"IVD Medical Device" means a device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.  This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

"IVD Medical Device for Self-testing" means any device intended by the manufacturer for use by lay persons.


General Classification System for IVD Medical Devices

Principles of Conformity Assessment for IVD Medical Devices