Product Classification
Accurate and accountable Medical Device Classification is crucial for a successfully regulated and registered Medical Device.
Finding out your class will determine what services you’ll need in order to get your medical device to market. Your device can fall into one of four categories:
Low Risk
Low – Moderate Risk
Moderate – High Risk
High Risk
Find Your Product Class
Class A (low risk)
Rule 1
1(a) A non-invasive device to be used as a mechanical barrier or for compression or for absorption of exudates—Class A.
Rule 2
2(a) A non-invasive device used to channel or store body liquids or tissues, liquids or gases that are to be infused, administered or introduced into a patient—Class A.
Rule 4
A non-invasive device is Class A, unless the device is classified at a higher level under another rule.
Rule 5
5(a) Invasive devices that are not connected to an active medical device, or are intended for connection to a Class A medical device only and are for transient use—Class A.
Rule 6
6(b) A reusable surgical instrument—Class A.
Rule 12
An active device is Class A, unless the device is classified at a higher level under another rule.
Rule 14
14(b) Devices that only contains animal tissues that have been rendered non-viable and the device is only intended by the manufacturer to come into contact with intact skin – Class A
Rule 15
15(c) A device specifically for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses – Class C.
Note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class A.
Class A Examples
| A |
| absorbent pads |
| active devices for recording |
| adhesive dressing strip (not sterile) |
| administration sets for gravity infusion |
| artery forceps |
| C |
| cervical collars and gravity traction devices or compression hosiery |
| chisels |
| compression bandage used for sprains |
| cotton wool |
| D |
| dental curing lights |
| dental impression materials |
| dental patient chairs |
| dentures removable by the patient |
| diagnostic devices for thermography |
| dressing for nose bleeds |
| E |
| exam gloves |
| examination lights |
| excavators |
| L |
| leather straps associated with limb prostheses |
| H |
| handheld dental mirrors |
| hospital beds |
| I |
| island dressings |
| N |
| non-sterile dressings |
| O |
| osteotomes |
| ostomy pouches |
| P |
| patient hoists |
| plaster bandages |
| processing or viewing of diagnostic images |
| prostatic balloon dilation catheters |
| S |
| scissors |
| surgical microscopes |
| syringes without needles |
| T |
| tissue clamps |
| tissue forceps |
| U |
| urine collection bottles |
| W |
| wheelchairs |
| wound drainage collection bottles and incontinence pads |
| wound strips and gauze dressings to act as a barrier or absorb exudates from the wound |
Class B (low – moderate risk)
Rule 1
1(b) A non-invasive device to be used in contact with injured skin (including a device the principal intention of which is to manage the microenvironment of a wound)—Class B.
Rule 2
2(b) A non-invasive device to channel or store a liquid or gas that is to be infused, administered or introduced into a patient and may be connected to an active medical device classified as Class B or higher—Class B.
2(c) A non-invasive device to channel blood, to store or channel other body liquids, or to store an organ, parts of an organ or body tissue that is to be later introduced into a patient—Class B.
Rule 3
3(b) A non-invasive device to be used in treatment consisting of filtration, centrifugation or exchanges of gas or heat—Class B.
Rule 5
5(b) Invasive devices that are not connected to an active medical device, or are intended for connection to a Class A medical device only and are for short- term use—Class B.
5(e) Invasive devices for long-term use in the oral cavity as far as the pharynx or in an ear canal to the ear drum, or in a nasal cavity and are not liable to be absorbed by the mucous membrane—Class B.
5(f) Invasive device with respect to body orifices, to be connected to an active medical device that is classified as Class B or higher—Class B.
Rule 6
6(a) Surgically invasive device for transient use—Class B.
Rule 7
7(a) Surgically invasive device for short-term use—Class B.
Rule 8
8(b) A surgically invasive device for long-term use to be placed in the teeth—Class B.
Rule 9
9 (i)(a) An active medical device for therapy to administer energy to a patient, or exchange energy to or from a patient—Class B.
Rule 10
10(i)(a) A device to supply energy that will be absorbed by a patient’s body (except a device that illuminates the patient’s body in the visiblespectrum)—Class B.
10(i)(b) A device to be used to image in vivo distribution of radiopharmaceuticals in patients—Class B.
10(i)(c) A device used for direct diagnosis or monitoring of vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class B.
Rule 11
11 (a) An active device to administer or remove medicine, body liquids or other substances—Class B.
Rule 15
15(b) A device intended for disinfecting medical devices prior to end point sterilisation or higher level disinfection – Class B
Class B Examples
| A |
| adhesives for topical use |
| B |
| bridges |
| C |
| cardioscopes with or without pacing pulse indicators |
| centrifugation of blood for transfusion or auto transfusion |
| chest retractors for cardiac surgery |
| clamps |
| crowns |
| cryosurgery equipment |
| D |
| dental hand pieces |
| diagnostic ultrasound |
| drills |
| dental adhesives used for root canal therapy |
| dentine adhesives |
| E |
| electrical acupuncture |
| electroencephalographs |
| electronic thermometers |
| evoked response stimulators |
| external bone growth stimulators |
| electrocardiographs |
| F |
| feeding pumps |
| fissures sealants |
| fixed dental prostheses |
| G |
| gamma cameras |
| H |
| heat and moisture exchangers |
| heat exchangers |
| hydrogel dressings |
| hypodermic needles and syringes |
| hard contact lenses |
| hearing aids |
| I |
| infusion cannulae |
| J |
| jet injectors for vaccination |
| L |
| long-term storage of biological substances and tissues such as corneas |
| M |
| magnetic and electromagnetic energy muscle stimulators |
| magnetic resonance equipment |
| N |
| nasopharyngeal airways |
| non-medicated impregnated gauze dressings |
| O |
| orthodontic wire |
| oxygen tubing and masks; anaesthetic tubing and breathing circuits |
| P |
| perineal reduction devices |
| polymer film dressings |
| positron emission tomography |
| powered nasal irrigators |
| pulp testers |
| particulate filtration of blood in an extracorporeal circulation system |
| phototherapy for skin treatment and for neonatal care |
| powered dermatomes |
| R |
| removal of carbon dioxide from the blood and/or adding oxygen |
| S |
| single photon emission computer tomography |
| skin closure devices or temporary filling materials |
| sperm and human embryos |
| stents |
| suckers |
| suction catheters or tubes for stomach drainage |
| surgical gloves |
| surgical swabs |
| some surgical retractors for example |
| sterilizers specifically intended to sterilize medical devices |
| suction equipment |
| suture needles |
| syringes and tubing for infusion pumps |
| T |
| temporarily store and transport of organs for transplant |
| TENS devices |
| tracheal tubes |
| tracheostomy tubes connected to a ventilator |
| Tubes for blood transfusion |
| U |
| urinary catheters |
| V |
| vaginal pessaries |
| W |
| warming or cooling blood in the extracorporeal circulatory system |
| washers-disinfectors intended specifically for disinfecting non-invasive medical devices |
Class C (moderate – high risk)
Rule 1
1(c) A non-invasive device to be used for wounds that have breached the dermis and where the wounds can only heal by secondary intent—Class C.
Rule 2
2(d) A non-invasive device to store blood – i.e. blood bags -Class C.
Note: if the blood bags have a function greater than storing purposes and include systems for preservation other than anti-coagulants then other rules may apply.
Rule 3
3(a) A non-invasive device to modify the biological or chemical composition of blood, other body liquids, or other liquids to be infused in the patient—Class C.
Rule 5
5(d) Invasive devices that are not connected to an active medical device, or are intended for connection to a Class A medical device only and are for long- term use—Class C.
Rule 6
6(c) A surgically invasive device for transient use to supply energy in form of ionising radiation—Class C.
6(d) A surgically invasive device for transient use to have a biological effect or be wholly or mainly absorbed—Class C.
6(e) A surgically invasive device for transient use to administer medicine via a delivery system, and where the administration is potentially hazardous to the patient—Class C.
Rule 7
7(b) A surgically invasive device for short-term use to administer medicine—Class C.
7(c) A surgically invasive device for short-term use to undergo a chemical change in a patient’s body(except a device intended to be placed in the teeth)—Class C.
7(d) A surgically invasive device for short-term use to supply energy in the form of ionising radiation – Class C.
Rule 8
8(o) Implantable maxillo-facial implants and devices such as nails, plates and screws for small joints and long term orthopaedic use– Class C
Rule 9
9 (i)(b) An active device to administer or exchange energy in a potentially hazardous way, having regard to the nature, density and site of application of the energy—Class C.
(The term “potentially hazardous” refers to the type of technology involved and the intended application)
9(ii) An active device to control or monitor, or directly influence the performance of an active medical device for therapy of the kind in the previous entry—Class C.
Rule 10
10(i)(d) A device to diagnose and or monitor vital physiological parameters of a patient, and the nature of variations monitored could result in immediate danger to the patient—Class C.
Note: For this clause ‘variations monitored’, is taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm.
10(ii)(a) A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology—Class C.
10(ii)(b) A device to control, monitor or directly influence the performance of a device in the previous entry—Class C.
Rule 11
11(b) An active device to administer or remove medicine, body liquids or other substances in a way that is potentially hazardous to the patient, having regard to the substances, the part of the body concerned, and the characteristics of the device—Class C.
Rule 15
15(a) A device specifically for sterilising medical devices, or disinfecting as the end point of processing – Class C.
15(c) A device specifically for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses – Class C.
Note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class A.
Rule 16
16 (a) A device for contraception or the prevention of sexually transmitted diseases—Class C.
Class C Examples
| A |
| apnoea monitors |
| auto exposure control systems |
| after-loading control devices |
| anaesthesia machines |
| anaesthetic vaporisers |
| B |
| blood bags (including those containing or coated with an anticoagulant) |
| bone wax |
| bradytherapy devices |
| bone cement |
| bone plates (orthopedic use) |
| bone screws (orthopedic use) |
| biological sensors |
| blood gas analysers used in open-heart surgery |
| blood warmers |
| blood pumps for heart-lung machines |
| C |
| condoms |
| comfort solutions |
| contraceptive diaphragms |
| cardioscopes |
| catheters containing or incorporating radioactive isotopes where the isotope is not intended to be released into the body |
| D |
| diagnostic x-ray sources |
| denture disinfecting products |
| disinfectants for the fluid pathways of haemodialysis equipment |
| disinfectants for ocular prosthesis |
| dialysis equipment |
| E |
| external feedback systems for active therapeutic devices |
| electrocautery |
| external defibrillators |
| electroconvulsive therapy equipment |
| H |
| high-frequency electrosurgical generators |
| hard contact lens solutions |
| heat exchangers used in intensive care |
| hyperbaric chambers |
| I |
| infusion pumps |
| intravenous cannulae |
| infant incubators |
| intensive care monitoring systems |
| intraosseous transcutaneous amputation prosthesis |
| L |
| lung ventilators |
| lithotriptors |
| linear accelerators |
| M |
| maxillo-facial implants |
| medical gas mixers |
| moisture exchangers in breathing circuits |
| N |
| nebulisers where the failure to deliver the appropriate dosage form could be hazardous |
| P |
| personal insulin injectors |
| pens |
| physiotherapy ultrasound devices |
| pressure regulators for medical gases |
| R |
| radioactive sources for after-loading therapy |
| radiotherapy afterloading controls systems |
| S |
| surgical / tissue adhesives |
| surgical lasers |
| surgical equipment and invasive dental equipment |
| T |
| therapeutic X-ray sources |
| therapeutic cyclotrons |
| V |
| ventilators |
| W |
| washers-disinfectors for endoscopes |
| warming blankets for unconscious patients |
Class D (high risk)
Rule 6
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.
Rule 7
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.
Rule 8
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
Rule 13
13 A device incorporating a substance that if used separately would be a medicine and has an ancillary action on the body—Class D.
Rule 14
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.
Rule 16
16 (b) An implantable or invasive device for long- term use—Class D.
Class D Examples
| A |
| absorbable sutures |
| aneurysm clips |
| angioplasty balloon catheters |
| anti-adhesion barriers |
| antibiotic bone cements |
| B |
| bioactive adhesives and implants through the attachment of surface coatings such as phosphorylcholine |
| biological heart valves |
| C |
| cardiac output probes and temporary pacemaker leads |
| cardiovascular catheters |
| cardiovascular sutures |
| catgut sutures |
| clinician’s programming device for pacemakers |
| CNS electrodes |
| condoms with spermicide |
| connonoid paddles |
| contraceptive intrauterine devices (IUDs) |
| contraceptive intrauterine devices (IUDs) containing copper or silver |
| coronary artery probes |
| coronary stents |
| cortical electrodes |
| D |
| 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 made from collagen |
| drug eluting stents |
| E |
| electrode leads associated with pacemakers |
| endodontic materials with antibiotics |
| H |
| haemostatic sponge |
| heparin coated catheters |
| I |
| 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 lenses |
| K |
| knee or shoulder joint replacement systems and components |
| M |
| mammary / breast implants |
| meniscul joint fluid replacement |
| M |
| mammary / breast implants |
| meniscul joint fluid replacement |
| N |
| nerve stimulators |
| neurological catheters |
| O |
| ophthalmic irrigation solutions principally intended for irrigation |
| P |
| pacemakers |
| patient control devices for nerve stimulation devices |
| peripheral vascular grafts |
| porcine xenograft dressings |
| prosthetic heart valves |
| pulmonary stents |
| R |
| rechargeable non-active drug delivery systems |
| S |
| shunts |
| spinal stents |
| stents |
| surgical adhesive |
| surgically implanted contraceptive devices |
| T |
| 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 |
| V |
| vascular prostheses |
| vascular stents |
| W |
| which contain components which support the metabolism of the endothelial cells of the cornea |