UDI Studio
UDI Studio · Guides

Should I choose a new or an existing Basic UDI-DI?

Distinguish the group identifier from the article’s UDI-DI and choose the registration workflow.

Basic UDI-DI, shortened to BUDI in UDI Studio, identifies a group of devices. UDI-DI identifies the individual device variant or configuration, not a single physical unit or serial number. Your internal article number is a separate reference.

Before choosing a workflow

  • Have the assigned BUDI and UDI-DI identifiers and their issuing entities ready.
  • Check whether the BUDI is already registered in EUDAMED under the regulation you will select.
  • Confirm which variants belong to the group using your product records. A valid-looking code does not establish the right grouping.

UDI Studio prepares registration XML; it does not assign official identifiers. Issuing entities have different formats and check-character rules. For example, a GS1 BUDI is a GMN, while its UDI-DI is a GTIN. Do not create a BUDI by adding an arbitrary suffix to a GTIN.

If the BUDI is already registered

  1. Choose MDR or IVDR according to the product’s applicable regulation.
  2. Choose add articles under an existing BUDI. Use the group identifier already registered under that regulation.
  3. Import the article list and select the new UDI-DI to register. Fill missing BUDI values manually if needed.
  4. Complete the form, create the XML and upload it through the matching EUDAMED service. Check the response.

If the BUDI is new

  1. Choose the applicable regulation, then register a new BUDI.
  2. In this tool, select one first article and complete both group and article information.
  3. Create and upload that file, then confirm successful registration in EUDAMED.
  4. For the remaining articles, return to the existing-BUDI workflow and use the now-registered group identifier.

Downloading either file does not complete registration. Keep the EUDAMED response before moving to the next step.

Official documentation