The proDERM Guide to Risk Classification of Medical Devices

On May 26, 2021, Regulation (EU) 2017/745 on Medical Devices (Medical Device Regulation, MDR) comes into force simultaneously in all EU member states. This will result in significant changes with regard to the market approval of medical devices. Among other things, the MDR changes the allocation of a medical device to a risk class with new or changed regulations.

This guideline is intended to support manufacturers in assigning medical devices to a risk class. It is a translation of the rather non-transparent set of rules (Annex VIII of the MDR) into a simplified form, on the basis of which a category-specific classification can be made.

The categories are non-invasive devices, invasive devices, active devices and other devices. You can use the buttons to navigate directly to the respective areas and thus determine the risk class of your product as quickly as possible¹.

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
IIaif it can be connected to an active device of the class IIa, class IIb or class III
IIaif 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)
IIbif it is a blood bag
Iin 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
IIawhen the treatment for which the device is used consists of filtration, centrifugation or the exchange of gas or heat
IIbin 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
Iif it is intended to be used as a mechanical barrier, for compression or for absorption of exudates
IIbif 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
IIaif it is principally intended to manage the micro-environment of injured skin or mucous membrane
IIain 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
Iif it is intended to be used as a mechanical barrier, for compression or for absorption of exudates
IIbif 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
IIaif it is principally intended to manage the micro-environment of injured skin or mucous membrane
IIain 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
Iif it is intended for transient use
Iif 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
IIaif it is intended for short-term use
IIaif 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
IIbif it is intended for long-term use
IIaif 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
Iif it is a reusable surgical instrument
IIbif it is intended to supply energy in the form of ionizing radiation
IIbif it has a biological effect or is wholly or mainly absorbed
IIbif 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
IIIif 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
IIIif it is specifically intended for use in direct contact with the heart, central circulatory system or central nervous system
IIaall other cases
Rule 7

Your device is a surgically invasive device for short-term use?

Class
IIbif it is intended to supply energy in the form of ionizing radiation
IIbif it is intended to administer medicines
IIIif 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
IIIIf it is specifically intended for use in direct contact with the heart, central circulatory system, or central nervous system
IIIif it has a biological effect or is wholly or mainly absorbed
IIIif it undergoes chemical change in the body and is not placed in the teeth
IIain all other cases
Regel 8

Your device is an implantable device or a surgically invasive device intended for long-term use?

Class
IIaif it is intended to be placed in the teeth
IIIif it is intended for use in direct contact with the heart, the central circulatory system or the central nervous system
IIIif it has a biological effect or is wholly or mainly absorbed
IIIif it is intended to undergoes chemical change in the body and is not placed in the teeth
IIIif it is intended to administer medicines
IIIif it is an active implantable device or its accessory
IIIif it is a breast implant or surgical mesh
IIIif it is a total or partial joint replacement (with the exception of ancillary components such as screws, wedges, plates and instruments)
IIIif 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)
IIball 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
IIbif 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
IIaif the aforementioned case does not apply
Rule 9

Your device is an active therapeutic device intended to administer or exchange energy?

Class
IIbif 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
IIain 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
Iif it is intended to illuminate the patient’s body, in the visible spectrum
IIaif 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)
IIaif it is intended to image in vivo distribution of radiopharmaceuticals
IIaif it is intended to allow direct diagnosis or monitoring of vital physiological processes (no vital physiological parameters)
IIbif 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
IIbif these decisions may cause a serious deterioration of a person’s sate of health condition or surgical intervention
IIIif these decisions may cause death or irreversible deterioration in a person’s health
IIain all other cases

Your device is software intended for monitoring of physiological processes?

Class
IIbif 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
IIaif 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
IIbif 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
IIaif 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
IIIthis 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
IIIif it is an implantable or a long term invasive device
IIbif 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
IIbif it is a disinfecting solution or washer-disinfector intending specifically to be used for disinfecting invasive devices, as the end point of processing
IIaif 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
IIIThis 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?

Class
IIaif it presents a negligible potential for internal exposure
IIbif it presents a low potential for internal exposure
IIIif it presents a high or medium potential for internal exposure
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
IIIif it or its metabolites are systemically absorbed by the human body in order to achieve the intended purpose
IIIif it achieves its intended purpose in the stomach or lower gastrointestinal tract or its metabolites are systemically absorbed by the human body
IIaif 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
IIbin all other cases
Non-invasive 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
IIaif it can be connected to an active device of the class IIa, class IIb or class III
IIaif 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)
IIbif it is a blood bag
Iin 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
IIawhen the treatment for which the device is used consists of filtration, centrifugation or the exchange of gas or heat
IIbin 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
Iif it is intended to be used as a mechanical barrier, for compression or for absorption of exudates
IIbif 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
IIaif it is principally intended to manage the micro-environment of injured skin or mucous membrane
IIain all other cases
Rule 1

Your device is a non-invasive medical device that is not covered by rules 2-4?

Class
I
Invasive Devices
Rule 4

Your device comes into contact with injured mucous membrane?

Class
Iif it is intended to be used as a mechanical barrier, for compression or for absorption of exudates
IIbif 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
IIaif it is principally intended to manage the micro-environment of injured skin or mucous membrane
IIain 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
Iif it is intended for transient use
Iif 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
IIaif it is intended for short-term use
IIaif 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
IIbif it is intended for long-term use
IIaif 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
Iif it is a reusable surgical instrument
IIbif it is intended to supply energy in the form of ionizing radiation
IIbif it has a biological effect or is wholly or mainly absorbed
IIbif 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
IIIif 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
IIIif it is specifically intended for use in direct contact with the heart, central circulatory system or central nervous system
IIaall other cases
Rule 7

Your device is a surgically invasive device for short-term use?

Class
IIbif it is intended to supply energy in the form of ionizing radiation
IIbif it is intended to administer medicines
IIIif 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
IIIIf it is specifically intended for use in direct contact with the heart, central circulatory system, or central nervous system
IIIif it has a biological effect or is wholly or mainly absorbed
IIIif it undergoes chemical change in the body and is not placed in the teeth
IIain all other cases
Regel 8

Your device is an implantable device or a surgically invasive device intended for long-term use?

Class
IIaif it is intended to be placed in the teeth
IIIif it is intended for use in direct contact with the heart, the central circulatory system or the central nervous system
IIIif it has a biological effect or is wholly or mainly absorbed
IIIif it is intended to undergoes chemical change in the body and is not placed in the teeth
IIIif it is intended to administer medicines
IIIif it is an active implantable device or its accessory
IIIif it is a breast implant or surgical mesh
IIIif it is a total or partial joint replacement (with the exception of ancillary components such as screws, wedges, plates and instruments)
IIIif 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)
IIball 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
IIbif 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
IIaif the aforementioned case does not apply
Active Devices
Rule 9

Your device is an active therapeutic device intended to administer or exchange energy?

Class
IIbif 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
IIain 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
Iif it is intended to illuminate the patient’s body, in the visible spectrum
IIaif 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)
IIaif it is intended to image in vivo distribution of radiopharmaceuticals
IIaif it is intended to allow direct diagnosis or monitoring of vital physiological processes (no vital physiological parameters)
IIbif 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
IIbif these decisions may cause a serious deterioration of a person’s sate of health condition or surgical intervention
IIIif these decisions may cause death or irreversible deterioration in a person’s health
IIain all other cases

Your device is software intended for monitoring of physiological processes?

Class
IIbif 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
IIaif 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
IIbif 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
IIaif 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
Other Devices
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
IIIthis 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
IIIif it is an implantable or a long term invasive device
IIbif 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
IIbif it is a disinfecting solution or washer-disinfector intending specifically to be used for disinfecting invasive devices, as the end point of processing
IIaif 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
IIIThis 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?

Class
IIaif it presents a negligible potential for internal exposure
IIbif it presents a low potential for internal exposure
IIIif it presents a high or medium potential for internal exposure
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
IIIif it or its metabolites are systemically absorbed by the human body in order to achieve the intended purpose
IIIif it achieves its intended purpose in the stomach or lower gastrointestinal tract or its metabolites are systemically absorbed by the human body
IIaif 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
IIbin all other cases

¹Please note that this document is only a guideline. A right to a binding assignment to a risk class cannot be derived from this document. If in doubt, the assignment must be discussed with a notified body