Classification of Medical Devices6 November, 2019
According to EU Medical Device Regulation 2017/745, the medical devices are grouped into four basic categories:
Invasive medical devices
Active medical devices
Devices are divided into classes as mentioned below:
Class I – Devices that are non-sterile and do not have a measuring function (low risk)
Class Is: Product that is delivered sterile
Class Im: Product with measuring function
Class Ir: Products that are re-processed or re-used
Class IIa (medium risk)
Class IIb (medium/high risk)
Class III (high risk)
According to Annex VIII of EU MDR 2017/745, there are 22 rules for classification of devices. The MDD had 18 rules for classification. The rules are based on potential risks associated with the device, their technical design and manufacture of the device.
Rule 1– Non-invasive devices
Rule 2 – Non-invasive devices intended for channelling or storing (Which includes cells)
Rule 3 – Non-invasive devices that modify the biological or chemical composition of blood, body-liquids, other liquids and cells
Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane
Rule 5 – Devices invasive in body orifices
Rule 6 – Surgically invasive devices for transient use
Rule 7 – Surgically invasive devices for short term use
Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc)
Rule 9 – Active therapeutic devices intended to exchange or administer energy
Rule 10 – Active devices for diagnosis & monitoring, emit ionizing radiation
Rule 11 – Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes (from class I to class III)
Rule 12 – Active devices intended to administer and/or remove medicinal products, body-liquids or other substances
Rule 13 – All other active devices
Rule 14 – Devices incorporating a medicinal substance including human blood or plasma
Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases
Rule 16 – Specific disinfecting, cleaning and rinsing devices
Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation
Rule 18 – Devices utilizing non-viable tissues or cells of human origin or tissues of animal or derivatives
New rules included in the MDR:
Rule 19 – Devices incorporating or consisting of nanomaterial
Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation
Rule 21 – Substances or of combinations 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
Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management
Annex XVI of EU MDR 2017/745 mentions the below products as devices for the first time:
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 applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.