Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

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

Self-certification based on the Technical Documentation

Marketing Authorisation Application (MAA)

MAA

NB

EU Technical Documentation 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

17

EUROPA – European Commission – Growth – Regulatory policy - SMCS

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

The Organisation for Professionals in Regulatory Affairs

1 8

18

9