Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 1/40)
Character Range: 37681–40461

2                               IVD medical devices and in‑house IVD medical devices  1         2         3         4

 (2) In the table:
 (a) the lowest level of medical device classification is specified in column 2; and
 (b) successively higher levels of classification are specified in columns 3 to 5; and
 (d) a device specified in a column has the same level of classification as any other device specified in that column.

3.2  Classification of medical devices
 (1) A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2.
 (2) An IVD medical device has the medical device classification applying under the classification rules set out in Schedule 2A.

3.3  Principles for applying the classification rules
 (1) For the purpose of classifying a medical device, the principles set out in this regulation apply.
 (2) A medical device is classified as follows:
 (a) if the medical device is a medical device other than an IVD medical device—having regard to the intended purpose of the device;
 (b) if the medical device is an IVD medical device or an in‑house IVD medical device—having regard to the intended purpose of the device in accordance with the following risk classes:
 (i) Class 1 IVD medical device or Class 1 in‑house IVD medical device—no public health risk or low personal risk;
 (ii) Class 2 IVD medical device or Class 2 in‑house IVD medical device—low public health risk or moderate personal risk;
 (iii) Class 3 IVD medical device or Class 3 in‑house IVD medical device—moderate public health risk or high personal risk;
 (iv) Class 4 IVD medical device or Class 4 in‑house IVD medical device—high public health risk.
 (3) If a medical device is designed to be used in combination with another medical device, each of the devices is classified separately.
 (4) An accessory to a medical device is classified separately from the medical device.
 (5) If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.
 (5A) A medical device production system has the same classification as the medical device the system is intended to produce.
 (6) If a medical device is not designed to be used solely or principally in a specific part of a patient's body, the medical device is 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 classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules.
 (8) For classification of a medical device system or a medical device procedure pack, medicines are not considered