Classification criteria for medical devices
The classification of medical devices is the responsibility of the manufacturer or distributor. It must be carried out in accordance with the Classification Rules set out in Annex VIII of European Regulation 745/2017 (on medical devices) and IVDR 746/2017 (on in vitro diagnostic medical devices – IVDs).
The classification is verified by the Notified Body. Depending on the classification of the medical device, it must comply with different requirements.
Medical devices are classified into the following types:
Class I medical devices
Class I medical devices are those that do not come into contact with the patient or that come into contact with intact skin. They also include those that penetrate an orifice for less than 60 minutes (temporary or transient use). Class I devices are, in turn, classified as follows:
- Class I sterile: examination gloves, gauze, bandages.
- Class I with a measuring function: non-electronic thermometers. Other
- Class I medical devices: reusable surgical instruments, walking frames, wheelchairs, hospital beds, devices for moving and immobilising patients, surgical gowns, disposable booties, etc.
Class IIa medical devices
Products in this class are those that are introduced into the body through a body orifice or by surgical means, but are not intended to remain there. They also include products that supply energy or substances, or those that modify physiological processes, provided this is not done in a potentially dangerous manner. This classification also includes disinfectants for non-invasive products. They require CE marking.
Some products in this class are: needles, cannulas, contact lenses, catheters, hearing aids.
Class IIb medical devices
Some implantable devices fall into this class, although most are Class II. These devices may affect physiological processes or administer hazardous substances or energy. This classification also includes devices intended for the diagnosis of vital functions. This category includes medical devices for contraception or the prevention of sexually transmitted diseases, as well as disinfectants for invasive devices.
Example: intraocular lenses, blood bags, insulin pens, diagnostic X-ray equipment, incubators for newborns, etc.
Class III medical device
This classification includes medical devices intended to come into contact with the central nervous system for therapeutic or diagnostic purposes, devices containing medicinal substances, devices that are completely absorbed by the body, and those containing animal derivatives.
Some examples of this class are: heart valves, pacemakers, stents, hip prostheses, defibrillators and cardiac catheters.
In vitro diagnostic medical device
This classification includes reagents, reagent products, calibrators, control materials, instruments, apparatus, systems, kits, equipment components or computer software that enable the analysis of samples derived from the human body (including blood and tissue donations) to provide information on physiological or pathological processes or conditions, congenital physical or mental abnormalities, predisposition to a condition or disease, safety and compatibility with potential recipients, and even to predict the response or reaction to treatment and to establish and monitor therapeutic measures already in place.
Some in vitro diagnostic medical devices include: pregnancy tests, COVID-19 tests, sample tubes and diagnostic kits.