On 12 April 2024 WHO announced the expansion of prequalification of in vitro diagnostics to include diabetes. Manufacturers interested in undergoing a prequalification assessment for these products have been invited to consult the WHO website to access the technical specifications and contact the in vitro diagnostics assessment team at diagnostics@who.int to schedule a pre-submission meeting. A webinar for manufacturers was held to introduce the prequalification specifications and the assessment process.
The prequalification assessment process consists of the following components:
- review of a product dossier;
- performance evaluation, including operational characteristics;
- inspection of a manufacturing site against all applicable requirements of ISO 13485:2016; and
- labelling review.
WHO prequalification builds on a risk-based approach whereby considerations such as the risk class of the product, the novelty of the technology, the manufacturer’s experience level with the type of product and specific public health concerns are considered. The need to undertake a prequalification independent evaluation also follows risk-based principles. In this context and as part of a broader effort to streamline assessment processes WHO has taken the executive decision to waive prequalification performance evaluations for in vitro diagnostic medical devices for monitoring of blood glucose in capillary blood and HbA1c point-of-care assays. For such products the prequalification assessment will include the review of a product dossier, a site inspection and labelling review.
This measure enters into force with immediate effect. Manufacturers of products affected by this measure will receive an official communication from WHO.
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