Definition of Medical Device
While the we are currently under the transition period from the Medical Device Directive to the Medical Device Regulation which will effectively replaces it from May 2020, both definitions are presented below.
Medical Device Directive 93/42/EEC defines 'medical device' in Article 1, p.2:
2. For the purposes of this Directive, the following definitions shall apply:
(a) ►M5 ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ◄
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
(b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
Under the Medical Device Regulation 2017/745/EU, the definition of a medical devices is expanded and defined as follows under Article 2, p. 1:
For the purposes of this Regulation, the following definitions apply:
(1) ‘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.