GLOSSARYEU
Registration (EU)
Before placing a device on the market, a manufacturer, authorized representative, or importer registers in the EU electronic system and receives a single registration number (SRN). The manufacturer also assigns each device a Basic UDI-DI and provides it to the UDI database. Changes to the registration must be updated within one week.
What is registered
- Economic operators
- The manufacturer, authorized representative, or importer submits the Annex VI, Part A, Section 1 information. The competent authority obtains the SRN and issues it (Article 31).
- Devices
- The manufacturer assigns a Basic UDI-DI to the device, other than a custom-made device, and provides it to the UDI database with the core data elements in Part B of Annex VI (Article 29).