Various international regulations (see EU MDR & IVDR and US FDA) require medical device suppliers to assign a Unique Device Identification (UDI) to products. GS1 is an accredited party for issuing UDIs and can help you with GS1 compliant barcodes.
A UDI is the worldwide unique harmonised identification of medical devices by means of a unique numeric or alphanumeric code that consists of two parts:
- A Device Identifier (DI): a mandatory, fixed part that uniquely identifies the supplier and the device. We call this the Unique Product Number.
- A Production Identifier (PI): a variable part of the UDI. It is up to the supplier to check in the legislation which parts the PI must contain.
The identification is made by means of AIDC*, as well as in HRI**, on the medical device label (on all packages and sometimes on the medical device itself). International standards are followed for this.
* (Automatic Identification and Data Collection - AIDC) (1 dimensional or 2 dimensional matrix barcode or RFID)
* In human readable form: Human Readable Interpretation (HRI).
As a supplier, you are obliged to register your data (=UDI-DI) in a regulated database organised by the government.
For America (FDA) this is UDID and you can publish your UDI-DI there from My Product Manager.
For Europe it is EUDAMED. We are currently looking into publishing the data via My Product Manager. Please let us know if you are interested in this.