What is the intended duration of use (in contact with the body) of the medical device?

Is the medical device dependent on an energy source other than the body or gravity?

Is it a medical device which consists only of software, e.g. an app?

Does the medical device penetrate (part of) the body through a body orifice or through the body's surface?

Is it intended to control, diagnose, monitor or correct a defect of the heart or the central nervous system through direct contact with those parts?

Special rule: Does the device have an essential impact on the efficacy and safety of the administered medicinal product or is it intended to treat life-threatening conditions?

Will the device be connected to an active medical device class IIa or higher?

Is the device intended to control, diagnose, monitor or correct a defect of the heart or the central circulatory system with direct contact to those parts?

Is it intended to allow direct diagnosis or monitoring of vital physiological processes?

Is it intended to be used in direct contact with the heart, central circulatory system or the central nervous system?

Is it intended to have a biological effect or to be (mainly) absorbed by the human body?

Is the device primarily intended to manage the micro-environment of the injured skin or injured mucosa?

Is it an invasive device of a non-surgical nature (enters the body through a body orifice)?

Is it intended to supply energy in the form of ionising radiation?

Is it only intended to illuminate the patient's body in the visible spectrum?

Is it a spinal disk replacement implant, or an implantable device that comes into contact with the spinal column (except screws, wedges, plates and instruments)?

Special rule: Is it an active therapeutic device with an integrated or incorporated diagnostic function that significantly determines patient management by the device?

Special rule: Is the device intended to administer medicinal products by inhalation? (invasive through a body orifice; not of surgical nature)

Do the decisions have an impact that may cause death or an irreversible deterioration of a person's state of health?

Is it intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology (incl. devices that control or monitor such devices, or which directly influence their performance)?

Do the decisions have an impact that may cause a serious deterioration of person's state of health or surgical intervention?

Is it software intended to monitor vital physiological parameters, where variations in these could result in immediate danger to the patient?

Is the software intended to monitor physiological processes?

Is the device a substance or a mixture of substances and is it intended for use in vitro (outside the body), in direct contact with human cells, tissues, or organs, or with human embryos before their implantation or administration into the body?

Is the device intended to be used for channelling or storing blood, bodily liquids, or for storing organs, organ parts, or body cells and tissue?

Is it intended for monitoring, controlling or directly influencing active implantable class III devices?

Does the device have little or no contact with the intact skin of a patient (non-invasive device)?

Is it an active therapeutic device that is intended to administer or exchange energy?

Special rule: Is it a device specifically intended for recording diagnostic images generated by X-ray radiation?

Is it a surgically invasive device intended for transient use?

Is it a surgically invasive device for short-term use?

Special rule: Is it a device containing a medicinal substance which, if used separately can be considered to be a medicinal product? This also applies to medicinal products derived from human blood or plasma, and that have an ancillary action to that of the device.

Is the device intended to modify the biological or chemical composition of human tissue or cells, blood or other body liquids before introduction into the body?

It is a total or partial joint replacement (except ancillary components such as screw, wedges, plates and instruments)?

Special rule: Is the device composed of (combination of) substances intended to be introduced into the human body via a body orifice or applied to the skin, and is it intended to be absorbed or locally dispersed by the human body?

Is it intended to undergo chemical change in the body (not in the teeth)?

Special rule: Is the device applied to the skin, or in the nasal or oral cavity as far as the pharynx, and does it achieve its intended purpose on those cavities?

Is the administration and/or removal of medicines, body-liquids or other substances done in a manner that is potentially hazardous, taking account of the nature of the substances involved, the body part concerned and the mode of application?

Does the treatment mentioned in 3a only consist of filtration, centrifugation, or exchange of gas or heat?

Is it intended to have a biological effect or be (mainly) absorbed?

Will the device be used in the oral cavity, ear canal or nasal cavity?

Is it intended for the channelling or storing of blood, body-liquids, cells or tissue, liquids or gases, for infusion or administration or introduction into the body?

Special rule: Does the device achieve its intended purpose in the stomach or lower gastointestinal tract, and is the device, or its metabolism (side) products, then systemically absorbed by the human body?

Is it intended to administer to or exchange energy with the human body in a potentially hazardous way?

Special rule: Is it a device intended to be used for disinfecting or sterilizing medical devices? (No devices that are intended to clean other devices by meaning of physical action only) 

Is it intended to undergo chemical changes in the body (except devices placed in the teeth)?

Special rule: Is it a device used for contraception or the prevention of the transmission of sexually transmitted diseases?

Is the device intended to be used as a mechanical barrier, as a compressor, or for absorption?

Special rule: Does the device incorporate in, or consist of, nanomaterial?

Nanomaterial consists of at least 50% of particles sized between 1-100nm.

Is it intended to supply energy that will be absorbed by the human body (except for devices intended to illuminate the body in the visible spectrum)?

Special rule: Is it a device intended to be used for disinfecting, cleaning, rinsing or hydrating contact lenses?

Is it intended to be used in direct contact with the heart, central circulatory system or central nervous system?

Is it intended to administer medicines via a delivery system, of which the mode of administration is potentially hazardous?

Is it intended to control, monitor or influence the performance of an active therapeutic device class IIb?

Is it intended to emit ionizing radiation for therapeutic purposes, including any tools to control, monitor or influence such devices?

How high is the potential for internal exposure?

Is the device - or does the device contain - software intended to provide information that is used to make decisions with diagnosis or therapeutic purposes?

Special rule: Is the device, or metabolism (side) products, systemically absorbed by the human body to achieve the intended purpose?

Special rule: Is it a disinfecting solution or washer-disinfector intended specifically to be used for disinfecting invasive devices as the endpoint of processing?

Are the vital physiological parameters of such a nature that variations in these could result in immediate danger to the patient? (For example; variations in cardiac performance or respiration) Or are they intented for diagnosis in clinical situation where the patient is in immediate danger?

Special rule: Is the device made from non-viable animal tissues or cells, or derivatives thereof, and does it not only come into contact with intact skin?

Special rule: Is it a device utilising non-viable tissues or cells of human or animal origin, or their derivatives?

Is it intended to image the in vivo distribution of radiopharmaceuticals?

Is the device intended for use on wounds where the dermis or mucous membrane is broken and can only heal by secondary intent?

Is it an implantable or surgically invasive device and intended for long-term use?

Is it intended to administer medicinal products?

Is it intended to supply energy in the form of ionizing radiation?

Is it an active implantable device or an accessory?

Can the device be connected to an active device (class IIa or higher)?

Is it an active device intended to administer and/or remove medicines, body-liquids, or other substances to or from the body?

Is it intended to have a biological effect or to be (mainly) absorbed?

Is it an active device intended for diagnosis and monitoring?

Special rule: Is it an implantable or long term invasive device?

Does the device come in contact with injured skin or injured mucous membrane?

Is it another active device, other than mentioned in rules 9, 10, 11 or 12?

Based on the rules of the MDR, your product most likely falls into

 Class III. The risk of your device is very high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

To the roadmap

Class III

Based on the rules of the MDR, your product most likely falls under Class IIa. The risk of your device is relatively high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

Class IIa

Based on the rules of the MDR, your product most likely falls into Class IIb. The risk of your device is relatively high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

Class IIb

Based on the rules of the MDR, your product most likely falls into Class I. The risk of your device is relatively low. The manufacturer self-assesses and self-certifies the device. Find out what needs to be done before this self-certification can take place in the roadmap.

If the product has a measuring function (class Im), is packaged sterile (class Is) or is a reusable surgical instrument (class Ir), the technical file must be assessed by a Notified Body.

Which class is your medical device?

Class:

Class
I

Class
IIa

Class
IIb

Class
III

Which class is your medical device?

Class:

ClassI

ClassIIa

ClassIIb

ClassIII

Class
I

Class
IIa

Class
IIb

Class
III