The Medical Devices Introductory Course 2020

In-Vitro Diagnostics

Transition to IVDR: • May 2022 • Currently 80-90% IVDs are ”self-declared” - i.e.: have no CA or NB involvement in CE Marking • Under IVDR: >90% will require NB involvement • Different classification (A, B, C, D) but many other aspects common to MDR (e.g.: conformity assessment routes)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

IVDD / IVDR What is NOT Included Products for general laboratory use, unless they have special characteristics or have been modified for diagnostic use

E.g. Centrifuge – unless something specific to make IVD HPLC – unless built into equipment Pipette Plate readers Mass spectrometer Refrigerators

The Organisation for Professionals in Regulatory Affairs