medical device
Definitions over time (1)
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25/05/2017 – 24/04/2020 Article 2, Medical Device Regulation (MDR) Scope: Whole act
For the purposes of this Regulation, the following definitions apply:
‘medical device’ means 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 one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
Other definitions of this term in this act (1)
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