Manufacturers are required to generate a Unique Device Identification (UDI) code for their products, which should be displayed on the device label and packaging. Importers must check if the product is registered in the EUDAMED system before introducing it to the market. Importers also need to provide their data in the system.
Within 7 days of importing each device, distributors must enter the Basic-UDI code, manufacturer's name and address, as well as the type and trade name of the device, system, or procedure pack in the system.
We can provide assistance with the product notification or registration processes.