Overview
ISO 18113-1:2022 - "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements" defines the core concepts and general principles for information that manufacturers must supply with in vitro diagnostic (IVD) medical devices. As the first part of the ISO 18113 series, it standardizes terminology, establishes essential labelling requirements, and provides a foundation for subsequent parts that address reagents, instruments and self‑testing. The 2022 edition updates definitions, adds references to UDI (Unique Device Identification), and aligns with recent regulatory changes (including EU requirements and IMDRF guidance).
Key topics and technical requirements
ISO 18113-1:2022 focuses on clear, consistent information supply for safe and effective use of IVDs. Major technical topics and requirements include:
- Terms and definitions: A comprehensive, harmonized glossary for IVD labelling (general terms, performance characteristic terms).
- General requirements for information supplied (Clause 4), covering:
- Instructions for use (format, content, delivery methods)
- Symbols and identification colours (consistent symbol use per ISO 15223‑1)
- Values and nomenclature (how performance data and measurands are expressed)
- Microbiological state and handling indications
- Changes to the IVD medical device and communication of updates
- Disclosure of residual risks and assistance/contact information
- Identification of components and automatic identification/data capture (AIDC) guidance
- Annex A: Informative guidance on performance characteristics of IVD medical devices.
- Exclusions: Does not address language requirements (national laws apply), nor apply to devices for performance evaluation, shipping documents, Safety Data Sheets, or marketing information.
Practical applications and who uses this standard
ISO 18113-1:2022 is practical for organizations involved in IVD labelling, regulatory compliance and product documentation:
- Manufacturers - for writing compliant labels, instructions for use, and product documentation.
- Regulatory affairs and quality managers - to align device labelling with international best practices and risk management (ISO 14971) and quality systems (ISO 13485).
- Technical writers and usability engineers - for consistent terminology and format, and to support IEC 62366‑1 usability processes.
- Notified bodies and regulators - as a reference for conformity assessment and harmonization across jurisdictions.
- Clinical laboratories and procurement - to understand label content and performance claims.
Related standards
- ISO 18113 series (Parts 2–5) - device-specific labelling requirements for reagents, instruments, and self‑testing
- ISO 15223‑1 - symbols for medical device information
- ISO 13485 - quality management for medical devices
- ISO 14971 - risk management for medical devices
- IEC 62366‑1 - usability engineering for medical devices
Keywords: ISO 18113-1:2022, in vitro diagnostic, IVD labelling, manufacturer information, UDI, instructions for use, performance characteristics, ISO standards.
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