IFU-Anatomie

Anatomy of Sterile Packaging Labels

Labels, Symbols, and IFU Inserts for Sterile-Packaged Medical Devices

The primary label is located directly on the sterile barrier — the innermost packaging layer that maintains product sterility. It contains the absolutely critical information: product designation, lot number (LOT), expiry date, sterilization method (as ISO 15223-1 symbol), UDI barcode or DataMatrix code, manufacturer identification, and the CE marking with Notified Body number. Due to extremely limited space, symbols are predominantly used here.

Challenge

The primary label typically offers only a few square centimeters of space to accommodate all mandatory information — often in multiple languages. Date formats (YYYY-MM-DD per ISO 8601 vs. locale-specific formats), numeric decimal separators (comma vs. period), and the representation of units of measurement vary. Additionally, the UDI must remain machine-readable and must not be impaired by other label information. The product designation must appear in the official language of the target market, while space exists for a maximum of two to three lines of text.

Solution with manualworks

manualworks offers an integrated label preview system that instantly visualizes the translated primary label in the target format and highlights space overflows in color. Date formats are automatically standardized to ISO 8601 or adapted to target country conventions. A symbol-text optimization suggests where text can be replaced with ISO 15223-1 symbols to save space.

MDR Annex I, Chapter III, Section 23.2 lists the minimum requirements for labeling on packaging, including product designation, manufacturer details, lot number, UDI, expiry date, and sterilization method. MDR Article 10(11) mandates provision in the official language of the respective Member State.

Frequently Asked Questions

Do symbols on sterile packaging need to be translated per ISO 15223-1?+

The symbols themselves are language-independent and are not translated — that is precisely their advantage per ISO 15223-1. However, MDR Annex I, Chapter III, Section 23.1 point (g) requires that the symbols used are explained in the instructions for use, and these explanations must be translated. Additionally, not all markets accept symbols alone without accompanying text. manualworks maintains a complete database of all ISO 15223-1 symbols with translated explanatory texts for all target languages.

What special requirements apply to the labeling of sterilization methods?+

The sterilization method must be clearly indicated on the packaging, typically via ISO 15223-1 symbols (e.g., symbol 5.2.4 for ethylene oxide sterilization, 5.2.7 for radiation sterilization). Additionally, notices such as "Do not resterilize" or conditions for resterilization must be clearly stated. For ethylene oxide-sterilized products, additional warnings about residual levels may be required. manualworks ensures that all sterilization-related texts and symbols are standard-compliant in every language version.

How does manualworks handle limited space on sterile labels?+

The limited space on sterile packaging is one of the greatest challenges for multilingual labeling. manualworks offers several approaches: First, a symbol-first strategy using standard-compliant ISO 15223-1 symbols instead of text wherever possible. Second, an intelligent layout system that calculates the text volume per language and suggests the optimal label format. Third, the option to link via QR code to an electronic IFU (eIFU) per Regulation (EU) 2021/2226 when physical space is insufficient for all languages.

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