(1) Subject to subregulation (2), in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evaluation procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular:

(a)

clause 1 of Schedule 1 (identification of the benefits and risks associated with the use of the device); and

(b)

clause 3 of Schedule 1 (use of the device for its intended purpose); and

(c)

clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device).

(2)

This regulation does not apply to any of the following:

(a)

an exempt device (other than an exempt device of a kind described in item 1.3 or 1.5 of Schedule 4);

(b)

a medical device that is the subject of an approval under section 41HB of the Act;

(c)

a medical device that is the subject of an authority under section 41HC of the Act.