Overview
EN ISO 18113-2:2024 - "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use" is the CEN-adopted European version of ISO 18113-2:2022. It specifies labelling and information requirements that manufacturers must supply for in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. The standard covers labels for outer and immediate containers and the instructions for use (IFU), and can also apply to accessories. It explicitly does not apply to IVD instruments/equipment or to reagents intended for self-testing.
Key Topics and Requirements
This part of the EN/ISO 18113 series defines content and format expectations to ensure safe, effective use and regulatory alignment. Key technical topics include:
- Manufacturer identification and contact details required on labels.
- IVD reagent identification: reagent name, purpose/intended use and device type.
- Traceability elements: batch code / lot number and Unique Device Identifier (UDI) requirements.
- Contents and composition: listing reagents, calibrators and controls included in the kit.
- Storage, transport and handling conditions and expiry date information.
- Warnings, precautions and safety statements for professional users.
- Instructions for use (IFU): reagent preparation, limitations, required additional equipment, and safe combination instructions.
- Analytical and diagnostic performance information: essential performance claims (e.g., sensitivity, specificity) and other performance characteristics relevant to intended use.
- Document and change control practices for labelling and IFU updates.
The standard is intended to be read together with EN ISO 18113-1 (terms and general requirements) and relevant normative references (e.g., ISO 15223-1, ISO 14971). Annex ZA maps this standard to the General Safety and Performance Requirements of EU Regulation (EU) 2017/746.
Applications and Who Uses It
EN ISO 18113-2:2024 is used by:
- IVD manufacturers preparing labels, packaging and IFUs for reagents, calibrators and controls (professional use).
- Regulatory and quality teams to demonstrate compliance with labelling requirements and to support conformity with Regulation (EU) 2017/746 where applicable.
- Notified bodies and auditors assessing labelling, IFU content and traceability during conformity assessments.
- Clinical laboratories and procurement teams reviewing reagent information for safe implementation and inventory control.
Practical applications include designing compliant outer and immediate container labels, assembling IFUs that communicate safe handling, and documenting traceability (lot/UDI) for post-market surveillance.
Related Standards
- EN ISO 18113-1 (Terms, definitions, general requirements)
- ISO 14971 (Risk management for medical devices)
- ISO 15223-1 (Medical device symbols and labelling)
Using EN ISO 18113-2:2024 helps manufacturers produce clear, compliant labelling that supports patient safety, regulatory submissions, and effective use of professional IVD reagents.