Unique Device Identifier for Medical devices sold for US Market

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