(1)

Subject to subregulations (2) and (3), the minimum conformity assessment procedures that must be applied to a Class I medical device (other than a medical device used for a special purpose) are the declaration of conformity (not requiring assessment by Secretary) procedures.

(2)

If the device is intended by the manufacturer to be supplied in a sterile state, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures to the device, the production quality assurance procedures (other than clause 4.7) must also be applied to the device.

(3)

If the device has a measuring function, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures, one of the following sets of procedures, as the manufacturer prefers, must also be applied to the device:

(a)

the verification procedures (other than clause 3.5);

(b)

the production quality assurance procedures (other than clause 4.7);

(c)

the product quality assurance procedures (other than clause 5.7).

Note
The manufacturer of a Class I 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).