EU MDCG 2022-2:2022现行

This guidance should be applied to all products meeting the definition of an IVD per Article 2(2) of the IVDR: 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.