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IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
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June 25, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
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May 1, 2024
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