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

[ Vol. 7 , Issue. 3 ]

Author(s):

Shashank Nayak*, M.P. Venkatesh and Pramod Kumar T.M   Pages 237 - 243 ( 7 )

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.

Affiliation:

Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka

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