UDI (Unique Device Identification) is a method for marking and identifying medical devices to provide a globally unique identification in both distribution and use to increase traceability.
Many countries enact laws requiring companies that manufacture, label or distribute medical devices to identify them with a Unique Device Identifier (UDI). Important information to know is that a GTIN (Global Trade Item Number) issued by GS1 Sweden can be used as a UDI in several countries and areas such as the US.
Regulations of UDI
The US Food & Drug Administration (FDA) and the European Commission have developed a number of rules and regulations to increase patient safety. The goal is a coordinated and consistent approach at global level, to increase patient safety and optimize patient care through coordinated legislation for UDI and by using global standards.
The US UDI Regulation describes how devices classified as medical devices are regulated and can be supplied in the US. It covers several classes of products sold in the United States and includes requirements related to identification, data collection, and trade item information. Legal requirements from the FDA are addressed to suppliers who use the Global Trade Item Number (GTIN) for their medical devices classified under Unique Device Identification (UDI) and sold to the U.S. market.
GS1 holds power of attorney as an issuing body for UDI by the FDA (Food & Drug Administration) in the United States. This means that GS1 is required by law to annually disclose which companies use GTIN to assign UDI to their products that are sold in the United States. This information is regularly required by the US FDA.
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Read more about UDI on GS1’s global website >
|Requirements for UDI according to IMDRF
|UDI, according to EU:s application in MDR and IVDR, is called
|GS1 applies UDI as follows
Unique Device Identification
|Unique item number Unique identification of products and their packaging for medical devices as well as in-vitro diagnostics products.
Device Identifier (DI), i.e. identity for a Medical Device.
(Global Trade Item Number) uniquely identifies each medical device.
|Unique production number, i.e. information associated with one product when it is manufactured and packaged.
Production Identifier (PI), Production Identification, i.e. information from the time of production.
For medical devices intended exclusively for retail outlets (e.g. retail trade), UDI-PI does not need not be included in the barcode/2D code on the packaging.
|Additional information (AI)
By using GS1 standard (AI) – Application Identifiers, production information can be entered into a data carrier such as in
GS1-128 or GS1 DataMatrix:
(17) Expiration date
(10) Batch/LOT number
(21) Serial number
(11) Date of manufacture
(8012) Software version
of the products unique identification and the production information normally required for a medical device.
|AIDC, Automatic Identification and Data Capture.
|With reading equipment automatically read from data carriers such as GS1-128, GS1 Datamatrix, EPC/RFID containing GTIN and production information. When production information is not on the product, GTIN can be read from barcode EAN 13.
|Share information about an item
Item data linked to the unique identification should be stored in a database and shared with those who need access to that data
|Unique Device Identification Database, i.e. Database GUDID in the US,
Database UDID within EUDAMED for the EU
|With GDSN, data can be transferred to the European database EUDAMED. GDSN, (Global Data Syncronisation Network) is a standard for independent item databases developed by users of the GS1 standard to obtain a common standard of describing item data and communicating item data in this global network.
|Primary identification of product model
|The basic UDI-DI is the primary identifier for a product model. It is that product identifier (DI) that is assigned at the level of the product’s user unit.
|GMN, Global Model Number. GMN is used to uniquely identify a product model. Each item in the UDID database is identified by a GTIN. GMN is one of several attributes specified for each item in the UDID database. One GTIN can belong to exactly one GMN. A group of GTIN can all belong to the same GMN. To figure out the check digit for your model number, GMN, go here https://www.gs1.org/services/check-character-calculator
|The product that is used directly in a patient or during the treatment of a patient
|The user unit is identified by GTIN.
|Manage unique instance of a product
|For example, to distinguish two equal products from each other
With GTIN and Serial Number, a product becomes completely unique and can be used for example to distinguish a surgical instrument so that a specific instrument can return to the same grid after use and that this particular instrument has been used for an identified patient.
FREQUENTLY ASKED QUESTIONS
Why do you need to know this?
As part of the UDI Regulation in the US, GS1 is one of the accredited issuing authority. This requires us to store information about companies that use GS1 standards to assign UDI to their products that are sold in the United States. This information needs to be reported regularly to the US FDA.
What are the consequences of saying no?
If your product is not sold in the United States as medical equipment, there will be no consequences. If you have a product or products sold in the United States and they are classified as medical devices, please answer yes. If we have not shared your information and GTIN with the US FDA, there may be problems with your medical devices that are already on the US market.