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Unique Device Identifier

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TH E H I S TO R Y O F U D I
Unique Device Identifier (UDI):
In 2007, the U.S. FDAdeveloped a labeling system that would uniquely identify every single medical
device (MD) on the market. TheGlobal Harmonization TaskForce (GHTF)soon recognized the global
relevance of such a system and adopted a respective guidance that was last released in 2013 by the
International Medical Device Regulators Forum (IMDRF),an international cooperation of regulators
made up of industry stakeholders and GHTFsuccessors. (Interestingly, Medical device manufacturers
experienced in the U.S. market have quickly recognized the similarity of the EUregulation as
compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines.)
Following the global trend in handling the traceability of medical devices, the EUCommission has
clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in
the final text of the new EUMedical Device Regulation (MDR)2017/745.
TheEUUDISystem, like the U.S. UDIrequirements, will be implemented in phases, starting with the
highest risk classes first, and lowest risk classes last.

3. U D I D EFI N I TI O N
Parts of UDI
Unique Device Identifier (UDI) the “Unique Device Identifier” (UDI) will be created and maintained by
the device manufacturer based on global device identification standards. With certain exceptions, a
UDIwill be required to appear on the label of a medical device and be composed of two parts:
1.Device Identifier (DI) - a mandatory, fixed portion of a UDIthat identifies the specific versionor
model of a device; and
2.Production Identifier(s) (PI) –a conditional, variable portion of a UDIthat identifies one or more of
the following when included on the label of a device. Thiswill be dependent upon the
manufacturer’s internal quality system.
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4. *Thelot or batch number within which a device wasmanufactured;
*Theserial number of a specificdevice;
*Theexpiration date of a specific device;
*Thedate a specific device was manufactured;
Therefore, UDI=DI+PI.
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5. D O Y O U W A N T
TO C O N TI N U E
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