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, ...

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 ...

In a session on the impact of IVDR on molecular testing, presenters noted a lack of clarity and flexibility while endorsing new amendments.

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 ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006.

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 ...

BRUSSELS – The European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device ...

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the ...

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 ...

Early diagnosis through the use of in vitro diagnostics (IVDs) plays a critical role in patient outcomes and in supporting the healthcare system as a whole. IVDs are defined in the new EU IVDR ...

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 ...