The EN ISO 18113 series outlines key requirements that manufacturers must provide for information accompanying in vitro diagnostic (IVD) medical devices, including the product label and instructions for use. It encompasses various aspects of IVD medical devices, with specific parts in the standard series dedicated to reagents and instruments intended to meet the specific needs of both professional and self-testing users.
This five-part series was revised in 2022 with updated definitions, terms, and general principles for labelling, providing uniformity and clarity. Revision of the series considered major developments such as the European IVD medical devices regulation and the growing use of unique device identification around the world.
This standard series is crucial for ensuring that users of IVD medical devices receive comprehensive and understandable information to use them correctly. It supports global trade by streamlining regulatory compliance, enabling quicker access to new technologies and treatments. For manufacturers, the EN ISO 18113 series may help reduce the need for localized versions of labels and instructions. This efficiency can lead to cost savings and faster market entry. For healthcare providers and patients, standardized labelling enhances the usability of diagnostic devices, contributing to better patient outcomes and safer healthcare practices.
Consistent labelling improves the safe use and performance of these devices, potentially reducing errors in clinical settings. Consider a laboratory technician using an IVD instrument to perform glucose tests. With the EN ISO 18113 series, the device’s labelling includes clear instructions and standardized symbols, regardless of the technician’s language. This reduces the risk of misinterpretation and errors, ensuring accurate test results and timely diagnosis for patients. Such improvements in labelling practices enhance the overall quality of healthcare delivery.
The EN ISO 18113 series plays a pivotal role in harmonizing the information provided with IVD medical devices, fostering safer, more effective use, and facilitating international trade and regulatory compliance. These standards were developed by ISO Technical Committee 212 Working Group 3 in parallel with CEN/TC 140, whose Secretariat is held by DIN, the German Standardization Body, thanks to support and funding from the European Commission.
This article was written with the collaboration of MedTech Europe, the European trade association for the medical technology industry. For more information, please contact Carlos Pérez Barrionuevo, Manager Regulatory Affairs at MedTech Europe.
