1. non invasive device
1.1. Rule 1 Either not touching patient or contacting only intact skin Class I
1.2. Rule 2 Channelling or storing for eventual infusion, administration or introduction into the body Class I
1.2.1. or
1.2.1.1. If connected to an active device in class IIa or higher or channeling or storing blood or other body liquids Class IIa
1.3. Rule 3 Modify biological or chemical composition of blood, body liquids intended for infusion Class IIb
1.3.1. or
1.3.1.1. If Only filtration, centrifugation or exchange of gas or heat Class IIa
1.4. Rule 4 in contact with injured skin or mucous membrane (intended as a mechanical barrier, for compression or for absorption of exudates) Class I
1.4.1. or
1.4.1.1. If Intended for wounds which breach dermis and heal only by secondary intent Class IIb
1.4.2. or
1.4.2.1. If Intended to manage micro-environment of wounds and other or all other cases Class IIa
2. invasive devices
2.1. Rule 5 invasive in body orifice or stoma (not surgically)
2.1.1. Intended for transient use (< 60min) Class I
2.1.2. Short term use (> 60min; < 30d) Class IIa
2.1.2.1. or
2.1.2.1.1. If used in oral cavity as far as the pharynx or in an ear canal up to the ear drum or nasal cavity Class I
2.1.3. Long term use (> 30d) Class IIb
2.1.3.1. or
2.1.3.1.1. If used in oral cavity as far as the pharynx or in an ear canal up to the ear drum or nasal cavity Class IIa
2.1.4. Connected to active class IIa or higher devices Class IIa
2.2. Rule 6 surgically invasive devices transient use (<60min) Class IIa
2.2.1. or
2.2.1.1. If intended to control, diagnose, monitor or correct heart defect / central circulatory system through direct contact with those body parts Class III
2.2.1.2. If reusable surgical instruments Class I
2.2.1.3. If direct contact with heart or central circulatory/nervous system Class III
2.2.1.3.1. If direct contact with heart or central circulatory/nervous system Class III
2.2.1.4. If energy in form of ionising radiation is supplied Class IIb
2.2.1.5. If device has biological effect or absorbed Class IIb
2.2.1.6. If intended to administer drug product in a hazardous manner Class IIb
2.3. Rule 7 surgically invasive device short term use (> 60min; < 30d) Class IIa
2.3.1. or
2.3.1.1. If intended to control, diagnose, monitor or correct heart defect / central circulatory system through direct contact with those body parts Class III
2.3.1.2. If direct contact with heart or central circulatory/nervous system Class III
2.3.1.3. If energy in form of ionising radiation is supplied Class IIb
2.3.1.4. If device has biological effect or absorbed Class III
2.3.1.5. If chemical change in body (except in teeth) Class IIb
2.3.1.6. If intended to administer drug product Class IIb
2.4. Rule 8 implantable devices and long-term surgically invasive devices Class IIb
2.4.1. or
2.4.1.1. If placed in teeth Class IIa
2.4.1.2. If direct contact with heart or central circulatory/nervous system Class III
2.4.1.3. If device has biological effect or absorbed Class III
2.4.1.4. If chemical change in body (except in teeth) Class III
2.4.1.5. If intended to administer drug product Class III
2.4.1.6. If active implantable device or accessories Class III
2.4.1.7. If breast implants or surgical meshes Class III
2.4.1.8. If joint replacements (not ancillary components as screws etc) Class III
2.4.1.9. If in contact with the spinal column (not components as screws etc) Class III
3. active devices
3.1. Rule 9 active therapeutic devices intended to administer or exchange energy Class IIa
3.1.1. or
3.1.1.1. if in a hazardous way Class IIb
3.1.2. or
3.1.2.1. if active device controls or monitors or actively influence performance of active therapeutic class IIb devices Class IIb
3.1.3. or
3.1.3.1. if emitting ionizing radiation for therapeutic purposes incl devices which control or monitor or actively influence performance of such devices Class IIb
3.1.4. or
3.1.4.1. if active device controls, monitors, directly influence performance of active implantable devices Class III
3.2. Rule 10 active devices intended for diagnosis and monitoring if supplying energy absorbed by human body or if imaging in-vivo distribution of radiopharmaceuticals Class IIa
3.2.1. or
3.2.1.1. if intended to illuminate the patient's body in the visible spectrum Class I
3.2.2. or
3.2.2.1. if specifically intended to monitor vital parameter where variations could result in immediate danger Class IIb
3.2.3. or
3.2.3.1. if emitting ionizing radiation for diagnostic and therapeutic or therapeutic interventional radiology Class IIb
3.3. Rule 11 Software Class I
3.3.1. or
3.3.1.1. If software is supporting diagnosis or therapeutic decisions Class IIa
3.3.1.1.1. or
3.3.1.1.2. or
3.3.2. or
3.3.2.1. If software is monitoring physiological processes Class IIa
3.3.2.1.1. or
3.4. Rule 12 Active devices administering / removing medicinal products or other substances to/from body Class IIa
3.4.1. or
3.4.1.1. if done in a potentially hazardous manner taking into account the substances involved Class IIb
3.5. Rule 13 all other active devices Class I
4. special rules
4.1. Rule 14 Devices incorporating as an integral part a medicinal product if used separately Class III
4.2. Rule 15 Devices for contraception or prevention of sexually transmitted diseases Class IIb
4.2.1. or
4.2.1.1. if implantable or long term invasive Class III
4.3. Rule 16 Devices specifically used for disinfecting / sterilizing medical devices Class IIa
4.3.1. or
4.3.1.1. if disinfection solutions / washer-disinfectors to disinfect invasive devices as the end point processing Class IIb
4.3.2. or
4.3.2.1. if used for contact lenses Class IIb
4.4. Rule 17 Devices recording diagnostic images generated by X-ray radiation Class IIa
4.5. Rule 18 Devices utilizing non-viable tissues/cells of human or animal origin or derivates (not devices only in contact with intact skin) Class III
4.6. Rule 19 Devices incorporating nanomaterial
4.6.1. if presenting medium/high potential for internal exposure Class III
4.6.2. if presenting low potential for internal exposure Class IIb
4.6.3. if presenting negligible potential for internal exposure Class IIa
4.7. Rule 20 Non surgical invasive devices with respect to body orifices administering a medicinal product by inhalation Class IIa
4.7.1. or
4.7.1.1. if mode of action has an essential impact efficacy and safety of the medicinal product or intended for life threatening conditions Class IIb
4.8. Rule 21 Substance based devices introduced via body orifice or applied to skin and absorbed by / locally dispersed in the human body Class IIb
4.8.1. or
4.8.1.1. if systematically absorbed Class III
4.8.2. or
4.8.2.1. if achieving purpose in stomach or lower gastrointestinal tract and systematically absorbed Class III
4.8.3. or
4.8.3.1. if applied to skin / nasal or oral cavity as far as pharynx Class IIa