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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

EU IVDR Regulatory Changes: An Overview of Requirements in (EU) 2017/746

Author(s): Shashank Nayak*, M.P. Venkatesh and Pramod Kumar T.M

Volume 7 , Issue 3 , 2020

Page: [237 - 243] Pages: 7

DOI: 10.2174/2213476X07666200327143023

Price: $65

Abstract

IVDR is the new regulatory basis for placing IVDs in the market, making them available and putting them into service in the European market. EU IVDR regulation is much bigger than the impact of EU IVDD, which is a bold statement to make, considering the significant industry- wide impact as it presents challenges to the manufacturer. Rather, it is largely a revision that contains guidance on how to fulfill the existing IVDD requirements. IVDR focused on the IVD-specific provisions therein regarding classification, performance evaluations, clinical data, conformity assessments and notified bodies. IVDR presents enormous change to the IVD industry, not only because it needs a significant change in technical documentation and Quality management system, but also because it changes the relationship with the economic operator and their responsibilities.

Keywords: Directives, classification rules, in vitro diagnostic regulations (IVDR), EU, notified bodies, regulatory changes.

Graphical Abstract
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