The proderm guide to risk classification of medical devices
Rule 2: Your product intends for channeling or storing blood, other body fluids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body?
| Class | |
| IIa | if it can be connected to an active device of the class IIa, class IIb or class III |
| IIa | if it is used for channeling or storing blood or other body liquids or for the storage of organs, organ parts or body cells and tissues (with the exception of blood bags) |
| IIb | if it is a blood bag |
| I | in all other cases |
Rule 3: Your device intends to change the biological or chemical composition from human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body?
| Class | |
| IIa | when the treatment for which the device is used consists of filtration, centrifugation or the exchange of gas or heat |
| IIb | in all other cases |
Your device consists of a substance or a mixture of substances and is 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 prior to their implantation or administration into in the body?
| Class |
| III |
Rule 4: Your device comes into contact with injured skin or mucous membrane?
| Class | |
| I | if it is intended to be used as a mechanical barrier, for compression or for absorption of exudates |
| IIb | if it is intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent |
| IIa | if it is principally intended to manage the micro-environment of injured skin or mucous membrane |
| IIa | in all other cases |
Rule 1: Your device is a non-invasive medical device that is not covered by rules 2-4?
| Class |
| I |
Rule 4: Your device comes into contact with injured mucous membrane?
| Class | |
| I | if it is intended to be used as a mechanical barrier, for compression or for absorption of exudates |
| IIb | if it is intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent |
| IIa | if it is principally intended to manage the micro-environment of injured skin or mucous membrane |
| IIa | in all other cases |
Rule 5: Your device is related to body orifices, is not a surgically invasive device and is not intended for connection to an active device, or is it intended for connection to an active class I product?
| Class | |
| I | if it is intended for transient use |
| I | if it is intended for short-term use in the oral cavity up to the pharynx, in the ear canal up to the eardrum or in the nasal cavity |
| IIa | if it is intended for short-term use |
| IIa | if it is intended for long-term use in the oral cavity up to the pharynx, in the ear canal up to the eardrum or in the nasal cavity and cannot be absorbed by the mucous membrane |
| IIb | if it is intended for long-term use |
| IIa | if it is intended for connection to an active device of class IIa, class IIb or class III |
Rule 6: Your device is a surgically invasive device for transient use?
| Class | |
| I | if it is a reusable surgical instrument |
| IIb | if it is intended to supply energy in the form of ionizing radiation |
| IIb | if it has a biological effect or is wholly or mainly absorbed |
| IIb | if it is intended for the administration of medicinal products via a delivering system and this administration is done in a manner that is potentially hazardous taking account of the mode of application |
| III | if it is specifically intended for the monitoring, diagnosis, control or correction of a defect of the heart or the central circulatory system through direct contact with those parts of the body |
| III | if it is specifically intended for use in direct contact with the heart, central circulatory system or central nervous system |
| IIa | all other cases |
Rule 7: Your device is a surgically invasive device for short-term use?
| Class | |
| IIb | if it is intended to supply energy in the form of ionizing radiation |
| IIb | if it is intended to administer medicines |
| III | if it is specifically intended for the monitoring, diagnosis, control or correction of a defect of the heart or the central circulatory system through direct contact with those parts of the body |
| III | If it is specifically intended for use in direct contact with the heart, central circulatory system, or central nervous system |
| III | if it has a biological effect or is wholly or mainly absorbed |
| IIb | if it undergoes chemical change in the body and is not placed in the teeth |
| IIa | in all other cases |
Rule 8: Your device is an implantable device or a surgically invasive device intended for long-term use?
| Class | |
| IIa | if it is intended to be placed in the teeth |
| III | if it is intended for use in direct contact with the heart, the central circulatory system or the central nervous system |
| III | if it has a biological effect or is wholly or mainly absorbed |
| III | if it is intended to undergoes chemical change in the body and is not placed in the teeth |
| III | if it is intended to administer medicines |
| III | if it is an active implantable device or its accessory |
| III | if it is a breast implant or surgical mesh |
| III | if it is a total or partial joint replacement (with the exception of ancillary components such as screws, wedges, plates and instruments) |
| III | if it is an implant to replace the spinal disc or an implantable device that comes into contact with the spinal column (with the exception of components such as screws, wedges, plates and instruments) |
| IIb | all other cases |
Rule 20: Your device is an invasive device with respect to body orifices and is intended for the delivery of medicines by inhalation and is not surgically invasive in nature?
| Class | |
| IIb | if its mode of action has an essential impact on the efficacy and safety of the medicinal product administered or if it is intended for the treatment of life-threatening conditions |
| IIa | if the aforementioned case does not apply |
Rule 9: Your device is an active therapeutic device intended to administer or exchange energy?
| Class | |
| IIb | if the administration of energy to the human body or the exchange of energy with the human body, taking into account the nature, density and part of the body to which the energy is applied, presents a potential hazard due to the characteristics of the device |
| IIa | in all other cases |
Your device is intended to monitor or control the performance of active therapeutic class IIb devices or to directly influence the performance of these devices?
| Class |
| IIb |
Your device is intended to emit ionizing radiation for therapeutic purposes, including devices that control or monitor such devices or that directly influence their performance?
| Class |
| IIb |
Your device is intended to control, monitor or directly influence the performance of active implantable devices?
| Class |
| III |
Rule 10: Your device is intended for diagnostic and monitoring purposes?
| Class | |
| I | if it is intended to illuminate the patient’s body, in the visible spectrum |
| IIa | if it is intended to supply energy which is absorbed by the human body (except for devices intended to illuminate the patient’s body, in the visible spectrum) |
| IIa | if it is intended to image in vivo distribution of radiopharmaceuticals |
| IIa | if it is intended to allow direct diagnosis or monitoring of vital physiological processes (no vital physiological parameters) |
| IIb | if it is specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters could result in an immediate danger to the patient, e.g. variations in cardiac performance, respiration, activity of the central nervous system, or when it is intended for diagnosis in clinical situations where the patient is in immediate danger |
Your device is intended to emit ionizing radiation and for diagnostic or therapeutic radiology, including devices for interventional radiology and devices which control or monitor such devices or which directly influence their performance?
| Class |
| IIb |
Rule 11: Your device is software that is designed to provide information that can be used to make decisions about diagnostic or therapeutic purposes?
| Class | |
| IIb | if these decisions may cause a serious deterioration of a person’s sate of health condition or surgical intervention |
| III | if these decisions may cause death or irreversible deterioration in a person’s health |
| IIa | in all other cases |
Your device is software intended for monitoring of physiological processes?
| Class | |
| IIb | if it is intended for monitoring of physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient |
| IIa | if the aforementioned case does not apply |
The software you have developed is not one of the categories mentioned above?
| Class |
| I |
Rule 12: Your device is intended to administer and/or remove medicinal products, body fluids or other substances to or from your body?
| Class | |
| IIb | if it is 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 |
| IIa | if the aforementioned case does not apply |
Rule 8: Your device is an active implantable device or its accessory?
| Class |
| III |
Rule 22: Your device is an active therapeutic device with an integrated or incorporated diagnostic function which significantly determines patient management by the device, such as closed loop systems or automated external defibrillators?
| Class |
| III |
Rule 13: Your device is active and not covered by rules 8-12 or 22?
| Class |
| I |
Rule 14: Your device incorporates, as an integral part, a substance which, if used separately can be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC and that has an action ancillary to that of the device?
| Class | |
| III | this also applies if it is a medicinal product made from human blood or blood plasma within the meaning of Article 1 No. 10 of the aforementioned Directive |
Rule 15: Your device is intended to be used for contraception or prevention of the transmission of sexually transmitted diseases?
| Class | |
| III | if it is an implantable or a long term invasive device |
| IIb | if the aforementioned case does not apply |
Rule 16*: Your device is specifically intended for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses?
| Class |
| IIb |
Your device specifically intends for disinfecting or sterilizing medical devices?
| Class | |
| IIb | if it is a disinfecting solution or washer-disinfector intending specifically to be used for disinfecting invasive devices, as the end point of processing |
| IIa | if the aforementioned case does not apply |
*This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
Rule 17: Your device is specifically intended for recording diagnostic images generated by X-ray radiation?
| Class |
| IIa |
Rule 18: Your device has been manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable?
| Class | |
| III | This does not apply to devices manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact only with intact skin. |
Rule 19: Your device incorporates or consists of nanomaterial?
|
Rule 21: Your device is composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and it is absorbed by or dispersed locally in the body?
| Class | |
| III | if it or its metabolites are systemically absorbed by the human body in order to achieve the intended purpose |
| III | if it achieves its intended purpose in the stomach or lower gastrointestinal tract or its metabolites are systemically absorbed by the human body |
| IIa | if it is applied to the skin or in the nasal or oral cavity as far as the pharynx and achieves its intended purpose on these cavities |
| IIb | in all other cases |
