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

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

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 3 , 2020


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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.

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Article Details

VOLUME: 7
ISSUE: 3
Year: 2020
Published on: 27 March, 2020
Page: [237 - 243]
Pages: 7
DOI: 10.2174/2213476X07666200327143023
Price: $25

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