Sept. 17, 2026—BioMérieux’s BioFire Respiratory 2.1 Plus and BioFire FilmArray Pneumonia Plus panels have received the CE mark under the IVDR as class D in vitro diagnostic devices, the highest risk classification under the regulation. The classification is driven by the inclusion of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) on both test menus.
“We are proud to be among the first companies to receive IVDR class D certification for multiplex syndromic tests that include MERS-CoV. Achieving this milestone under the EU’s strictest standards validates the quality of these two BioFire panels, empowering European health care systems and professionals to maintain preparedness for emerging and high-consequence respiratory threats,” Jennifer Zinn, BioMérieux executive vice president of clinical operations, said in a press statement.
The RP2.1Plus panel provides broad syndromic testing for upper respiratory infections in about 45 minutes while the PNPlus panel detects a wide range of bacterial and viral pathogens as well as key antimicrobial resistance markers in about one hour.
The IVDR-certified panels will be available on the European market early next year.