What classification is my medical device?

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Medical devices are classified according to the level of harm they may pose to users or patients. The following tool will assist in determining the classification of a medical device that is not an In Vitro Diagnostic device. There are separate classification rules for IVD devices.

Please read the following before you start

• Medical devices are classified according to their intended purpose, as specified by the manufacturer.
• Where a device has more than one specified purpose, the correct result will be based on the purpose with the highest classification. For example a catheter that is intended to be used short-term in peripheral arteries would be a Class IIa device. One that is intended to be used in the central circulatory system, would be a Class III device. If a manufacturer produced a catheter that was intended to be used in both the peripheral and central circulatory systems, it would be Class III because this is the highest classification for the device's intended purpose.
• Where more than one classification rule applies to the device, the correct classification is the highest classification. For example, a device used in surgery that depends on a source of energy would be covered by both 'invasive' device rules and 'active' device rules.
• Where a device is used in combination with another medical device, the classification rules must be applied separately to each device. This includes any accessories to the medical device.
• Where a medical device is driven or influenced by an item of software that is not embedded in the device, the software has the same classification as the medical device. This includes Apps on a mobile device like a smart phone or tablet.

accessory means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.

active implantable medical device means an active medical device that is intended by the manufacturer:

1. either:
   1. to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
   2. to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
2. to remain in place after the procedure.

active medical device means:

1. a medical device that is intended by the manufacturer to:
   1. depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
   2. act by converting this energy; but
2. does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software is an active medical device.

implantable medical device means a medical device (other than an active implantable medical device) that is intended by the manufacturer:

1. to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure;
2. to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure;
3. to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure.

intended purpose, of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:

1. the information provided with the device;
2. the instructions for use of the device;
3. any advertising material applying to the device;
4. any technical documentation describing the mechanism of action of the device.

joint replacement medical device means an implantable medical device:

1. that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and
2. that (either alone or together with one or more other implantable medical devices):
   1. replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
   2. provides primary fixation to the bone for the replacement articulating surface; or
   3. connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph or and operates as an intrinsic element of the joint replacement;

but does not include an ancillary medical device.

ancillary medical device means an implantable medical device that:

1. consists of screws, plates or wedges;
2. is intended by the manufacturer to be used to:
   1. provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint;
   2. provide bone substitution in relation to, or additional fixation for, any such device;
   3. (iii) otherwise assist any such device;

where the individual requirements of a patient make it appropriate to do so.

The classification for some medical devices is pre-determined. Check to see if your device is in any of the following groups:

Group A

This group includes medical devices that contain:

• a medicine that acts on the patient to provide a secondary effect in addition to the device's main intended purpose (like drug coated stents), this does not include devices whose main intended purpose is to deliver a medicine (like syringes or infusion pumps)
• non-viable animal origin material, except if the device is only intended to contact intact skin. Some examples include wound dressings with collagen and heart valves with animal tissue leaflets
• any materials of microbial or recombinant origin, such as hyaluronic acid or recombinant proteins.

Note: If Group A is applicable you should select this option even if your medical device is also listed in another group.

Group B

This group includes medical devices that are:

• breast implants
• knee, hip or shoulder joint replacement implants
• motion‑preserving device for the spine (such as a spinal disc replacement)
• intended for contraception or prevention of sexually transmitted diseases and that are implantable or invasive for long-term use
• active implantable medical devices
• implantable accessories to active implantable medical devices
• active devices that are intended to control, monitor or directly influence the performance of an active implantable medical device 

Group C

This group includes medical devices that are:

• blood bags, including those that contain an anti-coagulent
• ancillary medical devices for use in joint replacement surgery
• intended for disinfecting, cleaning, rinsing or hydrating contact lenses
• intended for disinfecting another medical device
• intended for contraception or prevention of sexually transmitted diseases and that are not implantable or invasive for long-term use
• intended to administer medicines or biologicals by inhalation where
  • the mode of action of the device is important to its efficacy and safety of the biological; or 
  • it is intended to treat a life threatening condition.
• substances or combinations of substances introduced into the human body through a body orifice other than the nasal cavity, or beyond the pharynx in the oral cavity

Group D

This group includes medical devices that:

• record patient images (through a method that relies on energy outside the visible spectrum), or
• are anatomical models (physical or virtual), or
• are intended to be used to administer medicines or biologicals by inhalation that does not treat a life threatening condition or where mode of action does not affect the efficacy and safety of the biological or medicine, or
• are substances or combinations of substances introduced into the human body through the nasal or oral cavity as far as the pharynx and achieves its purpose in that cavity, or
• are substances or combinations of substances applied to and absorbed by the skin and achieves its intended purpose on the skin, or
• are software, programmable or programmed and used to generate a virtual anatomical model

and are also intended to be used for either or both of the following:

• the diagnosis or monitoring of a disease, injury or disability
• the investigation of the anatomy or of a physiological process.

Group E

This group includes devices that:

• are intended to be used only to clean another medical device (other than contact lenses) by means of physical action
• are for export only
• contain non-viable animal origin material and are intended to contact intact skin only and are not supplied sterile

Non-invasive devices may come into contact with a patient or they may not, but they do not penetrate the body of a patient. This means they do not enter any body orifices such as the mouth or nostrils; they do not touch the eyes; and even though they may come into contact with injured skin, they do not pierce the skin in any way.

An invasive medical device is one that is intended by the manufacturer to be used, in whole or in part, inside the body of a human being. This includes devices that enter a body orifice or that penetrate the surface of the body, or that enter the body in the context of a surgical operation. A medical device that touches the surface of the eye, such as a contact lens, is considered to be in a body orifice.

Non-invasive medical devices can be grouped into the following categories:

• devices that are intended to channel, store or modify blood, liquids or gases, or that are intended to store body tissues or organs, that will be introduced into the body
• devices that are intended to contact injured skin such as bandages or wound dressings
• other non-invasive devices

Other purposes for non-invasive devices include collecting body liquid for liquids that won't be re-infused, immobilising or supporting body parts, providing physical support for patients, assisting in diagnosing a patient or providing patient treatment.

Examples of other non-invasive devices

Urine collection bottles, ostomy pouches, incontinence pads or collectors used with wound drainage devices, bandages used to aid the healing of a sprain, casts for fractured limbs, cervical collars, gravity traction devices, compression hosiery, patient hoists, walking aids, wheelchairs, stretchers, corrective glasses, stethoscopes, surgical drapes, conductive gels and electrodes for EEG or ECG.

Supplied sterile

A medical device that is sterilised before it is released by the manufacturer is considered to be 'supplied sterile'.

Some medical devices must be sterilised before they are used, even though they are new from the manufacturer. These are not supplied sterile.

Medical devices that are intended to be in contact with injured skin may be intended for the following:

1. to provide a mechanical barrier, or compression, or absorb exudates from a wound
2. to manage the micro-environment of a wound, for example by keeping it moist
3. to be used for wounds that have breached the dermis and can only heal by secondary intent

Examples of devices in this category include gauze pads, adhesive bandages, elastic bandages, hydrogels and barrier creams.

Note: Devices which replace injured skin and remain in place after the procedure are considered to be implantable. If this applies to your device you should go back and select 'invasive device'.

Devices in this category are primarily intended to:

1. channel or store blood or body liquids that will be infused, administered or introduced into a patient, or
2. store an organ, part of an organ or body tissue that is to be later introduced into a patient (this includes containers and any liquids, gels or other storage media), or
3. channel or store a liquid or gas that is to be infused, administered or introduced into a patient (this includes devices that may be connected to an active medical device that is Class IIa or higher), or
4. modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, only by filtration, centrifugation or exchanges of gas or heat.
5. modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, by any means other than filtration, centrifugation or exchanges of gas or heat.

Examples of devices in this category:

Drug delivery systems, breathing circuits, syringes for infusion pumps, devices intended for storage of organs or tissues for transplantation (this includes containers and any liquids, gels or other storage media), refrigerators intended for storing blood, hemodialysis machines, devices used for particulate filtration of blood in an extracorporeal circulation system, centrifugation of blood for transfusion or autotransfusion, removal of carbon dioxide from the blood and/or adding oxygen, and warming or cooling blood in the extracorporeal circulatory system.

Invasive in a body orifice or surgically invasive?

Body orifice:

• means a natural opening, or a permanent artificial opening, in a human being's body; and
• includes the external surface of a human being's eyeball

This type of medical device only enters a natural orifice such as the nasal cavity or the mouth, or a permanent created orifice; it does not cut through the surface of the body or any surface of the orifice.

Surgically invasive:

These types of medical devices are intended to be used with the aid, or in the context, of a surgical operation; and also includes devices that penetrate the body in any way other than by entering a body orifice.

Some invasive devices that enter body orifices may be connected to an active medical device.

What is an active medical device?

An active medical device is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Class IIa or higher active devices include those that are intended to diagnose, treat or monitor patients by delivering or exchanging energy with the patient, or that are intended to deliver or remove medicine or other liquids to or from a patient.

The classification of body orifice invasive devices depends on the duration of use and where they are used in the body.

Intended duration

Transient use: intended to be used continuously for less than 60 minutes.

Short‑term use: intended to be used continuously for at least 60 minutes but not more than 30 days.

Long-term use: intended for continuous use for more than 30 days.

Surgically invasive medical devices can be grouped according to the intended duration of use. The classification of a device is based on the longest duration of intended use for the device.

Duration of use

Transient use: Less than 60 minutes of continuous use

Short-term use: Continuous use from 60 minutes up to 30 days

Long-term use: Continuous use for more than 30 days

Implantable : A device that will remain permanently in place following a procedure

Transient use surgically invasive medical devices may be intended for the following:

1. to be reusable surgical instruments
2. to supply energy in the form of ionising radiation
3. to have a biological effect
4. to be wholly, or mostly, absorbed by the patient's body
5. to administer medicine to a patient by means of a delivery system in a potentially hazardous way, having regard to the characteristics of the device
6. to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient where the device is not a reusable surgical instrument

Supplied sterile

A medical device that is sterilised before it is released by the manufacturer is considered to be 'supplied sterile'.

Some medical devices must be sterilised before they are used, even though they are new from the manufacturer. These are not supplied sterile.

Based on your selections, your medical device is Class Is.

Is your device active?

However, if your device is also active, you will need to continue below to check whether this results in a higher classification. We recommend that you take note of the above result, as the higher classification of your two results is the correct classification for your device.

What is an active medical device?

An active medical device is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software that is a medical device is an active medical device.

What defines a measuring function?

A medical device has a measuring function if the device is intended by the manufacturer to measure:

• quantitatively a physiological or anatomical parameter; or
• a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.

Is your device active?

If your device is also active, you will need to continue below to check whether this results in a higher classification.

What is an active medical device?

An active medical device is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software that is a medical device is an active medical device.

Based on your selections, your non-invasive medical device is Class Im.

Is your device active?

However, if your device is also active, you will need to continue below to check whether this results in a higher classification. We recommend that you take note of the above result, as the higher classification of your two results is the correct classification for your device.

What is an active medical device?

An active medical devices is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software that is a medical device is an active medical device.

Long-term use and implantable surgically invasive medical devices may be intended for the following:

1. to be placed in the teeth and to undergo a chemical change in a patient's body
2. to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth)
3. to have a biological effect
4. to administer medicine to a patient
5. to be wholly, or mostly, absorbed by the patient's body
6. to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient.

Note: The term 'placed in the teeth' includes a medical device that is intended to penetrate a tooth, but does not include a medical device that is intended to penetrate a tooth and enter the gum or bone beyond the tooth.

Based on your selections, your medical device is Class IIb.

Is your device active?

However, if your device is also active, you will need to continue below to check whether this results in a higher classification.

What is an active medical device?

An active medical device is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software that is a medical device is an active medical device.

Surgically invasive medical devices for short-term use may be intended for the following:

1. placed in the teeth and to undergo a chemical change in a patient's body
2. undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth)
3. supply energy in the form of ionising radiation
4. administer medicine to a patient
5. be wholly, or mostly, absorbed by the patient's body
6. used in direct contact with the central nervous system, central circulatory system or heart of a patient
7. have a biological effect

Note: The term 'placed in the teeth' includes a medical device that penetrates a tooth, but does not include a medical device that penetrates a tooth and enters the gum or bone beyond the tooth.

Based on your selections, your medical device is Class IIa.

Is your device active?

However, if your device is also active, you will need to continue below to check whether this results in a higher classification. The higher classification of your two results is the correct classification for your device.

What is an active medical device?

An active medical device is one that is intended by the manufacturer to:

• depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
• act by converting this energy.

However, active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.

Note: Software that is a medical device is an active medical device.

Active implantable medical devices are active devices that are intended to be wholly or partially placed into the body, including a body orifice, and to remain there after the procedure.

There are classification rules that apply to active medical devices that are:

• software (including Software as a Medical Device)
• programmed
• programmable.

The terms ‘programmed’ or ‘programmable’ are intended to capture hardware active medical devices incorporating software or any other form of software-type instruction set (such as field programmable gate arrays).

For software-based medical devices (including those that can be programmed) that provide a diagnosis or screen for a disease or condition, the classification depends on whether:

• the information is provided to a relevant health professional to make a decision, or
• the software makes the decision, or the information is provided to a person other than a relevant health professional to make a decision.

The term ‘relevant’ describes the health professional with the appropriate expertise intended to use the provided information to assist them in making a diagnosis. The information provided by a medical device under this classification rule is not to be solely relied upon for the diagnosis.

For example, a relevant health professional for diagnosis and treatment recommendations for certain forms of cancer would be an oncologist, whereas a general practitioner would not be considered to be a relevant health professional in that case.  However, a general practitioner could be a relevant health professional for diagnosing other sorts of diseases and conditions.

Is the device intended to do any of the following?

1. Diagnose or screen for a disease or condition that may
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health without urgent treatment, or
   3. pose a high risk to public health
2. Specify or recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health, or
   3. pose a high risk to public health
3. Provide information as therapy to a person that may result in:
   1. the death of the person, or
   2. a severe deterioration in the state of the person’s health.

Is the device intended to do any of the following?

1. Diagnose or screen for a disease or condition that
   1. is a serious disease or serious condition or, 
   2. a disease or condition that may pose a moderate risk to public health
2. Monitor the state or progression of a disease, condition or parameter that could indicate that:
   1. the person or another person may be in immediate danger, or
   2. there may be a high risk to public health
3. Specify or recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. be harmful to a person (but not lead to their death or a severe deterioration in their state of a health), or
   2. pose a moderate risk to public health
4. Provide information as therapy to a person that may cause serious harm to the person (not death or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient, where the administration or transfer of energy occurs in a potentially hazardous way, or used to control, monitor, or directly influence, the performance of a medical device that does this
6. Monitor vital physiological parameters of a patient, where the nature of the variations monitored could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system
7. Emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology or used to control or monitor, or directly influence, the performance of a device that does this
8. Used to administer or remove medicine, body liquids or other substances to or from a patient, where the administration or removal of the substances is potentially hazardous to the patient.

Is the device intended for one or more of the following?

1. Diagnose or screen for a disease or condition that:
   1. would NOT lead to the death of a person, or a severe deterioration in the state of a person’s health without urgent treatment, or
   2. is NOT a serious disease or serious condition,
   3. does NOT pose a risk to public health
2. Monitor the state or progression of a disease, condition or parameter that does not indicate whether:
   1. the person or another person may be in danger (but not immediate danger), or
   2. there may be a moderate risk to public health
3. Specify or recommend a treatment or intervention, where the treatment or intervention, or its absence:
   1. would not cause harm to a person, or
   2. does NOT pose a risk to public health
4. Provide information as therapy to a person that may cause harm to the person (not serious harm, death or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient (where the energy is non-hazardous)
6. Supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum)
7. Image in vivo distribution of radiopharmaceuticals in a patient
8. Used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than those that could result in immediate danger to the patient)
9. Used to administer or remove medicine, body liquids or other substances (that are non-hazardous) to or from a patient.

Is the device intended to do any of the following?

1. Screen for a disease or condition that may
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health without urgent treatment, or
   3. pose a high risk to public health
2. Specify a treatment or intervention, where the treatment or intervention, or its absence may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health, or
   3. pose a high risk to public health.
3. Provide information as therapy to a person that may result in:
   1. the death of the person, or
   2. a severe deterioration in the state of the person’s health.

Is the device intended to do any of the following?

1. Provide information to a relevant health professional for them to make a diagnosis of a disease or condition that may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health without urgent treatment, or
   3. pose a high risk to public health
2. Provide information that is to be used for monitoring the state or progression of a disease or condition, or parameters that could indicate that:
   1. the person or another person may be in immediate danger, or
   2. there may be a high risk to public health.
3. Recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health, or
   3. pose a high risk to public health.
4. Provide information as therapy to a person that may cause serious harm to the person (not death or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient, where the administration or transfer of energy occurs in a potentially hazardous way, or used to control, monitor, or directly influence, the performance of a medical device that does this
6. Monitor vital physiological parameters of a patient, where the nature of the variations monitored could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system
7. Emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology or used to control or monitor, or directly influence, the performance of a device that does this
8. Used to administer or remove medicine, body liquids or other substances to or from a patient, where the administration or removal of the substances is potentially hazardous to the patient.

Is the device intended to do any of the following?

1. Provide information to a relevant health professional for them to make a diagnosis of a disease or condition that is:
   1. a serious disease or serious condition, or 
   2. a disease or condition that may pose a moderate risk to public health
2. Provide information that is to be used for monitoring the state or progression of a disease or condition, or parameters that could indicate that:
   1. the person or another person may be in danger (but not immediate danger), or
   2. that there may be a moderate risk to public health
3. Recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. be harmful to a person (but not lead to their death or a severe deterioration in their state of a health), or
   2. pose a moderate risk to public health
4. Provide information as therapy to a person that may cause harm to the person (not serious harm, death or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient (where the energy is non-hazardous)
6. Supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum)
7. Image in vivo distribution of radiopharmaceuticals in a patient
8. Used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than those that could result in immediate danger to the patient)
9. Used to administer or remove medicine, body liquids or other substances (that are non-hazardous) to or from a patient.

A medical device has a measuring function if the device is intended by the manufacturer to measure:

1. quantitatively a physiological or anatomical parameter, or
2. a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.

Additional categories of active devices include:

1. Active devices for therapy: Active devices that are intended to be used to treat patients , by supporting, modifying replacing or restoring biological functions or structures, while treating or alleviating an illness, injury or handicap. This includes Software that is used to provide therapy to a patient and instant chemical hot/cold packs indicated to help reduce pain and swelling etc.
2. Active devices for diagnosis: Active devices that are intended to supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. This includes Software that is used to aid in diagnosing a patient's condition
3. Active devices for delivering or removing medicines or other substances to or from a patient's body
4. Active devices for therapy with a diagnostic function where the purpose is to significantly determine patient management 
5. Other active devices: Any other active medical devices that are not covered by the categories above.

Some active medical devices are intended to be used to administer medicine, body liquids or other substances to a patient, or to remove medicine, body liquids or other substances from a patient. This may be non-hazardous or potentially hazardous to the patient.

Non hazardous

Examples of active devices for administering or removing medicine or other substances that are not likely to be hazardous to the patient include suction equipment, feeding pumps, jet injectors for vaccination, nebulisers to be used on conscious and spontaneously breathing patients (depending on the intended medication).

Potentially hazardous

In some cases the administration or removal of the medicine, body liquids or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient's body concerned, and the characteristics of the device.

Examples of active devices for administering medicine or other substances that could potentially be hazardous to the patient include infusion pumps, anaesthesia equipment, dialysis equipment, hyperbaric chambers and nebulisers where the failure to deliver the appropriate dosage characteristics could be hazardous.

Active devices for diagnosis are intended to supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

These devices may be intended for the following:

1. to illuminate a patient's body in the visible spectrum
2. to supply energy that will be absorbed by a patient's body
3. to image in vivo distribution of radiopharmaceuticals in a patient
4. to allow direct diagnosis or monitoring of vital physiological processes of a patient
5. to monitor vital physiological parameters of a patient, where the nature of any variations monitored are of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system)
6. to emit ionising radiation and to be used for diagnostic radiology
7. to control or monitor, or directly influence, the performance of a device that emits ionising radiation for diagnosis.

Examples of active devices for diagnosis

Magnetic resonance imaging equipment, diagnostic ultrasound, evoked response stimulators, gamma cameras, electronic thermometers, stethoscopes and blood pressure monitors, electrocardiographs, monitors/alarms for intensive care, biological sensors, oxygen saturation monitors and apnoea monitors.

Active devices for therapy are intended to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.

These devices may be intended for the following:

1. to administer energy to a patient or exchange energy to or from a patient
2. to administer or exchange energy to or with a patient in a potentially hazardous way considering the nature, density and site of application of the energy
3. to control or monitor, or directly influence, the performance of a device that delivers or exchanges energy to or with a patient in a potentially hazardous way.

Some examples of active devices for therapy (non-hazardous energy delivery) include devices for therapeutic massage, muscle stimulators, powered dental hand pieces, hearing aids, neonatal phototherapy equipment and ultrasound equipment for physiotherapy.

Some examples of active devices for therapy (potentially hazardous energy delivery) include electrocautery devices, UV or laser light devices for corneal modification, baby incubators, external pacemakers and defibrillators, lithotriptors, therapeutic X-ray and other sources of ionizing radiation.

Supplied sterile

A medical device that is sterilised before it is released by the manufacturer is considered to be 'supplied sterile'.

Some medical devices must be sterilised before they are used, even though they are new from the manufacturer. These are not supplied sterile.

Measuring function

A medical device has a measuring function if the device is intended by the manufacturer to measure:

• quantitatively a physiological or anatomical parameter; or
• a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.

Based on your selections, the classification of your medical device is Class Is.

About Class Is

Class Is medical devices are considered to be of lower risk. They require conformity assessment certification for their manufacturer before they can be included in the Australian Register of Therapeutic Goods (ARTG). The certification can be provided by the TGA or a European Notified Body.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates (forms and guidance)

Thank you for completing this online tool. Please contact the TGA if you require further information or assistance.

Based on the selections you have made, the classification of your device is Class Im.

About Class Im

Class Im devices are considered to be lower risk. They require conformity assessment certification for their manufacturer before they can be included in the Australian Register of Therapeutic Goods. The certification can be provided by the TGA or a European Notified Body.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates (forms and guidance

Thank you for completing this online tool. Please contact the TGA if you require further information.

Based on the selections you have made, your device classification is Class IIa.

About Class IIa

Devices of this classification are considered to be of low-moderate risk and require conformity assessment certification for the manufacturer of the device before they can be included in the Australian Register of Therapeutic Goods (ARTG). The certification can be provided by either the TGA or a European Notified body.

Note: some devices have more than one classification. The higher of the classifications is the correct one.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates (forms and guidance)

Thank you for completing this online tool. Please contact the TGA if you require further information or assistance.

Based on your selections, the classification of your medical device is Class IIb.*

*Exception - Sterile saline eye irrigation solutions intended to act on the surface of the eye to flush the eye of irritating particulates/chemicals will remain classified as Class I sterile medical devices.

About Class IIb

Class IIb devices are considered to be of moderate-high risk and require conformity assessment certification for the manufacturer of the device before they can be included in the Australian Register of Therapeutic Goods (ARTG). The certification can be provided by either the TGA or a European Notified body.

Note: some devices may have more than one classification. The higher of the classifications is the correct one.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates (forms and guidance)

Thank you for using this online tool. Please contact the TGA if you require further information or assistance.

Based on your selections, the classification of your medical device is Class III.

About Class III

Devices of this classifications are considered to be high-risk and require conformity assessment certification for both the manufacturer of the device and for the design of the device before they can be included in the Australian Register of Therapeutic Goods (ARTG). The certification can be provided by either the TGA or a European Notified body.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates(forms and guidance)

Thank you for completing this online tool. Please contact the TGA if you require further information or assistance.

Based on the selection you have made, the classification of your device is Class III.

About Class III

Class III devices are considered to be high risk.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)
• Application for conformity assessment certificates (forms and guidance)

Thank you for completing this tool. Please contact the TGA if you require further information or assistance.

Based on your selections, the classification of your device is Class I.

About Class I

Devices of this classification are considered to be low-risk and do not require conformity assessment certification before they can be included in the Australian Register of Therapeutic Goods (ARTG). They are included in the ARTG on the manufacturer's declaration that the devices comply with the relevant essential principles for safety and performance.

Useful links

• Medical device regulation basics
• Australian regulatory guidelines for medical devices (ARGMD)

Thank you for using this online tool. Please contact the TGA if you require further information or assistance.

This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.

If you would like further information you should contact the TGA (the TGA's website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.

The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.

These materials are based on the scheme as at 25 November 2021.