Class D

Rules for Classification

6(f) Surgically invasive device intended for use in direct contact with the central nervous system –Class D

6(g) Surgically invasive device for transient use to diagnose, monitor, control or correct a defect of the heart, or central circulatory system through direct contact—Class D.

7(e) A surgically invasive device for short-term use to have biological effect—Class D.

7(f) A surgically invasive device for short-term useto be wholly, or mostly, absorbed by a patient’sbody—Class D.

7(g) A surgically invasive device for short-term use to be used in direct contact with the central nervous system—Class D.

7(h) A surgically invasive device for short-term use to be specifically used to diagnose, monitor, control or correct a defect of the heart, or central circulatory system, through direct contact with these parts of the body—Class D.

8(a) All implantable devices and surgically invasive devices for long-term use—Class D.

8(c) A surgically invasive device for long-term use to be used in direct contact with the heart, the central circulatory system or the central nervous system—Class D.

8(d) A surgically invasive device intended to be life supporting or life sustaining—Class D

8(e) A surgically invasive device intended to be active implantable medical device—Class D

8(f) An implantable accessory to an active implantable medical device—Class D.

8(g) An active device to control, monitor or directly influence the performance of an active implantable medical device—Class D.

8(h) A surgically invasive device for long-term use intended by the manufacturer to have a biological effect—Class D.

8(i) A surgically invasive device for long-term use tobe wholly, or mostly, absorbed by a patient’s body—Class D.

8(j) A surgically invasive device for long-term use to administer medicine—Class D.

8(k) A surgically invasive device for long-term use to undergo a chemical change in the patient’s body(except a device that is to be placed in the teeth)—Class D.

8(l) Breast Implants – Class D

8(n) Implantable orthopaedic devices for total replacement for a hip, knee or shoulder joint – Class D

13 A device incorporating a substance that if used separately would be a medicine and has an ancillary action on the body—Class D.

14(a) Devices that contain animal or human cells or tissues or derivatives, whether viable or that have been rendered non-viable, are Class D.

Devices that contain tissues, cells or substances of microbial or recombinant origin are Class D, even if the device is only intended to come into contact with intact skin.

16 (b) An implantable or invasive device for long- term use—Class D.

Examples
absorbable sutures
absorbable sutures
aneurysm clips
angioplasty balloon catheters
anti-adhesion barriers
anti-adhesion barriers
antibiotic bone cements
antibiotic bone cements
bioactive adhesives and implants through the attachment of surface coatings such as phosphorylcholine
biological heart valves
biological heart valves
cardiac output probes and temporary pacemaker leads
cardiovascular catheters
cardiovascular catheters
cardiovascular sutures
catgut sutures
catgut sutures
clinician’s programming device for pacemakers
clinician’s programming devices for pacemakers
CNS electrodes
condoms with spermicide
condoms with spermicide
connonoid paddles.
contraceptive intrauterine devices (IUDs)
contraceptive intrauterine devices (IUDs) containing copper or silver
coronary artery probes
coronary stents
cortical electrodes
defibrillators
defibrillators and nerve stimulators
devices utilising hyaluronic acid of animal origin
dressings incorporating an antimicrobial agent
dressings incorporating an antimicrobial agent where the purpose of such an agent is to provide ancillary action on the wound
dressings incorporating an antimicrobial agent where the purpose of such an agent is to provide ancillary action on the wound
dressings made from collagen
drug eluting stents
electrode leads associated with pacemakers
endodontic materials with antibiotics
haemostatic sponge
heparin coated catheters
heparin-coated catheters
implantable pacemakers
implants
implants and dressings made from collagen
Implants claimed to be bioactive
including the pericardium and a carotid artery shunt
infusion ports
intra-ocular fluids
intra-ocular fluids
intra-ocular lenses
knee or shoulder joint replacement systems and components
mammary / breast implants
meniscul joint fluid replacement
meniscule joint fluid replacement
nerve stimulators
neurological catheters
ophthalmic irrigation solutions principally intended for irrigation
pacemakers
patient control devices for nerve stimulation devices
peripheral vascular grafts
porcine xenograft dressings
porcine xenograft dressings
prosthetic heart valves
pulmonary stents
rechargeable non-active drug delivery systems
shunts
spinal stents
stents
surgical adhesive
surgically implanted contraceptive devices
thoracic catheters intended to drain the heart
tissue fillers based on hyaluronic acid derived from bacterial fermentation processes
tissue fillers based on hyaluronic acid derived from bacterial fermentation processes.
Total hip replacement systems and components
vascular prostheses
vascular stents
which contain components which support the metabolism of the endothelial cells of the cornea
Application