Overview
ISO 18113-2:2022 - "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use" specifies labelling and instructions-for-use requirements for in vitro diagnostic (IVD) reagents, calibrators and control materials intended for professional use. The standard applies to outer and immediate container labels and to the instructions for use (IFU). It excludes IVD instruments/equipment and IVD reagents for self‑testing. The 2022 edition adds requirements for Unique Device Identifier (UDI) information and updates alignment with international regulatory practice.
Keywords: ISO 18113-2, in vitro diagnostic, IVD reagents, labelling, instructions for use, UDI, calibrators, controls, professional use, label requirements, regulatory compliance.
Key Topics
The standard details what manufacturer-supplied information must be included and how it should be presented. Major technical topics include:
- Identification: reagent name, component IDs for kits, batch/lot number and where applicable UDI.
- Label content (outer and immediate containers): manufacturer name/address, reagent identification, contents, intended use/purpose, storage/transport/handling, expiry date, warnings and precautions.
- Instructions for use (IFU): intended purpose, principles of the examination method, reagent preparation, recommended equipment, sample collection/handling/storage, examination and control procedures, result calculation and interpretation.
- Performance and limitations: analytical and clinical performance characteristics, measuring interval, biological reference intervals, and documented limitations of use.
- Traceability: traceability of values assigned to calibrators and control materials.
- Document control and references: literature references and versioning of IFU.
Applications
ISO 18113-2 is practical for:
- Producing compliant labelling and IFUs for IVD reagents, calibrators and controls.
- Ensuring consistent kit component identification across packaging and documentation.
- Demonstrating conformity to labelling expectations for regulatory submissions and audits.
- Harmonising manufacturer labelling across jurisdictions by aligning with IMDRF-aligned requirements.
Who uses this standard
- IVD manufacturers (labelling, regulatory and quality teams)
- Regulatory affairs and compliance professionals preparing submissions
- Clinical laboratory managers and procurement specialists verifying product information
- Technical writers and designers of IFUs and product labels
Related standards
- ISO 18113-1 - general requirements and definitions for IVD labelling
- ISO 18113-3 - labelling for IVD reagent systems used with instruments (where applicable)
- ISO 15223-1 - symbols for medical device labelling
- ISO 14971 - risk management for medical devices
- ISO 8601-1 - date/time representation
Use ISO 18113-2 to create clear, compliant labelling and instructions that support safety, traceability and regulatory alignment for professional-use IVD reagents.
Open preview (PDF)In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use