The Medical Devices Introductory Course 2020

What is outside the Scope of the IVDD / IVDR?

These are NOT IVDs • Breathalyzers to test drunk drivers • Drug tests designed and marketed to screen employees • Tests for veterinary

The Organisation for Professionals in Regulatory Affairs

IVDD Conformity Routes – “General IVD”

i.e. All IVD devices, except those in Annex II and self-test

General device

Annex III EC Declaration of Conformity (self declaration)

CE Mark

The Organisation for Professionals in Regulatory Affairs