Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...

The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional ...

AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray ...

Biomerica has received CE-marking for its food intolerance tests tailored for ulcerative colitis (UC) and Crohn's disease, under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR).

One of the main challenges of transitioning from CE-IVD products to IVDR is aligning with the everchanging clinical guidelines for diagnostic devices. Under IVDR, manufacturers must generate a ...

The firm's CT/NG Positive Run Control and STI Negative Run Control will be the first products CE-marked under IVDR.

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations.

IVDR certification positions Biomerica favorably ... products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic Medical ...

is proud to announce that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic Medical Devices ...