Medical device is defined as any instrument, equipment, material or other article used on its own or jointly, including software required for it to function correctly, which is intended by the manufacturer to be used on humans for the following purposes :
- for diagnostic, prevention, control, treating or diminishing an illness
- for diagnostic, control, treating, for diminishing or compensating an injury or handicap,
- for studying, replacing or modifying part of the anatomy or a physiological process,
- for mastering conception,
and whose principal intended action in or on the human body is not obtained by pharmacological or immunological means or by metabolism but whose function can be assisted in such a way.
An accessory is defined as an article which, although not a device, is specifically intended by its manufacturer to be used with a device to enable the use of that device in line with the instructions of the manufacturer of the device.
An active medical device is defined as any medical device that, in order to function, depends on a source of electric energy or any other source of energy other than that generated by the human body or by gravity and working by converting that energy. Medical devices intended to transmit energy, substances or other elements, without any significant change, between an active medical device and the patient are not considered as active medical devices.
An active implantable medical device is defined as any active medical device that is designed to be partly or totally implanted by means of a surgical or medical operation into the human body or, by means of a medical operation, into an orifice of the body and which is intended to stay there after the operation.
A tailor-made device is defined as any device that is specifically manufactured according to instructions written by a suitably qualified practitioner indicating, under his responsibility, the specific characteristics of the design and if it is intended only for being used on one particular patient.
Federal Agency for Medicines and Health Products
Health Products Division
Place Victor Horta, 40 box 40
Fax : +32 (0)2 524 81 20
Email : email@example.com