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Technical documentation

Note

If you experience any issues with the Excel files, simply right click the link and then click on Save link as. This will download the file to your computer.

Data dictionaries (Excel files)

Common

EUD Common - data dictionary

Actor

ACT - data dictionary

UDI/Devices

UDI Devices - data dictionary

Certificates

CRF - certificates - data dictionary

CRF - Refused certificates and applications - data dictionary

CRF - varia - data dictionary

CRF - CECP - data dictionary

Market Surveillance

MSU - data dictionary

Business rules/enumerations

Common

EUD Common - business rules

EUD Common - enumerations

Actor

AIM - enumerations

ACT - business rules

ACT - enumerations

AIM - business rules

Certificates

CRF - business rules

CRF - enumerations

CIPS

CIPS - business rules

Market Surveillance

MSU - business rules

UDI/Devices

UDI Devices - business rules

UDI Devices - enumerations

Vigilance

Vigilance - business rules

Data exchange documents

Templates

Business justification

Third-party agreement

Technical onboarding

Service definitions

DTX for CAs - services definition

DTX for EOs - services definition

DTX for NBs - services definition

XSD

XSD schemas.zip

CAs - XML samples.zip

EOs - XML samples.zip

NBs - XML samples.zip

Miscellaneous

Format of the EUDAMED DI identification number

Note

The XSD schemas above version (v.3.0.9) relate to the current platform release (v 3.8).

The release affects the XSD version number of the DTX services. You need to adapt the XSD version number in your service requests before using the M2M service or Bulk upload service.