The MDR classification system does not radically differ from the MDD, although it takes better into account the level of invasiveness and level of toxicity (e.g. absorbable sutures).
Any dispute between the manufacturer or authorized representative and the notified body regarding the classification should be brought to the competent authority for a decision.
The classification system might be subject to change by future implementing act from the commission.
The Medical Device Regulation divides MD into classes I, Is, Im, IIa, IIb and III, taking into account the intended purpose and risk as per Annex VIII :
- Class I-Devices low risk such as stethoscopes, bandages, etc. The devices are non-invasive, also some low risk software. The manufacturer must complete a technical file and shall self declare the conformity of their product
- Class I sterile-Devices are low risk such as sterile bandages, administration sets for infusion, The devices are non-invasive. The manufacturer must draw up a technical file and apply to a European Notified Body to get the sterilization process certified.
- Class I measuring-Devices are low risk such as measuring spoons and cups, etc. The devices are non- invasive. The manufacturer must draw up a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with metrology.
- Class IIa-Devices low-medium risk devices such as a hearing-aid. The manufacturer must draw up a technical file and apply to a European Notified Body to get its its quality management system certified. During the audit, the notified body will verify the technical file of a representative device for each category of devices verified
- Class IIb-Devices are medium-high risk. Examples include ventilators and intensive care monitoring equipment. The manufacturer must draw up a technical file and apply to a European Notified Body to get its quality management system certified. During the audit the notified body will verify the technical file of a representative device per device generic device group.
- Class III These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves, some high risk software. The manufacturer must draw up a technical file and apply to a European notified Body to get is Quality Management System certified. The notified body shall review the technical documentation. In addition prior to issuing the technical documentation review certificate, the notified body shall pass its summary of evaluation to the Commission which may decide together with Member States to require a further evaluation by a group of experts.
For all devices, manufacturer shall draw up an EU Declaration of Conformity.
18 Rules of Classification
The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices.
- Rule 1– Non-invasive devices.
- Rule 2 – Non-invasive devices intended for channeling or storing (now includes cells)
- Rule 3 – Non-invasive devices that modify 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 take 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.
- Devices used for contraception or prevention of sexually transmitted diseases.
- 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:
- 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 includes the following products as devices for the first time:
- Contact lenses or other items intended to be introduced into or onto the eye. e.g. coloured contact lenses without correction of vision;
- 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 apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.