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.
IMDRF (International Medical Device Regulator Forum)has developed requirements that the USA introduced in 2013 and that resulted in two EU regulations – Medical Devices Regulation (MDR) AND In-Vitro Diagnostics Regulation (VDR). 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.
|Requirements for UDI according to IMDRF||UDI, according to EU:s application in MDR and IVDR, is called||GS1 applies UDI as follows|
|Unique identification||UDI |
Unique Device Identification
|GS1 standards |
|Unique item number Unique identification of products and their packaging for medical devices as well as in-vitro diagnostics products.||UDI-DI |
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.||UDI-PI |
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
|Automatic reading |
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|
|User unit||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.