When to apply Master UDI-DI
- For device families with multiple technical variants sharing the same intended purpose.
- Where differences do not alter the core performance or risk profile.
- When the same Basic UDI-DI and essential product information apply.
Standard vs. custom-made lenses
- Standard lenses: grouped under a Master UDI-DI, easing identification and reporting.
- Custom-made lenses: documented separately, with distinct requirements; not all parameter adjustments qualify a lens as custom-made.
Data and registration requirements
Manufacturers must ensure consistency across Basic UDI-DI, Master UDI-DI, and UDI-DI entries. Updates in EUDAMED must reflect changes affecting traceability, with complete audit trails for modifications.
Frequent compliance pitfalls
- assigning too many UDIs instead of grouping variants.
- material modifications treated as “variants” instead of requiring a new Master UDI-DI.
- discrepancies between IFU, labelling, and EUDAMED entries.
Summary
The Master UDI-DI system simplifies surveillance, reduces regulatory burden, and increases transparency. For patients, it means better assurance of device traceability and safety — a key step in reinforcing trust in one of the most widely used medical devices worldwide.