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 |