# UDI and EUDAMED: unique identification and EU database | INOPREX

> UDI (unique device identification) and EUDAMED: how medical devices are labelled and registered in the European database under EU MDR — UDI-DI, basic UDI-DI, modules.

Quelle: https://inoporex.de/en/wissen/udi-eudamed/

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## UDI and EUDAMED: identification and the EU database

Unique device identification and the European medical device database — mechanics and obligations.

UDI (unique device identification) is the system for unambiguous identification of medical devices: each device receives a UDI-DI (product identifier) and a production identifier (PI), shown on label and packaging. EUDAMED is the European database in which devices, manufacturers, certificates and incidents are registered. Both systems are linked by the EU MDR.

## Structure of the UDI

- UDI-DI: unique product identifier from an authorised issuing agency (e.g. GS1)
- PI (production identifier): batch or serial number, expiry date, manufacturing date
- Basic UDI-DI: parent identifier for registrations and documents
- UDI carrier: barcode or human-readable text on label and packaging

## EUDAMED modules

EUDAMED comprises modules for actors (registration), devices (UDI), certificates, clinical investigations, vigilance and post-market surveillance. Registration duties apply stepwise per the MDR transition plan.

## Frequently asked questions

**Which devices need a UDI?**

All medical devices placed on the market under the MDR — with exceptions such as custom-made devices. Labelling duties apply stepwise by risk class.

## Applied to your project

We apply these rules directly to your project — from classification to market access. First assessment within two working days.

Stand: 2026-10-22 · Fachlich verantwortlich: INOPREX Scientific Direction