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 Coordinating Group (MDCG) has revised several documents addressing the ...
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.
On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of ...
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 ...
Last year, Roche Diagnostics became the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR) in the European Union. Now, Roche has scored ...
Recently, Autobio’s Automated Mass Spectrometry Microbial Identification System, Autof MS Series, has obtained the EU IVDR (In Vitro Diagnostic Regulation) Class C registration certificate from the EU ...
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