bioMérieux has announced that its BIOFIRE Respiratory 2.1 plus Panel and BIOFIRE FILMARRAY Pneumonia plus Panel have been CE-marked under the EU IVDR as Class D devices, the highest risk class. The classification reflects the inclusion of MERS-CoV on both test menus.
The company says the IVDR-certified panels will become available on the European market early next year, and that laboratories will continue to receive the current panels without disruption, as product design and intended purpose are unchanged.
Source: bioMérieux (press release)
Date: 16 September 2026
Original: https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2026/press-releases/PR_CE-Marking_Class-D_BIOFIRE-Panels_2026.pdf