SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, ...

Notified bodies have been warning in recent weeks that the envisioned changes to the regulation might create new headaches for IVD makers in Europe.

Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union ...

The European Commission’s Medical Device Coordination Group (MDCG) on 8 July issued an updated guidance to help manufacturers, notified bodies and health institutions classify in vitro diagnostic (IVD ...

GLASGOW, Scotland--(BUSINESS WIRE)--Dxcover, a global leader in AI-enabled technologies, today announced that its breakthrough liquid biopsy medical device has successfully achieved CE marking under ...

R&D Systems Hematology Controls and Calibrators has completed the Class B Certification under the new European Union In Vitro Diagnostic Regulation This press release updates the IVDR Classification ...

Draft guidelines from the European Commission aim to assist companies in determining whether their products, including ...

William Fry’s Charleen O’Keeffe goes through everything you need to know about upcoming changes to medical devices regulations in the EU. The new Medical Devices Regulation (MDR) and In-vitro ...

OGT, A Sysmex Group Company, announces that IVDR-certification has been granted for eight CytoCell ® fluorescence in situ hybridisation (FISH) probes important for patient management in haematological ...

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

This press release updates the IVDR Classification to Class B from the prior Class C. MINNEAPOLIS, Nov. 11, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH ) has recently achieved In Vitro ...