Paris-based Eurobio Scientific said Tuesday it has obtained in vitro diagnostic regulation (IVDR) CE markings for its EurobioPlex line of polymerase chain reaction (PCR) tests.
Specifically, the CE markings enable it to market three of its PCR tests as Class C in vitro diagnostic medical devices for the detection of infectious diseases.
Other tests in the EurobioPlex line, CE-marked via a regulation in place before May 26, 2022, are still being marketed. However, CE marking has to occur no later than May 2025 for the firm’s Class D devices, which detect diseases presenting a high risk, including HIV and hepatitis; May 2026 for Class C devices; and May 2027 for Class B and A devices.
The new CE marking follows the company's annual audit by its French notified body GMED. Eurobio Scientific said that the CE marking and ISO certification in France according to the new, more stringent European standards represent a fundamental step in its group's development. They complement a similar certification obtained by its subsidiary GenDx, the firm said.