Devices falling under the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 are 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:
- 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.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; ‘medical device’ means ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745.
The following products are excluded from the IVDR scope:
- products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
- invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
- internationally certified reference materials;
- materials used for external quality assessment schemes.