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Clinical Investigation Plans The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV ISO 14155

The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How.

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Guardant360 CDx Gains European Union Certification for Tumor Profiling in Solid Tumors

Guardant360 CDx received In Vitro Diagnostic Regulation certification for tumor mutation profiling in solid tumors and for companion diagnostic indications in NSCLC and breast cancer.

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Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications
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Guardant Health, Inc.: Guardant Health Receives EU IVDR Certification for Guardant360 CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Blood-based test for comprehensive genomic profiling of solid cancers meets requirements under stricter EU In Vitro Diagnostic Regulation IVDR certification from TÜV SÜD enables broader adoption

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Drivers with certain tyres warned they will need to drive '3mph slower'

Drivers with certain tyres warned they will need to drive '3mph slower'
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