The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems ...

IVDR: where are we now in molecular testing? How IVDR implementation is progressing in molecular biology laboratories in different European countries IVDR, the new EU legislation for in-vitro ...

The EU Commission has published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on 16 December 2025, ...

The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The ...

The In Vitro Diagnostic Regulation (IVDR) is the European Union’s set of rules aimed at improving the quality, safety, and reliability of IVDs. This regulation is impacting the in vitro diagnostic ...

First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (CDNA) – The Transplant Company ™ – a leading precision medicine company focused on the discovery, development, and commercialization of ...

Full portfolio of QIAstat-Dx panels now CE-IVDR certified for use in clinical syndromic testing, underscoring commitment to highest-quality diagnostics CE-IVDR clearance granted for QIAstat-Dx ...