Medical device manufacturers operating in both US and EU markets must maintain accurate UDI data in two separate regulatory databases: GUDID (Global Unique Device Identification Database) in the US and EUDAMED in the EU. The UDI concept is shared — but the required data attributes, formats, and submission rules diverge significantly.
The Core Distinction
Both GUDID and EUDAMED require UDI-DI (Device Identifier) and UDI-PI (Production Identifier) data. Both associate this data with specific device attributes. But the attribute definitions, field requirements, and regulatory interpretations are different enough that you cannot use GUDID data as a direct template for EUDAMED submissions.
Key risk: Teams that copy GUDID submissions directly into EUDAMED without attribute reconciliation consistently create compliance gaps — particularly for single-use designation, MRI safety, and sterility data fields.
Field-by-Field Comparison
| Data Field | GUDID (US FDA) | EUDAMED (EU MDR) | Match? |
|---|---|---|---|
| Device Identifier (UDI-DI) | Required — GS1, HIBCC, or ICCBBA format | Required — same issuing agencies recognized | YES |
| Brand Name | Required | Required | YES |
| Device Description | Required — free text | Required — aligned with intended purpose in CER | PARTIAL |
| Single Use Designation | Yes/No field | Yes/No + must align with labeling and IFU labeling requirements | PARTIAL |
| MRI Safety | Conditional — required if implantable | Required for implantable devices — ASTM F2503 categories | PARTIAL |
| Sterility | Sterility method field | Sterile + sterilization method — broader requirement | PARTIAL |
| GMDN Code | Not required | Required — GMDN code or EMDN code | NO |
| Clinical Size | Optional structured fields | Required for specific device categories | PARTIAL |
| Reference / Catalog Number | Required | Required as Reference Number | YES |
| Packaging Levels | Required — base package and above | Required — each packaging level needs a separate UDI-DI | PARTIAL |
| Risk Class | Not required | Required — EU MDR risk classification | NO |
| Notified Body Number | Not applicable | Required for Class II and above | NO |
The GMDN Code Gap
One of the most frequently missed EUDAMED requirements is the GMDN (Global Medical Device Nomenclature) or EMDN code. GUDID does not require this field. Companies that build their regulatory data workflow around GUDID requirements will not have GMDN codes assigned for their products — and will face delays at EUDAMED registration when the field is required.
Packaging Level UDI-DI Requirements
Both systems require data for each packaging configuration, but the EU applies a stricter interpretation: each distinct package configuration with a different UDI-DI must be registered separately in EUDAMED. US GUDID allows more flexibility in how packaging hierarchies are documented. This means EUDAMED submissions typically require more individual records than GUDID for the same product range.
Managing Dual-Database Accuracy
For manufacturers maintaining both databases, the primary risk is divergence — GUDID updated after a labeling change, EUDAMED not updated (or vice versa). This requires a formal regulatory data management process that:
- Connects labeling change control to both database update requirements
- Assigns clear ownership for each database
- Includes a periodic reconciliation review (at minimum annually)
- Maintains an audit trail of changes in both systems