--- title: "One Study, Two Markets: Designing HPV Clinical Performance Studies for IVDR and WHO PQ" description: "Can one HPV clinical performance study support both IVDR and WHO Prequalification? Learn how to align requirements and avoid duplicate studies." url: https://qbdgroup.com/en/blog/hpv-clinical-performance-studies-ivdr-who-pq type: "Blog post" language: en published: 2026-10-14 author: "Sara Peeters & Davy Vanden Broeck" category: "Clinical" publisher: "QbD Group" citation: "QbD Group, \"One Study, Two Markets: Designing HPV Clinical Performance Studies for IVDR and WHO PQ\", https://qbdgroup.com/en/blog/hpv-clinical-performance-studies-ivdr-who-pq" --- # One Study, Two Markets: Designing HPV Clinical Performance Studies for IVDR and WHO PQ > Can one HPV clinical performance study support both IVDR and WHO Prequalification? Learn how to align requirements and avoid duplicate studies. You have an in vitro diagnostic (IVD) assay with potential applications in Europe and Africa. The conventional approach may be to plan two independent clinical performance studies, each built around a different regulatory pathway. But is that always necessary? With the right strategy, one integrated evidence programme may be able to support both EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and World Health Organization (WHO) Prequalification (PQ), helping avoid unnecessary duplication, time and cost. The important qualification is that the requirements need to be considered **before the protocol is written, not after the study is complete**.

In This Blog Post:

## Can One Clinical Performance Study Meet Both IVDR and WHO PQ Requirements? This is one of the questions we hear most often from manufacturers developing HPV assays for multiple markets. In many cases, the answer is yes. However, an integrated study must be designed to generate evidence that is relevant to both frameworks. A study that meets one pathway's expectations does not automatically meet the other's. The opportunity is therefore not simply to reuse a finished study. It is to identify overlapping requirements and remaining differences early enough to address them within a coordinated study design. ## The Same Evidence Foundation, Viewed Through Different Lenses Both IVDR and WHO PQ rely on clinical evidence, but they assess it through different lenses. ### IVDR: Safety and Performance for the Intended European Use Under the IVDR, the manufacturer needs evidence that the device achieves its intended purpose safely and performs as claimed. That assessment is tied to the intended population, users and settings, together with the applicable clinical performance requirements. For an HPV assay, the study design should therefore reflect the intended clinical use and the claims the manufacturer wants to support in the European market. ### WHO PQ: Performance in Public Health Screening Programmes WHO PQ brings an additional public health perspective: will the assay perform appropriately in the screening programmes and environments where it is expected to be deployed? That question can be especially important in resource-limited settings, where available infrastructure, user training and operational conditions may differ from those at the sites used for European studies.

The same underlying assay may therefore need evidence from different populations or settings to support both pathways. Those differences should be identified before recruitment and site selection begin.

## Usability Requirements Also Need to Be Considered Together The difference in perspective also shapes usability evidence. For WHO PQ, practical usability considerations include whether intended users can operate the assay effectively in real-world screening programmes, potentially across different training levels, infrastructures and epidemiological settings. Under the IVDR, usability evidence focuses on user-related risks and critical tasks, helping demonstrate that the device can be operated safely and as intended by its specified users. These perspectives overlap, but they are not interchangeable. An integrated programme should assess whether its usability activities address the relevant users and conditions for each pathway, rather than assuming one study environment represents them all. ## Four Steps Towards an Integrated IVDR and WHO PQ Strategy ### 1. Start With the Intended Purpose Begin by defining what the HPV assay is intended to do and which clinical claims it must support. The intended purpose should guide the selection of study populations, users, settings and performance endpoints. If the claims or target settings differ between markets, make those differences explicit. They may affect which evidence can be shared and which additional work is needed. ### 2. Map All Applicable Requirements For an HPV assay classified as Class C under the IVDR, consider the relevant clinical performance study requirements in Annexes XIII and XIV. For WHO PQ, identify the applicable Technical Specifications Series documents and performance evaluation requirements for the assay and its intended application. A requirement-by-requirement comparison helps distinguish evidence that can serve both pathways from evidence that needs a market-specific justification or additional activity. ### 3. Align Clinical Claims and Performance Targets Compare the claims, performance targets and study conditions required by both frameworks. Pay particular attention to potential gaps in the populations represented, epidemiological context, intended users and operating environments. The aim is not to force different requirements into a single generic protocol. It is to establish where alignment is defensible and where specific study elements are needed. ### 4. Design the Study to Address the Gaps Only after mapping the requirements should the protocol be finalised. The design can then incorporate shared evidence needs while addressing additional populations, sites, user groups or settings where justified. Depending on the identified gaps, an integrated evidence strategy might still require supplementary data or separate study components. The value lies in planning these needs together, rather than discovering them after the first study has finished. ## Map Both Pathways Before Drafting the Protocol The takeaway is simple: **map both regulatory pathways before drafting the study protocol, not after.** Building IVDR and WHO PQ requirements into the evidence strategy from the start can reduce unnecessary duplication and make better use of study resources. It can also help manufacturers identify early where a single dataset will not be sufficient.

One integrated strategy does not mean identical requirements. It means designing deliberately for both markets.

## Explore an Integrated HPV Clinical Evidence Strategy With QbD Group Planning an HPV assay for Europe and markets where WHO Prequalification matters? QbD Group can support the early mapping of regulatory and clinical performance requirements and help translate the identified gaps into a coherent evidence strategy. Want the full picture? [Watch our on-demand webinar](/en/webinars/ivdr-who-requirements-hpv-studies-on-demand) with Sara Peeters and Prof. Davy Vanden Broeck to explore how an integrated approach can support both IVDR and WHO PQ. --- Source: https://qbdgroup.com/en/blog/hpv-clinical-performance-studies-ivdr-who-pq — © QbD Group. Quote freely with attribution and a link back.