Knowledge · UDI and EUDAMED
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.