---
title: "Multiplex STI PCR Test: Supporting a Smooth IVDR Journey"
description: "Learn how we supported a global IVD manufacturer in achieving IVDR compliance for their multiplex STI PCR test, ensuring timely CE-marking and future regulatory confidence."
url: https://qbdgroup.com/en/case-studies/multiplex-sti-pcr-test-supporting-a-smooth-ivdr-journey
type: "Case study"
language: en
published: 2025-07-29
publisher: "QbD Group"
citation: "QbD Group, \"Multiplex STI PCR Test: Supporting a Smooth IVDR Journey\", https://qbdgroup.com/en/case-studies/multiplex-sti-pcr-test-supporting-a-smooth-ivdr-journey"
---
# Multiplex STI PCR Test: Supporting a Smooth IVDR Journey
> Learn how we supported a global IVD manufacturer in achieving IVDR compliance for their multiplex STI PCR test, ensuring timely CE-marking and future regulatory confidence.

Our client is a **global IVD manufacturer**, known for its expertise in **molecular diagnostics and point-of-care solutions**. With a strong presence in infectious disease testing and a clear ambition to expand across Europe, the company continues to push the boundaries of innovation in the in vitro diagnostics space.

## Challenge

As part of its growing portfolio, the client developed a **fully automated multiplex real-time PCR panel** capable of detecting eight common sexually transmitted infection (STI) pathogens. To bring this product to the European market, they needed to obtain **CE-marking under the In Vitro Diagnostic Regulation (IVDR)**.

While the technical innovation was sound, the **clinical performance study** required for IVDR compliance presented a unique challenge. The need to collect sufficient samples for multiple low-prevalence pathogens made the study both logistically and scientifically complex. On top of that, **staying within timelines** was critical.

## Approach

QbD Group stepped in with a **hands-on and strategic approach**, tailored to the client’s needs. We started by shaping a clinical performance evaluation plan that met all IVDR requirements, without overcomplicating the operational side.

Working closely with the client, we calculated a sample size that was both statistically solid and feasible in real-world conditions. We then selected study sites across the EU that provided access to the right patient populations, improving enrolment feasibility from the outset.

## Result

By combining regulatory know-how with pragmatic execution, we helped the client **successfully gather the clinical evidence needed for IVDR compliance.** The study remained on schedule, enabling a **timely CE-marking submission**.

Just as importantly, the collaboration laid a strong foundation for future IVDR submissions, giving the client greater confidence moving forward.

This project not only supported the launch of an innovative diagnostic tool, but it also **reinforced the client’s position as a trusted player in the European molecular diagnostics market**.
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Source: https://qbdgroup.com/en/case-studies/multiplex-sti-pcr-test-supporting-a-smooth-ivdr-journey — © QbD Group. Quote freely with attribution and a link back.