EN ISO 18113-4:2024 PDF

Overview

EN ISO 18113-4:2024 - In vitro diagnostic medical devices: Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) specifies labelling and instructions-for-use (IFU) requirements for IVD reagents, calibrators and controls intended for self-testing. Adopted by CEN in 2024, this standard applies to outer and immediate container labels and to IFUs for self-test reagents and related accessories. It does not cover IVD instruments/equipment or reagents intended for professional use.

Key topics and technical requirements

The standard defines the essential labelling content and presentation rules to support safe, effective self-testing. Major technical topics include:

• Manufacturer identification: clear manufacturer name and contact details on the outer container and/or IFU.
• Identification of the IVD reagent: unambiguous device name and description to differentiate kit components.
• Batch code / lot number: traceability requirements for recall and quality control.
• Unique Device Identifier (UDI): UDI placement and format guidance relevant to self-test reagents.
• Contents and kit component identification: listing of reagents, accessories and single-use items.
• Intended use / intended purpose: user-focused statement of what the self-test detects and limitations.
• In vitro diagnostic use statement: clear indication that the device is an IVD for self-testing.
• Storage and handling conditions: temperature, humidity, and special handling instructions.
• Expiry date and stability: labelling of expiry and any conditions affecting shelf life.
• Warnings and precautions: critical safety information and user alerts that must be prominent in IFU and labels.
• Presentation of IFU: layout, readability and component identification to support lay users.

The standard also addresses how to present information on both outer and immediate containers (single-container vs multi-component kits) and cross-references risk management and symbol standards.

Practical applications and users

EN ISO 18113-4:2024 is intended for:

• IVD manufacturers preparing labels and IFUs for consumer self-test kits (e.g., rapid antigen tests, home pregnancy tests, self-sampling reagents).
• Regulatory affairs and quality teams ensuring compliance with EU IVDR (Regulation (EU) 2017/746) and national regulations.
• Technical writers and labelling designers creating user-centred IFUs and packaging.
• Notified bodies and conformity assessors evaluating labelling compliance during audits.
• Distributors and importers verifying labelling meets market requirements.

Applying this standard improves user safety, traceability, and regulatory conformity for consumer-facing IVD products.

Related standards

• ISO 18113-1 (terms, definitions and general requirements)
• ISO 14971 (risk management for medical devices)
• ISO 15223-1 (symbols for medical device labelling)
• EU Regulation (EU) 2017/746 (IVDR) - Annex ZA maps presumption of conformity where applicable

Keywords: EN ISO 18113-4:2024, in vitro diagnostic, IVD reagents, self-testing, labelling, instructions for use, UDI, IVDR compliance.