Closed amadeuspzs closed 2 years ago
The Medical Devices Regulations 2002 defines a medical device as:
an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which— (a)is intended by the manufacturer to be used for human beings for the purpose of- (i)diagnosis, prevention, monitoring, treatment or alleviation of disease, (ii)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (iii)investigation, replacement or modification of the anatomy or of a physiological process, or (iv)control of conception; and (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;
Suggested wording:
This proof of concept does not meet the definition of a medical device and is not intended to be used for the diagnosis, prevention, monitoring, treatment or alleviation of disease
or
This proof of concept is not intended to be used for the diagnosis, prevention, monitoring, treatment or alleviation of disease and does therefore not meet the definition of a medical device
or
This proof of concept is intended to demonstrate the technical validity of applying X technique to Y dataset in order to solve Z. It is not intended for deployment in a clinical or non-clinical setting without further development.
Implemented in #9
e.g. not classed as medical device