Overview
EN ISO 18113-5:2024 specifies the requirements for information supplied by manufacturers of in vitro diagnostic (IVD) instruments intended for self-testing. Published by the European Committee for Standardization (CEN), this standard ensures that users receive comprehensive and clear labelling and instructions necessary for the correct, safe, and effective use of IVD instruments and their associated apparatus or accessories used in self-testing scenarios. The standard is harmonized with international regulations, particularly focusing on alignment with the General Safety and Performance Requirements of Regulation (EU) 2017/746 for in vitro diagnostic medical devices.
Key Topics
- Manufacturer-Supplied Information: Defines essential labelling elements, including identification, intended use, safety instructions, and warnings, that must be provided with IVD self-testing instruments.
- Labeling Requirements: Specifies the format, content, and placement of labels on devices, emphasizing the need for clarity and user understanding, including the use of internationally recognized symbols.
- Unique Device Identification (UDI): Outlines provisions for including a UDI on IVD instruments to assure traceability and regulatory compliance.
- Instructions for Use: Details the elements required in user manuals, including assembly, operation, performance, troubleshooting, and safe disposal, clearly targeting laypersons and non-professional users.
- Scope Limitations: Applies strictly to IVD self-testing instruments, apparatus, and accessories, but excludes servicing instructions, IVD reagents, and devices intended solely for professional use.
- Regulatory Harmonization: Supports conformity with European regulations and international frameworks, aiding manufacturers in meeting both safety and performance requirements.
Applications
EN ISO 18113-5:2024 is crucial for:
- Manufacturers of IVD Self-Testing Devices: Ensures consistent, clear, and compliant information is provided for end-users to operate devices safely and effectively within home or non-clinical settings.
- Regulatory Compliance: Supports manufacturers in gaining CE marking and presumption of conformity with Regulation (EU) 2017/746, streamlining market approval within Europe.
- Device Labelling and Packaging: Guides the design of labels and user documentation, ensuring instructions, warnings, and symbols are accessible and comprehensible for lay users.
- User Safety and Device Performance: Reduces the risk of misuse and enhances patient safety by requiring explicit instructions for use, storage, handling, installation, and maintenance.
- Accessory and Software Providers: Assures that any apparatus or equipment used with IVD self-testing instruments is also adequately labelled and described in documentation.
Related Standards
For comprehensive IVD labelling and safety, EN ISO 18113-5:2024 should be used alongside related standards, including:
- EN ISO 18113-1:2024: General definitions and labelling requirements for all IVD medical devices.
- EN ISO 15223-1:2021: Medical device symbols and requirements for information supplied by the manufacturer.
- EN ISO 14971:2019: Medical device risk management principles.
- EN 61010-1:2010 & EN IEC 61010-2-101:2022: Safety requirements for electrical equipment and IVD medical equipment.
- EN 61326-2-6:2021: EMC requirements for laboratory equipment.
- EN 62366-1:2015: Usability engineering for medical devices.
Conclusion
Adherence to EN ISO 18113-5:2024 is vital for IVD manufacturers targeting the self-testing market, ensuring that consumers are provided with all necessary information for the safe and correct use of diagnostic instruments. By following this standard, manufacturers facilitate regulatory approval, enhance product safety, and improve the overall user experience, supporting higher standards of patient care and home diagnostics.
