The UDI code must be applied in specific places to ensure maximum accessibility and readability:

  • On all levels of packaging: on the label of the primary packaging (the first wrapping that comes into direct contact with the device or product) and on the secondary packaging (the outer wrapping that contains one or more primary packages).
  • Directly on the device itself (permanent UDI marking): if technically feasible and if the device is intended for re-use. In this case, a permanently engraved DataMatrix code is often used.

With regard to tertiary packaging, which is typically used for shipping, there is no obligation to report the UDI of the individual device, although it may contain aggregation UDI codes.

The UDI must appear in two complementary formats:

  • AIDC (Automatic Identification and Data Capture): format readable by scanners and automated systems (e.g. DataMatrix, linear barcode).
  • HRI (Human Readable Interpretation): clear human-readable text format.

Exceptions and additional rules:

  • Limited space: if the space on the label is too small, only the AIDC format is required.
  • Devices for use outside healthcare facilities (e.g. home care): for these devices, the human readable part (HRI) is always mandatory, even if this would prevent the inclusion of the scannable format (AIDC).
  • Packaging hierarchy: If the UDI cannot be placed on the packaging unit due to a lack of space, it can be placed on the next higher packaging level, which must have its own unique UDI.
  • Individually packaged Class I and IIa (Medical Devices) and Class A and B (IVD) packaged individually: for these devices, the UDI holder is not required on the packaging of the individual unit, provided that the UDI holder is placed on the next higher level of packaging and can be easily identified and retrieved by the user.
  • Devices for retail sale only: the UDI in AIDC format is not mandatory if it is replaced by a standard EAN/UPC barcode.
  • Transparency of the packaging: if the UDI is already clearly legible or scannable through the packaging, there is no need for an additional UDI carrier on the packaging.

For further details, see Section 4 of Annex VI Part C of the MDR and IVDR Regulations.

Examples of UDI affixing on Medical Devices