in vitro diagnostic medical device definition

in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, 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:
in vitro diagnostic medical device means an in vitro diag­ nostic medical device within the meaning of point (b) of Article 1(2) of Directive 98/79/EC;
in vitro diagnostic medical device means a medical device which—

More Definitions of in vitro diagnostic medical device

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,
in vitro diagnostic medical device means an in vitro diagnostic device or accessory within the meaning of, respectively, points (b) or (c) of Article 1(2) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices2 which is EEE;
in vitro diagnostic medical device means an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746;
in vitro diagnostic medical device means an in vitro diagnostic device or accessory within the meaning of, respectively, points (b) or (c) of Article 1(2) of Directive 98/79/EEC and which is electrical and electronic equipment.
in vitro diagnostic medical device means an in vitro diagnostic device or accessory as defined in regulation 3.1.3 and 3.1.4 of the In Vitro Diagnostic Medical Devices Regulations, which is EEE;
in vitro diagnostic medical device means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746; [Am. 62]
in vitro diagnostic medical device means an in vitro diagnostic device or accessory within the meaning of, respectively, points (b) or (c) of Article 1(2) of