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 ...
Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, ...
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 ...
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 ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 ...
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 ...
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 ...
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