Basic UDI-DI Card
Basic UDI-DIs are required to register EU UDI-DIs. The Basic UDI-DI represents the primary identifier of a product model or product group. It is used to identify the product and is assigned at the usage unit level. Thus, it is independent of packaging units and at the same time the most important classification criteria for data records in the EUDAMED database.
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 Basic UDI-DI. Once a Basic UDI-DI has been marked as registered in EUDAMED - indicated by the Version No. field being greater than 0 - certain fields are not editable.
General FastTab
| Field | Description |
|---|---|
| Code | Specifies a code that you can select. |
| Description | Specifies the description of the Basic UDI-DI. |
| UDI Status | Specifies whether the UDI-DI is ready to be uploaded to the EUDAMED database. |
| Used in No. of EU UDI-DIs | Specifies the number of EU UDI-DIs that are using the current basic UDI-DI code. |
| Blocking Date | Specifies the date on which the UDI Status was set to Blocked. |
| 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 number. |
| DI No. | Specifies the device identifying number for the basic UDI-DI. In case of the GS1 issuing agency, a GS1 global model number (GMN) is expected. You can assign a GMN either manually, or run the Create GMN action. |
| Device Model Code | Specifies the code of the device model. |
| Device Model Name | Specifies the name of the device model. |
| Legacy | Specifies whether a legacy application legislation (MDD, AIMDD, IVDD) is applied. Legacy devices cannot be exported to the EUDAMED database. |
| Application Legislation | Specifies the applicable legislation of the device; either medical device regulation (MDR) or in vitro diagnostic regulation (IVDR). |
| MDR Device Type | Specifies whether the basic UDI-DI represents a standard device, a system or procedure pack. A system means a combination of products, either packaged together or not, which are intended to be inner-connected or combined to achieve a specific medical purpose. A procedure pack means a combination of products packaged together and placed on the market to achieve a specific medical purpose. |
| Special Device | Specifies if the basic UDI-DI is a special device type, and if so, the type of the special device type. |
| Kit Device | Specifies whether the basic UDI-DI is part of a kit. If set, a related Basic UDI-DI must be populated. |
| Related Basic UDI-DI | Specifies a system, procedure pack or kit basic UDI-DI that the current basic UDI-DI is part of. |
| No. of Medical Purposes | Specifies the number of medical purposes. For system or procedure packs, at least one purpose must be provided. |
| Producer Contact No. | Specifies the producer that registers the system or procedure pack. |
| Manufacturer SRN | Specifies the single registration number (SRN) of the manufacturer that registers the device. The value is read from the Our SRN field on the UDI setup page. |
| Auth. Represent. Contact No. | Specifies the contact number of the authorized representative associated with the basic UDI-DI. For manufacturers which are not established in the European Union, providing the authorized representative is required. Only a contact with a EUDAMED SRN can be chosen. |
Regulatory FastTab
| Field | Description |
|---|---|
| Application Legislation | Specifies the applicable legislation of the device; either medical device regulation (MDR) or in vitro diagnostic regulation (IVDR). |
| MDR Risk Class | Specifies the product class regarding the medical device regulation. |
| IVDR Risk Class | Specifies the product class regarding the in-vitro diagnostic regulation. |
| CE Mark Notified Body | Specifies the notified body involved in the CE conformity assessment procedure. A value is required to print the CE mark on labels, but not for submission to EUDAMED. |
| CE Ident No. required | Specifies whether the notified body's identification number is required whenever the CE mark is printed. The field is visible as soon as a CE Mark Notified Body is indicated. |
| No. of Certificates | Specifies the number of product certificates covering the Basic UDI-DI. |
| No. of Clinical Investigations | Specifies the number of clinical investigations performed for the Basic UDI-DI. |
UDI Characteristics FastTab
| Field | Description |
|---|---|
| Animal Tissues/Cells | Specifies whether the device has presence of animal tissues or cells or their derivates. |
| Human Tissues/Cells | Specifies whether the device has presence of human tissues or cells or their derivates. |
| Procedure Pack Device | Specifies if the basic UDI-DI is referring to a procedure pack which is a device in itself. A procedure pack means a combination of products packaged together and placed on the market to achieve a specific medical purpose. |
| System Device | Specifies if the basic UDI-DI is referring to a system which is a device in itself. A system means a combination of products, either packaged together or not, which are intended to be inner-connected or combined to achieve a specific medical purpose. |
| Human Product | Specifies if the device contains substances which may be considered medicinal product derived from human blood or plasma. |
| Contains Medicinal Substances | Specifies if the device contains substances which may be considered medicinal product, but not derived from human blood or plasma. |
| Active Device | Specifies if the basic UDI-DI corresponds to an active device or not. Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. |
| Administer Medicinal Substances | Specifies whether the device is used to administer or remove a medicinal substance. |
| Implantable | Specifies if the basic UDI-DI corresponds to a device that is implantable or not. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device. |
| Implantable Exceptions | Specifies if the registered device is sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates wires, pins, clips and connectors. |
| Measuring Function | Specifies if the device has a measuring function or not. |
| Reusable Surgical Instrument | Specifies if the device is a reusable surgical instrument or not. Reusable surgical instrument means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out. |
| Microbial Substances | Specifies if the device contains presence of substances of microbial origin. |
| Reagent | Specifies if the device is a reagent or not. |
| Companion Diagnostic | Specifies if the device corresponds to a device that has a role of companion diagnostic device or not. Companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to: identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. |
| Instrument | Specifies if the device is an instrument or not. |
| Near Patient Testing | Specifies if the device is near patient testing or not. Device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional. |
| Professional Testing | Specifies if the device is designed to be used for professional testing or not. |
| Patient Self-Testing | Specifies if the device is a patient self-testing device or not. Device for self-testing means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services. |
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 Basic 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. |
Field Values & Dependencies
Some fields are considered mandatory because of the value of another field. The table below lists the most important dependencies.
| Field / Value | Description of Dependencies |
|---|---|
| Application Legislation = MDR | If the Application Legislation = MDR, then MDR Device Type needs to be filled |
| MDR Device Type = Standard | If MDR Device Type = Standard, then Special Device needs to be filled. Also the UDI Characteristics FastTab is displayed and the following mandatory fields needs to be filled: - Animal Tissues/Cells - Human Tissues/Cells - Procedure Pack Device - System Device - Human Product - Medicinal Product - Active Device - Administer Medicinal Product - Implantable - Measuring Function - Reusable Surgical Instrument |
| MDR Device Type = Procedure Pack | If MDR Device Type = Procedure Pack then Medicinal Purpose and Producer Contact No. needs to be filled. |
| Application Legislation = IVDR | If the Application Legislation = IVDR then Special Device Type and Kit Device needs to be filled. |
| Application Legislation = IVDR | If Application Legislation = IVDR then UDI Characteristics FastTab is displayed and the following mandatory fields needs to be filled: - Animal / Tissues / Cells - Human Tissues / Cells - Microbial Substances - Reagent - Companion Diagnostic - Instrument - Near Patient Testing - Professional Testing - Patient Self-Testing |
| Kit Device = Yes | If Kit Device = Yes than Related Basic UDI – DI needs to be filled. |
| Application Legislation = IVDR | If Application Legislation = IVDR then other Product Risk (IVDR Risk Class) classes can be chosen. |
Actions
The actions on the Basic 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 | Create EUDAMED export file | Creates and downloads a EUDAMED export file. The action is available only for already EUDAMED registered Basic UDI-DIs (having a Version No. greater than 0). |
| Actions | Copy from UDI-DI | Copies Basic UDI-DI values and related tables from another Basic UDI-DI. |
| Related | Medical Purposes | Opens the Medical Purposes page to view or edit the medical purposes. |
| Certificates | Opens the Certificates page where existing certificates can be viewed or new certificates can be edited. For more information, see Certificate Types. |
|
| Clinical Investigations | Opens the Clinical Investigations page where existing clinical investigations can be viewed or new clinical investigations can be edited. | |
| Related > History | Show Change History | Opens the Change Log Entries page which is filtered to the belonging Basic UDI-DI Date Item. The Change Log Entries 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. The action is only active if change log entries exist. |
Data Changes on Basic UDI-DI Data Entries
Some information is transferred from the Basic UDI DI records to the linked EU UDI DI records. If changes are to be made to already released Basic UDI-DI data sets, all associated EU UDI-DI data sets must first be set to the Open status. No changes to the base UDI-DI data set are possible if there are linked released EU UDI-DI data sets. Also the status of the base UDI-DI cannot be reset from Released to Open if linked released EU UDI-DI records exist.
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