Question 1

Is EUDAMED registration mandatory?

Accepted Answer

Yes. Following Commission Decision (EU) 2025/2371, four EUDAMED modules became mandatory on 28 May 2026. New MDR and IVDR devices must be registered before being placed on the EU market, and legacy devices still being supplied must be registered by 28 November 2026.

Question 2

What is the difference between a Basic UDI-DI and a UDI-DI?

Accepted Answer

The Basic UDI-DI is an EU grouping key that bundles devices sharing the same intended purpose, risk class, and essential design characteristics. It anchors technical documentation and EUDAMED records and never appears on the label. The UDI-DI identifies one specific version or model and does appear on the label.

Question 3

How many data elements does FDA GUDID require?

Accepted Answer

Up to 65 data elements per device record, each with its own format rules and controlled vocabularies. Submission is by HL7 SPL through the FDA Electronic Submissions Gateway or via the GUDID web interface.

Question 4

What changes require a new Device Identifier?

Accepted Answer

Any change creating a new version or model: a new size or dimension, a change in labeled quantity, a change in sterility, clinically relevant specification changes, or a new brand name or model designation. Cosmetic label updates generally do not.

Question 5

When did Australia's UDI requirements take effect?

Accepted Answer

Australia's TGA requirements began on 1 July 2026 for Class III and Class IIb devices. Class IIa follows on 1 July 2027, Class Is and high-risk IVDs on 1 July 2028, with full compliance by 1 July 2030.

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