in vitro diagnostic medical device

The definition covers reagents, instruments, software and specimen receptacles. The intended purpose decides whether a product is an IVD, so a general laboratory product is not one unless it is specifically intended for in vitro diagnostic examination.

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software 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 on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

IVDR, Article 2(2)

device, whether used alone or in combination, intended by the manufacturer (3.9) for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles [SOURCE: ISO 18113-1:2009, 3.27, modified — NOTE deleted.]

ISO 14971:2019, clause 3.7