The Medical Devices Introductory Course 2020

Official Definitions • IVDs are then broken down into various types of action • concerning a physiological or pathological process or state; • concerning congenital physical or mental impairments; • concerning the predisposition to a medical condition or a disease; • to determine the safety and compatibility with potential recipients;

• to predict treatment response or reactions; • to define or monitoring therapeutic measures. • Sample Collection Device

The Organisation for Professionals in Regulatory Affairs

• EU regulation started in the 1990’s • IVD Directive 98/79 EC 1998 with application in 2003. • “New Approach” Directives that set requirements in terms of manufacturing, labelling and performance of the IVD • Required the application of a CE mark • Notified Body approval for Annex 2 list plus self-tests History of IVD Regulation - EU

The Organisation for Professionals in Regulatory Affairs