Source: https://hibc.de/en/udi-en/faq-en.html
Timestamp: 2019-04-22 16:06:54+00:00

Document:
What does “Plain Text” mean? Shall the encoded data be printed adjacent to a code, e.g. to Data Matrix, or is it enough to print human readable information text like REF: 123XYZ LOT: 1234 SN: 67890, etc.?
... and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology.
§ 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter.
(2) Automatic identification and data capture (AIDC) technology.
(b) The UDI must include a deviceidentifier segment.
Note: Other text fields printed on the label for Company, REF, LOT, SN and relevant symbols are subject to other regulations as well, as the Expiry Date printed as format YYYY-MM-DD but can be encoded as MMYY in the symbol (see also question 6).
Shall a label indicate that an UDI is present by a special symbol telling „here is the UDI code“?
58791, Table 1) ...requires only that a label ‘‘disclose’’ the presence of AIDC technology. See § 801.40(c).
§ 801.40(c), so that it requires that the label or device package disclose the presence of AIDC technology without specifying how.
Does a revision or model change require a new UDI for the version?
(b) A device identifier shall be used to identify only one version or model.
(c) In the event that a version or model of a device is discontinued, its device identifier may not be reassigned to another device.
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package.
58807 If the labeler makes a change to a device that is required to bear a UDI on its label, and determines that the change results in a new version or model, the labeler must assign a new device identifier to that device and to all associated device packages.
58817 Device package means a package that contains a fixed quantity of a particular version or model of a device.
Yes, each model revision requires a new UDI to be registered and labeled.
With HIBC the body of the HIBC Primary Code can stay where the labeler may add an alpha or numeric revision indicator for building the new UDI-DI.
Note: Using the GS1 system a new GTIN generated for each model / version.
Shall all parts of a reprocessed MD bear a UDI?
§ 801.20 Label to bear a unique device identifier.
(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.
58814 03, § 801.45, any device that has to be labeled with a UDI also has to bear a permanent marking providing the UDI on the device itself if the device is intended for more than one use and intended to be reprocessed before each use.
The text just refers to “devices” but does not mention parts building the device.
How can LOT & Serial numbers and manufacturer date be encoded with HIBC as a possible option of a UDI-PI and what is the date format?
What is the correct date format for the eye readable part of the label (behind the date emblem) and can the encoded date format differ?
day (for example, 2013–09–30). Format for AIDC: …comments suggested that the date format should not apply to data communicated by AIDC technologies (e.g., bar codes and radiofrequency identification (RFID). FDA agrees that we should not attempt to regulate how data is communicated by AIDC technologies, or the order in which specific information is communicated by AIDC.
The final rules differentiate between a date format printed in human readable text and the format of the associated encoded date. Where the printed format “must be” YYYY-MM-DD the same date can be determined by the code structure and encoded in bar code differently.
If the encoded format is MMYY then the printed date is completed by the last day of that month, e.g. 0913 will be printed as text 2013-09-30.
Note: HIBC supports the format YYMMDD among the others.

References: § 801
 § 830
 § 801

§ 801

§ 801
 § 801