Technical Guidance Series 5 (TGS–5) for WHO Prequalification – Diagnostic Assessment: Designing Instructions for Use for in Vitro Diagnostic Medical Devices
(2017; 37 pages)

Abstract

WHO prequalification is coordinated through the Department of Essential Medicines and Health Products. Prequalification of in vitro diagnostic medical devices (IVDs) is intended to promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable manner. The focus is on IVDs for priority diseases and their suitability for use in resource-limited settings. For prequalification, WHO undertakes a comprehensive assessment of individual IVDs through a standardized procedure that is aligned with international best regulatory practice. It also undertakes post-qualification activities for IVDs to ensure their ongoing compliance with prequalification requirements.

The instructions for use (IFU) is a critical part of an in vitro diagnostic medical device (IVD); it is expected to effectively communicate the product information to the intended user and ensure the safe use of the IVD. The IFU communicates the purpose for which the IVD should be used, who should use it, how the IVD works, what types of specimens it should be used with, what materials and reagents are needed to perform the IVD, how to perform the test, how to interpret the test result, the limitations of the test, warnings and precautions that need to be considered when using the IVD, and evidence to support IVD performance claims. It therefore communicates all that the user needs to know to make good clinical use of the IVD.

Any information that the manufacturer includes in the IFU should be supported by documentation; for example, the results of well-controlled studies to substantiate performance claims, and manufacturing specifications for the stated composition of test kit components. Manufacturers have a regulatory responsibility to ensure the safe use of their product.

WHO reviews the IFU as part of the WHO prequalification assessment. The IFU is reviewed for clarity, correctness, consistency with the information submitted in the product dossier and with international guidance, requirements and suitability for the target user group for WHO prequalified IVDs. This document draws on documents developed as part of the Roll Back Malaria “mRDT Harmonization Taskforce” (mHarT) initiative to harmonize aspects of testing using malaria rapid diagnostic tests (RDTs), and suggests ways to make tests more user-friendly.

This document provides guidance on the approaches to be taken by manufacturers in designing IFU for products that are eligible for WHO prequalification. The general principles in this document can be applied to both paper and electronic IFUs; however, specific requirements relating to data security, file format and accessibility for electronic IFUs available on the Internet or on media (e.g. IFUs for IVDs intended for professional use that require regular software updates and self-test IVDs) are outside the scope of this document. In addition, labelling other than the IFU (e.g. primary and secondary package labels, and instrumentation manual requirements) are outside the scope of this document. Specific requirements can be found in the International Organization for Standardization (ISO) 18113 standard series regarding package labelling and instrumentation manual requirements. WHO expects these standards to be used to demonstrate conformity.

Related documents
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 1, 2019