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Medtech Insight

Notified Body Process For Consulting EMA On Companion Diagnostics

Jul 04 2022

• By Vibha Sharma

Liquid Biopsy Technology Concept - Early Detection of Cancer Through Circulating DNA Mutations - Innovative Cancer Screening Technology - Innovation in Oncology - 3D Illustration — IVD Regulation makes it mandatory for companion diagnostics to undergo a conformity assessment by a notified body • Source: Shutterstock

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Europe Regulation Guidance Documents Diagnostics In Vitro Diagnostics Medical Device

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