The Medical Devices Introductory Course 2020

What are IVD’s

• PCR discovered in 1983 by Mullis and Smith (Nobel prize) • Perkin Elmer and Cetus launch the "PCR-1000 Thermal Cycler" and "AmpliTaq DNA Polymerase".IVD’s in 1985 • Human genome project in 2003 led to Next Generation sequencing (NGS). • Software and sample collection devices can also be an IVD

The Organisation for Professionals in Regulatory Affairs

Official definitions

• IVD’s are considered by regulators around the world to be medical devices (e.g. USA) • Non Active, Active, Active Implantable, (Not pharmaceutical!) • Some regulators go further and break down IVD’s into their own category (IMDRF, EU) • …intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information. (EU)

The Organisation for Professionals in Regulatory Affairs