(1)

Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIb medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers:

(a)

the full quality assurance procedures (other than clause 1.6); or

(b)

the type examination procedures and:

(i)

the verification procedures; or

(ii)

the production quality assurance procedures; or

(iii)

the product quality assurance procedures.

(2)

If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers:

(a)

the full quality assurance procedures (other than clause 1.6); or

(b)

the type examination procedures and the production quality assurance procedures.

Note
The manufacturer of a Class IIb medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level — see subregulation 3.4 (3).