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Coding standards
The UDI Carrier [Automated Identification for Data Capture (AIDC) and human readable interpretation (HRI) representation of the UDI] shall be on the label or on the device itself and on all higher levels of device packaging.
The UDI must appear in a plain-text version/human readable information (HRI) and in a form that uses AIDC technology. AIDC means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or another computer system via an automated process. The HRI consists of legible characters that can easily be read by people. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label.
For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall, however, appear on the label even if this results in there being no space for the AIDC.
For other specific requirements related to the UDI carrier, please consult Section 4 of Annex VI Part C of the two Regulations.
UDI placement criteria for software
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Where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software.
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The UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an about file, or included on the start-up screen.
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Software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API).
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Only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as about menu, splash screen etc.
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The human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.
For more details, please refer to the MDCG 2018-5 document:
Additionally, the following document and video may assist also:
“Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices” (May 2021; MDCG 2021-10):