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Paragraph 2 Purpose of clinical investigation

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

The purposes of the clinical investigation are:

(a)

to verify that, under normal conditions of use, the performances of the device comply with those indicated in paragraph 2 of Schedule 2; and

(b)

to determine any undesirable side effects, under normal conditions of use, and assess whether they are reasonably acceptable risks having regard to the intended performance of the device.