Your cart is currently empty!
MDR Classification Wizard
This tool is designed to help you determine the classification of your medical device under the EU Medical Device Regulation 2017/745
Disclaimer
This material is provided by Practical RA solely to provide a general overview of the EU Medical Device Regulations (2017/745) Annex VIII Classification Rules. It should not be taken as a detailed description of the EU MDR or as specific advice on the application of the MDR Classification Rules in particular cases.
If you would like further information you should review MDR Annex VIII or relevant Guidance Documents such as MDCG 2021-24 “Guidance on classification of medical devices”, which contains more detailed information on all aspects of the Classification Rules.
Practical RA 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 were last updated on the 24th July 2024.
Do you accept the above terms?
Failure to accept disclaimer
You are unable to continue using this tool unless you agree to the terms of the disclaimer.
Go back and try again or contact Practical RA for more information.
Important considerations
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.
| Medical Device Classification | Level of Potential Harm |
|---|---|
| Class I | Lowest |
| Class Is, Class Im, Class Ir | Low |
| Class IIa | Low to Moderate |
| Class IIb | Moderate to High |
| Class III | High |
Please read the following before you start
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. Software can also be a “stand-alone” medical device.
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.
Are you ready to begin?
Example Medical devices with pre-determined classifications
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 human or animal tissues, cells or derivatives, 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
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
- surgical meshes
- intended for contraception or prevention of sexually transmitted diseases and that are implantable or invasive for long-term use
- active implantable medical devices
- accessories to active implantable medical devices (whether active and/or implantable or not)
- active devices that are intended to control, monitor or directly influence the performance of an active implantable medical device
- active therapeutic devices with incorporated diagnostic functions that significantly determine patient management. Examples include closed loop systems or automatic external defibrillators
Group C
This group includes medical devices that are:
- blood bags, including those that contain an anti-coagulent
- screws, wedges, plates and instruments used in joint replacement, spinal disc replacement or implants in contact with the spinal column (i.e. ancillary components)
- intended for disinfecting, cleaning, rinsing or hydrating contact lenses
- disinfecting solutions or washer solutions specifically intended for invasive devices at end point of processing
- intended for contraception or prevention of sexually transmitted diseases and that are not implantable or invasive for long-term use
Group D
This group includes medical devices that are:
- intended for recording diagnostic images generated by X-ray radiation. For example, X-ray films or digital X-ray detectors. This does not include devices which produce the X-ray radiation themselves (X-ray machines)
- intended specifically for disinfecting or sterilizing medical devices, excluding contact lenses or disinfection of implantable devices, which are described in Group C above
Group E
This group includes medical devices that:
- incorporate or consist of nanomaterials
- are composed of substances to be introduced into the human body via a body orifice or applied to the skin, and that are absorbed by or locally dispersed in the body.
Which group does your medical device belong to?
Class III
Based on your selections, the classification of your medical device is Class III.
About Class III
Devices with this classification 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 marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Useful links
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Class IIb
Based on your selections, the classification of your medical device is Class IIb.
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 marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Note: some devices may have more than one classification. The higher of the classifications is the correct one.
Useful links
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Class IIa
Based on your selections, the classification of your medical device is Class IIa.
About Class IIa
Class IIa devices are considered to be of low-moderate risk and require conformity assessment certification for the manufacturer of the device before they can be marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Note: some devices may have more than one classification. The higher of the classifications is the correct one.
Useful links
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Class Ir
Based on your selections, the classification of your medical device is Class Ir (reusable).
About Class Ir
Class Is devices are considered to be of lower risk. They require conformity assessment certification for their manufacture before they can be marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Note: the conformity assesment will focus on the reusable aspects of the device.
Note: some devices may have more than one classification. The higher of the classifications is the correct one.
Useful links
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2019-5 Guidance Notes for Manufacturers of Class I Medical Devices
- MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Class I Self Certified
Based on your selections, the classification of your medical device is Class I Self Certified.
About Class I
Devices of this classification are considered to be low-risk and do not require conformity assessment certification before they can be marketed in the EU. They are marketed in the EU based on the manufacturer’s declaration that the devices comply with the relevant General Safety and Performance Requirements of the MDR (Annex 1). Though conformity assessment is not required, manufacturers must still compile the relevant Technical Documentation as described in MDR Annex II and III.
Note: some devices may have more than one classification. The higher of the classifications is the correct one.
Useful links
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2019-5 Guidance Notes for Manufacturers of Class I Medical Devices
- MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Is your device invasive or non-invasive?
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, nostrils, or stoma; they do not touch the eyeballs; 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 eyeball, such as a contact lens, is considered to be in a body orifice.
Based on the above definition, what type of device do you think you have?
Non-invasive devices
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
Based on the intended purpose of your non-invasive device, which category is appropriate?
Non-invasive – Other
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.
Is your non-invasive medical device supplied sterile?
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.
Based on the above definition, does your medical device have a measuring function?
Active devices
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 the above definition, is your device also active?
Class Is
Based on your selections, the classification of your medical device is Class Is (Class I sterile).
About Class Is
Class Is devices are considered to be of lower risk. They require conformity assessment certification for their manufacture before they can be marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Note: the conformity assesment will focus on the sterility aspects of the device.
Useful links
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2019-5 Guidance Notes for Manufacturers of Class I Medical Devices
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Active devices
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 the above definition, is your device also active?
Class Im
Based on your selections, the classification of your medical device is Class Im (Class I measuring).
About Class Im
Class Is devices are considered to be of lower risk. They require conformity assessment certification for their manufacture before they can be marketed in the EU. The certification should be provided by a European Notified body designated to the MDR.
Note: the conformity assesment will focus on the measuring aspects of the device.
Useful links
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2019-5 Guidance Notes for Manufacturers of Class I Medical Devices
Thank you for completing this online tool. Device classification can be nuanced. We encourage you to review MDCG 2021-24 Guidance Document to ensure all aspects of your device classification have been considered.
Non-invasive – Handle or modify substances for administration to a patient
Devices in this category are primarily intended to:
- Channel or store blood or body liquids that will be infused, administered or introduced into a patient, or
- 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
- 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
- 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.
- 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.
Based on the above, what is the intended purpose of your device?
Class IIa unless active
Based on your selections, your medical device is Class IIa unless it is also an active device.
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. 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.
Based on the above definition, is your device also active?
Standalone software- Used to take decisions
The software provides information which is used to take decisions with diagnosis or therapeutic purposes.
Do these decisions have an impact that could cause:
1. Death or irreversible deterioration of a person’s health? Or,
2. Serious deterioration of a person’s health or a surgical intervention?
Examples of impact causing death or irreversible deterioration of a persons health could include decisions relating to diagnosising or treating acute stroke.
Examples of impact casuing serious deterioration of a persons heath or surgical intervention could include decisions relating to diagnosing depression or detecting abnormalities in heartbeats.
Based on the above, is Item 1 or 2 applicable to your software?
Active devices – Active implantable medical devices
Active implantable medical devices (AIMD) 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.
Based on the above description, is your active medical device an AIMD, or an accessory to an AIMD?
Active devices – software devices
There are classification rules that apply to software as a active medical devices, including:
- software used as part of an active medical device, including wearable devices
- standalone software
- mobile apps or tablet apps.
When considering the classification of software, the operating system on which the software runs is not relevant. Therefore, the same rules apply to hardware active medical devices incorporating software, standalone software running on a computer or mobile applications.
Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices (see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses etc.
Does your active medical device include medical device software (including standalone software)?
Standalone software- Is it for a diagnostic or therapeutic purposes?
Is the software intended to do any of the following?
1. Provide information used to take decisions for diagnosis or therapeutic purposes, or
2. Monitor physiological processes
Based on the above, what does your software do?
Active devices
Additional categories of active devices include:
- 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.
- 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
- Active devices for delivering or removing medicines or other substances to or from a patient’s body
- Other active devices: Any other active medical devices that are not covered by the categories above.
Based on the above descriptions, which category applies to your active medical device?
Active devices for therapy – integrated diagnosis function
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 include an integrated or incorporated diagnostic function, which significantly determines the outcomes of patient management with the device, for example, a closed loop system.
Examples include automated external defibrillators or automated external insulin pumps with integrated continuous blood glucose monitoring, which adapts the insulin dose delivered (closed loop system).
Based on the above, does your active device also have integrated diagnostic functions which significantly determines patient management?
Active devices for therapy
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:
- to administer energy to a patient or exchange energy to or from a patient
- 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
- to emit ionizing radiation for therapeutic purposes, including devices which control, monitor or influence such devices
- to control or monitor, or directly influence, the performance of another Class IIb active therapeutic device
- to control or monitor, or directly influence, the performance of an active implantable device
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.
Which intended purpose is relevant for device?
Active device – Measuring function
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 the above definition, does your medical device include a measuring function?
Is your active device supplied sterile?
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 the above description, is your medical device supplied sterile??
Non-invasive – In contact with injured skin
Medical devices that are intended to be in contact with injured skin may be intended for the following:
- to provide a mechanical barrier, or compression, or absorb exudates from a wound
- to manage the micro-environment of a wound, for example by keeping it moist
- 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’.
Which of the above purposes is your device intended for?
Active devices for diagnosis
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:
- to illuminate a patient’s body in the visible spectrum
- to supply energy that will be absorbed by a patient’s body
- to image in vivo distribution of radiopharmaceuticals in a patient
- to allow direct diagnosis or monitoring of vital physiological processes of a patient
- 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)
- to emit ionising radiation and to be used for diagnostic radiology
- 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.
Which of the above intended purposes is relevant for your active device for diagnosis?
Measuring function
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.
Based on the above definition, does your medical device have a measuring function?
Class Im unless active
Based on your selections, your 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.
Based on the above definition, is your device also active?
Invasive device
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.
Based on the above definitions, how is your device intended to be invasive?
Class Is unless active
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 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.
Based on the above definition, is your device also active?
Class I unless active
Based on your selections, your medical device is Class I.
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.
Based on the above definition, is your device also active?
Invasive in a body orifice – Duration
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.
Based on the above definitions, which is the duration for your device’s intended use?
Invasive in a body orifice – Connected to an Class IIa, IIb or III active device
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.
Is your device intended to be connected to an active medical device that is classified as Class IIa or higher?
Class IIb unless active
Based on your selections, your medical device is Class IIb unless it is also an active device.
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. 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.
Based on the above definition, is your device also active?
Is your device supplied sterile, have a measuring function, or is 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 the above description, is your medical device supplied sterile?
Surgically invasive – Duration of use
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
Based on the above descriptions, what is the longest duration of intended use for your device?
Surgically invasive – Transient use
Transient use surgically invasive medical devices may be intended for the following:
- to be reusable surgical instruments
- to supply energy in the form of ionising radiation
- to have a biological effect
- to be wholly, or mostly, absorbed by the patient’s body
- 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
- to diagnose, monitor, control or correct a defect of the heart or the central circulatory system of a patient through direct contact with these parts of the body.
Which intended purpose Is applicable for your transient-use medical device?
Surgically invasive – Short-term use
Surgically invasive medical devices for short-term use may be intended for the following:
- placed in the teeth and to undergo a chemical change in a patient’s body
- 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)
- supply energy in the form of ionising radiation
- administer medicine to a patient
- be wholly, or mostly, absorbed by the patient’s body
- used in direct contact with the central nervous system of a patient
- have a biological effect
- diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body.
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.
Which intended purpose is applicable for your surgically invasive device for short-term use?
Surgically invasive – Long-term use and implantable
Long-term use and implantable surgically invasive medical devices may be intended for the following:
- to be placed in the teeth and to undergo a chemical change in a patient’s body
- 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)
- to have a biological effect
- to administer medicine to a patient
- to be wholly, or mostly, absorbed by the patient’s body
- 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.
Which intended purpose is applicable for your long-term or implantable surgically invasive device?
Nanomaterials or introduced substances
Devices containing nanomaterials have specific classificaiton rules under the MDR.
Similarly, devices which contain substances to be introduced via a body orifice or applied to the skin, and then absorbed or locally disperesed within the body also have defined classification rules. For the purpose of this rule, nails are also considered as falling under ‘skin’.
Which of the following is applicable to your device?
Nanomaterials
The concept of internal exposure is a key element for the classification of devices incorporating or consisting of nanomaterials. The potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure.
The Scientific Committee on Emerging
and Newly Identified Health Risks (SCENIHR) uses the uses the terms high/medium/low/negligible to define the potential internal systemic exposure of all organ systems (see Table 3 of the linked report).
The same wording is used in the MDR to divide nanomaterial devices into the following categories:
1. Devices containing nanomaterials with high or medium potential for internal exposure
2. Devices containing nanomaterials with low potential for internal exposure
3. Devices containing nanomaterials with negligible potential for internal exposure
Note: While Table 3 of the SCENIHR report is a good starting point, every individual device needs to be classified taking into account its own specific characteristics with regard to the potential release of free nanoparticles taking also into account the exposure by the same nanomaterial via daily exposure routes
Based on the above, which of the following categories is applicable to your device?
Substances to be introduced via orifice or skin and absorbed or locally dispersed
This rule covers a wide range of exclusively substance-based medical devices. In this context, ‘substance’ means any matter that is part of the medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC.
The classification takes into account the site of application of the medical device as well as the site where the medical device performs its action in or on the human body. For the purpose of this rule nails are also considered as falling under ‘skin’
These devices can be divided into the following categories:
1. Devices where they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose
2. Devices which achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body
3. Devices which are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities
Based on the above, which of the following categories is applicable to your substance-containing device?
Invasive in a body orifice – administer medicinal product by inhalation
Some invasive devices that enter body orifices may be be used to facilitate a respiratory route of drug delivery.
In contrast to other rules covering devices that administer medicinal products, the MDR has a rule specifically intended to cover medical devices where the impact of the medical device on the efficacy and safety of the administered medicinal product is critical. The rule also covers drug delivery products that are intended to treat life-threatening conditions.
Is your invasive device intended to administer a medicinal product by inhalation?
Invasive in a body orifice – administer medicinal product by inhalation
Some invasive devices that enter body orifices may be be used to facilitate a respiratory route of drug delivery.
Devices of this type can be:
1. Invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation; or
2. Devices which fall under Category 1. above but their mode of action has an essential impact on the efficacy and safety of the administered medicinal product (e.g. nebulisers); or
3. Devices which fall under Category 1. above but they are intended to treat life-threatening conditions.
Based on the above, whichof the Categories does your device fall under?
Standalone software- Diagnosis or therapeutic purposes?
Some standalone software can be used to provide information which is used to take decisions with diagnosis or therapeutic purposes. The classification of these devices is dependent upon the potential risks to the patient as a result of the decisions taken based on the software.
The MDR classifies these risks as follows:
1. Decisions that have an impact that may cause death or an irreversible deterioration of a person’s state of health
2. Decisions that have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention
Based on the above, which of the Categories does your device fall under?
Standalone software- monitor physiological processes?
Some standalone software can be used to monitor physiological processes. The classification of these devices is dependent upon the nature of the physiological processes being monitored by the software.
The MDR classifies these risks as follows:
1. Software intended to monitor physiological processes
2. Software under Category 1., which are intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient
Based on the above, which of the Categories does your software fall under?
Active devices for administering medicine
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.
Note: If your device is intended to be invasvive via a body orifice to adminster medicincal substances via inhation, you should follow the decision path here.
Is your device likely to deliver or remove medicine or other substance to or from a patient in a potentially hazardous way?
Invasive via body orifice– Short-term use
Short-term use devices which are invasive via a body orifice may be intended for use in the following anatomical locations:
- In the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity
- All other anatomical locations, including beyond the pharynx or ear drum.
Which anatomical location is your device intended to be used in/up to?
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. 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.
Based on the above definition, is your device also active?
Device supplied sterile or with a measuring function?
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 the above description, is your medical device supplied sterile, or have a measuring function?
Invasive via body orifice– Long-term use
Long-term use devices which are invasive via a body orifice may be intended for use in the following anatomical locations:
- In the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity (and are not liable to be absorbed by the mucous membrane)
- All other anatomical locations and cases. This includes beyond the pharynx or ear drum, or liable to be absorbed by mucous membranes
Which anatomical location is your device intended to be used in/up to?
Software- monitor physiological processes?
Some software can be used to monitor physiological processes. The classification of these devices is dependent upon the nature of the physiological processes being monitored by the software.
The MDR classifies these risks as follows:
1. Software intended to monitor physiological processes
2. Software which is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient
Based on the above, which of the Categories does your software fall under?
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.