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Qualification

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As a general rule, a product qualifies as a medical device if it serves a medical purpose and its primary mode of action is not pharmacological, immunological, or metabolic.

The decision on qualification should be based on the intended purpose of the device, as stated by the manufacturer. Medical devices can range from items such as bandages, implants, and pacemakers to standalone software.

In vitro diagnostic (IVD) medical devices refer to medical devices used to examine samples from the human body for medical purposes.

The definitions below further clarify what is required for something to qualify as a medical device and IVD medical device.

Some products that fall outside these definitions are still subject to the medical device/IVD medical device regulations. This includes accessories for medical devices/IVD medical devices, as well as a group of products that resemble medical devices in terms of function and risk profile. Learn more about this in the sections below.

Definition of medical devices

Medical devices are defined in MDR Article 2 (1) as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by 
the manufacturer to be used, alone or in combination, for human
beings for one or more of the following specific medical purposes:

  • Diagnosis, prevention, monitoring, prediction, prognosis, 

    treatment or alleviation of disease,

  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

  • Investigation, replacement or modification of the anatomy or of 

    a physiological or pathological process or state,

  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

And which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical 
devices:

  • Devices for the control or support of conception;

  • Products specifically intended for the cleaning, disinfection or sterilisation of medical devices, accessories for medical devices and products listed in Annex XVI. 

Definition of IVD devices

In vitro diagnostic (IVD) medical devices are defined in IVDR Article 2 (2) as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  1. Concerning a physiological or pathological process or state
  2. Concerning congenital physical or mental impairments
  3. Concerning the predisposition to a medical condition or a disease
  4. To determine the safety and compatibility with potential recipients
  5. To predict treatment response or reactions
  6. To define or monitoring therapeutic measures

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

Accessories for medical devices/IVD devices

Accessories are defined in MDR Article 2 (2) an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

A corresponding definition for accessories to IVD medical devices can be found in IVDR Article 2 (4).

Products without an intended medical purpose

Certain groups of products that, according to the manufacturer, have only an aesthetic or other non-medical purpose but resemble medical devices in terms of function and risk profile are covered by the MDR.

The relevant products are listed in MDR Annex XVI:

  1. Contact lenses or other items intended to be introduced into or onto the eye.

  2. 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.

  3. 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.

  4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

  5. 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.

  6. 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.

Classification of medical devices and IVD medical devices

Medical devices are categorized into risk classes based on the associated risks of their use. Classification involves determining the risk class of the device.

Read more

Useful EU guidelines for qualification and classification

EU regulations on medical devices