--- title: "One Integrated HPV Study for IVDR and WHO Prequalification" description: "How an integrated evidence strategy can support two market-access pathways while reducing duplicate clinical study activities." url: https://qbdgroup.com/zh-cn/case-studies/integrated-hpv-study-ivdr-who-prequalification type: "Case study" language: zh-cn published: 2026-10-07 author: "Sara Peeters & Dr. Davy Vanden Broeck" category: "Case Study" publisher: "QbD Group" citation: "QbD Group, \"One Integrated HPV Study for IVDR and WHO Prequalification\", https://qbdgroup.com/zh-cn/case-studies/integrated-hpv-study-ivdr-who-prequalification" --- # One Integrated HPV Study for IVDR and WHO Prequalification > How an integrated evidence strategy can support two market-access pathways while reducing duplicate clinical study activities. A global IVD manufacturer was developing a multiplex real-time PCR point-of-care assay for high-risk HPV DNA detection in primary cervical cancer screening. The device was intended for European and African markets, which meant clinical evidence had to support both IVDR CE marking and WHO Prequalification. Together with AML, Belgium’s National Reference Laboratory for HPV, QbD Group developed one integrated evidence strategy that addresses both pathways without running two separate clinical performance programmes. ## Challenge Both pathways rely on clinical evidence, but assess it differently. The IVDR requires proof that the device performs as claimed for its intended purpose and population. WHO Prequalification adds a public-health perspective, including settings where screening infrastructure and laboratory resources differ substantially from Europe. Mapping both against the intended purpose highlighted several challenges: - Aligning **clinical claims and endpoints** across two frameworks - Representing **European screening and relevant low- and middle-income country settings** in one programme - Defining **endpoints and sample sizes** that address both evidence strategies - Selecting an appropriate **comparator and reference standard**, where few well-established assays remain available - Capturing relevant **genotype and specimen diversity** - Demonstrating **usability in resource-limited settings**, which a laboratory study alone cannot show ## Approach We designed the evidence strategy around market access rather than creating separate studies for each framework. ### 01 Start with the intended purpose We first defined the intended use, users, setting, clinical context and claimed specimen types, because these determine the evidence needed downstream. ### 02 Map requirements and identify gaps IVDR requirements and current WHO expectations were mapped side by side to identify where evidence could be shared and where targeted additional evidence would be needed. ### 03 Build around a common scientific framework WHO uses an independent evaluation against the **Meijer criteria** as the performance-evaluation component for HPV nucleic acid tests. For the IVDR, these criteria provide a relevant benchmark for the state-of-the-art assessment and clinical validation approach. ### 04 Select the right reference-laboratory network We partnered with **AML, Belgium’s HPV National Reference Laboratory** and a member of **WHO HPV LabNet**, with experience in Meijer-based evaluations. Its collaboration with the Kenyan HPV reference laboratory extended the strategy into an African setting. ### One Evidence Strategy, Three Complementary Components The Meijer criteria form the common scientific foundation. A core clinical accuracy study is complemented by reproducibility testing at AML and in an African reference laboratory, and by a field usability study with claimed users in resource-limited settings. ![Integrated HPV evidence strategy: clinical accuracy, intra- and inter-laboratory reproducibility and field usability, designed to support IVDR CE marking and WHO Prequalification](/__l5e/assets-v1/c72f05e0-2daa-47d4-903a-5d7dce893d48/hpv-integrated-evidence-framework-v2.png) QbD Group’s network of qualified sites in more than 25 countries across Europe and Africa made it possible to match each component to the right site. ## Result ### One Strategy for Two Market-Access Pathways The strategy was designed around both pathways from the outset, identifying where evidence can serve both and where targeted additional activities are needed. It is designed to support IVDR CE marking and WHO Prequalification while avoiding duplicate clinical study activities. The programme is ongoing; clinical and regulatory outcomes will be reported once available. - A **Meijer-based clinical accuracy study** serving both pathways - **Reproducibility testing in Europe and Africa**, adding the geographical evidence needed for WHO - A **field usability study** addressing workflow, training needs and operational feasibility - Both pathways **mapped upfront**, with the intended purpose guiding populations, settings and claims - A **recognised reference-laboratory network** supporting the scientific credibility of the approach --- Source: https://qbdgroup.com/zh-cn/case-studies/integrated-hpv-study-ivdr-who-prequalification — © QbD Group. Quote freely with attribution and a link back.