Module 18 - Drug Device Combinations and Other Technologies

Definition of Medical Device ‘medical device’ means any instrument, apparatus, appliance, software, reagent, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which – (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap/disability, (iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process, or (iv) control or support of conception; and (v) providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, (vi) products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) [EU MDR] and of those referred to in the first paragraph of this point. (b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means , even if it is assisted in its function by such means, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device; (a) is intended by the manufacturer to be used for human beings for the purpose of: (i) diagnosis, prevention, monitoring, prognosis, treatment or alleviation of disease,

*** TEXT IN RED is taken from the EU MDR (Article 2(1)) and is applicable in Northern Ireland, but does not apply to Great Britain under UK MDR Regulation 2

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Exclusions

UK MDR Regulation 3 Certain things are excluded from the remit of the medical device regulations and therefore products containing certain things cannot be considered as Medical Devices: e.g.

• Most human derived products • Viable animal tissues

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