Division 2.4 Rule 8

All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:

• to be placed in the teeth, in which case they are in Class IIa,

• to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,

• to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,

• or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.