Basic UDI-DI

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.

Bei der Erfassung der Basic-UDI-DI wird diese, abhängig vom Codierungsformat ermittelt. Die Ermittlung und weitere Informationen sind unter Stammdaten UDI beschrieben.

Verwendung dieses Programms

Felder

Überschriftsformat

Feldbezeichnung Erklärung
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.

Device Data

Feldbezeichnung Erklärung
Single Registration Number (SRN) SRN of the Manufacturer that registers the Device.
Verantwortliche Firma Bei der Basic UDI-DI und UDI-DI wird über die verantwortliche Firma gesteuert, aus welcher Firma die Labeler Identification Code (LIC), Company Identification Number (CIN), Notified Body, Single Registration Number (SRN) und Labeler DUNS Number ermittelt werden. Hierbei gilt folgendes:
  • Wird in der verantwortlichen Firma nichts angegeben, erfolgt der Zugriff über die Masterfirma.
  • Die verantwortliche Firma von der Basic UDI-DI muss mit der der UDI-DI übereinstimmen.
  • Die verantwortliche Firma kann bei der Basic UDI-DI nur während der Anlage angegeben werden und bei der UDI-DI nur geändert werden, sofern noch keine UDI-DI für EUDAMED oder FDA erfasst bzw. generiert wurde.
  • Die Labeler Identification Code (LIC) beim Codierungsformat HIBC bzw. Company Identification Number (CIN) beim Codierungsformat IFA ist Bestandteil der Basic UDI-DI und UDI-DI und wird auf Ebene vom Medizinprodukt angezeigt.
  • Der Notified Body wird auf Ebene vom Medizinprodukt angezeigt und wird bei einer Änderung von der verantwortlichen Firma nicht automatisch geändert. Soll der Wert aus der Firma neu ermittelt werden, muss das Feld geleert werden.
  • In der Basic UDI-DI werden bei der Single Registration Number (SRN) über den Matchcode alle in der verantwortlichen Firma hinterlegten SRNs angezeigt und es kann eine davon ausgewählt werden.
  • Die Labeler DUNS Number wird bei der UDI-DI für FDA angezeigt.
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 and 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.
Additional Information
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.

Field is applicable for System and Procedure Packs and refers to the Indication of the specific medical purpose of the System or Procedure Pack Producer.
XML upload information
Current Version (Basic UDI-DI) Current Version of the Basic UDI-DI, which should be equal to the corresponding Basic UDI-DI version in the EUDAMED database.
Last XML-Generation (Basic UDI-DI) Date of the last XML-generation (Upload of new Basic UDI-DI or Update of an existing Basic UDI-DI).

MDR / IVDR Data

Feldbezeichnung Erklärung
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.
Is it a suture, staple, etc. Property defines if the registered Device is 'suture', 'staple' , 'dental filling' etc. Property is applicable only for Devices having Risk Class II b and having the property 'Implantable' marked.
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.


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