Werfen has received CE marking for its Aptiva antiphospholipid syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents, meaning the in vitro diagnostics can now be used in the EU.

Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.

The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

Devyser Diagnostics AB has entered an in vitro diagnostic development agreement with Illumina, Inc. (Nasdaq: ILMN). The agreement enables Devyser to develop and offer its in vitro diagnostic (IVD) tests on Illumina MiSeqDx next-generation sequencing (NGS) instrument in the United States and Europe.

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.

Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.

Revvity said on Monday it has received a CE-IVD mark for a molecular testing platform that can be used to screen newborns for spinal muscular atrophy and severe combined immunodeficiency.

Roche announced on Monday that its hepatitis B immunoassay has received CE marking and is available for use in countries accepting the regulatory designation.

Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.