| Class I | Class IIa | Class IIb | Class III | |
|---|---|---|---|---|
| Non-Invasive (infusion/introduction into the body) | Connected to a class IIa, class IIb or class III active device Intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body | Bloodbags | ||
| Non-Invasive (in contact with skin) | Intended to be used as a mechanical barrier, for compression or for absorption of exudates | If they are principally intended to manage the micro-environment of injured skin or mucous membrane All other cases | Intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent | |
| Non-Invasive (intended for modifying human tissue) | The treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat | Intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body | Consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body | |
| Invasive Devices | Intended for transient use Short term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity | Intended for short-term use Long term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity Devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device | Intended for long-term use | |
| Surgically Invasive Devices (Transient Use) | Reusable surgical instruments | All other Surgically Invasive Devices intended for transient use | Intended to supply energy in the form of ionising radiation Have a biological effect or are wholly or mainly absorbed Intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application | Intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body Intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system |
| Surgically Invasive Devices (Short-term Use) | All other Surgically Invasive Devices intended for short-term use | Intended to supply energy in the form of ionising radiation Intended to undergo chemical change in the body (except if placed in teeth) | Intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body Intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system Have a biological effect or are wholly or mainly absorbed | |
| Implantable devices and long-term surgically invasive devices | Intended to be placed in the teeth | All other implantable devices and long-term surgically invasive devices | Intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system Have a biological effect or are wholly or mainly absorbed Intended to undergo chemical change in the body (except if placed in teeth) Intended to administer medicinal products Active implantable devices or their accessories Breast Implants or surgical meshes Total or parital joint replacements (with the exception of ancillary components such as screws, wedges, plates and instruments) Spinal disc replacement implants or are implantable devices that come into contact with the spinal column (with the exception of ancillary components such as screws, wedges, plates and instruments) | |
| Active Therapeutic Devices | Intended to administer or exchange energy | Characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance | All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices | |
| Active devices Intended for diagnosis and monitoring | Intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient’s body, in the visible spectrum | If they are intended to image in vivo distribution of radiopharmaceuticals If they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger Intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance | ||
| Software | All other software | intended to provide information which is used to take decisions with diagnosis or therapeutic purposes Intended to monitor physiological processes | 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 | Have an impact that may cause death or an irreversible deterioration of a person’s state of health Have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention |
| Active Devices | All other active devices | intended to administer and/or remove medicinal products, body liquids or other substances to or from the body | intended to administer and/or remove medicinal products, body liquids or other substances to or from the body done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application | |
| Devices that are composed of substances that are intended 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 human body | if they 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 | All other cases | if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose if they 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 | |
| * Special Rules | All other active devices | Devices specifically intended for recording of diagnostic images generated by X-ray radiation | All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses | Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are nonviable or rendered non-viable |
| * Devices containing Nanomaterials | if they present a negligible potential for internal exposure | if they present a low potential for internal exposure | if they present a high or medium potential for internal exposure |
List of Groups of Products Without An Intended Medical Purpose
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
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