Qualification as a medical device

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. 

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 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).

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.