BASIS-UDI Verwaltungsprogramm

Struktur Basis UDI

Die Basis UDI-DI ist die primäre Kennung eines Produktmodells, welche auf Ebene der Gebrauchseinheit des Produkts zugewiesen wird. Sie ist das wichtigste Ordnungsmerkmal für Datensätze in der UDI-Datenbank und ist in den einschlägigen Bescheinigungen und EU-Konformitätserklärungen ausgewiesen.

GS1 Format

GS1 Company Prefix                                                                       -> Die GS1 Company Prefix ist Bestandteil der Globalen Lokationsnummer (GLN). Die GLN ist in oxaion im Firmenstamm  verwaltbar. Die Länge des Präfixes aus der GLN kann in der Vorlauftabelle VRLUDI eingestellt werden.

Model Reference           "MODELIDENTIFIER11“                             -> manuelle Eingabe             

Check Characters           „S8“                                                           -> wird automatisch ermittelt


HIBC Format

HIBC Basic UDI‐DI Flag Character           “++”                                  -> fix

Labeler Identification Code (LIC)            "A999"                               -> Firmenstamm (UFIRMP)

Model Identifier                                         "MODELIDENTIFIER11     -> manuelle Eingabe

Check Characters                                       "S8"                                  -> wird automatisch ermittelt

               

(HIBC) Beispiel Basis-UDI -> ++A999MODELIDENTIFIER11S8       


Verwendung dieses Programms

Felder

Device Data

FeldbezeichnungErklärung
Device information
Device Name Information allowing the identification of the device - Device Name. At least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI.
Device Model Information allowing the identification of the device - Device Model. At least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI.
Regulation
Applicable Legislation Applicable Legislation of the Device. The device can have only one Applicable Legislation. Either a Regulation value can be selected/provided (MDR or IVDR) or a Directive Regulation value (MDD, AIMDD or IVDD) - in the case of Directive Devices.
Risk Class Risk Class of the Device associated with the Basic UDI-DI. Device Risk Class is dependent directly on the Applicable Legislation of the Device.
Data
Multi Component Device 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 or Kit. Property is a applicable for Standard Devices (not Systems or Procedure Packs).
Special Device Type 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.
Tissues and cells - animal Property defines if the Device has presence of animal tissues or cells or their derivates.
Tissues and cells - human Property defines if the Device has presence of human tissues or cells or their derivates.
Tissues and cells - microbial origin Property defines if the Device contains presence of substances of microbial origin.

MDR / IVDR Data

FeldbezeichnungErklärung
Medical Device Regulation (MDR)
Active Device Property defines 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.
Intended to administer or remove medicinal product Property defines if the Device is intended to administer or remove medicinal product.
Implantable Property defines 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.
Measuring Function Property defines if the Device has a Measuring Function or not.
Reusable Surgical Instruments Property defines 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 sterilisation have been carried out.
Human product check Defines if the Device containes substances which may be considered medicinal product derived from human blood or plasma.
Medicinal product check Defines if the Device containes substances which may be considered medicinal product.
In Vitro Diagnostic Regulation (IVDR)
Companion Diagnostic
Property defines 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.
Reagent Property defines if the Device is a reagent or not.
Instrument Property defines if the Device is an Instrument or not.
Intended for near patient testing Property defines if the Device 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.
Intended for patient self testing Property defines if the Device is Self Patient 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.
Intended for professional testing Property defines if the Device is designed to be used for Professional Testing or not.
Kit

Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device.


Additional Information

FeldbezeichnungErklärung
Device Certificate Information
Certificate Number 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 Certificate Number of the Product Certificate.
Revision Number 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 Certificate Revision Number of the Product Certificate.
Notified Body 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.
Certificate Type 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.
Expiry Date 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 Certificate Expiry Date of the Product Certificate.
Clinical Investigation Information
Clinical Investigation Reference Link
Clinical Investigations associated to the Basic UDI or UDI-DI.

References the Clinical Investigation Link, storing the details of Clinical Investigations associated to the Basic UDI-DI or UDI-DI.

Clinical Investigation Reference Number (non EU) When registering the Device - where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation must be provided. Field stores the Clinical Investigation Number provided by the user when the Clinical Investigation is not registered in EUDAMED.
Country (non EU)
Countries outside EU were Clinical Investigation is performed. 

List of Countries were the Clinical Investigation has been performed.

Field is optional and can be provided only for Clinical Investigations performed Outside EU (Non EU Countries only).

If provided, the Clinical Investigation is considered to be NonEU Clinical Investigation.

Authorised Representative The SRN of the Authorised Representative associated with the Basic UDI-DI. For Manufacturers which are not established in the Union (NonEU Manufacturers) providing the Authorised Representative for the Basic UDI-DI is required.
Medical Purpose of the System or Procedure Pack Medical Purpose of the System or Procedure Pack.

Überschriftsformat

FeldbezeichnungErklärung
Basic UDI-DI Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.). The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
Issuing Entity Issuing agency code for the issuer as defined by SO/IEC 15459.
Manufacturer Identification (SRN) SRN of the Manufacturer that registers the Device.

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