Devices: definitions and different classes

What is a device?

As a patient/user, you may come across the word "device". This word refers to all medical devices, custom-made medical devices, in vitro diagnostic medical devices, their accessories and certain products without an intended medical purpose.

  1. Medical device
  2. In vitro diagnostic medical device (IVD)
  3. Custom-made devices
  4. Accessories for medical devices or in vitro diagnostic medical devices
  5. Devices for non-medical use
  1. Medical device

A medical device:

  • can be an instrument, apparatus, appliance, implant, reagent, material or other article, or an application or software;
  • acts alone or in combination (with several other devices).

A medical device has a medical purpose. There are all kinds of devices used for:

  • diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease (e.g. blood pressure monitors, ultrasound scanners or scanners providing images of the inside of the body);
  • diagnosis, treatment, alleviation of or compensation for injuries or disabilities (e.g. bandages, hearing aids, crutches, wheelchairs);
  • the investigation/examination, replacement or modification of the anatomy or a physiological or pathological process (e.g. hip or knee implants, leg prostheses, breast implants);
  • control or support of conception (e.g. condoms);
  • cleaning, disinfection or sterilisation of other devices.

A device does not act like a medicinal product. Its mode of action is neither pharmacological, immunological nor metabolic.
However, a medicinal product can assist the action of a device (e.g. a condom with spermicide).

  1. In vitro diagnostic medical device (IVD)

"In vitro" simply means "in glass", which means that these tests are carried out outside the body, in test tubes or using other equipment. These tests are performed on samples such as blood or tissue taken from the human body.  

An IVD:

  • is intended to be used in vitro for the examination of samples from the human body;
  • can be a reagent, control material, kit, instrument, apparatus, a piece of equipment, software or a system, or the containers for urine and stool collection...;
  • acts alone or in combination;
  • is used to obtain medical information.

The information gathered by IVDs can be diverse and relate to:

  • the patient's physiological state (relating to the state of the body or one of its functions) (e.g. pregnancy tests, ovulation tests, etc.);
  • the presence of or predisposition to a medical condition or disease (e.g. screening tests for the human immunodeficiency virus - HIV); 
  • the presence of a congenital anomaly (e.g. trisomy 21 risk assessment test - NIPT);
  • compatibility between donor and recipient (e.g. determination of blood group);
  • defining or monitoring therapeutic measures (e.g. monitoring drug concentration);
  • the response to a medicinal product before or during treatment (safety and/or efficacy of the medicinal product for the patient). These are companion diagnostics.
  1. Custom-made devices

A custom-made device is a device  intended to be used exclusively by a particular patient and exclusively to meet that patient's medical needs. It is expressly made in accordance with a written prescription which gives specific design characteristics (e.g. dental prostheses, orthopaedic shoes/insoles).

  1. Accessories for medical devices or in vitro diagnostic medical devices

Accessories for medical devices or IVDs are not medical devices or IVDs, but are used with them to enable or assist their use. These are also subject to device regulations (e.g. ultrasound gels, lubricants intended for use with medical devices such as gloves, endoscopes or condoms).

  1. Devices for non-medical use

Devices for non-medical use have an operation and risk profile similar to that of medical devices. These devices are listed in Regulation (EU) 2017/745 (Annex XVI "List of groups of products without an intended medical purpose").

They include six groups for non-medical use.

  1. "Fashion" contact lenses (e.g. colour lenses).
  2. "Aesthetic" implants (e.g. breast implants).
  3. Filling substances (e.g. hyaluronic acid).
  4. Devices for liposuction/lipolysis/lipoplasty.
  5. Devices emitting high-intensity electromagnetic radiation (laser, ultraviolet, infra-red, etc.) for certain skin treatments (e.g. tattoo or hair removal).
  6. Devices intended for brain stimulation that use electrical currents or electromagnetic fields.
  • The different classes of medical devices

Medical devices and in vitro diagnostic medical devices are classified according to their hazardousness and intended use.
In Europe, medical devices are divided into classes I to III.

  • Class I (the lowest risk class)
    Examples: prescription glasses, vehicles for individuals with disabilities, crutches, compresses, compression bandages.
  • Class IIa (medium/measured potential risk)
    Examples: contact lenses, ultrasound equipment, dental crowns, skin staples, hearing aids, ultrasound machines.
  • Class IIb (high/high potential risk)
    Examples: condoms, lens disinfectants, infusion pumps.
  • Class III (highest risk class)
    Examples: breast implants, stents, hip prostheses and pacemakers.

In vitro diagnostic medical devices (IVDs) are divided into classes A to D.

  • Class A (low individual risk and low public health risk)
    Products for general laboratory use intended by the manufacturer for in vitro diagnostic procedures.
    Examples: specific cleaning solutions, certain dyes.
  • Class B (moderate individual risk and/or low public health risk)
    Examples: pregnancy screening, cholesterol determination. 
  • Class C (high individual risk and/or moderate public health risk)
    Examples: detection of certain sexually transmitted agents (Chlamydia, Herpes, human Papilloma virus, etc.), cancer screening or diagnostic tests, most self-tests.
  • Class D (high individual risk and high public health risk)
    Examples: screening tests for HIV, SARS-CoV-2 or hepatitis C, blood group marker (ABO).
 
Last updated on 01/12/2023