Eurobio Scientific: IVDR CE markings for PCR tests
These markings will enable the company 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 under the old regulations before May 26, 2022, benefit from an extension period, enabling them to be marketed until they obtain their IVDR CE mark, which must be obtained by May 2025 at the latest for class D devices (high-risk diseases, HIV, hepatitis, etc.)..), May 2026 for class C, and May 2027 for sterile classes B and A.
'This qualification is a strong signal to our partners and customers of the quality of our teams and our products', commented Cathie Marsais, Vice President Operations at Eurobio Scientific.
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