COLOGNE, Germany and LITTLETON, Mass., Dec. 03, 2020 (GLOBE NEWSWIRE) -- TÜV Rheinland LGA Products GmbH is Notified Body for the EU Regulation on In Vitro Diagnostics (IVDR) 2017/746. “We are ...

Biosynex SA, a French health diagnostics group, has successfully acquired their first CE markings under the new IVDR regulation for a range of in vitro diagnostic products, a move that showcases ...

CE-marked under the EU IVDR regulation, Diagnostics.AI's platform is the first to deliver AI algorithmic transparency and per-test auditability for clinical PCR diagnostics As the May 26th CE-IVDR ...

Previously governed by the IVDD (Directive 98/79/EC), the IVDR (Regulation (EU) 2017/746 on in-vitro diagnostics) took effect on May 26, 2022, after a five-year transition period, requiring ...

Thermo Fisher Scientific Inc., announced that the Applied Biosystems™ CytoScan™ Dx Assay and Applied Biosystems™ Chromosomal Analysis Suite (ChAS) Dx software now comply with In Vitro Diagnostic ...

The IVDR registration certifies that the SOPHiA DDM™ Platform's genetic analysis meets the European IVDR 2017/746 requirements, which govern the sale of in vitro diagnostic devices within the ...