ISO 18113-4:2022 PDF

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 18113-1 (general requirements and terms)
• ISO 15223-1 (symbols for medical device labelling)
• ISO 14971 (risk management for medical devices)
• ISO 18113-5 and device-specific standards such as ISO 15197 and ISO 17593 (where applicable)

ISO 18113-4:2022 helps harmonize self-test IVD labelling worldwide, improving user safety and regulatory clarity for manufacturers and regulators.