification of a device).
• Simplify the integration of device use information into data systems.
• Provide for more rapid identification of medical devices with adverse events.
• Provide for more rapid identification of solutions to reported problems.
• Provide more accurate, more efficient resolution of device recalls.
• Better focused and more effective FDA safety communication.
• Can be used in educational and informational materials.
• Can be used in inventory management.
• Can help identify alternative devices.

12. Acronyms
• GTIN Global trade item number
• DPM Direct Part Marking
• DI Device Identifier
• PI Production Identifier
• AI Application Identifier
• GUDID Global Unique Device Identification Database
• AIDC Automatic identification and data capture