bioMérieux obtains Class D CE marking for two respiratory tests
The in vitro diagnostics specialist has achieved a regulatory milestone by obtaining, for two of its syndromic respiratory tests, the most demanding classification provided for under the European regulation on in vitro diagnostic medical devices. This CE marking concerns panels including the Middle East respiratory syndrome coronavirus (MERS-CoV), the pathogen responsible for this highest level of risk classification.
Two BIOFIRE panels classified at the highest risk level
bioMérieux announced on September 16, 2026 that its BIOFIRE Respiratory 2.1 plus (RP2.1plus) and BIOFIRE FILMARRAY Pneumonia plus (PNplus) panels received CE marking under the IVDR regulation as Class D in vitro diagnostic devices, the highest risk classification provided for under the regulation. According to the company, this classification is linked to the inclusion of MERS-CoV in both test menus. Class D is reserved for tests intended to detect pathogens presenting a high risk to public health. According to the press release, bioMérieux is among the first companies to obtain this certification for multiplex syndromic tests including MERS-CoV.
European availability expected in early 2027
The BIOFIRE RP2.1plus panel provides syndromic testing of upper respiratory tract infections in approximately 45 minutes, while the BIOFIRE FILMARRAY PNplus panel supports the diagnosis of lower respiratory tract infections by detecting a broad range of bacterial and viral pathogens as well as antimicrobial resistance markers, in approximately one hour. The company indicates that the newly certified IVDR panels will begin to be available on the European market in early next year. In the interim, laboratories will continue to receive the RP2.1plus and PNplus panels without interruption, as no modifications have been made to the design or intended use of the products.
