Module 18 2021

06/02/2021

IVD-R Class C CDx device under NB and MPA review

IVDD self declaration

MPA/ European Medicines Agency (EMA)

Medicinal Products Authority (MPA)

QMS plus TD assessment Audit

Quality Management System Notified Body Audit

Marketing Authorisation Application (MAA)

MAA

NB

Self-certification based on the Technical Documentation

EU Technical Documentatio n assessment

IVD Manufacturer

Pharma

IVD Manufacturer

Pharma

The new CDx conformity assessment procedure is a very complex one

The Organisation for Professionals in Regulatory Affairs

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https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Which NBs are designated for devices intended to be used as CDx ?

The Organisation for Professionals in Regulatory Affairs

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