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Unique Device Identification#

Abbreviations#

Abbreviations Comment
DUNS Data Universal Numbering System
ESG Electronic Submissions Gateway
UDI Data Dictionary Overview of UDI datasets published by the EU Commission (last accessed on 03.09.2021).
EUDAMED European Database on Medical Devices
UDI Unique Device Identification
UNC Uniform Naming Convention
XSD XML Schema Definition
XML Extensible Markup Language

Introduction#

For reporting UDI data into EUDAMED, data from the article master as well as new data to be specified are used. The UDI information can be written to an XML file or printed. XML files containing UDI data exported from GUDID can be imported into Microsoft Dynamics Business Central™.

Note

The Unique Device Identification UDI (EUDAMED) module is an activation module, which can only be used with additional licensing and activation.

Facilities UDI - EUDAMED in KUMAVISION#

To set up the UDI EUDAMED interface, call up the "UDI setup" via the user search.

UDI Establishment#

In the "UDI Setup" the basic setups are made:

Field Description
Standard allocation point The standard allocation point.
Standard manufacturer SRN The manufacturer's Stadard SRN

Actions Ribbon#

Field Description
Initilize Creates the default master data. Must be executed once after activating the module.
New Base DI Creates a new DI (BASIC DI, UDI DI, Secondary DI, etc.)

Ribbon Belonging#

The menu ribbon contains the option for central master data maintenance. The following descriptions are taken from the UDI Data Dicitonary of the European Commission:

Field Description
Annex XVI „Field stores the reference to the Intended purpose other than medical of the Device (UDI-DI).
Field stores the values regarding the Intended purpose of the Device other the medical one`s as they are descubed in the Annex XVI of MDR Regulation.“
CMR Categories “Mentions if the Device has a CMR (Carcinogenic,Mutagenic or toxic to Reprodution (CMR) ) substance in it`s composition”
Clinical Size Types „Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit
The Type of Clinical Size (example : length, width, etc.)”
Device Certificate Types “When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.
Property defines the type of Product Certificate associate with the Device.”
Issuing Entities „Assigned Issuing Entities that will generate the DI Codes allocated for all DI`s inside Eudamed (Basic UDI DI, UDI-DI, Unit of Use DI, Secondary Di, Package level DI).
The Commission shall designate one or several entities to operate a system for assignment of UDIs ('issuing entity')”
MDN Codes „The Nomenclature Code(s) associated with the UDI-DI.
The corresponding CND Nomenclature Code will be stored in the field”
Measure Units “Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit
Clinical Size Measure Unit”
Multi Component Devices “Property defines if the Basic UDI-DI is refering to a System which is a Device in itself, Procedure pack which is a Device in itself (in accordance with the Art. 22(4) MDR) or Kit.
Property is applicable for Standard Devices (not Systems or Procedure Packs)
Option Kit is only applicable in case of IVDR Devices and System which is a Device in itself, Procedure pack which is a Device in itself are applicable only in case of MDR Devices”
Notified Bodies „When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device.
Property stores the reference to the Notified Body that issued the Product Certificate”
Risk Classes “Risk Class of the Device associated with the Basic UDI-DI.
Device Risk Class is dependent directly on the Applicable Legislation of the Device.”
Special Devices „Property defines if the Device is a Special Device Type anf if so, the type of Special device Type.
In case the Device is a Standard Device having the option System or Procedure Pack (which is a Device in itself) or a System or Procedure Pack - field is not supplied.”
Storage Handling Conditions „References the Storage and Handling Conditions associated to the Device (UDI-DI)”
Type of Subastances „Field stores the details regarding the type of medicinal substance registered (Substance which can be considered a Medicinal Product or Substance which may be considered a medicinal product derived from human blood or plasma)”
Warning Values „Field stores the Type of Critical Warnings or Contra-Indications, being required in this case.”
Product Designer “Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device.
Reference to an Organisation details provided in case the Manufacturer that designed and manufactured the device is not present in EUDAMED.”
Base DI List List of all (also assigned) DIs (BASIC-DI, UDI-DI, Secondary DI, etc.)
Change Log Entries List for all changes of UDI information

Base DI List#

This list is the central list in which all DIs are stored. This applies to DIs that are already in use (e.g. Basic UDI-DI or UDI-DI) as well as to DIs that are not in use and have been acquired from the corresponding allocation bodies. UDI master data records can be stored for Basic UDI-DI, UDI-DI and EUDAMED DI.

)

Field Description
Code Contains the corresponding UDI-DI (e.g. GTIN or HIBC)
Allocation office Contains the corresponding allocation point (e.g. GS1)
Description Optional field for a more detailed description of the UDI record which is not reported to EUDAMED.
DI Type Describes the DI type (e.g. Basic UDI-DI, UDI-DI or Secondary DI).
Use in EUDAMED Indicates whether the DI is part of an EUDMAED data set.

Ribbon#

Field Description
EUDAMED Create record Creates a EUDAMED data set (Basic UDI-DI, UDI-DI and EUDAMED DI)
New Creates a new row in the Base DI list
Audit Trail Opens the change log of the EUDAMED data set
Open DI Card Opens the EUDAMED data set
Open DI versions Opens the DI version overview
Open article links Opens the artiecl link belonging to the EUDAMED data set

Basic UDI Card#

The Basic UDI master data can be entered in the Basic UDI card. The fields are to be filled according to the UDI Data Dictionary. Fields that do not originate from the Data Dictionary are listed in German and in the following.

Information register General#

|Field| Description| |Description |A free description text can be assigned.| |Released| Indicates whether the version of the record has been released.| |Active |Indicates the version that is currently being edited or was last edited.| |Internal version |Specifies the version.|

Ribbon#

Field Description
Create new version Creates a new version of the UDI master data set
Release version Releases the current version.
Export Creates an XML file from the UDI master data set which can be uploaded to EUDAMED.
Open DI versions Opens the overview of existing DI versions of a UDI master data set
Audit Trail Opens the change log of the EUDAMED data set

UDI-DI Card#

The UDI-DI master data can be entered in the UDI-DI card. The fields are to be filled according to the UDI Data Dictionary. Fields that do not originate from the Data Dictionary are listed in German and in the following.

Information register General#

Field Description
Description A free description text can be assigned.
Released Indicates whether the version of the record has been released.
Active Indicates the version that is currently being edited or was last edited.
Internal version Specifies the version.

Ribbon#

Field Description
Create new version Creates a new version of the UDI master data set
Release version Releases the current version.
Export Creates an XML file from the UDI master data set which can be uploaded to EUDAMED.
Open DI versions Opens the overview of existing DI versions of a UDI master data set
Open item links Assigns a UDI-DI to an article and, if applicable, its variant and unit code.
Audit Trail Opens the change log of the EUDAMED data set
Actions - Functions#
Field Description
Copy UDI data Copies the UDI master data from another UDI master data set
Delete Basic UDI Link Deletes the assigned Basic UDI.
Delete Secondary UDI link Deletes the assigned Secondary UDI.
Delete Unit of Use DI link Deletes the assigned Unit of Use DI.
Delete Direct Marking DI link Deletes the assigned Direct Marking DI.
Related Delete Legacy Device Shortcut Deletes the associated legacy device.
Delete Product Designer Link shortcut Deletes the assigned link to the Product Designer.

EUDAMED-DI Card#

The UDI-DI master data can be entered in the EUDAMED-DI card. The fields are to be filled according to the UDI Data Dictionary. Fields that do not originate from the data dictionary are listed in German and in the following.

Inforegister Basic UDI#

Field Description
Description A free description text can be assigned.
Released Indicates whether the version of the record has been released.
Active Indicates the version that is currently being edited or was last edited.
Internal version Specifies the version.

Ribbon#

Field Description
Create new version Creates a new version of the UDI master data set
Release version Releases the current version.
Export Creates an XML file from the UDI master data set which can be uploaded to EUDAMED.
Open DI versions Opens the overview of existing DI versions of a UDI master data set
Open article links Assigns a UDI-DI to an article and, if applicable, its variant and unit code.
Audit Trail Opens the change log of the EUDAMED data set.
Actions - Functions#
Field Description
Copy UDI data Copies the UDI master data from another UDI master data set
Delete Secondary UDI link Deletes the assigned Secondary UDI.
Delete Unit of Use DI link Deletes the assigned Unit of Use DI.
Delete Direct Marking DI link Deletes the assigned Direct Marking DI.
Delete UDI-DI device link Deletes the assigned UDI-DI.
Delete EUDAMED ID link Deletes the assigned EUDAMED ID.
Delete Product Designer Link shortcut Deletes the assigned link to the Product Designer.