The European Commission has proposed another extension to the deadline for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR), a new regulatory framework for diagnostics like ...
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a ...
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.
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 ...
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 ...
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