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)

Do you have a Class A medical device? Contact us now and we’ll help you get it to market.

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.

5(c) Invasive devices that are for short-term use in the oral cavity as far as the pharynx, in an ear canal to the ear drum, or in a nasal cavity—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)

Do you have a Class B medical device? Contact us now and we’ll help you get it to market.

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.

7(i) A surgically invasive device for short-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body—Class B. Note: for this clause, a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but that does not enter the gum or bone beyond the tooth.
Rule 8

8(b) A surgically invasive device for long-term use to be placed in the teeth—Class B.

8(m) A surgically invasive device for long-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body is Class B. Note: for this rule a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but does not enter the gum or bone beyond the tooth.
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)

Do you have a Class C medical device? Contact us now and we’ll help you get it to market.

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)

Do you have a Class D medical device? Contact us now and we’ll help you get it to market.

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