Meridian Bioscience Clears Major EU Hurdle with IVDR Certification

CINCINNATI, OH – February 24, 2026 – Meridian Bioscience has successfully obtained crucial CE marking for a wide range of its Alethia® molecular diagnostic assays under Europe's stringent In Vitro Diagnostic Regulation (IVDR). The certification, a significant milestone for the Cincinnati-based company, ensures that these critical tests for infectious diseases can remain on the market and available to healthcare providers across the European Union.

The certification, issued by the French Notified Body GMED, covers several key products in the Alethia portfolio, including tests for Pertussis, Group B Streptococcus (GBS), Cytomegalovirus (CMV), Malaria, Chlamydia, Gonorrhea, and Herpes Simplex Virus (HSV) 1 & 2. These assays, now classified as higher-risk Class C devices, have been confirmed to meet the rigorous new standards for safety, quality, and clinical performance.

Navigating the IVDR Gauntlet

The transition to the IVDR (EU) 2017/746 represents one of the most substantial regulatory upheavals the diagnostics industry has ever faced. Replacing the former In Vitro Diagnostic Directive (IVDD), the new regulation aims to bolster patient safety by imposing dramatically stricter requirements on manufacturers.

Under the old IVDD framework, an estimated 80% of diagnostic products could be self-certified by the manufacturer. The IVDR has flipped this model on its head, with roughly 80% of all in vitro diagnostics now requiring a comprehensive review and conformity assessment by an independent Notified Body. This shift has created a massive bottleneck, as a limited number of designated Notified Bodies struggle to manage the surge in applications.

For manufacturers, the path to compliance is an arduous one, demanding extensive technical documentation, robust clinical evidence to support performance claims, and comprehensive post-market surveillance systems to monitor products once they are in use. The financial burden is immense. A recent survey by MedTech Europe found that personnel costs for managing quality systems and technical documentation account for 90% of compliance expenses. Furthermore, the costs of maintaining and re-certifying products over a five-year cycle are projected to exceed initial certification fees by 70% for IVD manufacturers.

The result has been a high-stakes environment where many companies have struggled, with some being forced to withdraw products from the European market altogether, creating potential gaps in diagnostic availability. The challenges are so profound that industry reports indicate a significant drop in manufacturers choosing the EU as their initial launch market for new innovations.

A Competitive Edge in a Shifting Market

In this challenging landscape, successfully achieving IVDR certification is more than just a regulatory necessity; it is a significant competitive differentiator. By navigating the complex process, Meridian Bioscience has demonstrated the robustness of its quality management systems and regulatory strategy, placing it among a group of industry leaders who have proven their ability to meet Europe's highest standards.

Major players like Roche Diagnostics, Hologic, and Bio-Rad have also been publicizing their IVDR milestones, signaling a new benchmark for market participation. Meridian’s achievement with its Alethia portfolio solidifies its position as a reliable long-term partner for European laboratories.

“This achievement reflects Meridian’s unwavering commitment to quality, regulatory excellence and customer continuity,” said Andy Kitzmiller, Chief Executive Officer of Meridian Bioscience, in a statement. “The transition to IVDR is one of the most demanding regulatory shifts our industry has faced. Successfully certifying our Alethia product demonstrates the strength of our teams and reinforces our long-term dedication to supporting healthcare providers across Europe with reliable, high-performance molecular diagnostics.”

Ensuring Access to Critical Infectious Disease Diagnostics

Beyond the business implications, Meridian's certification has a direct impact on public health and patient care. The newly certified Alethia assays provide rapid and accurate detection of diseases that pose significant health risks, allowing for timely diagnosis and treatment.

The Alethia platform utilizes loop-mediated isothermal amplification (LAMP) technology, which allows for rapid molecular testing without the need for complex and expensive thermal cycling equipment, making it well-suited for a variety of clinical laboratory settings.

The clinical utility of these tests is well-documented. For instance, the Alethia CMV assay, designed for detecting congenital Cytomegalovirus in newborns from saliva swabs, has shown extremely high accuracy in clinical studies, with one demonstrating 100% positive agreement and 99.8% negative agreement compared to a reference method. Its simplicity enables its use outside of specialized reference labs, expanding access to crucial neonatal screening.

Similarly, the Alethia Malaria assay offers sensitivity comparable to gold-standard PCR tests but delivers results in under an hour. With an improved limit of detection, it can identify parasites at levels far below the threshold of traditional microscopy or rapid diagnostic tests, which is critical for early and accurate diagnosis in both endemic and non-endemic regions. By securing IVDR certification for these and other tests for pertussis, GBS, and sexually transmitted infections, Meridian ensures that European clinicians do not lose access to these vital diagnostic tools.

A Commitment to Quality and the European Market

The certification from GMED, a respected Notified Body, underscores the quality of the technical files and clinical evidence Meridian submitted for its Class C devices. This external validation provides an additional layer of confidence for the laboratories and hospitals that rely on these products daily.

“This milestone reflects the strength of our quality systems and the dedication of our regulatory, quality, and product teams,” noted Susan Bogar, Vice President of Regulatory Affairs at Meridian Bioscience. “We are proud to continue supporting our European customers with IVDR-compliant molecular diagnostics that deliver reliable, actionable results.”

As a fully integrated life science company with a history of providing diagnostic solutions for infectious diseases, this achievement is a cornerstone of Meridian's European strategy. The successful certification of the Alethia portfolio not only secures current market access but also sends a clear signal of the company's long-term commitment to meeting the evolving regulatory standards and serving the needs of the European healthcare community.