Unique Device Identification (UDI)
A worldwide system for unique identification of medical devices is introduced with European regulation (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics (IVDR). It is based on the UDI (unique device identifier), a generic term for product recognition from basic UDI, UDI-DI and UDI-PI. All master data of a product group will be stored in the European medical devices database EUDAMED of the European Commission using basic UDI. The UDI-DI (UDI Device Identifier) is a product identifier that must be assigned to the product itself or its pack. The UDI-PI (UDI Production Identifier) contains product information such as batch number or expiry date.
The following contents are available: