---
title: "Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access"
description: "Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively."
url: https://qbdgroup.com/en/case-studies/multiplex-respiratory-antigen-test-accelerating-ivdr-market-access
type: "Case study"
language: en
published: 2025-08-19
publisher: "QbD Group"
citation: "QbD Group, \"Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access\", https://qbdgroup.com/en/case-studies/multiplex-respiratory-antigen-test-accelerating-ivdr-market-access"
---
# Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access
> Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.

Our client is a **global leader in IVD**, specializing in **molecular diagnostic platforms and point-of-care testing solutions**. With a strong foothold in **infectious disease diagnostics**, they are actively expanding their molecular testing portfolio across Europe, bringing innovative tools to meet evolving healthcare needs.

## Challenge

The client developed a **multiplex respiratory antigen** **assay** designed for rapid detection of multiple common respiratory viruses from a single nasal or nasopharyngeal swab. Intended for professional and near-patient use, this test offers the advantage of quickly differentiating key respiratory infections on a single device.

Their urgent **goal was to secure CE-marking under the IVDR framework** as fast as possible, aiming to launch ahead of the upcoming respiratory virus season. The shifting landscape, moving beyond COVID-19 to broader respiratory panels, meant **timing was critical** for maintaining a competitive edge and supporting public health efforts.

However, the client faced regulatory uncertainty. While COVID-19 was classified as Class D with specific common specifications, the other respiratory analytes fell under different rules, complicating the path to compliance.

## Approach

QbD Group developed a focused **IVDR clinical plan** that balanced strict regulatory requirements with the **need for speed**. We designed a tailored performance evaluation to generate solid clinical data within a tight timeline.

**Leveraging our strong network** of study sites, we quickly identified locations capable of handling both professional and near-patient testing during the busy respiratory season. **We managed ethical approvals, contracts, and logistics** efficiently to launch the study without delay.

Throughout the process, **we maintained close oversight**, tracking progress and addressing challenges promptly. Clear communication and agile decisions helped us navigate the regulatory landscape smoothly.

## Result

Our **flexible and proactive approach** enabled the client to **gather the necessary clinical evidence for IVDR CE-marking right on schedule**. Thanks to our wide-reaching clinical partnerships, sample collection was fast-tracked, taking full advantage of the respiratory season peak.

The collaborative and adaptive project management style ensured that **every regulatory and operational milestone was met promptly**. This timely delivery empowered the client to launch a distinct respiratory testing solution in Europe, strengthening their position as an innovation frontrunner during a critical period for public health.
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Source: https://qbdgroup.com/en/case-studies/multiplex-respiratory-antigen-test-accelerating-ivdr-market-access — © QbD Group. Quote freely with attribution and a link back.