WHO’s performance evaluation procedure for in vitro diagnostics
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World Health Organization
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iii, 19 p.
WHO’s performance evaluation of in vitro diagnostics (IVDs) establishes a standardized procedure to independently assess the performance and operational characteristics of diagnostic products, including their suitability for use in resource-limited settings, as a prerequisite for WHO prequalification. This normative document defines the scope, requirements and processes governing performance evaluation, positioning it as a distinct but essential step preceding prequalification assessment. It is intended primarily for manufacturers seeking to submit products for evaluation and provides a structured overview of eligibility criteria, submission requirements and procedural conditions. The document details the full evaluation pathway, including submission and review of expressions of interest, commissioning modalities, roles of performance evaluation laboratories, and conditions for initiating and conducting evaluations. It describes the generation, review and ownership of evaluation results, as well as decision-making processes regarding successful completion. Key provisions address confidentiality, conflicts of interest, data sharing and publication of results, including public assessment reports used to inform procurement decisions. The procedure clarifies that evaluation outcomes inform, but do not guarantee, prequalification decisions, and outlines conditions for termination, withdrawal and financial responsibilities, ensuring transparency, consistency and integrity.
WHO’s performance evaluation of in vitro diagnostics (IVDs) establishes a standardized procedure to independently assess the performance and operational characteristics of diagnostic products, including their suitability for use in resource-limited settings, as a prerequisite for WHO prequalification. This normative document defines the scope, requirements and processes governing performance evaluation, positioning it as a distinct but essential step preceding prequalification assessment. It is intended primarily for manufacturers seeking to submit products for evaluation and provides a structured overview of eligibility criteria, submission requirements and procedural conditions. The document details the full evaluation pathway, including submission and review of expressions of interest, commissioning modalities, roles of performance evaluation laboratories, and conditions for initiating and conducting evaluations. It describes the generation, review and ownership of evaluation results, as well as decision-making processes regarding successful completion. Key provisions address confidentiality, conflicts of interest, data sharing and publication of results, including public assessment reports used to inform procurement decisions. The procedure clarifies that evaluation outcomes inform, but do not guarantee, prequalification decisions, and outlines conditions for termination, withdrawal and financial responsibilities, ensuring transparency, consistency and integrity.