|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.