Common Terms Used and their definitions are following
|Medical Device||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 sterilization of devices
|Invasive Device||‘Invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body|
|Single-use device||A single-use device means a device that is intended to be used on one individual during a single procedure|
|Accessory for a medical device||Accessory for a medical device means 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 devices (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);|
|Active Device||Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances, or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device
|Implantable Device||Implantable device means any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
|Intended Purpose||Intended Purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation|