The current edition, ISO 15223-1:2021, is harmonized for use under the EU MDR and IVDR and is recognized by FDA as a consensus standard. It added symbols for the medical device itself, the importer and distributor, the UDI, patient identification and others. Symbols let manufacturers avoid translating text on small labels and keep labeling consistent across markets.

Why it matters for labeling

Symbols have to match the standard's graphics and meanings, and they have to be present and legible at every packaging level. Mistakes are easy to miss visually: a symbol from the older 2012 edition, a date-of-manufacture symbol where a use-by date is intended, or a symbol that was dropped from one language variant. Symbols that aren't covered by the standard need to be explained in the information supplied.

Common mistakes

  • Using symbols from an outdated edition
  • Using the wrong symbol for a date, such as manufacture instead of use-by
  • Symbols too small to read, or distorted
  • A symbol missing from some packaging levels or language versions

Sources