New Zealand Legislation: Regulations

13 Principles for applying the risk classification rules

• (1) The principles set out in this regulation must be applied when determining the correct risk classification for a medical device under the risk classification rules set out in Schedule 2.

  (2) A medical device must be classified having regard to the intended purpose of the device.

  (3) If a medical device is designed to be used in combination with another medical device, each of the devices must be classified separately.

  (4) An accessory to a medical device must be classified separately from a medical device.

  (5) If a medical device is driven, or influenced, by an item of software, the software has the same risk classification as the medical device.

  (6) If a medical device is not designed to be used solely or principally in a particular part of a patient's body, the medical device must be classified having regard to the most critical specified use of the medical device.

  (7) If, based on the intended purpose of the device, 2 or more risk classification rules apply to the medical device, the medical device has the highest level of risk classification applying under the applicable risk classification rules.