- Published
- Updated
- Sources checked
A device family identifier becomes useful when reviewers can see which variants and claims the clinical evidence actually covers.
Basic UDI-DI — Define the regulatory scope
MDR Annex VI describes device identification and MDCG 2022-7 clarifies UDI concepts. Basic UDI-DI and UDI-DI serve different purposes and should not be used interchangeably.
Basic UDI-DI — Build the working record
Build a crosswalk linking Basic UDI-DI, device model, UDI-DI, intended purpose, technical file and clinical evaluation scope. Record exclusions and variant differences so a shared identifier does not conceal an evidence gap.
Basic UDI-DI — Check before release
- Match report scope to the current model list.
- Check variant-specific materials and performance differences.
- Control identifier changes alongside document revisions.
Basic UDI-DI — Record the decision and handover
Approve the family coverage rationale with product data and clinical owners. Reconcile the crosswalk before submissions and public summary revisions; a database acceptance message is not a clinical evidence assessment.
Frequently asked questions
- Does one Basic UDI-DI prove all variants are equivalent?
- No. Identifier grouping does not establish clinical equivalence or sufficient evidence.
- Is Basic UDI-DI the identifier on every package?
- Do not confuse it with the UDI carrier and device-level identifiers; verify the applicable labelling requirements.