Navigating the Transition: From IVDD to IVDR Compliance

The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a pivotal regulatory advancement in the EU for in vitro diagnostic (IVD) devices. Effective from 2022, the IVDR (2017/746) addresses the IVDD's limitations by introducing stringent re

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Publication Details

Published
2025-01-01
DOI
https://doi.org/10.4108/eai.13-11-2024.2355687
Primary Topic
Digitalization, Law, and Regulation
Type
article
Field-Weighted Citation Impact
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article

Navigating the Transition: From IVDD to IVDR Compliance

R Rashmitha, Shivanand K Mutta
Digitalization, Law, and Regulation
article

Navigating the Transition: From IVDD to IVDR Compliance

R Rashmitha, Shivanand K Mutta
article en

Abstract

The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a pivotal regulatory advancement in the EU for in vitro diagnostic (IVD) devices. Effective from 2022, the IVDR (2017/746) addresses the IVDD's limitations by introducing stringent re

Al-Ameen College of Pharmacy (IN)
Openalex Percentile: Top 60%
Digitalization, Law, and Regulation
DOIOpen Access PDFOpenAlex
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Navigating the Transition: From IVDD to IVDR Compliance — R Rashmitha, Shivanand K Mutta · (2025) | TGRS Research Map | TGRS