Overview
EN ISO 18113-3:2024 - "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use" sets out the labelling and instructions-for-use (IFU) requirements for in vitro diagnostic (IVD) instruments intended for professional use. Adopted by CEN from ISO 18113-3:2022, this European standard defines what manufacturers must supply with IVD instruments and related apparatus, equipment and, where applicable, accessories. It excludes instructions for servicing/repair, IVD reagents (including calibrators and controls), and instruments for self‑testing.
Key Topics
- Scope and exclusions - clarifies applicability to professional-use IVD instruments, apparatus, equipment and accessories, and lists what is outside scope.
- Labels and marking - mandatory identification elements such as instrument name, serial number and Unique Device Identifier (UDI) where applicable.
- Elements of the IFU - required content headings (manufacturer identification, intended use/purpose, storage and handling, warnings/precautions, installation, maintenance, performance information).
- Identification of modules and software - requirements for module and software versioning to support traceability and safety.
- Safety and limitations - guidance on warnings, precautions, residual risks and limiting conditions of use within a risk management framework.
- Installation and action on delivery - instructions that ensure safe set-up and commissioning by professional users.
- Regulatory alignment - informative Annex ZA maps the standard to General Safety and Performance Requirements of Regulation (EU) 2017/746 and describes how compliance can support conformity assessment.
Applications
EN ISO 18113-3:2024 is practical for:
- IVD manufacturers developing compliant labelling and IFUs for professional-use instruments.
- Regulatory affairs and quality managers preparing technical documentation and demonstrating conformity with EU IVD Regulation (EU) 2017/746.
- Technical writers and usability engineers creating clear IFUs, warnings, and software/module identification.
- Notified bodies and conformity assessors evaluating labelling, UDI implementation and the link to risk management and post-market surveillance.
- Clinical laboratories and procurement teams who rely on standardized IFUs to ensure safe installation, maintenance and operation of IVD instruments.
Using this standard helps reduce regulatory risk, improve device traceability (UDI), and ensure consistent, user-focused labelling across markets.
Related Standards
Key referenced standards for presumption of conformity include:
Keywords: EN ISO 18113-3:2024, IVD instruments, labelling, instructions for use, UDI, Regulation (EU) 2017/746, manufacturers, professional use.
