(News Bulletin 247) – Eurobio Scientific announces that in April 2023 it obtained the first CE IVDR markings for PCR tests in its EurobioPlex range, thus becoming “one of the first European companies to obtain such marking for its own products”.
These markings allow it to market the first 3 PCR tests in its EurobioPlex range as class C in-vitro diagnostic medical devices, requiring expertise in the molecular diagnosis of infectious diseases.
The other tests in the EurobioPlex range, which were already CE marked according to the old regulations before May 26, 2022, benefit from an extension period which allows them to be marketed until they obtain their CE IVDR marking which must intervene no later than May 2025 for class D devices (diseases presenting a high risk, HIV, hepatitis, etc.), May 2026 for class C, and May 2027 for sterile classes B and A.
‘This qualification is a strong signal that we send to our partners and customers about the quality of our teams and our products’, commented in substance Cathie Marsais, vice-president of operations at Eurobio Scientific.
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