This guideline serves as a comprehensive manual for the field evaluation of new technologies aiming for WHO PQS (Performance, Quality, and Safety) prequalification. In the background section (Part I), the role of the PQS team under the WHO Department of Essential Medicines and Health Products is highlighted. This team is entrusted with the task of prequalifying a variety of immunization-related equipment. The importance of field evaluation is emphasized, ensuring that devices not only perform as expected in real-world settings but are also acceptable to end-users and do not adversely affect the health system.
The instructions for manufacturers (Part II) guide them on the intricacies of interacting with the WHO PQS team during the field evaluation process. This includes determining the necessity of a field evaluation, obtaining approval for a specific country setting, selecting an independent evaluation partner, and submitting the results of the field evaluation.
In the planning section (Part III), manufacturers are provided with a roadmap to establish an evaluation team, set clear evaluation objectives, design the evaluation, and secure the necessary approvals. The overarching goal of the evaluation is to assess the performance of the device under field conditions, gauge its acceptability among users, and determine its impact on the health system. The guide concludes with an outline for the evaluation protocol and annexes that offer application forms and example templates for various stages of the evaluation journey.
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