Title:EU IVDR Regulatory Changes: An Overview of Requirements in (EU) 2017/746
Volume: 7
Issue: 3
Author(s): Shashank Nayak*, M.P. Venkatesh and Pramod Kumar T.M
Affiliation:
- Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka,India
Keywords:
Directives, classification rules, in vitro diagnostic regulations (IVDR), EU, notified bodies,
regulatory changes.
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.
