Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 4/40)
Character Range: 45411–48262

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).

3.7A  Class 3 IVD medical devices (other than devices to be used for a special purpose)
  The minimum conformity assessment procedures that must be applied to a Class 3 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers:
 (a) the full quality assurance procedures, other than clause 1.6 of Schedule 3; or
 (b) the type examination procedures and the production quality assurance procedures.
Note: The manufacturer of a Class 3 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).

3.7B  Class 3 in‑house IVD medical devices
  The conformity assessment procedures that must be applied to a Class 3 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.8  Class IIa medical devices (other than medical devices used for a special purpose)
 (1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIa 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 declaration of conformity (not requiring assessment by Secretary) procedures and:
 (i) the verification procedures (other than clause 3.5); or
 (ii) the production quality assurance procedures (other than clause 4.7); or
 (iii) the product quality assurance procedures (other than clause 5.7).
 (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 production quality assurance procedures (other than clause 4.7) and the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class IIa 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 or may be