Overview
ISO 18113-4:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing - specifies the required labelling and user information for IVD reagents, calibrators, and controls intended for self-testing. The standard covers information on outer and immediate container labels and on the instructions for use (IFU) intended for lay users. It does not apply to IVD instruments/equipment or reagents intended for professional use.
Key topics and requirements
The standard defines the content and presentation of manufacturer-supplied information, including:
- Identification elements
- IVD reagent name, batch code / lot number, and Unique Device Identifier (UDI) where applicable
- Clear identification of kit components (consistent naming/graphics across labels and IFU)
- Label content
- Requirements for outer container and immediate container labelling (single containers, small-label provisions)
- Contents listing and accessory applicability
- Intended use and performance
- Clear statement of intended purpose and in vitro diagnostic use
- Summary of performance characteristics, measuring interval and limitations
- Storage, handling and shelf life
- Storage conditions, expiry date, and shelf life after opening
- User information and safety
- Warnings, precautions, sample collection, step-by-step procedure to obtain and read results, control procedures, and interpretation guidance written for lay users
- Use of symbols in accordance with ISO 15223-1
- Traceability and documentation
- Traceability of values assigned to calibrators and control materials, literature references, and document control
- Risk management
- Requirements aligned with ISO 14971 for identifying labelling-related risks
Practical applications
ISO 18113-4:2022 is used to:
- Design compliant labels and instructions for self-test IVD kits (e.g., home pregnancy tests, infectious disease self-tests)
- Create patient-facing IFUs and packaging that meet international regulatory expectations
- Standardize labelling information for global market access and regulatory submissions
- Ensure consistent kit component identification and UDI implementation in supply chains
Who should use this standard
- IVD manufacturers, product managers and labelling teams
- Regulatory affairs and quality assurance professionals preparing submissions
- Technical writers and UX designers developing IFUs for lay users
- Notified bodies, regulators, and conformity assessment organizations assessing labelling compliance
Related standards
ISO 18113-4:2022 helps harmonize self-test IVD labelling worldwide, improving user safety and regulatory clarity for manufacturers and regulators.
Open preview (PDF)In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing