# EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec
> Verify Basic UDI-DI and UDI-DI data models for European EUDAMED regulatory compliance.

- **Canonical URL:** https://stanzaapi.com/tools/udi-decoder/standard/eu-mdr-eudamed-spec
- **Governing Standard:** FDA 21 CFR 801.20 / EU MDR 2017/745 (FDA AccessGUDID Database & IMDRF)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
EU MDR introduces the Basic UDI-DI as the main key in EUDAMED representing device models sharing intended purpose and risk class.

## Specification Matrix
| Identifier | Level | Format | Usage |
| --- | --- | --- | --- |
| Basic UDI-DI | Model / Family | GS1 GSRC / HIBCC / ICCBBA code | EU Certificates & Declarations of Conformity |
| UDI-DI | Packaged Item | GTIN-14 / HIBC Primary | Trade item packaging and barcode |

## Standard JSON Response Model
```json
{
  "eudamedValidation": "PASS",
  "basicUdiDi": "008848380DEVICEFAM88",
  "udiDi": "00884838012345",
  "mdrCompliant": true
}
```

## Frequently Asked Questions & Edge Cases
### Q: What is the difference between Basic UDI-DI and UDI-DI in Europe?
**A:** The Basic UDI-DI is purely an administrative regulatory key on certificates, whereas UDI-DI is printed directly on the device package barcode.