The Medical Devices Introductory Course 2020

IVDD Conformity Routes – “Self Test IVD”

Main route used by manufacturers With many self tests of make lots of changes

Main route used by manufacturers with only a few self test devices which do not frequently change

The Organisation for Professionals in Regulatory Affairs

IVDD Conformity Routes – “Annex IIB IVD”

Main route used by manufacturers

The Organisation for Professionals in Regulatory Affairs