The European market of medical devices is ruled by two fundamental regulations. Regulation 2017/745 covers all medical devices (including active implantable devices) except in vitro diagnostic medical devices, while the latter fall under Regulation 2017/746.
The European market of medical devices is ruled by two fundamental regulations. Regulation 2017/745 covers all medical devices (including active implantable devices) except in vitro diagnostic medical devices, while the latter fall under Regulation 2017/746.
According to Regulation 2017/745 medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability, which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
According to Regulation 2017/746, in vitro diagnostic medical device is 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 any medical condition.
According to Regulation 2017/745 medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability, which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
According to Regulation 2017/746, in vitro diagnostic medical device is 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 any medical condition.
MDRC assists manufacturers of medical devices and in vitro diagnostic medical devices with placing their products on the European Union market. Regardless of device’s type and class and the complexity of applicable regulatory procedures.
MDRC assists manufacturers of medical devices and in vitro diagnostic medical devices with placing their products on the European Union market. Regardless of device’s type and class and the complexity of applicable regulatory procedures.
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