24. Assignment of medical devices into classes

For the purposes of section 29(2)(a) of the Act, the classes of medical devices shall be as specified in Part I of the Third Schedule.

For the purposes of assigning a medical device into a class of medical devices under section 29(2)(b) of the Act, the following principles shall apply:

the Authority shall have regard to the intended purpose of the medical device;

if the medical device may be assigned into 2 or more classes of medical devices, the Authority shall assign the medical device into such of those classes as represents the highest health risk posed to an end-user of the medical device;

if the medical device is designed to be used in combination with another medical device, each of the medical devices shall be classified separately;

if the medical device has 2 or more intended purposes, the medical device shall, subject to sub-paragraph (b), be assigned into a class of medical devices having regard to the most critical intended purpose of the medical device.

For the purpose of determining the health risk posed to an end‑user of a medical device under paragraph (2)(b), the Authority is to have regard to —

the general criteria for risk classification of medical devices in Part II of the Third Schedule; and

the risk classification rules for medical devices set out on the Authority’s website.

For the purposes of section 29(2)(a) of the Act, the classes of medical devices shall be as specified in Part I of the Third Schedule.

For the purposes of assigning a medical device into a class of medical devices under section 29(2)(b) of the Act, the following principles shall apply:

the Authority shall have regard to the intended purpose of the medical device;

if the medical device may be assigned into 2 or more classes of medical devices, the Authority shall assign the medical device into such of those classes as represents the highest health risk posed to an end-user of the medical device;

if the medical device is designed to be used in combination with another medical device, each of the medical devices shall be classified separately;

if the medical device has 2 or more intended purposes, the medical device shall, subject to sub-paragraph (b), be assigned into a class of medical devices having regard to the most critical intended purpose of the medical device.

For the purpose of determining the health risk posed to an end‑user of a medical device under paragraph (2)(b), the Authority is to have regard to —

the general criteria for risk classification of medical devices in Part II of the Third Schedule; and

the risk classification rules for medical devices set out on the Authority’s website.