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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

Vigilance

Vigilance FSCA - data dictionary

Vigilance FSN - data dictionary

Vigilance MIR - data dictionary

Vigilance MTR - data dictionary

Vigilance NCAR - data dictionary

Vigilance PSUR - data dictionary

Old/Custom-made devices - 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

CI/PS

CI/PS - business rules

Market Surveillance

MSU - business rules

MSU - enumerations

UDI/Devices

UDI Devices - business rules

UDI Devices - enumerations

Vigilance

Vigilance - business rules

Vigilance - enumerations

Old/Custom-made devices - business rules

Old/Custom-made devices - enumerations

Data exchange documents

Templates

Business justification

Third-party agreement

Technical onboarding

Services definition

DTX for CAs - services definition

DTX for EOs - services definition

DTX for NBs - services definition

DTX for Vigilance - services definition

XSD

XSD schemas.zip

CAs - XML samples.zip

EOs - XML samples.zip

NBs - XML samples.zip

Vigilance - XML samples.zip

Miscellaneous

Format of the Unique Device Identifiers for the Legacy Devices

Note

The XSD schemas above version (v.3.0.16) relate to the current platform release (v 3.11.0).

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.