Medical Device Classification in the EU MDR
One of the first concerns for manufacturers of medical devices attempting to sell their products on the European market is to decide what class is suitable for their products. The Medical Device classification in the EU MDR of the product can affect how and when the notified body interacts with you as a manufacturer.
As regulatory change is made from Directive 93/42 / EEC on medical devices (MDD) and Active Implantable Medical Device (AIMDD) (90/385 / EEC) to Medical Device Regulation (MDR) No 2017/75, medical devices manufacturers are expected to consider changes in product classification criteria. For instance, the Medical Devices Regulation (MDR) now covers devices previously regulated by the Active Implantable Medical Devices Directive (AIMDD) 90/385 / EEC.
Also, it must be noted that the MDR even contains items in Annex XVI that, while aesthetic or non-medical, with no medical purpose, still must comply with the MDR specifications.
The classification rules can be found in Annex VIII of the MDR. In the MDD the rules could be found in Annex IX.
Details of the Medical Device classification in the EU MDR
Both the MDD and the MDR group medical devices according to four basic categories:
- Non-invasive devices
- Invasive medical devices
- Active medical devices
- Special Rules
Medical Device classification in the EU MDR: Duration of use
- ‘Transient’ means normally intended for continuous use for less than 60 minutes.
- ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
- ‘Long term’ means normally intended for continuous use for more than 30 days.
Medical Device classification in the EU MDR: Device classes
Devices are segmented into the classes noted below.:
- Class I – Provided non-sterile or do not have a measuring function (low risk)
- Class Is: A class I product that is delivered sterile
- Class Im: A product with a measuring function
- Class Ir: New sub-class for products that are reprocessed or re-used
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
Device Classification rules
There are now 22 rules in Annex VIII of the MDR. In both cases, the rules are based on the potential risks associated with the device, technical design, and manufacture of the device.
- Rule 1– Non-invasive devices
- Rule 2 – Non-invasive devices intended for channeling 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
Four new rules introduced from Medical Device classification in the EU MDR:
- Rule 19 – Devices incorporating or consisting of nanomaterial
- Rule 20 – Invasive devices concerning 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
The higher the risk and the higher the classification of the device, the higher the required participation of the notified body.
A new category of products under Medical Device classification in the EU MDR
Annex XVI of EU MDR introduces new products as medical devices. Note that the European Union Commission reserves the right to include more products in the future. The following categories have been introduced:
Aesthetic or wellness products
- Contact lenses or other items intended to be introduced into or onto the eye. e.g. colored contact lenses without correction of vision.
- Products intended to be totally or partially introduced into the human body through surgically invasive means to modify the anatomy or fixation of body parts except for 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.
You may go back to our EU MDR guide.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.