Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 5/40)
Character Range: 48015–50847

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 applied to a medical device that is classified at a higher level—see subregulation 3.4(3).

3.8A  Class 2 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 2 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 declaration of conformity (not requiring assessment by Secretary) procedures and the production quality assurance procedures, other than clause 4.7 of Schedule 3.
Note: The manufacturer of a Class 2 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).

3.8B  Class 2 in‑house IVD medical devices
  The conformity assessment procedures that must be applied to a Class 2 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.9  Class I medical devices (other than medical devices used for a special purpose)
 (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).

3.9A  Class 1 IVD medical devices (other than devices to be used for a special purpose)
  The