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Paragraph 2 General requirements

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

The device must achieve the performances intended by its manufacturer and, in particular, must be designed and manufactured in such a way that it is suitable for one or more of the following functions as specified by him:—

(a)

diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;

(b)

investigation, replacement or modification of the anatomy or of a physiological process;

(c)

control of conception.