Item numbers, UDI and CHRN: connect the right identifiers

1. Start with a real product

Choose a product from your own portfolio and bring together its item master, approved labelling, packaging data and regulatory product record. Note where each number is used and which team maintains it. Record the target market as well. For Switzerland, examine the information intended for swissdamed; for affected products exported to the EU, check the European context separately. A mapping sheet supports the data work but does not determine the legal status of your product.

2. Separate four regulatory purposes

Basic UDI-DI links devices with the same intended purpose, risk class and essential design and manufacturing characteristics; it is not a packaging code. UDI-DI identifies a device or packaging level. UDI-PI concerns production, such as a lot or serial number. In swissdamed, only the UDI-PI type is recorded, not the actual lot or serial number. CHRN identifies an economic operator in its registered role; it is not a product identifier. The European MDCG guidance explains Basic UDI-DI but is not binding law. Special cases, including legacy devices or Master UDI-DI, require a separate assessment. [1] [2] [3] [4]

3. Keep the internal item number in its own field

An internal number can serve purchasing, manufacturing or sales. Make its relationship to regulatory identifiers explicit instead of assuming equivalence. Add the packaging level, system of record, mapping source and responsible role to each record. Check with the business team whether the mapping is unambiguous or needs several relationships. The data model should reflect that decision; a convenient spreadsheet format should not make it on the team’s behalf.

4. Work through a fictional case together

Consider “Item A”, an entirely fictional example. The ERP has a sales item, the warehouse a lot record and the regulatory file the approved device identifier. Put these details in separate columns and connect them through a verified product relationship. Then examine a different packaging unit: which mapping does the team need to confirm? Use placeholders during the workshop, rather than invented UDI codes that appear valid. This is a checking exercise, not an instruction for assigning identifiers.

5. Check the mapping before importing

Ask regulatory affairs and the owners of item and production data to review the same sheet. Do they recognise the same product and packaging? Is a missing identifier visible as an unresolved task? Also test a duplicate item number, missing source evidence and a lot number accidentally placed in the product field. Define who resolves and who approves each case. Technical acceptance of an import does not replace this business review.

6. Share one data model across language regions

Teams in German-speaking Switzerland, Romandie and Ticino may use different field labels. Keep the business definition alongside each translated label. The identifier itself is not translated. A small glossary and a jointly checked example record help reveal misunderstandings during handovers. When a mapping changes, preserve a traceable record of the original relationship, the new decision and the responsible role. Scope and procedure should follow your quality management system.

Your next step

Bring an anonymised system overview and a representative product-data example to a discussion with VALNARO. Together, we can scope the need for RIM data mapping, interface clarification or targeted data cleansing. Expected results and service scope are agreed in advance. These proposed steps help your team plan the work; product-specific requirements and identifier assignment still need assessment by the responsible specialists.

Useful next steps

Sources and professional context