What Is The Definition of an IVD Device?
Does the product meet the definition of an in vitro diagnostic medical device? The first step is to determine if your product meets the definition of a medical device under the EU In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC definition: ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, 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:- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.