EU UDI-DI Card
In accordance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements, COSMO Unique Device Identification supports both the management of the Basic UDI data and the requirement relating to the UDI-DI data.
For each Item or Item Variant card, a EU UDI-DI record can be created by choosing Item > EU UDI-DI.
If the GTIN has already been entered in the GTIN field on the Item page and GS1 has been defined as the Issuing Agency in the UDI Setup, the GTIN is adopted as the DI number when the UDI data record is created. When creating the data record, the system checks whether the GTIN to be created is already used. If it is already in use, an error message is displayed and the creation of the EU UDI-DI data is stopped. For more information, see Generate GTINs.
Tip
Entries on several, subordinate pages are required. These pages can be accessed both through actions and drill-downs to fields that start with Number or No. in their names. It is best to edit all fields one after the other.
Fields
Certain fields are marked with a red asterisk. The red asterisk means that the field must be filled to complete a certain process that uses the field, such as releasing the EU UDI-DI.
General FastTab
| Field | Description |
|---|---|
| Is Parent Package | Specifies whether the current DI is supposed to contain other DIs. If the toggle is turned on, specify the child DIs in the Packaging Lines. |
| UDI Status | Specifies whether the UDI-DI is ready to be uploaded to the EUDAMED database. |
| Blocking Date | Specifies the date on which the UDI Status was set to Blocked. |
| Language Code | Specifies the language in which textual information (such as special storage condition texts and critical warnings) is provided. For further information, see UDI Languages. |
| Created At | Specifies the date and time when the UDI-DI data were created. |
| Created By | Specifies the user who created the UDI-DI data. |
| Modified At | Specifies the date and time when the UDI-DI data were last modified. |
| Modified By | Specifies the user who last modified the UDI-DI data. |
Identification FastTab
| Field | Description |
|---|---|
| Issuing Agency | Specifies the agency that issues the DI No., Package DI No. and Unit of Use DI No.. |
| DI No. | Specifies the device identifying number for the EU UDI-DI. If GS1 is used as the Issuing Agency, the GTIN is used at the DI No. For more information, see Generate GTINs. |
| Basic UDI-DI Code | Specifies the Basic UDI-DI to which the device is associated. |
| Legacy | Specifies whether a legacy application legislation (MDD, AIMDD, IVDD) is applied. The value is inherited from the Basic UDI-DI. Legacy devices cannot be exported to the EUDAMED database. |
| No. of Additional Descriptions | Specifies the number of additional product descriptions. These are mandatory for systems or procedure packs, for standard devices being marked as a system or procedure pack, or for kits. |
| Device Type | Specifies the device type according to the basic UDI-DI. It is used internally for dynamic field visibility control. |
| Secondary Issuing Agency | Specifies the agency that issues the secondary DI number. |
| Secondary DI No. | Specifies an optional device identifier that may be an alternate lookup to the primary DI. |
| Direct Marking required | Specifies whether direct marking is required. |
| Alternative DM DI required | Specifies whether an alternative direct marking DI is required. |
| DM Issuing Agency | Specifies the agency that issues the direct marking DI number. |
| DM DI No. | Specifies the alternative direct marking DI number. |
| Unit of Use DI No. | Specifies a virtual identifier to associate the use of a device to/on a patient when a base package contains more than one device. |
Device Name FastTab
| Field | Description |
|---|---|
| No. of Brand Names | Specifies the number of translated brand names. |
| Catalog No. | Specifies the reference or catalog number of the device. |
| Info URL | Specifies the website of the Manufacturer or Labeler where additional information about the device can be available. |
Manufacturer/Designer FastTab
| Field | Description |
|---|---|
| Product Designer Contact No. | Specifies the contact number of another legal or natural person who designed or manufactured the device. After an upload to EUDAMED, the Product Designer Contact No. cannot be changed. EUDAMED allows the correction of contact data, but not the addition, change, or removal of the product designer itself. For more information, see Update Product Designer Information. |
Packaging FastTab
| Field | Description |
|---|---|
| Is Parent Package | Specifies whether the current DI is supposed to contain other DIs. If the toggle is turned on, specify the child DIs in the Packaging Lines. |
| No. of Packaging Lines | Specifies the number of Packaging Lines set up for the current UDI-DI. |
| No. of Parent Package DIs | Specifies the number of packaging units that contain the current package DI. |
| Base Quantity | Specifies the base quantity in which the device is provided. The default value is 1. |
Regulatory FastTab
| Field | Description |
|---|---|
| Device Status | Specifies the status of the device concerning the EU market. The options are: - On the EU Market - No longer on the EU Market - Not Intended for EU Market |
| Device Status Date | Specifies the date when the device status was last updated. |
| No. of Market Infos | Opens the UDI-DI EU Market Infos page. Specifies the number of EU countries the device is or was made available on the market. |
| No. of EMDN Codes | Opens the UDI-DI EMDN Codes page. Specifies the number of assigned European Medical Device Nomenclature (EMDN) codes to reflect the design and intended purpose of the device. At least one code must be assigned. |
| New Device | Specifies if the device can be considered a new device. It should be considered to be new if: (a) there has been no such device continuously on the EU market during the previous three years for the relevant analyze or another parameter, (b) the procedure involves analytical technology not continuously used in connection with a given analyze or other parameter on the EU market during the previous three years. |
| Reprocessed Single Use | Specifies if the device is a reprocessed single use device. |
Characteristics FastTab
| Field | Description |
|---|---|
| Lot Specific Tracking | Specifies that the lot or batch number is required as part of the PI. The value is read from the item tracking code of the item the UDI-DI is attached to. |
| SN Specific Tracking | Specifies that the serial number is required as part of the PI. The value is read from the item tracking code of the item the UDI-DI is attached to. |
| Primary Tracking Identifier | Specifies which tracking numbers are used as part of the UDI-PI if both lot and serial number specific tracking apply. The options are All Tracking Numbers, Lot Number, and Serial Number. This field can be edited only when the UDI Status field is set to Open and if both Lot Specific Tracking and SN Specific Tracking fields are set to Yes. The value from this field is copied to Label Item Entries to be considered on label barcodes and is considered on UDI export. |
| Expiration Date Mandatory | Specifies whether expiration Date is required as part of the PI. |
| Manufacturing Date Mandatory | Specifies whether the manufacturing date is required as part of the PI. |
| Software Version Mandatory | Specifies whether the software version is required as part of the PI. The field is visible only if the linked basic UDI-DI is set up as a Software in the Special Device field. |
| No. of SH Conditions | Specifies how many storage & handling conditions have been set up for the device. |
| Clinical Sizes Category Code | Specifies the category of clinical sizes that the EU UDI-DI belongs to. Clinical sizes categories also contain any assigned attributes. |
Safety Info FastTab
| Field | Description |
|---|---|
| Sterile | Specifies if the UDI-DI is labeled as sterile or not. |
| Sterilization | Specifies if the UDI-DI needs to be sterilized before or use or not. |
| No. of Reuses | Specifies the maximum number of reuses applicable for the device. Use the -1 value when no maximum number of reuses is defined. |
| Contains Latex | Specifies if the device contains latex into its composition. |
| No. of Medicinal or Human Substances | Specifies the number of medicinal or human substances. |
| No. of CMR or Endocrine Substances | Specifies the number of CMR or endocrine-disrupting substances. |
| Electrical Brain Stimulation | Specifies whether the device is intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. |
| Contact Lenses | Specifies whether the device is intended to be introduced into or onto the eye. |
| EMR | Specifies whether the device emits high intensity electromagnetic radiation (e.g., infra-red, visible light and ultra-violet) intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. |
| Filling By Injection | Specifies whether the substance or item is intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. |
| Product in Body | Specifies whether the device is intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings. |
| Equipment for Adipose Tissue | Specifies whether the equipment is intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. |
Labels FastTab
Here data is stored which controls the printing of data and symbols on labels. They are not relevant for GUDID.
| Field | Description |
|---|---|
| Label Layout Code | Specifies which layout will be considered when printing a label for the current UDI-DI. |
| Product Description | Specifies an additional description to be printed on labels. |
| Importer Contact No. | Specifies the number of the contact who imported this device. The contact number is not passed to GUDID. |
| Distributor Contact No. | Specifies the number of the contact who distributed this device. The contact number is not passed to GUDID. |
| Country of Manufacture | Specifies a two letter or three letter country code to be printed as a symbol on labels. If no code is specified, the symbol will not be printed. |
| Date Symbol | Specifies whether to print the date symbol on labels. |
| Liquid Filter Pore Size | Specifies the value to be printed as a symbol on labels, e.g., 15 µm. If no value is specified, the symbol will not be printed. |
| No. of Sterilization Methods | Opens the UDI-DI Sterilization Methods page. Specifies how many sterilization methods have been set up for the device. |
| No. of Additional Symbols | Specifies the number of additional or electrical symbols to be printed on labels. |
EUDAMED Version FastTab
If a device has already been registered in EUDAMED, then all fields in the EUDAMED Version FastTab should be manually populated to reflect the current state. The values can be edited at any time. The Version State and Version Date fields are used for informational purposes only. The Version No. field determines whether certain fields are editable or not, and how the export file will be created. The Version No. is automatically increased by the application after every export.
| Field | Description |
|---|---|
| Version State | Specifies the state of the version in the EUDAMED database. |
| Version No. | Specifies the number of the version in the EUDAMED database. Any number greater than 0 indicates that the EU UDI-DI was already registered in EUDAMED. Since Legacy devices cannot be exported, their Version No. is always 0. |
| Version Date | Specifies the date when the version was last updated in the EUDAMED database. |
| Exported DI No. | Specifies the value that the DI No. was exported as. GTINs are exported with leading zeros until 14 digits are reached. |
Actions
The actions on the EU UDI-DI Card are described in the following table.
| Menu | Action | Description |
|---|---|---|
| Release/Reopen/Block | Release | Releases the UDI-DI to allow export. You must reopen the UDI-DI before you can make changes to it. When executing the function, the system checks the setup of the respective user permissions. If no suitable authorization to change to the desired status is set up, the system responds with an error message and the status change is canceled. For more information, see UDI Status Permissions. |
| Reopen | Reopens the UDI-DI to change it after it has been released. Exported UDI-DIs have the Released status and must be opened before they can be changed. | |
| Block | Blocks the UDI-DI to avoid any further changes or exports. | |
| Export | Add or Update UDI-DI | Creates and downloads a EUDAMED export file that is used to add or update the UDI-DI to EUDAMED. The action is available only for released EU UDI-DIs that have both the Is Parent Package and Legacy toggles turned off. |
| Update Market Information | Creates and downloads a EUDAMED export file to update market information. | |
| Update Product Designer | Creates and downloads one or more EUDAMED export files to update the product designer of selected UDI-DIs. | |
| Actions | Copy from Item | Copies EU UDI-DI values and related tables from the item that the variant is attached to. The action is visible only for UDI-DIs attached to an item variant. |
| Copy from UDI-DI | Copies EU UDI-DI values and related tables from another EU UDI-DI. This action is visible only for non-parent EU UDI-DIs not attached to item variants. | |
| Generate GTIN | Assigns a new GTIN to the DI No. field. For more information, see Generate GTINs. | |
| Related > Identification | Additional Descriptions | Opens the UDI-DI Additional Descriptions page where additional information about the product or details about specific features of the device can be viewed or edited. |
| Related > Device Name | Brand Names | Opens the UDI-DI Brand Names page where existing brand names can be viewed or new brand names can be edited. The entry of the brand names is language code dependent and depends on the respective database to which the data set is to be exported. Therefore, it is possible to enter FDA or GUDID relevant brand names as well as EU EUDAMED relevant brand names in the UDI Item Brand Names table. |
| Related > Packaging | Packaging Lines | Opens the UDI-DI Packaging Lines page. This action is only available if the Is Parent Package toggle is turned on. |
| Related > Regulatory | EMDN Codes | Opens the UDI-DI EMDN Codes page where EMDN codes assigned to the device can be viewed or edited. |
| EU Market Infos | Opens the UDI-DI EU Market Infos page where EU countries where the device is or was available can be viewed or edited. | |
| Related > Characteristics | Storage and Handling Conditions | Opens the UDI-DI Storage & Handling Conditions page where existing storage and handling conditions can be viewed or new storage and handling conditions can be edited. |
| Clinical Sizes | Opens the Clinical Sizes page where existing clinical sizes can be viewed, or new clinical sizes can be edited. The Clinical Sizes gives Information about the Size Type, the Attributes and belonging Size Values. | |
| Related > Safety Info | Medicinal or Human Substances | Opens the UDI-DI Medicinal or Human Substances page (see UDI-DI Medicinal or Human Substances ). |
| CMR or Endocrine-Disrupting Substances | Opens the UDI-DI CMR or Endocrine Substances page (see CMR Substances or Endocrine Disruptors). | |
| Related > Labels | Print Label Preview | Prints a label preview based on the current UDI data, and using dummy item tracking data. The Label Layout Code must be specified. |
| Sterilization Methods | Opens the Sterilization Methods page where existing sterilization methods can be viewed or new sterilization methods can be edited. These are relevant for label printing only. For more information, see UDI Sterilization Methods. |
|
| Additional Symbols | Opens the UDI-DI Symbols page. Here you can maintain additional or electrical symbols that are to be printed on labels. This data is not relevant for GUDID. | |
| Related > History | Show Change History | Opens the Change Log Entries page which is filtered to the belonging Basic UDI-DI Date Item. The page shows all Changes of that Basic UDI-DI Data, which should be recorded. All changes are displayed with date and time stamp, user ID, table description, field description, type of change, old value and new value. |
UDI-DI Medicinal or Human Substances
If a medical device is approved according to MDR and it is a standard product (not a procedure pack or system product), then the Medicinal or Human Substances can be recorded for the product. To edit the medicinal or human substances, choose Related > Safety Info > Medicinal or Human Substances.
| Field | Description |
|---|---|
| Item No. | Specifies the item number that the record is linked to. |
| INN | Specifies the International Nonproprietary Name of the substance. |
| Type | Specifies the type of the substance. The options are: - Medicinal Product - Human Product |
CMR Substances or Endocrine Disruptors
If a medical device is approved according to MDR and it is a standard product (not a procedure pack or system product), then the CMR substances and endocrine Disruptors can be recorded for the product. To edit the CMR substances, choose Related > Safety Info > CMR or Endocrine-Disrupting Substances.
| Field | Description |
|---|---|
| Item No. | Specifies the item number that the record is linked to. |
| CAS No. | Specifies the Chemical Abstracts Service (CAS) number of the substance. |
| EC No. | Specifies the European Community (EC) number of the substance in the format XXX-XXX-X. |
| Type | Specifies the type of the substance. The options are: - <Blank> - 1A CMR - 1B CMR - Endocrine-Disrupting |
Clinical Sizes FactBox
The Clinical Sizes FactBox displays the UDI-DI related clinical sizes. The clinical size relevant attributes and related values are displayed in the FactBox. Choose the Edit action of the FactBox to directly edit the belonging clinical sizes attributes and values.
Basic UDI-DI Details FactBox
The Basic UDI-DI Details FactBox displays the UDI-DI related Basic UDI-DI Details. All data from Basic UDI-DI Card are shown in the FactBox for better information.
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