ISO 18113 is officially titled:
"In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)"
It is composed of five parts:
Together, these parts set out the required content and format for labels, IFUs (Instructions for Use), and packaging across both professional and consumer self-testing IVDs.
The standard ensures the end-user clearly understands:
Incorrect or incomplete labelling of IVDs can lead to:
ISO 18113 helps mitigate these risks by ensuring that:
Implementing ISO 18113 provides a strong foundation for product safety, usability, and compliance:
Consistent use of terms, symbols, and layout across all product lines.
Ensures accurate translations and global usability of IFUs.
Reduces user errors and enhances confidence in home-use tests.
Meets labelling requirements for IVDR (EU), FDA (US), TGA (Australia), and WHO.
Ensures critical storage and expiry data are clearly communicated
With GMC's ISO 18113 consulting, your business gains significant competitive and regulatory advantages:
Well-structured labelling supports CE, FDA, CDSCO, and WHO submissions.
Clear instructions reduce misuse and errors, improving customer experience.
Proper warnings and usage details help defend against product claims.
Standardized labelling simplifies expansion to new countries.
Maintain consistent documentation across development, production, and post-market surveillance.
Ensure all labelling-related QMS processes are in sync with ISO and MDR frameworks.
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