Definition of medical devices
Definition of medical device
According to the Medical Devices Regulation (EU) 2017/745 (MDR) ‘medical device’ means 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 devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Definition of an in vitro diagnostic medical device
According to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) ‘in vitro diagnostic medical device’ means 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:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.
A medicinal product or a medical device?
Same problems can be treated with medicinal products and medical devices. From the perspective of applicable legislation, a product is either a medicinal product or a medical device. The key difference is that a medicinal product has a pharmacological, metabolic or immunological effect on the human body. A medical device does not.
Some products can also be a combination of a medicinal product and a medical device (e.g. syringes prefilled with a medicinal product). In that case, requirements set out in the regulations for both components apply.
More information on definitions and classification
MDCG 2021-24 Guidance on classification of medical devices
MDCG 2020-16 Rev. 2 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2